Related Spreadsheets are above
.png)
.png)
.png)
Saturday, July 31, 2021
Pfizer Has Over 5000 Batches Of VXX Responsible for At Least 1 Reported Death, Some Batches Are The Devils Work
1
.png)
.png)
.png)
Post settings
Labels
No matching suggestions
Published on
7/29/21 3:19 PM
Permalink
Location
Search Description
Options
Friday, July 30, 2021
You Got Long COVID, I Do. And Now It Appears There Is A Solution, 95% Cure Rate With Ivermectin
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088823/
Ivermectin in post-COVID-19 syndrome
Increasing reports of persistent, vexing, and even disabling symptoms after recovery from acute COVID-19 have been reported and that many have termed the condition as “Long COVID” and patients as “long haulers,” estimated to occur in approximately 10%–30% of cases.71–73 Generally considered as a postviral syndrome consisting of a chronic and sometimes disabling constellation of symptoms which include, in order, fatigue, shortness of breath, joint pains, and chest pain. Many patients describe their most disabling symptom as impaired memory and concentration, often with extreme fatigue, described as “brain fog,” and is highly suggestive of the condition myalgic encephalomyelitis/chronic fatigue syndrome, a condition well reported to begin after viral infections, in particular with Epstein–Barr virus. Although no specific treatments have been identified for Long COVID, a recent manuscript by Aguirre-Chang et al from the National University of San Marcos in Peru reported on their experience with ivermectin in such patients.74
They treated 33 patients who were between 4 and 12 weeks from the onset of symptoms with escalating doses of ivermectin;
0.2 mg/kg for 2 days if mild and
0.4 mg/kg for 2 days if moderate,
with doses extended if symptoms persisted.
They found that in 87.9% of the patients, resolution of all symptoms was observed after 2 doses with an additional 7% reporting complete resolution after additional doses. Their experience suggests the need for controlled studies to better test efficacy in this vexing syndrome.
----------------------------------------------------
Those poor sheep that turned their bodies into spike protein factories.
When the body is a spike protein factory...and the spike protein facilitates transmission...duh
The spike glycoprotein (S) mediates virus entry and is a primary determinant of cell tropism and pathogenesis. It is classified as a class I fusion protein, and is responsible for binding to the receptor on the host cell as well as mediating the fusion of host and viral membranes—A process driven by major conformational changes of the S protein.
We are in Phase 3 of 11 Phase plot of Global Domination and Depopulation -- A Peek At Your Dystopian Future (If You Live)
stock here:
When the government started "being honest" about Aliens, and coined the UAP Unidentified Aerial Phenomenon (to distance from the "crazies" of everything associated with UFOs and thus try to give more credibility to the new narrative they wish to spin).....well my Spidey Sense was tingling.
What phase are we in?
1) Floyd Event, the intentionally videoed murder of a black murder, a 9 minute snuff film. Choreographed and using 2 drug dealers who worked at the same Hispanic bar that was a haven for crime and drugs, with ownership tied to Saudi Arabia. To keep it simple and not get too many phases, we include the BLM bullshit in this phase, and all the racist bullshit, including CRT.
2) The Bio-Weapon and the creation of an over publicized "Pandemic", The murder of 60,000 seniors in nursing homes to pump the numbers and with one purpose to get Trump out of the office of president. The early fake movies from China showing people dropping dead in the streets, hospitals lined with body bags, hundreds of millions under quarantine, people having their apartment doors welded shut. Just saying, China is definitely complicit in all this. All the above examples were present to create panic about what is coming.
3) The "Vaccine" and Trump's complicity with Operation Warp Speed. We have yet to come to a conclusion about why Trump, an Anti-Vaxxer, jumped on this band wagon. And the Jesuit Fauci, using intentional misdirection to create confusion, fear, distrust and division. The push to maximum abuse by vaccinated Pregnant Women, and then little kids down to 3 YO. Part of this process is testing how well the extended fear combined with tweaked "messaging" could be used to even get past the Mother Child bond.
So what's next? Love to hear any ideas that others have.
4) UN with boots on the ground in the USA "investigating" structural racism.
5) Should the obviously and blatantly stolen election be one of the above phases? What about the COVID money handouts, bribes to get local governments to "go along", and to get citizens used to surviving on handouts?
6) Crash the stock market to create panic and need for "more handouts". Will this help kill off more small businesses?
7) Have China pull out of their massive investments in USA pension funds, bankruptcies of those funds, and despair taking more useless eaters off the planet.
8) Starting to see the effects of the Cytokine Storm that will kill off a good percentage of those vaxxed, just like the ferrets and monkeys with the early SARS vaccines that had horrible effect when they were re-challenged with a corona virus. That should be just a month or two away in fall. And those will be blamed on the greediness and callousness of the Un-vaxxed, as well as being categorized as a COVID death. Oh, and the "booster shots"
9) An EMP weapon timed in conjunction with an expected solar storm (they have 18 to 36 hours) to plan, grid down scenario, say in LA and such, and China arriving to "save the US".
and finally,
10) The Coming Alien Hoax, lets get the whole planet to unite as the only way to stave off the "Movie" of an impending Alien threat. There are some variations on this theme, which we will cover in the next article.
11) And let's not forget the depopulation agenda. The Jab will not be a 50% death rate within a year. Maybe a few percent. But the biggest effect of the bio-weapon and the Jabs will be on fertility. Cut the birth rate by say 35% and then the "Elite" have time to replace the lessening population with AI and Robotics, over say, a 40 year period. Replace the bio-slaves with technology to keep their power and privilege undamaged. That is my own original theory, and pretty sure I am the first to state it a few weeks ago.
---------------------------------------------
I wonder how they plan to deal with the remainder population after that kill off the easy kill sheep? There will be Sheep Dogs and Wolves left.
Conspiracy Fact Sites
stock here: Here are some sites that might not be on your radar. Obviously this is too long a list for daily review, and there will be some repetition of information.
But maybe broaden your reading list a bit. I have not spent any significant time on some of these site, love how they put controlled opposition Zerohedge near the very bottom! LOL
Thursday, July 29, 2021
Batch EP 1266 Pfizer -- A Horrific Batch That Kills
Pfizer Bath EP 1266 killed
| SYMPTOM_TEXT |
| Impact on quality of life; Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.; Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.; Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.; Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB regulatory authority number IT-MINISAL02-745788. A 86-years-old male patient received first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: EP2166), via an intramuscular route on 03Mar2021 as dose 1, 0.3 ml single in the right arm for covid-19 immunisation. The patient medical history included hypertension (intake of 2 tablets per day for high blood pressure) and walking difficulty, which worsened after vaccination. The patient concomitant medications included bisoprolol fumarate (CONGESCOR) for hypertension from an unknown date and unknown if ongoing. On 08Mar2021, the patient experienced Within few days of the first administration of the Pfizer COVID vaccine, the subject began to show signs of mental confusion and dizziness resulting in cerebral hemorrhage.On 10Mar2021 first access to the emergency room, family members report that the patient in a confusional state may had accidentally ingested some mouthwash. On 11Mar2021 second access to the emergency room following which he is hospitalized in neurology and had Impact on quality of life (10/10). Reporter stated that there were no other pathologies. the patient was in good health confirmed by blood tests carried out in the recent period prior to vaccination.The patient died on unspecified date and autopsy results was unknown. The outcome of the events was fatal. Sender''s comments:requested clinical documentation of hospitalization No follow-up attempts are needed. No further information is expected. Health Authority comment:The patient suffered from hypertension resulting in a daily intake of 2 tablets per day for high blood pressure and 1 tablet per day for the heart (CONGESCOR). There were no other pathologies. The patient was in good health confirmed by blood tests carried out in the recent period prior to vaccination. the patient had walking problems, which worsened after vaccination.; Reported Cause(s) of Death: Dizziness; Cerebral haemorrhage; Mental confusion; Head revolving around; Impact on quality of life |
| Cerebrovascular accident; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-BX20213039, Safety report unique identifier FR-AFSSAPS-2021037432. A 75-year-old male patient received 1st dose of BNT162B2 (COMIRNATY, lot number: EP2166) intramuscular in the left arm on 09Mar2021 as single dose for COVID-19 vaccination. Medical history included glaucoma and hypertension. Concomitant medications were unknown. The patient experienced cerebrovascular accident (AVC) and died on 23Mar2021. The patient had stroke on 23Mar2021without further details on D16 of a 1st dose of Comirnaty vaccine. The patient did not have COVID. Description of the effect: On D5 after vaccination, balance disorders with memory disorders, without medical consultation. On D16 at 4 am, malaise with disturbance of balance, then disturbance of consciousness, clonies of the upper limbs and jet vomiting. Home medical assistance, upon arrival, comatose patient, Glasgow at 3 with coiling, isocore but reactive pupils. No fever. Normal blood sugar. orotracheal intubation in rapid sequence in front of neurological failure. Switch to thrombolysis alert. CT angiography then MRI: stroke with occlusion of the proximal third of the basilar trunk with recent left occipital infarction associated with several old disseminated parenchymal infarctions of embologenic origin, fatal outcome. No autopsy was performed. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: AVC |
| dyspnoea; dry cough; COVID positive / fluctuating saturation after COVID-19; Lung complication, suspected pneumonia; Type 2 infarction due to hypoxia; Type 2 infarction due to hypoxia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number SE-MPA-2021-037898. Additional reference number includes SE-VISMA-1620722650778. An 83-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on Mar2021 (Lot Number: EP2166) as second dose, single dose for COVID-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration on Mar2021 (Lot number was not reported), at unspecified dose for an unspecified indication. Medical history included COVID-19 from Feb2021 to an unknown date, ongoing myalgia, ongoing mitral insufficiency, angina pectoris from an unknown date and unknown if ongoing and macular degeneration from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient received dose 1 of VAXZEVRIA (pending clarification) at the end of January 2021. The next day, the patient had a debut of pain between the shoulder blades that radiated between, against the sternum, started when she was resting and it lasted for a week, the medical record lists costosternal-type chest pain, suspected angiogenesis, she also states that she was very tired and went straight in to deep sleep. Arrived at hospital 12 days after vaccination. The patient stated that she had been heavy-breathing and had a fever in recent days. The form states that the dyspnoea started the day after the vaccination, the medical record states that the dyspnoea began 4 days later when the patient developed increasing dyspnoea. Saturated at 80%, get 5 liters of oxygen and saturation rose to 97-100%. Positive D-dimer, PCR positive. The patient thought the complications were due to the vaccine, she had not had it like this before, she stated. Initially, tinzaparin (INNOHEP) was given 14,000 units, DT thorax was negative for pulmonary embolism, but showed groundglass changes, which supported the suspicion that she had had COVID for several days before arriving at the hospital, she received treatment with dexamethasone, oxygen (mask and OPTIFLOW) and INNOHEP 4,500 units as thrombosis prophylaxis. Substantially complication-free care time, the patient was clear and oriented and could be discharged after 11 days of hospital care with a saturation of $g 95% on air. The patient was prescribed apixaban (ELIQUIS) 2.5 mg x2 to take to the follow-up visit. In the journal entry, the assessment is stated as an oxygen-demanding COVID-19 infection. The patient received dose 2 of VAXZEVRIA (pending clarification) was given in early March, 37 days after dose 1. The day after onset of effort dyspnoea with minimal exertion and discomfort / pain in the center of the chest without radiance, not aggravated by activity, she took nitro puffs which helped temporarily, but quickly needed to take more, the patient stated that she has not taken that much in several years, she also had a dry cough, but no fever / chills. The patient arrived at the health center 3 days later and then had saturation 75%, ECG (electrocardiogram)with widespread t-wave negativities, however, she had had it before, CRP M (C-reactive protein)$g 200, the patient was sent to hospital by ambulance. Patient was affected by breathing, but completely clear in the head and alert at rest with oxygen and afebrile. Saturation dropped rapidly during transfer to 65% without oxygen. Quick test showed COVID positive. Got 9 L oxygen and 2 g cefotaxime. Regular thin pulse, frequency 80, blood pressure 162/93, lactate 6.2, pH 7.245, LPK 15.5 ECG dynamics and chest pain may well be secondary to hypoxia. The patient was loaded with acetylsalicylic acid (BAMYL), transition to acetylsalicylic acid (THROMBYL). Cefotaxime 1gx3, ipratropium / salbutamol (COMBIVENT), sodium chloride inhalations and Nasal high flow oxygen (OPTIFLOW) were given as needed, thrombosis prophylaxis 4,500 units tinzaparin (INNOHEP). DT aortic angio showed no pulmonary embolism, but widespread densifications in both lungs of the ground-glass nature. Mediastinal lymphadenopathy, Cefotaxime were switched to piperacillin / tazobactam and moxifloxacin (AVELOX), methylprednisolone (SOLU-MEDROL) 500 mg to try to reduce inflammation. Palliative drugs were added the next day. Change to prednisolone after 4 days. New troponin increase and heart failure, received furosemide (FURIX) intravenously and KAD (catheter a demeur), 0 CPR, was admitted to IVA, hypoxic and insufficiency probably part of type 2 infarction. Lung X-rays six days after admission to the hospital generally showed reduced air content, severe failure. Type 2 infarction due to hypoxia. Got rising infection parameters and fever, they switched from piperacillin / tazobactam (TAZOCIN) to meropenem (MERONEM) + Anidulafungin (ECALTA). The patient deteriorated sharply, OPTIFLOW was withdrawn and the patient died shortly afterwards, 14 days after receiving dose 2 of VAXZEVRIA. The medical record states Lung complication, suspected pneumonia, fluctuating saturation after COVID-19. Type 2 infarction due to hypoxia. CRP 254 on income, 322 the day after, then down to 66 210312. 210314 CRP 163, drops to 66 210318. LPK 15-8-19-17,8-20. Sodium 132 on income, rises nicely to normal value, 134 210318. Potassium 3.1 210314, normalizes. LD 13.7. Trop 210308 249-205. ProBNP 9519 (as reported). The patient died on 2021. It was not reported if an autopsy was performed. Outcome was reported as Fatal. Report assessed as serious, death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: dyspnoea; dry cough; COVID positive / fluctuating saturation after COVID-19; Lung complication, suspected pneumonia; Type 2 infarction due to hypoxia; Type 2 infarction due to hypoxia |
