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From the 10/15/2021 release of VAERS data:

Found 17,128 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 93 out of 172

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VAERS ID: 1084892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Decubitus ulcer, Dyspnoea, Hypoxia, Peripheral ischaemia, Pneumonia aspiration, Pulmonary congestion, SARS-CoV-2 test, Sepsis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arteriopathy; Morbid obesity; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: SARS CoV2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021233020

Write-up: pressure ulcers; toe ischemia; disorders of consciousness; possible aspiration pneumonia; sudden congestion; Septicaemia/sepsis; Respiration labored; Hypoxia/desaturation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-NC20210580. A 77-year-old female patient received BNT162B2 (COMIRNATY, Batch number: EJ6788), intramuscular on the left deltoid, first dose on 26Jan2021 at single dose, for COVID-19 immunisation. Medical history included Type II diabetes, arteriopathy obliterating of the lower limbs, arterial hypertension and morbid obesity from unspecified dates. The patient''s concomitant medications were not reported. It was reported that vaccination carried out on 26Jan2021 (D1) done in the left deltoid. Clinical signs and chronology of facts was death in hospital, 3 days after vaccination, however with no obvious link to vaccination; cause of death indicated by the hospital was septicaemia/sepsis on 27Jan2021 starting on the skin (pressure ulcers and toe ischemia from unspecified dates). Patient was initially sent to the emergency room on 27Jan2021 for sudden congestion and hypoxia/desaturation attributed to disorders of consciousness (from unspecified date) with possible aspiration pneumonia (from unspecified date). Patient also experienced respiration labored on 27Jan2021. Summary of management was hospitalization. Evolution: Death due to the effect on 29Jan2021. Conclusion was sepsis with fatal course 3 days post vaccination. The patient underwent lab tests and procedures which included test against SARS CoV2 negative (no date specified). The patient died on 29Jan2021. It was not reported if an autopsy was performed. The pharmacovigilant notes: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Official Bulletin of the Minister in charge of Health no 84/50, January 24, 1985. Published in Therapy 1985; 40: 111-8. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Septicaemia/sepsis


VAERS ID: 1084893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Cerebrovascular accident, Dropped head syndrome, Faecaloma, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral hemorrhage; Manic depressive illness
Allergies:
Diagnostic Lab Data: Test Name: SARS CoV2 test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021233032

Write-up: Fecaloma; Cardiac arrest; Asthenia; suspicion of stroke; Dropped head syndrome; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The Regulatory Authority report number is FR-AFSSAPS-NC20210581. An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6788, expiration date not reported), intramuscular in the left deltoid on 26Jan2021 at a single dose for COVID-19 immunisation. Medical history included Manic depressive illness and cerebral haemorrhage from 2015. The patient''s concomitant medications were not reported. On 01Feb2021, the patient experienced asthenia, suspicion of stroke (leaned to the side) and dropped head syndrome and was referred to the emergency room on 02Feb2021. The patient was then hospitalized on 02Feb2021 for gastroenterology fecaloma. The patient died during the night of 02Feb2021 due to cardiac arrest depending on the hospital. It was concluded that Suspicion of stroke then cardiac arrest one week after vaccination. Other treatments included AVK. The patient underwent lab tests and procedures which included SARS CoV2 test which was negative on an unspecified date. It was not reported if an autopsy was performed. The pharmacovigilant notes: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest; Fecaloma; Dropped head syndrome; suspicion of stroke; Asthenia