| fall incident; had embolization to truncus coeliacus; duodenal ulcers; Duodenal bleeding; embolization to truncus coeliacus with splenic infarction/Splenic infarction; Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-042995. An 87-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EP2166), via an unspecified route of administration on 23Mar2021 as single dose for covid-19 immunisation. Medical history included cardiac assistance device (artificial cardiac pacemaker user) due to sick sinus syndrome, chronic obstructive pulmonary disease, hypertension, which were ongoing. Concomitant medications were budesonide (GIONA), olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT), acetylcysteine, allopurinol, bisoprolol, losartan/hydrochlortiazide, mirtazapine, simvastatin. Reported suspect adverse events were pulmonary embolism, duodenal bleeding and splenic infarction occurred in April 2021. The physician has also reported that the woman arrived at the emergency clinic on 19th of April 2021 due to fall incident. On trauma CT was found that that woman had embolization to truncus coeliacus with splenic infarction. The woman received a high dose of tinzaparin sodium (INNOHEP). The woman died a few days later (in Apr2021), the death was probably caused by bleeding from duodenal ulcers. In addition to the splenic infarction, according to postmortem examination the patient had pulmonary embolism, which has caused or contributed to the death. Report assessed as serious, death. Outcome was fatal for events pulmonary embolism, duodenal bleeding and splenic infarction, for fall, duodenal ulcers and embolization to truncus coeliacus was unknown. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Pulmonary embolism; Duodenal bleeding; Splenic infarction; Autopsy-determined Cause(s) of Death: pulmonary embolism; splenic infarction |
| Subcutaneous emphysema; acute bilateral pulmonary edema; Pain in arm; Oedema/hard edema of the limb; Necrotising fasciitis; ecchymotic streaks; replaced by water blisters; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-716695. An 81-year-old patient of an unspecified gender received first dose of BNT162B2 (COMIRNATY), intramuscular, administered in deltoid right on 05Mar2021 at 11:37 (Batch/Lot Number: EP2166; Expiration Date: 31May2021) as single dose for COVID-19 immunisation. Medical history included ongoing pancreatitis chronic, laparotomy, arteriosclerosis (coronary and aortic), ongoing benign prostatic hyperplasia and ongoing hyperplasia adrenal cortex. Concomitant medications included allopurinol (ZYLORIC, formulation: tablet, strength: 300 mg); lercanidipine (LERCADIP, formulation: film-coated tablet, strength: 20 mg); ferrous sulfate (TARDYFER, formulation: prolonged-release tablet, strength: 80 mg); pantoprazole sodium sesquihydrate (PANTORC, formulation: gastro-resistant tablet, strength: 20 mg); apixaban (ELIQUIS, formulation: film-coated tablet, strength: 5 mg); atenolol (formulation: film-coated tablet, strength: 100 mg); atorvastatin calcium (TOTALIP, formulation: film-coated tablet, strength: 20 mg); ascorbic acid/cupric oxide/tocopheryl acid succinate/xantofyl/zeaxanthin/zinc oxide (MACULAR) and serenoa repens (PROSTAMOL), all concomitants were taken for an unspecified indication, start and stop date were not reported. On 07Mar2021, the patient experienced subcutaneous emphysema, acute bilateral pulmonary edema, pain in arm, oedema and necrotising fasciitis. The evets were serious (fatal). Clinical course was reported as follows: on 07Mar2021 appearance of pain in the right arm. As the hours passed, the pain extended to the whole limb and was accompanied by the appearance of ecchymotic streaks then replaced by water blisters some of which opened upon arrival in the Emergency Department. Physical examination: adverse reactions except for the presence of water blisters dorsal surface elbows and third inferomedial arm, some already de-epithelialized with hard edema of the limb, poorly assessable arterial pulses. The patient underwent lab tests and procedures which included ALT/GPT, alpha amylase, enzyme natriuretic, total and fractionated bilirubin, total calcium, serum CPK, serum creatinine, functional fibrinogen, serum potassium, c-reactive protein, glycemia, ECG, complete blood count, Gamma-Glutamyl Transferase, lipasemia, procalcitonin, serum protein, prothrombin time, troponin and arterial or venous limb/district ultrasound, all on an unspecified date and unknown results, SARS-COV-2 test (rapid swab): negative on an unspecified date; APTT: 39,3, SGOT:149, azotaemia (10-50): 59 mg, Creatine kinase MM: 65.52 ng, Fibrin D dimer: unknown results, myoglobin blood (25-72): 17.358 ng, all on 07Mar2021. Therapeutic measures were taken as a result of the events and included treatment with sodium chloride 0.9%, PANTORC IV 40 mg (1FL in drip), arthrosylene 160 mg/2ml (1fl in drip), URBASON IV 40 mg (1fl in 100 cc of physiological solution), trimeton 10 mg/1 ml (1 fl intramuscular), MERREM 1000 mg (1 fl in 500 cc), VANCOTEX 1 g (1 fl IV), BENTELAN 4mg/2ml (1 fl IV). The patient died on 07Mar2021. An autopsy was performed, and the results were reported as follows: Anatomo-pathological report dated 09Mar2021, acute bilateral pulmonary edema in patients with morphological signs compatible with necrotizing fasciitis and vast subcutaneous emphysema of the upper limb and right hemithorax. Diffluent spleen and kidney as in initial shock stage. Hepatomegaly (liver weight 2400g), and chronic liver stasis in the second stage. Chronic pancreatitis. Non-stenosing calcific atherosclerosis of the coronary vessels and complicated aortic atherosclerosis in the abdominal area. Benign prostatic hyperplasia. Column hypertrophy of the bladder, adrenal cortical hyperplasia. Outcomes of laparotomy surgery. Multiple samples were taken for histological investigation. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Subcutaneous emphysema; Pain in arm; Necrotising fasciitis; Autopsy-determined Cause(s) of Death: Acute pulmonary oedema |
| Death/the adverse event as related to the patient''s primary diseases (cancer with metastases); This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is HU-OGYI-345421. A 78-year-old female patient received BNT162b2 (COMIRNATY), intramuscular, administered in left arm, on 18Mar2021 (Batch/Lot Number: EP2166) as 2nd single dose, at 0.3 ml, for COVID-19 immunisation. Medical history included cecal, liver and endometrial adenocarcinoma, hypertension, meningioma, hysterectomy and hiatus hernia. Concomitant medications included octreotide acetate (SANDOSTATIN LAR) from 25Mar2021, and temozolomide (TEMOZOLOMIDE ACCORD) from 24Feb2021. The first dose of BNT162b2 was administered on 25Feb2021. This case concerns the occurrence of death after BNT162b2 second injection. The patient was hospitalized on 29Mar2021 because of severe agranulocytosis and bleeding. The patient received antibiotics, GSF and thrombocyte transfusion. Her condition temporarily got better, but then it started to deteriorate. Later, pulmonary edema occurred. On 04Apr2021 at 9:00 the patient passed away. An autopsy was not performed. The event reported was ''death'' with no cause of death specified. Further information is not expected. Sender''s Comments: The reporter physician assessed the adverse event as related to the patient''s primary diseases (cancer with metastases), therefore the causal relationship is unlikely between the suspected drug and the event of death. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death/the adverse event as related to the patient''s primary diseases (cancer with metastases) |
| impaired general condition; confusion; diarrhea; suspected meningioma; multi organ failure; THROMBOCYTOPENIA; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB SE-MPA-2021-041737. A 92-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Mar2021 (Batch/Lot Number: EP2166) as single dose at the age of 92-year-old for COVID-19 immunisation. Medical history included ongoing hypertension, pneumonia in Mar2021, radius fracture in 2012. The patient''s concomitant medications were not reported. The patient received bnt162b2 (COMIRNATY), dose 1 in Feb2021 (Batch/Lot Number: Ej6790) as single dose at the age of 92-year-old for COVID-19 immunisation. In Apr2021 7 weeks after 2nd vaccination, the patient experienced thrombocytopenia, impaired general condition, confusion, diarrhea, suspected meningioma and multi organ failure on Apr2021. The patient underwent lab tests and procedures which included. The patient died on an unspecified date. The outcome of the events was fatal. It was not reported if an autopsy was performed. The course of events was as follows: Reported suspect adverse event was thrombocytopenia with start date 7 weeks after vaccination with dose two. She was essentially a healthy woman with the exception of hypertension. Admitted to the hospital ward due to impaired general condition, confusion and diarrhea. TPC (platelet) 29. Also Hb (hemoglobin) 105, SR (Sedimentation rate) 42, LD (lactate dehydrogenase) 22, Ferritin 1877, Transferrin 1, Homocystein 54 and LPK (prealbumin) 3.9. The latest previous TPC value 19 days earlier was 255. CT (computed tomogram) abdomen with diffuse heterogeneous spleen, possibly artifact, was recommended by radiologist to order additional survey. CT brain with newly discovered suspected meningioma. Assessed in consultation with a haematologist as suspected haematological malignancy. Not considered treatable with regard to the patient''s age, status and suspected meningioma. Thus no further investigation. Transfers to palliative care and the patient later dies calmly and quietly. Sampling was taken before this in view of the sudden onset of thrombocytopenia and vaccination administration. The patient has not received Heparin, Fragmin or similar preparations according to the medical record. P-HIT Antibodies IgG Positive. HPF4 Antibodies IgG Negative. The reporting physician discussed the case with a hematologist consultant and coagulation consultant. In summary, this is interpreted as a primarily probable hematological malignancy. There is a low degree of suspected vaccine side effect. Cause of death stated in the report as multi organ failure. No follow-up attempts possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: Multi organ failure |
| COVID-19 pneumonia; COVID positive; COVID-19 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-345321. A 68-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: EP2166), intramuscular, administered in arm left on 24Feb2021 as 1st dose, 0.3 ml single for COVID-19 immunisation. Medical history included COVID-19 pneumonia, varicosity, tonsillectomy, COVID-19, lymphoma (non-Hodgkin''s) from 2020 (low-grade B cell lymphoma progressed) and hypertension. The patient''s concomitant medications were not reported. On 08Mar2021 thee patient experienced COVID-19 pneumonia , COVID positive and COVID-19 infection. It was reported that on 08Mar2021 COVID-19 infection was confirmed and the patient was hospitalized. Chest X-ray also showed bilateral pneumonia. The patient received COVID therapy but his condition did not get better and passed away on 24Mar2021 at 07:00. The patient was diagnosed with incurable low-grade B cell lymphoma in 2020 which progressed, therefore the patient''s general condition was not adequate enough to recover from the COVID-19 infection. The patient underwent lab tests and procedures which included chest x-ray: bilateral pneumonia on 08Mar2021, chest x-ray: positive (confirmed pneumonia) on 16Mar2021, COVID-19 antigen test: positive on 08Mar2021. The patient died on 24Mar2021 due to COVID-19. An autopsy was not performed. Sender comments: As the patient got infected with COVID-19 after the first dose, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 |
| fell; rib fracture; weak state; confused state; condition deteriorated; Death; This is a spontaneous report from a contactable other health professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-345221. An 86-year-old female patient received second dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 10Mar2021 (Batch/Lot Number: EP2166) as 0.3 mL single dose for COVID-19 immunisation. Medical history included cataract operation, vascular dementia, urinary infection, osteoporosis, reflux esophagitis, asthma bronchial and pyelonephritis chronic, all from an unknown date and unknown if ongoing. Concomitant medications included glyceryl trinitrate (NITROMINT, formulation: transdermal patch) transdermal; theophylline (RETAFYLLIN); budesonide/formoterol fumarate (SYMBICORT) and spironolactone (VEROSPIRON) oral daily, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), intramuscular on 17Feb2021 (Batch/Lot Number: EL0725) as 0.3 mL single dose for COVID-19 immunisation. On 23Mar2021 the patient was hospitalized after she was found lying on the ground in her home. The old patient possibly fell because she had a rib fracture. The patient was in a weak, confused state the whole time. Despite the therapy (which also included parenteral antibiotics), the patient''s condition deteriorated and passed away on 04Apr2021. The patient underwent lab tests and procedures which included inflammatory parameters: laboratory results showed elevated inflammatory parameters and implied urinary infection, COVID-19 antigen test and COVID-19 PCR test: both negative on 22Mar2021. The patient died on 04Apr2021. The patient outcome of the events was unknown. An autopsy was not performed. Sender Comment: the reporter assessed the events as related to the patient''s primary diseases; therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Death |
| massive pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority NL-LRB-00535901. An 86-year-old female patient received second dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EP2166) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation and experienced no adverse event. The patient experienced massive pulmonary embolism on 14Mar2021. Targeted heart / vci emergency ultrasound (ER): wide right system, D-shape septum, Mc cullen sign +, empty left ventricle with moderate Left ventricular failure (LVF), VCI wide, does not collapse. No pericardial fluid. Conclusion: clear signs of legal tax with positive mc cullen sign, strong suspicion of obstructive shock due to massive pulmonary embolism. Electrocardiogram (ECG): SR 80 / min, normal cardiac axis, normal conductances, minimum segment (ST) depressions in I, V5-V6, no segment (ST) elevations, normal T-waves. After one-time filling (started from ambulance) no improvement, hemodynamics. With clear signs of legal tax on targeted emergency ultrasound with high suspicion of obstructive shock pulmonary embolism now no longer filled (due to worsening of circulatory situation in case of obstruction of the right system). Considering that it is too unstable for Computed tomography (CT) hemodynamically, consult IC about yes / no thrombolysis given deep shock and clear desire not to resuscitate want to become. Decided after assessment by intensivis. The patient did not have previous COVID-19 infection. The patient died on 15Mar2021 due to lung embolism. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: massive pulmonary embolism |