VAERS ID: 1084896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Heart rate
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Auricular fibrillation; Chronic kidney disease (on dialysis); Dialysis; Hyperlipidemia; Hypertension arterial; Obesity; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/47; Comments: before; Test Date: 20210128; Test Name: Blood pressure; Result Unstructured Data: Test Result:106/45; Comments: after; Test Date: 20210130; Test Name: Blood pressure; Result Unstructured Data: Test Result:141/56; Comments: before; Test Date: 20210130; Test Name: Blood pressure; Result Unstructured Data: Test Result:101/54; Comments: after; Test Date: 20210128; Test Name: pulse; Result Unstructured Data: Test Result:87; Comments: before; Test Date: 20210128; Test Name: pulse; Result Unstructured Data: Test Result:69; Comments: after; Test Date: 20210130; Test Name: pulse; Result Unstructured Data: Test Result:71; Comments: before; Test Date: 20210130; Test Name: pulse; Result Unstructured Data: Test Result:74; Comments: after
CDC Split Type: FRPFIZER INC2021232972

Write-up: Death unexplained/died; This is a spontaneous report from the regulatory authority-WEB, regulatory authority report number: FR-AFSSAPS-PS20210359. A contactable physician reported that a 73-year-old female patient received first dose of bnt162b2 (COMIRNATY solution for injection; lot number: EJ6788; expiry date: unknown) intramuscular in the right arm, on 28Jan2021, at a single dose, for COVID-19 immunisation. Medical history included chronic kidney disease on dialysis, type 2 diabetes mellitus, hypertension arterial, obesity, hyperlipidemia, atrial fibrillation (auricular fibrillation). The patient had no medical history of COVID-19. Concomitant medications were not reported. On Thursday, 28Jan2021, the patient underwent dialysis before the vaccination, without any noticeable event. The declarant indicated that she did not present any undesirable effects following the vaccination which could have unbalanced one of the chronic pathologies (no flu-like syndrome, no tachycardia, no feeling of chest tightness). On 28Jan2021, day of dialysis, the patient''s blood pressure (BP) before was 110/47, pulse (before) 87; BP (after) 106/45, pulse (after) 69. Treatments carried out during the session were Venofer, 2 skin diastop. On 30Jan2021, the patient also had a dialysis without any noticeable event. On the same day of dialysis (30Jan2021), BP (before) was 141/56, pulse (before) 71 BP (after) 101/54 Pulse (after) 71. Treatments carried out during the session were Venofer, 2 skin diastop, and Aranesp 150 ug. A diabetology consultation was scheduled for 01Feb2021. According to the declarant, the patient was rather stabilized for some time. On 31Jan2021, the patient died due to an unknown cause at her home. No autopsy was performed. Patient had no recent blood test. The declarant was briefed by the paramedics. In total, an unexplained death occurring 3 days after vaccination in a patient with numerous comorbidities. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained/died


VAERS ID: 1084897 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Blood sodium, Blood sodium increased, Death, Dehydration, Heart rate, Hypotension, Malaise, Oxygen saturation, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLIPRANE; FOLIC ACID; JOSIR; LASILIX [FUROSEMIDE]; METFORMIN; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; SERESTA; ZOPICLONE; ZYMA-D2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertensive heart disease NOS; Insulin-requiring type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: hemoglucotest; Result Unstructured Data: Test Result:10.4 mmol/L; Test Date: 20210127; Test Name: blood pressure; Result Unstructured Data: Test Result:still low but better tolerated; Test Name: blood pressure; Result Unstructured Data: Test Result:low but better torated mmHg; Test Date: 20210126; Test Name: blood pressure; Result Unstructured Data: Test Result:85/56 mmHg; Test Date: 20210126; Test Name: blood pressure; Result Unstructured Data: Test Result:149/86 mmHg; Test Date: 20210127; Test Name: natremia; Result Unstructured Data: Test Result:150 mmol/L; Test Date: 20210126; Test Name: pulse; Result Unstructured Data: Test Result:115 bpm; Test Date: 20210126; Test Name: saturation; Test Result: 94 %; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative; Test Date: 20210111; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021232913