| Vaccination failure; COVID-19; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. An 89-year-old male patient received bnt162b2 (COMIRNATY), first dose via an unspecified route of administration on 27Feb2021 at single dose, second dose intramuscularly administered in left arm on 20Mar2021 (Batch/Lot Number: EP2166) at 0.3 ml single, for COVID-19 immunisation. Medical history included atrial fibrillation, hypertension, congestive heart failure, COVID-19 pneumonia, COVID-19, all unknown if ongoing. Concomitant drugs included amoxicillin trihydrate, clavulanate potassium (AUGMENTIN DUO); alprazolam (FRONTIN); lacidipine (LACIPIL); furosemide; allopurinol (MILURIT); solifenacin succinate (VESICARE); troxerutin (VENORUTON); perindopril erbumine (PRENESSA); spironolactone (VEROSPIRON); potassium chloride (KALIUM-R); apixaban (ELIQUIS); tamsulosin hydrochloride (PROSOLIN); dexamethasone; pantoprazole. The patient experienced vaccination failure (death, hospitalization) on 28Mar2021, covid-19 (death, hospitalization) on 28Mar2021, covid-19 pneumonia (death, hospitalization) on 28Mar2021. The patient was hospitalized from 01Apr2021. The patient died on 09Apr2021. Clinical course: On 01Apr2021 the patient was hospitalized with a positive Covid-19 antigen test result and dyspnea. His oxygen saturation was 70% and laboratory tests also implied abnormalities in association with Covid-19. Chest X-ray confirmed bilateral Covid-19 pneumonia. The patient received covid treatment but his respiratory insufficiency intensified and passed away on 09Apr2021 at 8:20. An autopsy was not performed. The outcome of the events was fatal. Health Authority Comment: According to the SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. Vaccination failure can be considered possible as the patient died of Covid-19, 19 days after the second dose. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19; COVID-19 pneumonia |
| Cardio-respiratory failure; Status epilepticus; congestive hepatopathy; Covid-like symptoms; possible white brain matter damage; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-289021. This is a report received from a regulatory authority. A 72-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EP2166, expiry date: unknown), intramuscularly on 18Mar2021 (at the age of 72-year-old) at 0.3 ml, single for active immunization to prevent COVID-19. Medical history included epilepsy, vascular encephalopathy, meningioma and Incontinence of urine, all from an unknown date and unknown if ongoing. Concomitant medication included carbamazepine (NEUROTOP) taken for epilepsy. The patient previously took carbamazepine (TIMONIL). The patient experienced cardio-respiratory failure and status epilepticus on 07Apr2021. This serious, medically confirmed report concerned the occurrence of status epilepticus and cardiorespiratory failure resulting in death after bnt162b2 injection. At the time of this report the patient was under care due to epilepsy. On 07Apr2021 the patient had a grand mal seizure which lasted for 30 minutes. After the seizure the patient was somnolent, had difficulty in breathing and her oxygen saturation was low on 07Apr2021. The patient was transferred to the hospital on 07Apr2021. Cranial CT scan on 07Apr2021 showed abnormalities including edema and possible white brain matter damage. The patient had Covid-like symptoms on 07Apr2021, but both antigen and PCR tests were negative on 08Apr2021. Examinations also implied congestive hepatopathy and circulatory decompensation caused by cardiac insufficiency on 07Apr2021. On 08Apr2021 at 15:15 the patient suddenly passed away due to cardiorespiratory failure. The outcome of events cardio-respiratory failure and status epilepticus was fatal, outcome of the other events was unknown. The patient died on 08Apr2021 at 15:15. It was not reported if an autopsy was performed. Sender Comment: The causal relationship cannot be assessed between the suspected drug and the adverse events because the patient passed away before additional examinations. TTO was 20 days. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory failure; Status epilepticus |
| Intracerebral haemorrhage; Refractory hydrocephalus; Ischemic stroke - obstructive/lesion; Cardiorespiratory arrest due to vascular ischemia of the mid brain and vertebral arteries; atrial fibrillation; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number GR-GREOF-20213319. An 85-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 05Mar2021 (Lot Number: EP2166) as single dose for covid-19 immunisation. Medical history included hypertension from 2016, ischaemic stroke (transient ischemic stroke) from 2016. Concomitant medications included irbesartan (APROVEL), clopidogrel bisulfate (PLAVIX) from 13May2017 to an unspecified stop date, omeprazole (LOSEC [OMEPRAZOLE]), omeprazole (OMEPRAZOLE), irbesartan (APROVEL). On 19Apr2021 patient experienced intracerebral haemorrhage, refractory hydrocephalus, Ischemic stroke - obstructive/lesion. Patient was admitted on 19Apr2021, admittance cause reported as follows: Ischemic stroke -refractory hydrocephalus - intracerebral haemorrhage. The patient was admitted to clinic on 19Apr2021 due to right hemiparesis (climax: Glasgow Coma Scale (GCS) E3V4M6 13/15). Computerised tomogram (CT) Scan revealed extensive ischemic lesion of right cerebellum hemisphere with edema and pressure of brain stem on 4th ventricle. Medication in her admittage (in the clinic): MANNITOL 150 for 3 intravenous (iv), SALOSPIR 325 MG 1X1 per oral solution (os). It was followed atrial fibrillation and they administered 2 amp ANGORON in 100 D/W 5% in a 2 hours infusion and 6 amp ANGORON in 500 cc D/W %. On 20Apr2021 due to relapse neurologically signs she underwent a new CT Scan due to hydrocephalus and it was decided to underwent neurosurgeon procedure (external ventricular drainage). On unknown date in Apr2021 (reported by the regulatory authority as 24Apr2021) the neurological examination remains the same (serious). New CT Scan was performed which revealed intracerebral hemorrhage. Respiratory problems appeared so she was incubated. Finally, the patient died due to cardiac arrest following ischemia of brain stem - rear circulation. On 23Apr2021 patient died due to cardiorespiratory arrest due to vascular ischemia of the mid brain and vertebral arteries, intracerebral haemorrhage, hydrocephalus, ischemic stroke, it was reported that an autopsy was done, no results provided. Outcome of the other mentioned event was unknown. No follow-up attempts possible. No further information expected. Lot/Batch number already obtained.; Reported Cause(s) of Death: Cardiorespiratory arrest due to vascular ischemia of the mid brain and vertebral arteries; Intracerebral haemorrhage; Hydrocephalus; Ischemic stroke |
| Respiratory distress; Vaccination failure; COVID-19 positivity; This is a spontaneous report from a consumer or other non HCP downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-DJ20211054. Safety Report Unique Identifier: FR-AFSSAPS-2021048085. Declaration from an EHPAD director via the reporting portal of the Agency and registered under the number 2021.0503124559648. This consumer reported similar events for two patients. This is the first of two reports. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via intramuscular on 11Feb2021 (Lot Number: EJ6789) as single dose, dose 2 via intramuscular on 04Mar2021 (Lot Number: EP2166) as single dose for COVID-19 immunisation. Patient age at vaccination was reported as 69 years old. The patient medical history included ongoing diabetes, ongoing hypertension arterial, ongoing obesity, ongoing insufficiency renal, coronary arteritis. The patient had no history of COVID-19 disease. The patient''s concomitant medication included potassium chloride (DIFFU K), etifoxine hydrochloride (STRESAM), furosemide, insulin aspart (NOVORAPID), insulin glargine (LANTUS), clopidogrel bisulfate (PLAVIX), allopurinol (ZYLORIC), esomeprazole, nicorandil (IKOREL), bisoprolol. The patient experienced vaccine failure with a fatal outcome. The registrant reported on 26Apr2021, or 53 days after the injection of the second dose of vaccine, the occurrence of COVID-19 positivity. Before 26Apr2021 no variant has been identified. On 02May2021 the patient presented with respiratory distress requiring hospitalization. The patient died on 06May2021. The cause of death was reported as COVID infection following vaccination failure. Autopsy was not done. Hospitalization report pending. Several cases in the same AFDEP (Accommodation facility for dependent elderly people), in particular another death (DJ20211042). No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021546915 Different patient/ same AE and suspect product.; Reported Cause(s) of Death: COVID infection following vaccination failure; respiratory distress; COVID infection following vaccination failure |
| Oedema started at legs, spreads to whole legs, hands; oedema in the legs which spread throughout the legs into the buttocks, lower back; Little concentration so she falls asleep after a page of reading and can''t follow TV programs/Concentration loss; Sleepy: She is very sleepy so she falls asleep after a page of reading and can''t follow TV programs/Somnolence; Heart failure; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from a regulatory authority-WEB NL-LRB-00513409, received from Regulatory Authority. A 90-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EP2166), via an unspecified route of administration on 03Mar2021 as 2nd dose, 0.3 ml single for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included fluvoxamine maleate (FEVARIN) and diazepam, both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of COMIRNATY on 27Jan2021 for COVID-19 immunisation and experienced no adverse reaction. The patient experienced oedema started at legs, spreads to whole legs, hands and oedema in the legs which spread throughout the legs into the buttocks, lower back on an unspecified date, little concentration so she falls asleep after a page of reading and can''t follow tv programs/concentration loss and sleepy: she is very sleepy so she falls asleep after a page of reading and can''t follow tv programs/somnolence on an unspecified date; heart failure on 28Apr2021. Treatment: Oedema is treated with diuretics; however, that treatment is stopped in consultation with the GP because it caused more harm than good. Two weeks after the second vaccination, the patient developed oedema in the legs which spread throughout the legs into the buttocks, lower back and hands. It has affected the quality of life because it used to be a healthy woman who is now no longer able to move as smoothly as before and who can no longer dress herself. She has to pant often, but her heart appears to be fine. She does not experience dyspnoea. She has been to the GP who investigated her blood and urine but was unable to find any abnormalities. The internist too was not able to find abnormalities. The GP had given her diuretics, but they caused more harm than good, so the treatment was stopped. They made the patient anxious. Up until now, the patient can barely walk. The GP does not know what to do. Latency: oedema: 2 weeks after start, somnolence and concentration loss: latency unknown. The patient was a healthy woman who is no longer herself since the oedema. She can hardly walk anymore. Must pant then (heart is okay, not stuffy). She is very sleepy, little concentration so she falls asleep after a page of reading and can''t follow TV programs. The oedema breaks her skin. She can no longer dress herself, the reporter''s father (94) has to help her, she is awake at night (while she was always a good sleeper), she then gets out of bed but is physically difficult to get back in. The doctor has done extensive blood and urine tests. All values are normal. Subsequently, her mother went to the internist for an examination, he also concluded that everything is fine. She has now been given water pills from the doctor, but they have not helped, and the remedy was worse than the disease, because she became anxious. She can barely walk now, and her parents are desperate. The patient''s mother died today (28Apr2021) in the hospital, this week the cardiologist diagnosed heart failure. They don''t know if this started with Pfizer, only that the edema started 2 weeks after the 2nd vaccine and that she gained 25 kilos of fluid in a few weeks, from 53 to 80 kilos. She was leading a healthy life. The patient underwent lab tests and procedures which included blood test: no abnormalities and urine analysis normal: no abnormalities on an unspecified date. The outcome of concentration loss and somnolence is unknown, while of the rest was fatal. The patient died on 28Apr2021. It was unknown if an autopsy was performed. Oedema and oedema peripheral were reported as fatal, medically significant and serious per hospitalization by the regulatory authority. Case Summary and Reporter''s Comments Text: 28Apr2021 Follow-up received: Dear people, my mother died today in the hospital, this week the cardiologist diagnosed heart failure. We don''t know if this started with Pfizer, only that the edema started 2 weeks after the 2nd vaccine and that she gained 25 kilos of fluid in a few weeks, from 53 to 80 kilos . She was leading a healthy life. Hopefully this will be sufficient for you Kind regards. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 28Apr2021 Follow-up received: Dear people, my mother died today in the hospital, this week the cardiologist diagnosed heart failure. We don''t know if this started with Pfizer, only that the edema started 2 weeks after the 2nd vaccine and that she gained 25 kilos of fluid in a few weeks, from 53 to 80 kilos . She was leading a healthy life. Hopefully this will be sufficient for you Kind regards.; Reported Cause(s) of Death: Heart failure; Oedema started at legs, spreads to whole legs, hands; oedema in the legs which spread throughout the legs into the buttocks, lower back |
| Death/ died due to her long persisting heart disease; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HU-OGYI-255021. A 76-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 20Mar2021 (Batch/Lot Number: EP2166) as 1st dose, 0.3 ml single for COVID-19 immunization. Medical history included mitral stenosis with insufficiency, ischemic heart disease, hypertension, decompensation cardiac and atrial fibrillation. The patient''s concomitant medications were not reported. On 13Apr2021 at 13:35 the patient passed away. The cause of death was due to her long persisting heart disease. It was not reported if an autopsy was performed. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse event as the reporter physician assessed the adverse event as related to the patient''s primary diseases. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: cause of death was due to her long persisting heart disease |
| Dyspnea; Coughing; Cardiac failure left; Drug ineffective; COVID-19/COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-254821 reported on 19Apr2021. An 81-year-old male patient received bnt162b2 (COMIRNATY, tozinameran, concentrate for dispersion for injection, COVID-19 mRNA Vaccine embedded in lipid nanoparticles), dose 1 intramuscular, administered in left arm on 19Mar2021 (Batch/Lot Number: EP2166) as first dose, 0.3 mL single, for COVID-19 immunization/for active immunization to prevent COVID-19. Relevant medical history includes myocardial infarction acute, ischemic heart disease, COVID-19 and hypertension from unspecified dates and unknown if ongoing. The patient''s concomitant medications were not reported. On 08Apr2021, the patient''s COVID PCR test was positive. On 15Apr2021 the patient was admitted in the hospital because of coughing and dyspnea which started the day before (14Apr2021). The patient received oxygen therapy as his oxygen saturation was 85% and had severe dyspnea. On 17Apr2021 at 17:45 the patient died. The cause of death were COVID-19 infection and cardiac failure left. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 08Apr2021, and oxygen saturation: 85 % on an unspecified date. The patient died on 17Apr2021. It was not reported if an autopsy was performed. Case was reported as serious, medically confirmed. Sender Comment: According to the SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient received the first dose of Comirnaty on 19Mar2021 and got infected with the virus 20 days after, therefore immunity may not have developed yet without the second dose. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. Further information is not expected.; Reported Cause(s) of Death: Drug ineffective; Dyspnea; Coughing; COVID-19/COVID-19 PCR test positive; Cardiac failure left |