Write-up: died (death unexplained); dehydration with natremia at 150 mmol / L; dehydration with natremia at 150 mmol / L; Feeling sick; Tachycardia; Arterial hypotension; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB. Regulatory authority report number is FR-AFSSAPS-RS20210217. A 91-year-old male patient received first dose of BNT162b2 (COMIRNATY, lot number: EJ6788, expiry date not reported), intramuscular in the left arm on 25Jan2021 at single dose for COVID-19 immunization. Medical history included insulin-requiring type 2 diabetes mellitus, dementia, and hypertensive heart disease. Concomitant medications included paracetamol (DOLIPRANE), folic acid, tamsulosin hydrochloride (JOSIR), furosemide (LASILIX), metformin, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), oxazepam (SERESTA), zopiclone, and ergocalciferol (ZYMA-D2). On 26Jan2021, the patient was feeling sick with outcome of recovered on an unspecified date, had tachycardia with outcome of unknown, arterial hypotension with outcome of not recovered. The clinical course was reported as follows: The patient received a COVID test 3 days before entering care home on 11Jan2021: negative result. On 26Jan2021 afternoon, the patient vagal discomfort with arterial hypotension at 85/56 mmHg; pulse at 115 bpm; 94 percent saturation; t ? C at 36 ? C (hemoglucotest (HGT) 10.4 mmol / L during the midday meal). Recovery after a few minutes with BP controlled at 149/86 mmHg. Then, recurrence of drop in blood pressure at night without discomfort with blood pressure at 67/38 mmHg. Stopping the following medicines, JOSIR and SERESTA. On 27Jan2021, blood pressure still low but better tolerated. No discomfort. Treatment by administration of NaCl and compression stockings. Subsequently blood pressure still low. On balance, evidence of dehydration with natremia 150 mmol / L. Change from NaCl to G5%. No improvement in the patient''s condition, which is deteriorating. Administration of midazolam and oxycodone from 03Feb2021. The patient died (death unexplained) on 04Feb2021. It was not reported if an autopsy was performed.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: the fatal event is handled as related to suspect drug Comirnaty as a cautionary measure and for reporting purposes. The impacts 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: Death unexplained


VAERS ID: 1084898 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Wrong patient received product
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Palliative care
Preexisting Conditions: Medical History/Concurrent Conditions: Cachexia; Malnutrition; Starvation
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232776

Write-up: Death NOS; received injection of the vaccine when the family had not given their consent (error in the listing of patients at the (name of accommodation facility)); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority report number is FR-AFSSAPS-TO20210921. A 97-year-old female patient received BNT162B2 (COMIRNATY; Solution for injection, Lot number: EJ6788, unknown expiration), intramuscular on 09Feb2021 at a single dose for COVID-19 immunisation. Medical history included malnourished, starvation (unknown if ongoing), cachexia (unknown if ongoing), and palliative care since 07Oct2020. The patient''s concomitant medications were not reported. On 09Feb2021, the patient received injection of the vaccine when the family had not given their consent (error in the listing of patients at the (name of accommodation facility)) in a malnourished and cachectic person and in the unit protected in palliative care since 07Oct2020. The patient experienced death NOS without any particular symptoms on 16Feb2021. 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 NOS


VAERS ID: 1084917 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood test, Body temperature, Cholelithiasis, Culture urine, Fatigue, Hepatitis, Hypotonia, Pyrexia, Ultrasound abdomen
SMQs:, Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: T4; CARVEPEN; COZAAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (mild hypertension without medication)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: blood test; Result Unstructured Data: Test Result:cholelithiasis and liver inflammation; Test Date: 20210203; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 202102; Test Name: URINE CULTURE; Result Unstructured Data: Test Result:cholelithiasis and liver inflammation; Test Date: 202102; Test Name: upper lower abdominal ultrasound; Result Unstructured Data: Test Result:cholelithiasis and liver inflammation
CDC Split Type: GRPFIZER INC2021226195

Write-up: Abdominal pain; Fatigue; low grade fever/38 degree Celsius fever; atonia; cholelithiasis; liver inflammation; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB GR-GREOF-20211364. A 93-years-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EJ6134 and Expiration Date unknown) via intramuscular on 01Feb2021 at single dose for COVID-19 immunisation. Medical history included mild hypertension without medication. Concomitant medication included levothyroxine sodium (T4), carvedilol (CARVEPEN), losartan potassium (COZAAR). The next day (02Feb2021) she presented fatigue, low grade fever and atonia and on 03Feb2021 she presented 38 degree Celsius fever and abdominal pain. After several days in Feb2021, the symptoms did not retreat and the patient was examined by physician and did blood test, urine culture and upper lower abdominal ultrasound that diagnosed cholelithiasis and liver inflammation. She started Zinadol medication. On 18Feb2021 (15 days since the beginning of Zinadol per os administration, 2 dosage form per day, indication fever, possible cholecystitis) since there was no improvement, she was admitted to hospital, did examinations, hospitalization not needed and received guideline to continue Zinadol and undergo further check when there is improvement. Patient died on 21Feb2021 early hours. Seriousness criteria was provided as death and medically significant. The patient underwent lab tests and procedures which included 38 centigrade on 03Feb2021; blood test, urine culture and upper lower abdominal ultrasound that diagnosed cholelithiasis and liver inflammation in Feb2021. Treatment was received for fever, possible cholecystitis. The outcome of all events was fatal. An autopsy was not performed. Reporter comments: No medical history except for mild hypertension without medication. The patient received the first dose of Comirnaty on 01Feb2021. The next day she presented low grade fever and atonia and on 03Feb2021 she presented 38 degree Celsius fever and abdominal pain. After several days the symptoms did not retreat and the patient was examined by physician and did blood test, urine culture and upper lower abdominal ultrasound that diagnosed cholelithiasis and liver inflammation. She started Zinadol medication. On 18Feb2021 (15 days since the beginning of Zinadol per os administration, 2 dosage form per day, indication fever, possible cholecystitis) since there was no improvement, she was admitted to hospital, did examinations, hospitalization not needed and received guideline to continue Zinadol and undergo further check when there is improvement. She died on 21Feb2021 early hours. Sender comments: initial report with additional information. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: low grade fever/38 degree Celsius fever; atonia; abdominal pain; cholelithiasis; liver inflammation; fatigue


VAERS ID: 1084920 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COLECALCIFEROL; VASELINE CETOMACROGOL CREAM; MOVICOLON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia vascular; TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021221943

Write-up: vomiting, a few minutes after administration; Loss of consciousness; Nausea; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority [regulatory authority NL-LRB-00449312]. A 88-years-old female patient received BNT162B2 (COMIRNATY, lot number:EM0477) , via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation. Medical history included dementia vascular, transient ischaemic attack. Concomitant medication included colecalciferol, cetomacrogol, paraffin, liquid, propylene glycol, white soft paraffin (VASELINE CETOMACROGOL CREAM), macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON). Ten minutes following the vaccination, the patient became nauseous, had to vomit and became unconscious. The patient was treated with adrenaline which was not effective. The patient deceased after an unknown period.The patient died on an unspecified date. It was not reported if an autopsy was performed. All events were fatal. Case Summary and Reporter''s Comments Text : BioNTech / Pfizer vaccine (Comirnaty) -Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no -vomiting, few minutes after administration- Additional information ADR: then loss of consciousness -confounding factors-confounding factors: dementia Not Otherwise Specified (mixed, vascular component with TIA)-COVID19-Previous COVID-19 infection: No-Other- diagnostic procedures: no No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) -Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no -vomiting, few minutes after administration- Additional information ADR: then loss of consciousness -confounding factors-confounding factors: dementia Not Otherwise Specified (mixed, vascular component with TIA)-COVID19-Previous COVID-19 infection: No-Other- diagnostic procedures: no; Reported Cause(s) of Death: nausea; loss of consciousness; vomit