| Cardiac insufficiency; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-255121. A 80-years-old female patient received the first dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on 25Feb2021 (Lot Number: EP2166) as 0.3 ml single for covid-19 immunisation. Medical history included hyperlipidaemia unknown if ongoing, hypertension unknown if ongoing, peripheral arterial occlusive disease unknown if ongoing, pulmonary embolism from 05Feb2020 to 15Feb2020 (in chronic anticoagulant program). The patient''s concomitant medications were not reported. The patient experienced cardiac insufficiency on 16Mar2021. The patient died on 16Mar2021 at 11:50. The cause of death was cardiac insufficiency. It was not reported if an autopsy was performed. On 16Mar2021 at 11:50 the patient passed away. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse event as the reporter physician assessed the adverse event as related to the patient''s primary diseases. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Based on the information available the event cardiac insufficiency is attributed to patient''s multiple underlying medical conditions and assessed unrelated to BNT162b2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: Cardiac insufficiency |
| Vaccination failure; possibility of vaccination failure; cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB, regulatory authority number HU-OGYI-254921. An 85-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EP2166) as 2nd dose, 0.3 ml single for COVID-19 immunization. Medical history included epilepsy, benign meningioma, stomach cancer, stroke and cholecystectomy. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY) on 04Feb2021 (batch number: EP0725) for COVID-19 immunization. On 13Mar2021 at 13:45, the patient passed away. The cause of death was cardiac arrest. It was not reported if an autopsy was performed. The patient died 15 days after the booster shot, therefore there''s a possibility of vaccination failure, however the reporter physician assessed the adverse event as related to the patient''s primary diseases. The events were assessed as serious-fatal. Sender Comment: According to the guidelines of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient died 15 days after the booster shot, therefore there''s a possibility of vaccination failure, however the reporter physician assessed the adverse event as related to the patient''s primary diseases. Based on the above, the causal relationship cannot be excluded between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest |
| Cardiopulmonary insufficiency; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number HU-OGYI-253221. An 81-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EP2166), intramuscular into the left arm on 18Mar2021 as 0.3 mL, single for covid-19 immunisation. Medical history included dementia Alzheimer''s type, hypertension and paranoia from an unknown date. Concomitant medications included perindopril arginine (COVEREX AS) taken for hypertension from 07Apr2021 to 13Apr2021; clonazepam (RIVOTRIL) taken for agitation from 07Apr2021 to 13Apr2021; haloperidol (MANUFACTURER UNKNOWN) taken for dementia from 07Apr2021 to 13Apr2021; nebivolol (MANUFACTURER UNKNOWN) taken for hypertension from 07Apr2021 to 13Apr2021; enoxaparin sodium (CLEXANE) taken for thrombosis prophylaxis from 07Apr2021 to 13Apr2021. On 13Apr2021, the patient experienced cardiopulmonary insufficiency, which was serious as it lead to death. The patient was hospitalized from 07Apr2021 till 13Apr2021. It was reported that the patient did not require hospitalization due to sequelae of the vaccination but rather because of his worsening condition due to his severe Alzheimer''s type dementia. On 13Apr2021 at 23:15, the patient passed away. According to the patients death certificate, the cause of death was circulatory and respiratory insufficiency. While hospitalized, the patient received nebivolol, perindopril arginine for hypertension, clonazepam for agitation, haloperidol for dementia and enoxaparin sodim for thrombosis prophylaxis. The patient died on 13Apr2021. An autopsy was performed and results were not provided. Sender Comment: The patient received the first dose of Comirnaty on 18Mar2021 and passed away on 13Apr2021 therefore immunity may have not developed yet. The reporter physician also assessed the fatal outcome as not related to the vaccine. Based on the above, the causal relationship is not related between the suspected drug and the adverse event. The case is considered serious because the patient passed away. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: circulatory and respiratory insufficiency; circulatory and respiratory insufficiency |
| death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is HU-OGYI-228821. An 86-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EP2166), intramuscular in the left arm on 19Mar2021 as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing myocardial infarction and ongoing aortic valve stenosis from unknown dates. Concomitant medication included acetylsalicylic acid (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient experienced death on 10Apr2021. The patient died on 10Apr2021. An autopsy was performed and results were not provided. An autopsy was performed and results were not provided. In the opinion of the patients physician, the death was not related to the vaccination. Sender Comment: The patient died 22 days after vaccination. Death is not expected adverse event of COMIRNATY. It might be related to the patient''s chronic cardiovascular diseases. Based on the above, and in lack of detailed medical information, relationship between death and COMIRNATY is not assessable. The case is serious because the patient died. No further information is expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: unknown cause of death |
| Stroke 10 days after of receiving the second dose of the pfizer covid-19 vaccine; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-719979. An 81-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 26Mar2021 15:44 (Lot Number: EP2166; Expiration Date: 31May2021) as 30 ug, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 05Mar2021 administered at 16:58 for COVID-19 vaccination. The patient experienced stroke 10 days after of receiving the second dose of the Pfizer covid-19 vaccine on 05Apr2021 15:44. The patient died on an unspecified date due to stroke. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: stroke |
| suspected COVID-19; suspected COVID-19; weakness; confusion; dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (HU-OGYI-229421). A 93-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly, on 17Mar2021 (Lot number: EP2166) as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced weakness, confusion, and dyspnoea on 19Mar2021, which were reported as fatal. The patient also experienced suspected COVID-19 on 19Mar2021. Therapeutic measures were taken as a result of the events, which included favipiravir (MANUFACTURER UNKNOWN) from 03Apr2021. The patient died at home on 10Apr2021. The cause of death was assessed as suspected COVID-19 (reported as: unknown cause of death). It was not reported if an autopsy was performed. Sender''s Comment: Weakness is expected adverse event of COMIRNATY. Confusion and dyspnoea are not expected adverse events. The symptoms started two days after vaccination. They might have been already the symptoms of the patient''s suspected COVID-19. Based on the above, and in lack of detailed medical information, relationship between death and COMIRNATY is not assessable. The case is serious because the patient died. No further information is expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: suspected COVID-19; suspected COVID-19 |
| Dizziness; Fatigability; Appetite lost; Breathing difficult; diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021; This is a spontaneous report from a contactable consumer who is also the patient''s daughter downloaded from the regulatory authority-WEB, regulatory authority number RO-NMA-2021-SPCOV6833-FU1. A 63-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 07Mar2021 (Batch/Lot Number: EP2166) as SINGLE DOSE (1 DF) for covid-19 immunisation. Medical history included Cancer of head of pancreas (The patient had surgery for a pancreatic head cancer in December 2016). The patient''s concomitant medications were not reported. On 12Mar2021 the patient experienced fatigue/ Fatigability, dizziness, lack of appetite/ Appetite lost, difficult breathing/ Breathing difficult. The events were assessed as serious (hospitalization, fatal). The patient needed hospitalization where she was diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021. The patient underwent lab tests and procedures which included sars-cov-2 test: diagnosed with sars-cov-2 virus infection on 16Mar2021 (diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021). The patient died on 20Mar2021. It was not reported if an autopsy was performed. Sender Comment: Follow up information added on 26-Apr-2021: following investigation of the case, on 22-Apr-2021 it was concluded: it is denied that the death was caused by the post-vaccination reaction; the person was confirmed with COVID-19 infection on 16-Mar-2021 and died on 20-Mar-2021 at the Hospital. Routine follow-up is not conducted for HA-web reports. No follow-up attempts are needed. No further information is expected. The information about lot number was provided within the initial report. The case was closed for follow-up activities.; Reported Cause(s) of Death: Dizziness; Fatigability; Appetite lost; Breathing difficult |
| On 19Mar2021 she experienced respiratory failure for one day. Oxygen therapy administered. Death followed; This is a spontaneous report from a contactable healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-719569. A 99-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Mar2021 (Lot Number: EP2166) as single dose for covid-19 immunisation. The first dose was received in 19Feb2021. Medical history included diabetes mellitus. Concomitant medications included furosemide (LASIX), omeprazole; metformin hydrochloride (METFORMINA ACTAVIS), glyceryl trinitrate (DEPONIT), acetylsalicylic acid (CARDIOASPIRIN), allopurinol (ZYLORIC); all taken for an unspecified indication, start and stop date were not reported. On 19Mar2021 the patient experienced respiratory failure for one day. Oxygen therapy administered. Death followed. The patient died on an unspecified date. It was not reported if an autopsy was performed. Clinical course, therapeutic measures, outcome and additional relevant information: the patient was vaccinated with 1st dose of Pfizer vaccine on 19Feb2021 and with the 2nd dose of Pfizer vaccine on 13Mar2021. On 19Mar2021 she experienced respiratory failure for one day, she was treated with oxygen therapy, then she died. The reporter did not indicate the date of death, therefore further information has been requested in this regard.; Reported Cause(s) of Death: On 19Mar2021 she experienced respiratory failure for one day. Oxygen therapy administered. Death followed |
| Respiratory insufficiency; This is a spontaneous report received from a contactable Other Health Professional downloaded from the Agency Regulatory Authority WEB. The regulatory authority report number is IT-MINISAL02-718863. A 97-year-old female patient received second dose of bnt162b2 (COMIRNATY; Lot Number: EP2166), intramuscularly on 12Mar2021 as single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included atorvastatin calcium (TOTALIP) and clopidogrel bisulfate (PLAVIX). Historical vaccine includes first dose of bnt162b2 (COMIRNATY; Lot Number: EJ6790) on 19Feb2021 for COVID-19 immunization and experienced no adverse effect. The patient experienced respiratory insufficiency on 29Mar2021 for 8 days. It was also reported that the patient was hospitalized on an unspecified date and died due to respiratory insufficiency on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Respiratory insufficiency |
| cardiac arrest (duration of 30 minutes); This is as spontaneous report received from a contactable healthcare professional downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is IT-MINISAL02-718853. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Mar2021 (Lot Number: EP2166) as single dose for covid-19 immunisation. The patient received the 1st dose of bnt162b2 (COMIRNATY; lot number EJ6790) on 19Feb2021 for covid-19 immunization with no adverse reaction reported. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (ESCITALOPRAM ALTER). On 25Mar2021, the patient experienced cardiac arrest (duration of 30 minutes), causing death on 25Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardiac arrest |
| Sudden death; Vomited; This is as spontaneous report received from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-836497. A 92-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular, administered in the arm on 01Mar2021 (Lot Number: EP2166) as single dose for COVID-19 immunisation. Medical history included allergies to beta-lactam antibiotics, non-smoker, hypertension arterial (HTA) of 10-15 years of evolution, no DM, dyslipidaemia, no known heart disease, no surgical interventions, diverticulosis in colon, iron deficiency anaemia, hiatus hernia, osteoporosis, admission in December 2018 for acute pancreatitis of biliary origin (mild), AF: Not remarkable, Nephrourological history: follow-up in Nephrology Consultation, since 2004 with CKD of unaffiliated aetiology (Creatinine 2mg/dl), usual urinary infections, left renal lithiasis, with nephritic colic (at least 5), expulsion of clear urine, no haematuria, not frothy, and hypercholesterolaemia. Concomitant medications included furosemide (FUROSEMIDA) taken for an unspecified indication from 16Mar2018 to an unspecified stop date; simvastatina taken for hypercholesterolaemia from 04May2007 to an unspecified stop date; lisinopril taken for hypertension from 20Dec2018 to an unspecified stop date; carvedilol taken for hypertension, start and stop date were not reported. On 03Apr2021 (also reported as 03Mar2021) on waking up she was found inert with signs of death (sudden death). It was also reported that the patient vomited on 03Apr2021 (also reported as 02Mar2021), no fever or dyspnoea. 112 was called who administered primperan and prescribed hydration with oral serum for the event vomited. It was explained that it will be self-limited to 24-48 hours as a reaction to the vaccine. The patient died on 03Apr2021. It was not reported if an autopsy was performed. The outcome of the event vomited was unknown and sudden death was fatal. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: Sudden death |
| Cerebral venous thrombosis; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number ES-AEMPS-833579. A 45-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: ep2166), intramuscular on 04Mar2021 as a single dose for COVID-19 vaccination. The patient medical history included dyslipidaemia, obesity and paranoid schizophrenia; all from an unknown date. The patient previously received the first dose of bnt162b2 (COMIRNATY, lot number was not reported), intramuscular on 11Feb2021 for covid-19 immunisation. Concomitant medications included topiramate; alopurinol; paliperidona; simvastatin; and sertraline; all were taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebral venous thrombosis on 14Apr2021. The outcome of the event was fatal. The patient underwent lab tests and procedures which included computerised tomogram head abnormal: extensive venous thrombosis and occlusion of DIC with obliteration of cisternae of the base on 14Apr2021. The patient died on an unspecified date. Cause of death was cerebral venous thrombosis. It was unknown if an autopsy was performed. Case Summary and Reporter''s Comments Text; CEREBRAL VENOUS THROMBOSIS without THROMBOPENIA despite having passed more than 1 month since the last dose. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: CEREBRAL VENOUS THROMBOSIS without THROMBOPENIA despite having passed more than 1 month since the last dose.; Reported Cause(s) of Death: Cerebral venous thrombosis |