VAERS ID: 1084921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021226298

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-NL-LRB-00450128, Safety Report Unique Identifier NL-LRB-00454199. A 87-year-old female patient received bnt162b2 (COMIRNATY, lot: EJ6790), via an unspecified route of administration on 19Feb2021 at 0.3 mL, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included rivaroxaban (XARELTO). One day after vaccination (20Feb2021), the patient was death. The reporter described that it is suspected that the patient already deceased on the day of vaccination. It is unknown whether the patient had complaints after vaccination or not. The cause of death is unknown. The outcome of the event was fatal. The patient died on 20Feb2021. No autopsy was performed. Health Authority Comment: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Death Additional information ADR: the patient was found dead the day after the vaccination, there is not known information about possible complaints after the vaccination. It is suspected that the patient has already died on the day of the vaccination. Previous COVID-19 infection: No Follow-up received dated 23Jan021: I cannot answer most of the questions as I do not know enough about the patient and no access got her file. I had the inspection during a shift from the GP. In answer to the 1st question I can say that the primary cause of death in the patient is unknown. In answer to the last question: no autopsy was performed. For the other questions I want you refer to patient''s GP COMIRNATY batch EJ6790 No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on Pfizer policy, all death cause unknown events are assessed to be related to the subject drugs. This case will be reassessed when additional information becomes 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: death


VAERS ID: 1084923 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal obstruction, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diaphragmatic hernia
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite; Fracture; Swallowing difficult (had some trouble eating and swallowing for years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021226257

Write-up: Nausea; spontaneous total gastric occlusion/ spontaneous gastric closure; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00454720. A 92-year-old female patient received bnt162b2 (COMIRNATY, lot number: EJ6134), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunization. Medical history included ongoing diaphragmatic hernia, fracture in the diaphragm (she had had some trouble eating and swallowing for years); the patient was healthy before the vaccination. She recently became very sick following an administered tetanus vaccination for a dog bite. The patient''s concomitant medications were not reported. The patient experienced nausea on 29Jan2021, the event was reported as serious per death and hospitalization. At the same date as the day of vaccination, the patient experienced nausea. According to the reporter, the nausea lead to a spontaneous total gastric occlusion which was diagnosed at the hospital. The cause was a diaphragmatic hernia. The patient was treated by a laparoscopy and the occlusion was repaired. The outcome of nausea is fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no, Nausea. Hospitalization information: The nausea has resulted in a spontaneous gastric closure in which the hospital found that the stomach was quite high and tilted due to a fracture in the diaphragm (she had had some trouble eating and swallowing for years) confounding factors confounding factors, allergy: my mother did not take any asperient yet. never been ill in her life but coincidentally last bit on a bicycle by a dog and then teatanus injection and penicillin treatment which also made her very nauseous and even dead ill. Previous COVID-19 infection: No. Other diagnostic procedures: all kinds of investigations in X. No follow-up attempts are needed. No further information expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no, Nausea. Hospitalization information: The nausea has resulted in a spontaneous gastric closure in which the hospital found that the stomach was quite high and tilted due to a fracture in the diaphragm (she had had some trouble eating and swallowing for years) confounding factors confounding factors; Reported Cause(s) of Death: nausea; spontaneous total gastric occlusion/ spontaneous gastric closure


VAERS ID: 1084924 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Gastrointestinal haemorrhage, Influenza like illness
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BARNIDIPINE; SIMVASTATINE; CLOPIDOGREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021226270

Write-up: Death; Gastrointestinal bleeding; Influenza like illness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number : NL-LRB-00454938. An 83-year-old female patient received bnt162b2 (COMIRNATY) , via an unspecified route of administration on 22Feb2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included barnidipine, simvastatine, and clopidogrel. The patient experienced death on 24Feb2021, influenza like illness (non-serious) on 22Feb2021. Additional information: ''This serious spontaneous report from a physician concerns a female aged 83 years influenza like illness and who deceased following administration of covid-19 vaccin pfizer injvlst (action taken: not applicable) for covid 19 immunisation. On the day of vaccination, the patient experienced flu like symptoms, but she felt better on the following day. Two days after vaccination, the patient was found deceased. She probably died of a gastro-intestinal bleeding since bloody stool were seen at the place she was found. The patient was not known with gastro-intestinal problems. Drugs and latency: 1. covid-19 vaccin pfizer injection. Death: 2 days after start. Influenza like illness: 1 day after start''. Reporter''s Comment: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Death. Additional information on adverse drug reaction: the day of vaccination some flu-like symptoms reported in family, a day later she reported feeling better again. Patient died 2 days after vaccination. probably had gastrointestinal bleeding because of bloody stools where they were found. She was not familiar with gastrointestinal complaints or rectal bleeding. She did use clopidogrel, barnidipine and simvastatin (for several years) without complaints. So whether the death is related to the vaccination is difficult to prove but I do mention it . BSN available: Yes. Previous COVID-19 infection: No. Other diagnostic procedures: no, family does not want autopsy. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Death. Additional information on adverse drug reaction: the day of vaccination some flu-like symptoms reported in family, a day later she reported feeling better again. Patient died 2 days after vaccination. probably had gastrointestinal bleeding because of bloody stools where they were found. She was not familiar with gastrointestinal complaints or rectal bleeding...; Reported Cause(s) of Death: Gastrointestinal bleeding; Death


VAERS ID: 1084926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AFIPRAN; ELIQUIS; SOBRIL; NITROGLYCERIN; VENTOLINE [SALBUTAMOL]; PARACET [PARACETAMOL]; SELO-ZOK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive lung disease (Severe COPD); Hypertension; Lung embolism (Previous); Oxygen therapy (at home)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021221988

Write-up: FOUND DEAD; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB manufacturer report number NO-NOMAADVRE-FHI-2021-Ux338, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00016100. An 89-years-old female patient received bnt162b2 (COMIRNATY, LOT# EJ6789), intramuscular in left arm on 17Feb2021 17:00 at second single dose for covid-19 immunization. Medical history included severe chronic obstructive lung disease (COPD) and previous lung embolism, oxygen therapy at home, hypertension. Concomitant medication included metoclopramide hydrochloride (AFIPRAN), apixaban (ELIQUIS) for lung embolism, oxazepam (SOBRIL), nitroglycerin, salbutamol (VENTOLINE) for chronic obstructive lung disease, paracetamol (PARACET), metoprolol succinate (SELO-ZOK) for hypertension. The patient previously took first dose bnt162b2 (LOT# EM0477) on 28Jan2021 for covid-19 immunization and experienced back pain on 03Feb2021, increasing dyspnea on 10Feb2021, confusion (known from before) on 13Feb2021 and hypertension on 13Feb2021. One day after dose number 2 (18Feb2021), the patient was found dead in her home on the kitchen floor 10:55 am. It was unknown if an autopsy was performed. Reporter''s assessment: Elderly patient with several underlying diseases who was found dead the day after vaccination. Difficult to establish any connection with the vaccine, but still sends a routine report about this. Sender''s Comments: The most commonly reported adverse reactions with this vaccine were injection site pain (92%), fatigue (weakness) (70%), headache (65%), muscle pain (62%), joint pain (46%), chills (45%), nausea / vomiting (23%), swelling / tenderness in the shoulder area (20%), fever (16%), swelling (15%) or redness (10%) at the injection site. Most reactions were mild and transient, lasting a few days. Side effects were more pronounced after the second dose than after the first dose. Back pain, dyspnoea, confusion and hypertension are not listed as known side effects of the vaccine in the approved Summary of Product Characteristics (SPC) for Comirnaty. In general, the cause of death in multimorbid elderly and / or nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebrovascular diseases were accounted for 1 out of 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (about 20%), respiratory and infectious diseases (including pneumonia and sepsis) (about 15%), and cancer (about 10%). When vaccinating frail patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease(s). In the case in question, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease(s) or another random, concurrent cause that has nothing to do with the vaccination in question. Based on the information in the report and in accordance with international criteria, the causal relationship between the side effects and the vaccine is considered 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. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. Relatedness of drug to reaction(s)/event(s) Comirnaty/all events Source of assessment Regional Pharmacovigilance Center: Result of Assessment: Possible.; Reporter''s Comments: Elderly patient with several underlying diseases who was found dead the day after vaccination. Difficult to establish any connection with the vaccine, but still sends a routine report about this; Sender''s Comments: Linked Report(s) : NO-PFIZER INC-2021242202 Same patient, same suspect product, different vaccine dose and different events; Reported Cause(s) of Death: dead