| CEREBRAL HEMORRHAGE; new-onset headaches and was very tired and exhausted; new-onset headaches and was very tired and exhausted; blood pressure systolic: 220 mmhg on 12Apr2021 (Measured by the GP), and 150 mmhg on 12Apr2021 (Blood pressure measured on arrival at hospital).; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uxz3gm. An 85-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: EP2166) intramuscularly on 25Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (COMIRNATY, batch number unknown) on 04Feb2021 for COVID-19 vaccination. On 12Apr2021, the patient developed cerebral hemorrhage. Relevant laboratory findings and investigations included blood pressure systolic: 220 mmHg on 12Apr2021 (Measured by the GP), and 150 mmHg on 12Apr2021 (Blood pressure measured on arrival at hospital). The primary reporter stated that she was unsure of the causal link between vaccination and cerebral hemorrhage and pointed out that for this patient a hypertensive hemorrhage was also a possibility. The doctor further wrote that the patient after vaccination (2021) experienced new-onset headaches and was very tired and exhausted. The condition became acutely worse on 12Apr2021 and the patient was hospitalized on 12Apr2021. The patient died on 14Apr2021 for cerebral hemorrhage. It was not reported if an autopsy was performed. The outcome of other events was unknown. The case was considered to be Serious. The Regulatory Authority has assessed the causal relationship between the suspect product and the cerebral hemorrhage as Possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: CEREBRAL HEMORRHAGE |
| Lung infection; Decreased appetite; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-BX20213276 with safety report unique identifier FR-AFSSAPS-2021039850. A 71-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number EP2166), intramuscularly administered in the left arm on 26Feb2021 at a single dose for covid-19 immunization. Medical history included non-insulin-dependent diabetes mellitus and, cancer of lung - "treatment in progress, if any, not specified". The patient has not had covid-19. The patient''s concomitant medications were not reported. The patient experienced decreased appetite on 27Feb2021 with outcome of not recovered. At 1 month of vaccination, on 26Mar2021, the patient had lung infection with aggravation and hospitalization for 15 days (from an unspecified date in 2021 to an unspecified date in 2021) - the outcome was fatal. It was also reported "death of the patient - cause unknown" (pending clarification). The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. The patient has not been tested for covid-19 since the vaccination. Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures.; Reported Cause(s) of Death: lung infection |
| Fever; Confusion; large intracranial haemorrhage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-025067 and Sender''s (Case) Safety Report Unique Identifier SE-VISMA-1617714989586. A 75-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: EP2166), via an unspecified route of administration on Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history included chronic atrial fibrillation, cardiac failure right, sleep apnoea syndrome, chronic obstructive pulmonary disease, all ongoing. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunization. The patient experienced large intracranial haemorrhage on an unspecified date; fever and confusion on Mar2021 and was hospitalized. The patient underwent lab tests and procedures which included CT of the brain: extracranial haematoma on an unspecified date. The patient died on an unspecified date due to large intracranial haemorrhage. It was not reported if an autopsy was performed. The outcome of the events fever and confusion was unknown. Report was assessed as serious, hospitalization. The clinical course was reported as follows: Reported suspected adverse events were confusion and fever. Vaccination with dose 2 in Mar2021 and the next day the woman developed fever and confusion. She was hospitalised a day later, had fallen at home and a CT of the brain was performed, showing only extracranial haematoma. The woman was discharged after 4 days in the hospital but had a remaining tendency to fall. 19 days after the vaccination debut of expressive aphasia and paresis of the right arm and leg, arrived at emergency care. Had a large intracranial haemorrhage and died 2 days later. This was not reported as suspected adverse events. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: large intracranial haemorrhage |
| Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority FR-AFSSAPS-PO20211727 and received via Regulatory Authority. An 84-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via Intramuscular on 03Mar2021 left arm at single dose (Lot EP2166) for COVID-19 immunisation. Medical history included fitted sleep apnea syndrome, moderate arterial hypertension, glaucoma, onset of non-Alzheimer''s memory disorder, had a myocardial scintigraphy for chest pain on 18Jan2019 without specificity, has not seen the cardiologist since, had a Brain MRI: deficiency in the central nucleus which may correspond to an old TIA (Transient ischemic attack), did not have the Covid. Concomitant medications included long term with Atorvastatin 10 mg / day, indapamide, perindopril arginine (BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]) 5, acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) 100, and acetylleucine (TANGANIL)100. The patient previously received the first dose of BNT162B2 (COMIRNATY) for COVID-19 immunisation, presented a small rash on the first injection that he did not want to report waiting for information from cardiology intensive care. On 04Mar2021 of a severe myocardial infarction supported by intensive cardio care death on 07Mar2021 at 5:45 a.m. No autopsy was done. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial |
| severe form of COVID; vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PA20210461. Safety Report Unique Identifier FR-AFSSAPS-2021036800. A 93-years-old male patient (Husband of a resident) received bnt162b2 (COMIRNATY), dose 2 intramuscular on 05Mar2021 (Batch/Lot Number: EP2166) as 0.3 ml, single, dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot Number: EJ6795) as single dose for covid-19 immunisation. Medical history included Chronic obstructive pulmonary disease, Cardiac insufficiency, Hypertension arterial. No previous history of covid. Concomitant medication included fluindione (PREVISCAN [FLUINDIONE]); rosuvastatin calcium (CRESTOR); atenolol (ATENOLOL), Izaar. The patient had good tolerance for the first dose. The patient experienced severe form of covid and vaccination failure on 23Mar2021, which required hospitalization in Mar2021 and death on 26Mar2021. Clinical detail was reported as: the patient had respiratory symptoms about 7/8 days after the second dose of vaccine which the patient neglected. Then he presented with asthenia, fever and respiratory discomfort around 15 March 2021. He was hospitalised following his visit to the emergency room and died on 26 March 2021 of a severe form of COVID (65% invasion on the thoracic scan). The PCR done on 23Mar2021 showed an variant. IN TOTAL, severe SARS COV2 infection variant B117 resulting in the death of an elderly man with a risk factor for developing a severe form of the disease. The patient underwent lab tests and procedures which included thoracic scan: severe form of COVID (65% invasion on the thoracic scan) on Mar2021, Covid-19 PCR test: positive on 23Mar2021 variant. The patient died on 26Mar2021. An autopsy was not performed. NB: Imputation made "without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures". Reported Cause(s) of Death: SEVERE FORM OF COVID |
| Death; found dead in bed; Fallen and hit his head; Fallen and hit his head; This is a spontaneous report downloaded from the regulatory authority (Regulatory Authority Report Number: SE-MPA-2021-023862). A contactable physician reported that a 77-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EP2166) at the age of 77 years, intramuscular, in Mar2021, at a single dose, for COVID-19 immunization. The patient''s medical history included heart failure. The patient''s concomitant medications included furosemide (FURIX), atorvastatin, acetylsalicylic acid (TROMBYL), spironolactone, sertraline, enalapril, and metoprolol. The reported suspected adverse reaction was death. In Mar2021, the patient had fallen some day before he died and had hit his head. In Mar2021 the patient was found dead in bed 3 days after the vaccination (Mar2021). In conversations with the physician, he informs that an autopsy will not be performed. The outcome of event reported as "Death; found dead in bed", fatal, the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; found dead in bed |
| Death from natural causes; This is a spontaneous report from a contactable physician downloaded from the regulatory authority PT-INFARMED-B202103-2360. A 97-year-old male patient received (COVID-19 mRNA vaccine (with modified nucleoside) (Comirnaty), concentrate for dispersion for injection, 30 mcg/0.3 ml, batch EP2166, CAUL: 09621, dose of 0.3 ml) intramuscular as a single dose for COVID-19 immunization. Medical history included cardiac heart insufficiency; 1.5 L / min long duration supplementary oxygen for unknown respiratory condition with pulmonary hypertension. Concomitant medications were unknown. The patient died 15 days after the administration of the suspected vaccine. The reported cause of death was "death by natural causes". The patient had emergency medical care and was hospitalized. Oxygen therapy (1.5 L / min) was required due to unknown respiratory disease with pulmonary hypertension. There is also reference to previous heart failure. The Reporter is unaware of the usual medication of the patient. Outcome of ADR: Death. Relatedness of drug to reaction(s)/event(s): Source of assessment: Reporter Method of assessment: unknown, Result of Assessment: improbable. No follow-up attempts possible. No information expected.; Reporter''s Comments: Concomitant Medication-Unknown Did a Medication Error occur? -No Other information-Previous cardiac heart insufficiency; 1.5 L / min long duration supplementary oxygen for unknown respiratory condition with pulmonary hypertension; Reported Cause(s) of Death: Death from natural causes |
| Bacterial infection/Sepsis shock; Fever; not feeling well; This is a spontaneous report from a contactable consumer. A 60-year-old male patient (father of the reporter) received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 (at the age of 60-year-old) (Lot Number: EP2166) as single dose for COVID-19 immunisation. Relevant medical history included multiple blood infections and chronic blood infections, paralysis from 1997 (paralyzed for 23 years), bed sores, bacterial problems, general physical health deterioration (the patient was paralyzed and not in the best health shape) and iodine allergy. Concomitant medications were not reported. The patient died 3 days after receiving the vaccine. He had a blood infection and the doctor decided that it was ok to give him the vaccine. He had a fever and was not feeling well on 05Mar2021. The patient was hospitalized for the events. The patient died on 08Mar2021. An autopsy was not performed. The patient did not receive corrective treatments. The reporter commented that his dad was paralyzed and not in the best health shape and he was not sure why was he given the vaccine. The doctor told the reporter that he died from bacterial infection and the cause of death was septic shock (onset date 05Mar2021).; Reported Cause(s) of Death: Sepsis Shock |
| Chest pain; ST-T segment elevation; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority report number: SE-MPA-2021-024468). A contactable physician (contactable through Regulatory Authority only) reported that an 84-year-old female patient received BNT162B2 (COMIRNATY, Lot number: EP2166; Expiration date was not reported), intramuscular in Mar2021 as a single dose for COVID-19 immunization. Medical history included essential hypertension and hypothyroidism; both were unknown if ongoing. The patient''s concomitant medications were not reported. In Mar2021, 8 days after the vaccination, the patient had chest pain. The patient did not seek medical attention, then called the health center a week later, and was referred to the emergency room. The patient''s electrocardiogram (ECG) in Mar2021 ST-T segment elevation. The patient had underwent percutaneous coronary intervention for the reported events. The patient had died on an unspecified date in 2021 after two days of hospitalization. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Chest pain; ST-T segment elevation |
| sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20210907. A 65-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot: EP2166), intramuscular on 10Mar2021 as single dose for covid-19 immunisation. Medical history included chronic kidney disease stage V (with hemodialysis), chronic hemodialysis, peripheral arterial occlusive disease (multi-stented PAD), ischaemic heart disease (triple coronary bypass grafting with complications) and valvular heart disease (calcified aortic stenosis tight). Concomitant medications included atorvastatin; bisoprolol; clopidogrel; sodium polystyrene sulfonate (KAYEXALATE); levothyroxine; calcium carbonate (OROCAL); pantoprazole; paracetamol; sevelamer carbonate (RENVELA); folic acid (SPECIAFOLDINE); glyceryl trinitrate (TRINITRIN); alfacalcidol (UN ALFA) and warfarin. The patient did not have Sars-CoV2 infection. The physician reported sudden death of the patient in a few minutes while preparing to come to his dialysis session on 24Mar2021. He was 14 days after a first dose of bnt162b2 and had a significant cardiovascular history. The patient died on 24Mar2021. It was unknown if autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death |
| cardiac arrest; COVID-19 infection; fever (39 degrees Celsius); This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number GR-GREOF-20211826. A 75-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on 09Mar2021 (Batch/Lot Number: EP2166) at 75-years-old as 0.3 mL, single for COVID-19 immunization. Medical history included chronic dyslipidaemia from an unknown date and unknown if ongoing, unregulated arterial hypertension from an unknown date and unknown if ongoing, very high Body Mass Index (BMI) increased from an unknown date and unknown if ongoing, mild symptoms of infection of the upper respiratory tract from 05Mar2021 to an unknown date. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) taken for dyslipidaemia, start and stop date were not reported. On 09Mar2021, the patient experienced: fever (39 degrees Celsius) (non-serious), cardiac arrest (death, medically significant), COVID-19 infection (death, medically significant), death (as reported) (death, medically significant). The clinical course was reported as follows: According to the reporter, the patient on the day of the vaccination did not report any acute symptoms while he was providing his medical history, neither any allergies. The patient just reported the chronic dyslipidaemia treatment. It was the first dose of the vaccine COMIRNATY and the patient remained in the vaccination center for 15 minutes according to the guidelines; without presenting any symptoms. On 16Mar2021, the patient''s son, called the reporter to declare the death of his father. The patient''s son stated that the patient had a fever the same day of the vaccination and passed away approximately six hours later. A close relative was found positive with SARS-CoV-2 on 13Mar2021; and on the day of the report was still hospitalized. The patient was "buried after the death certificate from a private physician." On 18Mar2021, the patient''s son was contacted, who was also a physician. According to the patient''s son, his father had unregulated arterial hypertension, dyslipidaemia and very high Body Mass Index (BMI) (weighed 110 kilograms for over 40 years with 170 cm height). The patient, four days before his vaccination, had mild symptoms of infection of the upper respiratory tract (mild cough, sniffle and sore throat). On 09Mar2021, the patient was vaccinated and three hours later presented high fever (39 degrees Celsius). The patient three hours later died. The patient''s son stated that the physician who examined his father told him that he found representative data of cardiac arrest and the cause of death was cardiac arrest. Three days later, the patient''s wife was found positive with COVID-19 infection and was hospitalized. According to the patient''s son''s opinion, his father died from COVID-19 infection, even though the patient had not tested positive. The patient underwent lab tests and procedures which included body temperature: 39 Centigrade on 09Mar2021. The clinical outcome of the events: cardiac arrest, COVID-19 infection, death, was fatal. The clinical outcome of the event fever (39 degrees Celsius), was unknown. The patient died on 09Mar2021 due to cardiac arrest, death, COVID-19 infection (according to the patient''s son). It was unknown if an autopsy was performed. The causality assessment from the a regulatory authority for vaccines was unlikely; Method of assessment: a regulatory authority causality criteria. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: COVID-19 infection; Cardiac arrest |
| Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority -WEB, regulatory authority number FR-AFSSAPS-RN20210986. A 93-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: EP2166), intramuscular, administered in left arm on 03Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, mild cognitive impairment and, prostate cancer from an unknown date. Long-term treatment not reported. No history of allergy was reported. No history of COVID-19 was reported. Concomitant medications were not reported. On 24Mar2021 during the night, unexpected sudden death without prodrome, nocturnal, suggestive of embolism or cardiac accident without further information. Given the time of death and the uncertainty of the diagnosis and age, no examination was carried out and no autopsy was requested. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown results on an unknow date. The patient died on 24Mar2021. An autopsy was not performed. No follow-up attempts is possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained |
| Cardio-respiratory arrest; Difficulty breathing and speaking; Extreme tiredness; Appetite loss; Difficulty breathing and speaking; Swollen legs; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Feb2021 (Lot Number: EP2166) at 0.3 mL, single for covid-19 immunisation. The vaccine was administered at a Clinic. The patient''s medical history and concomitant medications were not reported. According to the reporting consumer, the patient was healthy without any known diagnosed pathologies. It was unknown if the patient had an allergies to medications, food, or other products. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Feb2021, the patient experienced extreme tiredness, appetite loss, difficulty breathing and speaking and swollen legs. No treatment was received for the adverse events. On 25Mar2021, the patient was deceased. The reported cause of death was cardio-respiratory arrest, tiredness, appetite loss, difficulty breathing and speaking and swollen legs. The patient died on 25Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: Difficulty breathing and speaking; Cardio-respiratory arrest; Extreme tiredness; Appetite loss; Difficulty breathing and speaking; Swollen legs |
| SUDDEN DEATH; collapsed outdoors due to cardiac arrest; collapsed outdoors due to cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-021651. An 86-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on Mar2021 (Batch/Lot Number: EP2166) as single dose for covid-19 immunisation. Medical history included hypertension, ulcerative colitis, chronic ischemic heart disease, unspecified, and hyperlipidaemia. Concomitant medications included acetylsalicylic acid (TROMBYL), prednisolone for ulcerative colitis, metoprolol, and candesartan. The patient experienced sudden death on Mar2021. The patient was at the outpatient care center for dressing a wound, good healing after light trauma and he was unaffected and well during the visit. Later, a relative reported that the day after the vaccination (Mar2021), the patient had collapsed outdoors due to cardiac arrest. An ambulance was called but the man''s life could not be saved. The patient died on Mar2021 due to sudden death. The outcome of the other events was unknown. No autopsy will be performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death |
| unknown cause of death; Intraventricular haemorrhage; Vertiginous disorder; Vomiting; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority-WEB IT-MINISAL02-701252 This is a report received from the Regulatory Authority. This 83-year-old male patient received BNT162B2 (COMIRNATY, lot number: EP2166, lot expiry (31May2021)), single dose, dose 1 via intramuscular route of administration in the right arm on 06Jan2021 at 10:00 AM at the age of 83 years-old) for COVID-19 vaccination. Medical history included nephrectomy. Concomitant medications were not reported. On 12Mar2021, the patient experienced vertigo, vertiginous disorder and vomiting occurring within minutes after administration of COVID-19 vaccine. On 12Mar2021, acute tetraventricular haemorrhage is documented following cerebral computerized tomography (without DCS). The patient was hospitalized for vertigo, vertiginous disorder, intraventricular haemorrhage and vomiting. The outcome of vertigo, vertiginous disorder, intraventricular haemorrhage and vomiting was reported as fatal. The patient died of an unknown cause on 16Mar2021. The stop date of vertigo, vertiginous disorder, intraventricular haemorrhage, unknown cause of death and vomiting It was unknown if an autopsy was performed. Reporter''s comments: Reported episode of malaise with mild dizziness and alimentary vomiting occurring a few minutes after the administration of vaccine for COVID-19 (PFIZER-BIONTECH). Acute tetraventricular haemorrhage is documented. Sender''s comments: Asked for follow-up from the referring doctor, he reports that the patient on 16Mar2021 was still hospitalized in intensive care in a pharmacological coma. Reporter''s comment: Died on 16Mar2021. Autopsy reports not yet available. Sender''s comment: Following a new request for follow-up, the reporter, together with reporting the patient''s death on 16Mar2021, provides clinical documentation, which is attached. No follow-up attempts possible. No further information expected. Follow-up (29Mar2021): This is a follow-up report received from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-701252 This is a report received from the Regulatory Authority. New information included: autopsy information(unknown), the new outcome of the all events: fatal with newseriousness criterium: death. Follow-up (01Apr2021): This is a follow-up report received from contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-701252. This is a report received from the Regulatory Authority. New information includes: The day of death (16Mar2021) and the stop date for all events (16Mar201).; Reporter''s Comments: Reported episode of malaise with mild dizziness and alimentary vomiting occurring a few minutes after the administration of vaccine for covid-19 (pfizer-biontech). Acute tetraventricular haemorrhage is documented. Died on 16Mar2021. Autopsy reports not yet available.; Reported Cause(s) of Death: Intraventricular haemorrhage; Vertiginous disorder; Vomiting; unknown cause of death |
| Pulmonary embolism; This is a spontaneous report from two contactable physicians downloaded from the regulatory authority-WEB, regulatory authority numberSE-MPA-2021-019669. Other Case identifier number: SE-MPA-1615871445349. An 82-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on Mar2021 (Batch/Lot Number: EP2166) as single dose for covid-19 immunisation. Medical history included widespread prostate cancer, heart failure, hypertension, diabetes. The patient''s concomitant medications were not reported. It can be deduced from the reports that the man was vaccinated 4-5 days before the diagnosis of pulmonary embolism. The man dies shortly after the pulmonary embolism is discovered. Cause of death is not specified in the report. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death |
| two cerebral hemorrhages; fell unconscious; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority report number is SE-MPA-2021-022425. A 75-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot Number: EP2166) as single dose for COVID-19 immunisation. Medical history included dementia alzheimer''s type and atrial fibrillation. The patient''s concomitant medications was anticoagulant, unspecified which. The patient previously took BNT162B2 (COMIRNATY, solution for injection, lot number: EJ6134), dose 1 in Jan2021 for COVID-19 immunisation. The patient experienced two cerebral heamorrhages one day after dose 2 which conflicts with submitted onset date of four days before dose 2. The man was found outside his home and transported to hospital, upon arrival he was conscious and able to state his date of birth/social security number but then fell unconscious. He remained unconscious until his death a few days later. The reporter writes that the man was in good health and walked every day. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: two cerebral hemorrhages; fell unconscious |
| possible cause of possible arrhythmia; possible cause of deteriorating general condition; she collapsed; felt a little bad; felt tired; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-1615363791551. An 84-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on Mar2021 (Batch/Lot Number: EP2166) as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac failure. The patient''s concomitant medications were not reported. In Mar2021, Possible cause of deteriorating general condition and possible arrhythmia was reported. After the vaccination, the patient felt a little bad and felt tired. The next day at 15:00, she collapsed. RLS 8 CPR started, narrow QRS complexes and ROSC (return of spontaneous circulation) are detected after 6min. DT (Diffusion tensor imagining) brain and angio as well as MRI only show age insults/infarcts. Shows a general slowdown. Neurological status improved, at best RLS 4. Echocardiography shows similar picture as before, possibly increased hypokinesia septally. Doubled NTproBNP and Troponin release. Extubated but hypercapne, inability to keep airways clear. The woman passing away about a week after arrival at hospital. It does not appear from the report whether the woman had any other contemporary medicines. The patient underwent lab tests and procedures which included angiogram: age insults/infarcts, echocardiogram: hypokinesia, possibly increased hypokinesia septally, magnetic resonance imaging: age insults/infarcts, n-terminal prohormone brain natriuretic peptide: doubled release, troponin: doubled release. It was not reported if an autopsy was performed. The patient died on an unspecified date. The outcome of the events felt a little bad, felt tired, and collapsed was not unknown. The events possible cause of possible arrhythmia, and possible cause of deteriorating general condition were fatal. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: possible cause of deteriorating general condition; possible cause of possible arrhythmia |
| death; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is PT-INFARMED-T202103-936. A 91-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscular on 01Mar2021 (lot number: EP2166) at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died on 10Mar2021 (9 days after the vaccine administration). The event was reported to have lasted about 1 minute, but the circumstance of death was not known. No drug-drug interaction or medication error was suspected. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s): Death: Source of assessment: Notifier, Method of assessment: Unknown, Result of Assessment: Unlikely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death |
| Other unspecified not fully defined and not complete cause of death; Sick of fever 39 degrees Celsius a day later; Decreased general condition; wheezing; rising blood pressure; decreased saturation; This is a spontaneous report from a contactable physician regulatory authority number SE-MPA-2021-019693. A 77-year-old male patient received bnt162b2 (COMIRNATY, lot number: EP2166), intramuscular on Mar2021 as 0.3 mL, single for covid-19 immunisation. The patient medical history included multiple system atrophy, Parkinson''s type MSA-P; hypertension and previous myocardial infarction; all from an unknown date and unknown if ongoing. On March 2020, the patient had a Covid-19 infection and unknown if ongoing. The patient''s concomitant medications were not reported. The reported events were other incompletely defined and unspecified causes of death on Mar2021. Clinical course reported as the patient was vaccinated with Comirnaty on March 2021. Sick of fever 39 degrees Celsius a day later. Decreased general condition, wheezing, rising blood pressure and decreased saturation. Died at night between days 4 and 5 after the vaccine was given. The outcome of sick of fever 39 degrees Celsius a day later, decreased general condition, wheezing, rising blood pressure and decreased saturation was unknown. Outcome of the unknown cause of death was fatal. Cause of death was unknown. The patient died on Mar2021. Autopsy will not be performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death |
| Intracerebral haemorrhage; Subarachnoid haemorrhage; This is a spontaneous report from contactable physicians downloaded from the Agency Regulatory Authority, regulatory authority number SE-MPA-2021-019656. Other unique identifier SE-MPA-1615884879618. A 74-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on Mar2021 (Batch/Lot Number: EP2166) as single dose for COVID-19 immunization. Medical history included hypertension, lung sarcoid, sleep apnea, asthma, and middle cerebral artery aneurysm from an unknown date. Concomitant medication included paracetamol (ALVEDON) from 20Mar2018 to an unspecified date; urea (CANODERM) from 09Oct2019 to an unspecified date; candesartan cilexetil (CANDESARSTAD) from 06Jun2020 to an unspecified date; fluticasone propionate (FLUTIDE) from 19Mar2018 to an unspecified date; sterculia urens gum (INOLAXOL N) from 20Mar2018 to an unspecified date; metoprolol from 29May2020 to an unspecified date; bendroflumethiazide (SALURES) from 27Feb2021 to an unspecified date; mucopolysaccharide polysulfuric acid ester (HIRUDOID) from 19Mar2018 to an unspecified date; and salbutamol sulfate (VENTOLINE) from 19Mar2018 to an unspecified stop date. The patient previously took doxazocin and experienced unspecified previous drug reaction. In Mar2021, it was reported that three days after the vaccination with Comirnaty the patient arrived at the emergency room with RLS 8, no spontaneous breathing, had a laryngeal mask and weak peripherals pulses. The patient was found unconscious in her home after an alert from a friend. She had stable vital parameters but RLS 8 and did not respond to pain stimulation, large dilated pupils that did not respond to light. High suspicion of cerebral event why the patient went directly to the CT brain scan which confirmed a large parenchymal hemorrhage frontotemporal left side and large amounts of subarachnoid hemorrhage and significant mass effect with midline excess. Not considered to be in question for neurosurgical evacuation due to the large intracerebral hemorrhage, already signs of entrapment and poor prognosis. The patient was taken to the Intensive care unit to investigate whether she was possibly a candidate for organ donation, but it appeared later that she had declined this. Relatives were informed of the patient''s condition. Renewed clinical examination showed that the patient had no cerebral activity and was pronounced dead at midnight and the respirator was turned off. The reporter had no/very low suspicion of connection with the vaccination. It was assessed as a large intracerebral bleeding, probable rupture of previously known aneurysm. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Intracerebral haemorrhage; Subarachnoid haemorrhage |