VAERS ID: 1084928 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021233391

Write-up: one person had heart attack and died; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date the patient had a heart attack and died. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1084929 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Death; A regulatory authority report (Poland) was received from a physician concerning a 73-years old, patient who received Moderna''s COVID-19 Vaccine (mRNA-1273) and the patient died. The patient''s medical history was not provided by the reporter. On 17 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot number G26761A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient died. Death occurred several days after vaccination . The Reporter described as uncertain of the effect of the vaccination on death. There is a time relationship between vaccination and the occurrence of side effects. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The cause of death was not reported. Autopsy performed was unknown.; Reporter''s Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender''s Comments: Zgon wystapil kilka dni po szczepieniu u starszej osoby. Nieznana jest historia medyczna pacjenta. Lekarz opisal jako niepewny wplyw szczepionki na zgon. Istnieje zwiazek czasowy miedzy szczepieniem a wystapieniem dzialan niepozadanych. Osoba zglaszajaca NOP zakwalifikowala go jako ciezki. URPL ocenil NOP jako ciezki.; Reported Cause(s) of Death: death


VAERS ID: 1085212 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood creatinine, Blood glucose fluctuation, Dyspnoea, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID CARDIO; LOSARTAN POTASSIUM; TORSEMIDE; FLUVASTATIN SODIUM; TAMSULOSIN HYDROCHLORIDE; PREDNISOLONE; PREGABALIN; NALOXONE HYDROCHLORIDE; METAMIZOLE SODIUM; PARACETAMOL; OMEPRAZOLE; SODIUM BICARBONATE; MAGNESIUM ASPARTATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy (known for allergy to Klacid.); Omarthrosis (the patient was known for severe pain from bilateral massive omarthrosis.)
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: creatinine; Result Unstructured Data: 94 mcmol/l; Test Date: 20210122; Test Name: blood sugar; Result Unstructured Data: 6.3 mmol/L
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: severe pain; hardly eaten, asthenic, very tired; Dyspnoea; high temperature 2 days; A regulatory authority report was received from a physician concerning a 88 years old male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The reported patient''s medical history includes that he was a polymorbid (list of diagnoses not known) patient known for severe pain from bilateral massive omarthrosis. He was in palliative care according to the reporter. Allergic to Klacid. Concomitant medications included ASS Cardio Spirig 100mg 1x1, Losartan Spirig 25mgx1, Torasemid Sandoz 10mg 2x2, Fluvastatin Sandoz 20mg 1x1, Tamsulosin 0.4mg 1x1, Targin 5 / 2.5mg 2X1, Lyrica 75mg 2x1, Novalgin 500mg 3x1 (+ in reserve max 3x1), Paracetamol SA 160mg 2x1 (+ in reserve max 4x1), Omeprazil Sandoz 20mg 1x1, Macrogol Sandoz 1x1, Magnesiocard 10mmol 1x1, and Spiricot 5mg 1x1. The patient was generally weak, deconditioned and no longer mobile, so they had proceeded with a conservative approach and purely palliative. On 20-Jan-2021, eight days prior to the death, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at an unspecified site for prophylaxis of COVID-19 infection. On 21-Jan-2021, the patient appeared weak and bedridden. On 22-Jan-2021, the patient had hardly eaten, was very tired, asthenic with blood pressure 98/60, temperature 37.8 ? C, dyspneic, received 2L of oxygen. In the evening he experienced pain in the shoulders and in the whole body, was very thirsty with blood sugar of 6.3 mmol / L and from this moment on the usual pharmacotherapy was no longer given. On an unknown date in Jan 2021 the creatinine level was 94 mcmol/L . On 23-Jan-2021, the patient had severe pain and could only eat 1 yogurt. He was afebrile. On 24-Jan-2021, from this moment the patient had difficulty to awaken but remained afebrile. On 25-Jan-2021, the patient could no longer be awakened and a fixed morphine dose was set. On 28-Jan-2021 in the morning, the patient died. Further course was not known. Death occurred 8 days after the administration of the Covid-19-Moderna vaccine. Reporter stated that immediately after vaccination, the patient did not experience any adverse reactions, in particular none were observed symptom attributable to a possible anaphylactic allergic reaction. In consideration of the palliative context, in the absence of laboratory and imaging data (not performed), only in the presence of a data of high temperature 2 days after the vaccine, which however normalized the following day, no other elements were emerged suggestive for a possible causal correlation between the vaccine and death. The reporter stated they believed there was unlikely the causal correlation between the Covid-19-Moderna vaccine and the death of this patient. Treatment of the event was not available. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of event, death was fatal. The patient died on 28-Jan-2021. The cause of death was unknown. The autopsy report was not provided.; Reporter''s Comments: Based on reporter''s causality and rationale, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Asthenia; Dyspnoea; High temperature; pain