| fever of 38.5 ? C; Edema upper limb; edema of vaccination arm; Oedema face; Hypotension; Tachycardia; Death unexplained; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The Regulatory Authority report number is FR-AFSSAPS-NT20210622. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 04Mar2021 14:00 (Batch/Lot Number: EP2166) as single dose for Covid-19 immunization. The patient received the first dose of Comirnaty on an unspecified date for Covid-19 immunization (unremarkable). Medical history included Covid-19 infection confirmed with positive PCR on 04Oct2020; ischaemic stroke, and type 2 diabetes mellitus: both from an unknown date and unknown if ongoing; No allergic history. Concomitant medications included bisoprolol, furosemide, acetylsalicylate lysine (KARDEGIC), metformin, alfuzosin hydrochloride (ALFUSIN), silodosin, finasteride, pantoprazole, ropinirole, alprazolam, oxazepam, zopiclone, mirtazapine, and olanzapine; all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient was living in an institution (GIR score 3) and vaccinated with a second dose of Comirnaty on 04Mar2021 at 2 pm. There was a post-vaccination surveillance for 20/30 minutes which was unremarkable. The next morning "around 8 a.m." (05Mar2021) when waking up (H + 19), the patient was found with a fever of 38.5 ?C, edema of the face and of the vaccinated arm, "hypotension of 9/5" and tachycardia. It was decided to hospitalize the patient, but the latter dies before the ambulance arrives, that is to say in less than an hour after the discovery of the first symptoms. The outcome of events was fatal. The patient died on 05Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained; Edema upper limb; Fever; Oedema face; Hypotension; Death unexplained; Tachycardia |
| SEPSIS; EMBOLISM MESENTERIC; MESENTERIC ISCHEMIA/acute on chronic mesenteric ischemia with necrosis of the small intestine; MESENTERIC ISCHEMIA/acute on chronic mesenteric ischemia with necrosis of the small intestine; acute on chronic mesenteric ischemia with necrosis of the small intestine; DIARRHEA; REDUCED GENERAL CONDITION; FALLING DOWN; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory authority report number NO-NOMAADVRE-FHI-2021-Uj3g9z, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00022624. An 86-years-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: EP2166), via unspecified route of administration on 26Feb2021 at a single dose for COVID-19 immunization. Medical history included Chronic Mesenteric Ischemia. The patient''s concomitant medications were not reported. On 27Feb2021, the patient experienced diarrhea, reduced general condition, and ''falling down''. On 01Mar2021, the patient developed sepsis, embolism mesenteric, mesenteric ischemia. On the same day, abdominal CT confirmed acute on chronic mesenteric ischemia with necrosis of the small intestine. The patient was admitted to hospital from 01Mar2021 to an unspecified date due to sepsis, embolism mesenteric, mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine. On an unspecified date in Mar2021, gastrointestinal surgery was performed and only 40 cm of viable intestines were found and this was not compatible with life. The patient died in Mar2021 due to sepsis, embolism mesenteric, and mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine. The outcome of the other events was unknown. It was not reported if an autopsy was performed. Sender Comment: The report applies to a patient who got diarrhea, reduced general condition and fell at home the day after the second dose of COMIRNATY. On 01Mar2021, the patient was hospitalized due to sepsis, embolism mesenteric, mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine. Abdominal CT showed acute on chronic mesenteric ischemia with necrosis of the small intestine. The reported reactions are not among the known side effects of this vaccine. As of today, we know a lot about side effects that occur in the days and weeks after vaccination, but we cannot rule out rare side effects or whether there should be side effects that only appear long after the vaccination. In each case, it is difficult to know whether the symptoms are due to the vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition and thus is disposed of in the relevant case. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis; Embolism mesenteric; mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine; mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine; mesenteric ischemia/acute on ch |
| bridging ischaemic stroke; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-701388. An 82-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, batch/lot number: EP2166), intramuscular on 05Mar2021 at 11:41 at 0.3 mL, single for SARS-CoV-2 vaccination. The patient''s medical history included thyroidectomy, ischaemic heart disease, and cognitive deterioration; all from an unknown date and unknown if ongoing. Concomitant medications included donepezil, bisoprolol fumarate (CARDICOR), acetylsalicylic acid, and levothyroxine sodium (EUTIROX); all taken for an unspecified indication, start and stop date were not reported. The patient experienced bridging ischaemic stroke on 06Mar2021, reported as the patient arrived at the emergency department on 06Mar2021 in a sleepy state. She was admitted to the emergency medicine ward on 11Mar2021 for coma in acute cerebral ischaemia. Her family reported that the patient had undergone the Pfizer vaccine on 05Mar2021. The patient died on 14Mar2021 due to the bridging ischaemic stroke. It was not reported if an autopsy was performed. Sender''s comment: Comirnaty vaccine batch EP2166 carried out on 05Mar2021 at 11.41. The report of the referring physician and the vaccination card always sent by the referring physician are attached. Requested additional data on previous pathologies or drugs taken by the patient and awaiting a reply. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: bridging ischaemic stroke |
| Hemorrhage of gastrointestinal tract, unspecified; This is a spontaneous report received from a contactable consumer or other non-HCP downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-LM20210562. Verbatim: Not medically confirmed. Patient notification Lot no EP2166, 1st dose 03Mar2021, left arm. Medical History, current diseases, context : COVID-19 disease history: NO, diabetes and cardiovascular disease. Description of Adverse Effect: Death of digestive hemorrhage on D3 of vaccination. The patient who lost weight due to diarrhea for a few weeks before vaccination. Brief observation, no further information available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhage of gastrointestinal tract, unspecified |
| suspected pulmonary embolism, during the diagnosis of a person who died in hospital, pending confirmation by histopathological examination; This is as spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is IT-MINISAL02-703463. A 84-year-old female patient received the first dose of BNT162B2 (COMIRNATY, COVID 19 COMIRNATY VACCINE (PFIZER): Booster dose number 1, formulation: Solution for injection, lot number: EP2166; Expiration date: not reported), via intramuscular route on 06Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Mar2021, The patient experienced suspected pulmonary embolism, during the diagnosis of a person who died in hospital, pending confirmation by histopathological examination. Reporter commented as, the patient died in hospital a few hours after admission two days after the first dose of the COMIRNATY vaccine. Diagnostic finding with suspicion of death due to pulmonary embolism (awaiting histological confirmation), Emergency department access documentation and autopsy report will be posted as soon as available. The patient underwent lab tests and procedures which included histological examination of the lungs: awaiting for the result on 11Mar2021. Outcome of the event was fatal. No follow-up attempts possible. No further information expected ad information on lot# already obtained.; Reporter''s Comments: Patient died in hospital a few hours after admission two days after the first dose of the Comirnaty vaccine . Diagnostic finding with suspicion of death due to pulmonary embolism (awaiting histological confirmation); Reported Cause(s) of Death: suspected pulmonary embolism, during the diagnosis of a person who died in hospital, pending confirmation by histopathological examination |
| Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-TO20211616. An 85-year-old female patient received bnt162b2 (COMIRNATY, Injection: D2), dose 2 intramuscular on 04Mar2021 (Lot Number: EP2166) as single dose (in "left") for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on an unspecified date (Lot Number: unknown) as single dose for COVID-19 immunization. The patient experienced infarct myocardial on 04Mar2021 (fatal). HISTORY OF THE CASE: Sudden death the night following the injection by myocardial infarction. The patient had no known cardiological history. EVOLUTION: Not reinstated on declaration date // 2021). The patient died on an unspecified date. It was not reported if an autopsy was performed. "Covid test: unknown" File in progress: request for additional information (atcd, other signs before death) No follow-up attempts are possible.; Reported Cause(s) of Death: Infarct myocardial |
| death; This is a spontaneous report from a contactable physician, downloaded from the WEB, regulatory authority number CZ-CZSUKL-21002656. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection; lot number: EP2166, expiration date was unknown), intramuscularly on 01Mar2021 at 0.3 mL, single for COVID-19 immunization. The patient''s medical history was not reported. The patient did not take any concomitant medicinal products. The patient experienced death on 05Mar2021. The patient died on 05Mar2021 after the first vaccination with COMIRNATY. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death/ patient died |
| Cardiac arrest; Shortness of breath/ dyspnoea; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the Regulatory Authority NL-LRB-00479712. An 81-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot Number: EP2166), via an unspecified route of administration on 10Mar2021 at age of 81-year-old at single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included beclomethasone/ formoterol/ glycopyrronium, simvastatine, omeprazole, carbasalate calcium, alendronic acid, propranolol, calcium carbonate/ colecalciferol (CALCIUM CARBONATE W/ VITAMIN D). No diagnostic procedures. No previous COVID-19 infection. On 15Mar2021, 5 days after BNT162B2, the patient experienced cardiac arrest and Shortness of breath/ dyspnoea. The outcome of events cardiac arrest and shortness of breath/ dyspnoea was fatal. The patient died on Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Dyspnoea |
| Sudden death (suspected cardiac); This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-700615. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EP2166), Intramuscularly on Left arm on 03Mar2021 18:54, at single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The physician reported for temporal correlation but, death not related to vaccination. The clinical report will be sent. The outcome of event was Fatal. No follow-up attempts possible. No further information expected.; Reporter''s Comments: reported only for temporal correlation but in my opinion death not related to vaccination; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the event cannot be totally excluded. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death |
| fall with bleeding at the cranial and nasal level; fall with bleeding at the cranial and nasal level; fall with bleeding at the cranial and nasal level; fall; This is a spontaneous report from a contactable other healthcare professional downloaded from a regulatory authority-WEB ES-AEMPS-795102. An 86-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 03Mar2021 (Lot Number: EP2166) at single dose for COVID-19 immunisation. Medical history included hypothyroidism, Type 2 diabetes, Anxiodepressive syndrome, osteoporosis, chronic venous insufficiency. Independent for basic activities of daily living. She was seen in the Rehabilitation Service on 01Feb2021. Clinical judgement: Low back pain, spondyloarthrosis, degenerative scoliosis. Right greater trochanter syndrome. Right coxarthrosis. Treatment: alternate paracetamol with metamizole magnesium (NOLOTIL) every 8h if pain. No hypertension, no dyslipidemia. No known heart disease or bronchopathy. Concomitant medications included levothyroxine sodium (EUTIROX); pentoxifylline (PENTOXIFILLINE); calcium pidolate, colecalciferol (OSVICAL D). The patient previously took calcium pidolate;colecalciferol (OSVICAL D), levothyroxine sodium (EUTIROX). It was reported that the first dose was administered and after 4 days, patient appeared deceased at her home without signs of violence. Four days after bnt162b2 administration, she was found dead on the bathroom floor. She showed signs of a fall with bleeding at the cranial and nasal level. The patient died on 08Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death |
| Vomiting; Chest pain; Cardiac arrest; Cardiogenic shock; Acute myocardial infarction; Weakness; Blood pressure decreased/blood pressure 90/60; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 69-year-old female patient received bnt162b2 (COMIRNATY) at the age of 69-year-old, via an unspecified route of administration on 26Feb2021 08:29 (Lot Number: EP2166; Expiration Date: 31May2021) as single dose for COVID-19 immunisation. Medical history included STEMI from an unknown date and unknown if ongoing, ongoing hypothyroidism, ongoing hypertension, and coronary artery disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported that the patient was hospitalized in the cardiology department from 28Feb2021, admitted with chest pain and vomiting. On 01Mar2021, the patient''s condition was stable, and her pulse was normal. On 02Mar2021 there was weakness, blood pressure decreased/blood pressure 90/60. On 04Mar2021, the patient''s health deteriorated, resuscitation was performed, then the patient was intubated and coronography (unknown results) was performed. On the same day (04Mar2021) at 05:50 there was a cardiac arrest, at 06:12 the patient died. The patient also experienced acute myocardial infarction, the secondary cause was cardiogenic shock on 04Mar2021. According to the death certificate, the initial cause was acute myocardial infarction, the secondary cause was cardiogenic shock, and the direct cardiac arrest. Chest pain and vomiting, weakness, blood pressure 90/60 were also reported as cause of death. It was unknown if an autopsy was performed. The reporting person classified them as serious. URPL (RA) also classified the application as a serious. Sender comment: Taking into account the entire clinical picture, it should be concluded that the symptoms were related to coronary artery disease, which had been diagnosed earlier. It is difficult to say whether exacerbation of coronary heart disease, MI and death were related to vaccination. In the database, 2 cases of unstable angina and 35 cases of acute myocardial infarction after COMIRNATY vaccine have been reported. There is a time relationship between the administration of the vaccine and the occurrence of the reaction. The reporting person classified it as serious, URPL also classified the report as serious. Relatedness of drug to all events assessed by Regulatory Authority as Unclassifiable (WHO method of assessment). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vomiting; Chest pain; Weakness; Blood pressure decreased/blood pressure 90/60; Acute myocardial infarction; Cardiac arrest; Cardiogenic shock. |
| CEREBRAL INFARCTION; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. An 88-year-old female patient received bnt162b2 (COMIRNATY), second dose intramuscular, administered in Arm Left on 24Feb2021 15:20 (Batch/Lot Number: EP2166) as single dose for covid-19 immunisation. The patient previously took the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation. Medical history included (reported as Multimorbid patient) type 2 diabetes mellitus, hypertension and heart failure, all from an unknown date and unknown if ongoing. Concomitant medication included candesartan cilexetil (ATACAND) taken for hypertension from 2016 to an unspecified stop date oral at 8 mg, 1x/day; acetylsalicylic acid, magnesium oxide (ALBYL-E) taken for type 2 diabetes mellitus from 2010 to an unspecified stop date oral at 75 mg, 1x/day; furosemide (FURIX [FUROSEMIDE]) taken for cardiac failure from 2018 to an unspecified stop date oral at 20 mg, 1x/day; lercanidipine hydrochloride (ZANIDIP) taken for hypertension from 2015 to an unspecified stop date oral at 10 mg, 1x/day; linagliptin (TRAJENTA) taken for type 2 diabetes mellitus from 2019 to an unspecified stop date oral at 5 mg, 1x/day. It was reported that the patient was admitted after being found by her son at 12:30 am on the day of admission, lying next to the bed. The son last observed her at 23:00 pm the night before, then she was in a habitual state. At hospitalization: neglect, left-sided hemiparesis, eye paresis, and clearly drooping corners of the mouth and dysarthria. No public assistance at home. It was reported that the patient with a large cerebral infarction six days (02Mar2021) after vaccination with covid-19 vaccine (Comirnaty). Rapid deterioration after hospitalization, and palliative treatment was started due to major irreversible brain damage, carotid stenoses bilaterally and age. She died nine days after the vaccination. The patient underwent lab tests and procedures which included computerised tomogram: ct caput (after hospitalization): on Mar2021 Large cerebral infarction. Central, right hemisphere, including basal ganglia. CT angio (after hospitalization): - Significant stenosis of the carotid bifurcation bilaterally. And lack of contrast filling throughout the course of the external carotid artery. The patient died on 05Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: A 88 years old woman with a large cerebral infarction six days after vaccination with covid-19 vaccine (Comirnaty). Rapid deterioration after hospitalization, and palliative treatment was started due to major irreversible brain damage, carotid stenoses bilaterally and age. She died nine days after the vaccination. Multimorbid patient with hypertension, heart failure and type 2 diabetes mellitus.; Reported Cause(s) of Death: cerebral infarction |
| Deterioration in general condition, worsening of general physical condition; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB, IT-MINISAL02-700476. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 (batch/lot number: EP2166; expiration date: 31May2021) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had deterioration in general condition, worsening of general physical condition on 13Mar2021. The patient died on 14Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Administration site: Left arm Sent from Agency; Reported Cause(s) of Death: Deterioration in general condition, worsening of general physical condition |
| Eating disorder; acute renal failure; dehydration; natremia at 166 mmol/L; worsening of dementia; notion of mottling; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB FR-AFSSAPS-PO20211322. An 83-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EP2166, expiry date not reported), intramuscular, administered in left arm on 02Mar2021 as 0.3 mL, single dose for covid-19 immunisation. Medical history included Dementia Alzheimer''s type (Alzheimer-type dementia) history (in nursing home) and hypothyroidism, both from an unknown date and unknown if ongoing at the time of the events. The patient''s concomitant medications were not reported. The patient had the first IM injection (0.3mL, left arm) of the Comirnaty vaccine (lot EJ6795) on 09Feb2021 for COVID-19 immunisation. Patient had hospitalization on 05Mar2021 to an unknown date in 2021, for acute renal failure, and dehydration (natremia at 166 mmol/L) in a patient with eating disorder, reported as refusing to eat; all on 05Mar2021. On entry, patient G15, opponent, clinical examination impossible (notion of mottling since 04Mar2021). Biological assessment at entry (05Mar2021): serum creatinine at 190 umol/l, uremia at 29 mmol/L, and natremia at 170 mmol/L. Establishment of SC hydration, introduction of treatment with morphine electric syringe pump 0.5 mg / h, and collective decision to limit acute care before death on 11Mar2021. As conclusion, the reporter mentioned a worsening of dementia in the post-vaccination context. Therapeutic measures were taken as a result of the events reported. The outcome of the event notion of mottling was unknown. The patient died on 11Mar2021. The causes of death were reported as eating disorder, acute renal failure, dehydration, natremia at 166 mmol/L, and worsening of dementia. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Eating disorder; acute renal failure; natremia at 166 mmol/L; dehydration; worsening of dementia |
| tired; Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-NT20210647. A 87-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Mar2021 (Batch/Lot Number: EP2166) as single dose on left arm for covid-19 immunisation. Medical history included recent stroke. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 12Mar2021. According to his wife, the patient had been tired in recent days. At around 6 a.m., the patient woke up screaming and died immediately. Intervention of the firefighters who ascertain the death. No COVID disease and no test performed. The patient died on 12Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death unexplained |
| Myocardial Infarction; Death unexplained; Pain in arm/pain in the injected arm; tingling; This is as spontaneous report received from a contactable consumer downloaded from the Regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-LM20210503. An 88-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EP2166), intramuscular, administered in arm left on 02Mar2021 as a single dose for COVID-19 immunisation. Medical history included arthrosis, hypercholesterolemia and hypertension arterial from an unknown date and unknown if ongoing, aortic incompetence from 2007 to an unknown date. The patient''s concomitant medications were not reported. Clinical course was as follows: On 02Mar2021, the patient had the first injection of the pfizer vaccine in the afternoon. On 03Mar2021, complained of pain in the injected arm, tingling described to her daughter over the phone, took paracetamol. No tachycardia (palpitations) described by the patient to her daughter. On 04Mar2021, called her daughter at 7:00 a.m., still complained of pain in the arm without other complaints, prepared to go to her cardiac ultrasound appointment, around 9:45 a.m. activation of the Presence system, phone call for verification but no response, the taxi driver who came to pick her up entered the home and found the patient on the ground, called the fire brigade, patient in cardiopulmonary arrest. Doctor noting death talked to family with myocardial infarction. The patient experienced death unexplained on 04Mar2021, pain in arm/pain in the injected arm and tingling on 03Mar2021. Therapeutic measures were taken as a result of pain in arm/pain in the injected arm and tingling. The outcome of the events was fatal. The patient died on 04Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: tingling; Pain in arm/pain in the injected arm; death unexplained; Infarct myocardial |
| sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-698035. An 86-year-old male patient received the first dose of bnt162b2 (COMIRNATY) (Lot Number: EP2166), intramuscular 0.3 mL, single on 10Mar2021 for COVID-19 immunisation. Medical history included ongoing chronic ischemic heart disease, ongoing diabetes mellitus. Concomitant medications included insulin for diabetes mellitus, pantoprazole sodium sesquihydrate (PANTORC), acetylsalicylic acid (CARDIOASPIRIN), amlodipine besilate, olmesartan medoxomil (BIVIS), fluvastatin sodium (LESCOL), tamsulosin hydrochloride (OMNIC), dutasteride (AVODART). The patient experienced sudden death on 12Mar2021. The patient died on 12Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death |
| Septic shock; Cardiogenic shock; Fasciitis necrotising; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA). The regulatory authority report number is IT-MINISAL02-697871. An 81-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EP2166, expiry date: May2021), via Intramuscular route, into Deltoid Right, on 05Mar2021 11:36 AM, at 0.3 ml single for SARS-CoV-2 vaccination. Medical history included Benign prostatic hyperplasia, Arterial hypertension and Dyslipidemia. Concomitant medications included oral amiodarone hydrochloride, at 200 mg, oral pantoprazole, at 40 mg and oral lercanidipine (LERCADIP, tablet), at 20 mg, oral allopurinol (ZYLORIC, 300 mg, tablet), at 300 mg, oral apixaban (ELIQUIS), at 5 mg, oral atenolol (ATENOLOLO EG, tablet, 50 mg), at 25 mg, oral ferrous sulfate (TARDYFER), at 80 mg, oral atorvastatin calcium (TOTALIP), at 20 mg; all for an unknown indication. On 06Mar2021, at 11:00, patient had Septic shock, Cardiogenic shock and Fasciitis necrotising. It was reported that on 06Mar2021, about 11 am, followed by progressive worsening and transferring to the ER of the hospital on 07Mar2021 at 00:26. The intake of Prostamol (1tabl) and Macular B forte (1tabl) supplements is reported. The reporter stated that patient sent by the ER of hospital for vascular surgery consultation in patient with suspected acute ischemia of the right upper limb, arrived at the triage of emergency and acceptance department at 05:16 on 07Mar2021, visited at 05: 26 in poor general condition, alert and collaborating, dyspnoic and at times agitated. The patient reported that had the first dose of anti-SARS-COV2 vaccine administered on 05Mar2021. The patient reported the appearance of edema, hyperemia and itching after about 24 hours from the first administration, he reported that he had been scratching and subsequently had blistering and pain in the whole right upper limb progressively worsening, thus he went to the ER of hospital after being first visited by the medical Service. At the ER of the hospital. He underwent blood tests, antigenic swab, cortisone therapy (urbason), antibiotics (merrem and vancomycin) and antihistamine, despite which the local clinical picture was progressively worsening. At our Emergency department the patient was subjected to molecular TNF, negative result, at 05:45 on 07Mar2021 he was taken to a CT section to perform chest and right upper limb CT in suspicion of acute ischemia; at 05:50 during the primary phase of the CT examination, before the administration of the contrast medium, the patient presented cardiocirculatory arrest for which resuscitation maneuvers began together with the anesthetists-resuscitators, according to the advanced cardiovascular life support (ACLS) protocol with an initial positive response. The patient was intubated, brain and chest CT scan was performed without Contrast medium and at 6:45 am on 07Mar2021 he was transferred to the red room of the emergency department, where the monitoring had been continued and at 6 :55 am presented a new episode of asystole. 5 cycles of cardiopulmonary resuscitation according to the ACLS protocol were performed without success; at 7:20 am on 07Mar2021 the death with diagnosis of necrotizing fasciitis, septic shock and cardiogenic shock was ascertained. The autopsy check of the body was requested, which was carried out on 09Mar2021. Seriousness of the events necrotizing fasciitis, septic shock and cardiogenic shock reported as fatal. Outcome of the events edema, Hyperemia and Itching was unknown. Outcome of events Septic shock, Cardiogenic shock and Fasciitis necrotising was fatal.; Sender''s Comments: The fatal events is assessed as possibly related to the suspect drug _comirnaty_____ based on strong temporal association, but consider also possible contributory effects from patient''s medical history and/or concomitant medications The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Septic shock; Cardiogenic shock; Fasciitis necrotising |
| Sudden death; Chest pain; Collapsed; This is a spontaneous report from a contactable physician from the Regulatory Authority. Regulatory Authority number: SI-JAZMP-NCPHV-2021SI0309_0309. An 81-year old male patient received his first dose of the BNT162B2 (COMIRNATY, batch EP2166, Expiration date 31May2021) intramuscularly on 05Mar2021 in the morning at single dose for COVID-19 immunization at home. Relevant medical history included dementia, ischemic heart disease, condition after STEMI, condition after prostate cancer, condition after large bowel volvulus, anemia and cachexia. Concomitant medications were not reported. On 05Mar2021 in the afternoon the patient collapsed in the bathroom. The patient was without signs of life when the physician arrived. The first EKG was asystole. An autopsy was ordered due to an unknown cause of death. The patient died unexpectedly at 5:58 p.m. On 5Mar2021, the patient complained of chest pain. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death |
| Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-14937. An 86-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 03Mar2021 (Lot Number: EP2166) as a single dose for COVID-19 immunization. Medical history included Multiple morbidities. The patient''s concomitant medications were not reported. On 09Mar2021 the patient experienced Death. The patient died on 09Mar2021. It was not reported if an autopsy was performed. Event assessed as serious. Sender Comment: Follow-up information has been requested. No follow-up attempts possible. No further information expected. COMIRNATY batch already obtained.; Reported Cause(s) of Death: unknown cause of death |
| dead; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-012965. Other Case identifier number: SE-MPA-1615191743107. A 77-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: EP2166), intramuscularly on Mar2021 at 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported, no known underlying diseases. The patient received vaccine in Mar2021 in the afternoon, felt well at least until the next morning. Alone at home in the forenoon the next day. The patient was found dead early in the afternoon the day after the vaccination. Probably died before 12 o''clock. Report assessed as serious, death. The patient died in Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death |
| Heart attack; This is a spontaneous report from a contactable consumer (patient''s daughter). A 70-year-old male patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, strength: 0.3 ml, Lot number: EP2166, expiration date: unknown) via an unspecified route of administration (location: Left arm) on 23Feb2021 at 10:00 AM at age of 70-year-old at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered at other facility. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included atorvastatin, metformin, and indapamide/ perindopril arginine (PRETERAX). The patient experienced heart attack on 28Feb2021 at 09:00 AM, seriousness criteria was reported as resulting to death. The patient didn''t receive any treatment for the event. Since the vaccination, he was not tested for COVID-19. The patient died on 28Feb2021 at 9:00 AM. The cause of death was reported as heart attack. An autopsy was not performed.; Reported Cause(s) of Death: Heart attack |
Subscribe to:
Posts (Atom)