VAERS ID: 1085213 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMANTADINE; SCOPODERM [HYOSCINE HYDROBROMIDE]; AMLODIPINE; METOPROLOL
Current Illness: COPD; Multiple sclerosis; Syndrome respiratory distress adult (restrictive respiratory syndrome (CV 14% of the predetermined value) with the installation of a non-ventilated invasive (VNI)); Tetraplegia; Urinary infection (recurrent); Von Willebrand''s disease (Type 2 A)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Cardiac arrest; A regulatory report was received from a physician concerning a 53-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced cardiac arrest and died. The patient''s medical history included restrictive respiratory syndrome, multiple sclerosis, tetraplegia, COPD, urinary infection, and von Willebrand''s disease. The concomitant medications included amantadine, amlodipine, metoprolol, scopolamine/hyoscine. On 22-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 300042460) intramuscularly for prophylaxis of COVID-19 infection. On 26-Jan-2021, 4 days after receiving the vaccine, the patient experienced cardiac arrest and was transported to the hospital in an ambulance. The patient died before arriving. Treatment information was not reported. Action taken with mRNA-1273 was not applicable. On 26-Jan-2021, the patient died due to cardiac arrest. Autopsy details were unknown.; Reporter''s Comments: Very limited information regarding these events has been provided at this time. Patient''s underlying conditions may have been contributory for the occurrence of this fatal event. No further follow-up information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1086537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021242195

Write-up: acute shortness of breath, immediately transferred to the hospital; Death NOS; COVID-19 respiratory infection; This is a spontaneous report downloaded from the regulatory authority-WEB [Regulatory Authority number AT-BASGAGES-2021-04883] from a contactable physician. An 87-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) (lot# EL1491), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death NOS (death) on 29Jan2021, acute shortness of breath, immediately transferred to the hospital (death, caused hospitalization on 27Jan2021) on 27Jan2021, COVID-19 respiratory infection (death) on 26Jan2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 26Jan2021. 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: COVID-19 respiratory infection; Acute dyspnea; Death NOS


VAERS ID: 1086540 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension (Art HT); Atrial fibrillation (VHF); COPD (COPD); Palliative care (palliative Situation)
Preexisting Conditions: Medical History/Concurrent Conditions: Infarct cerebral (St.p. ischemic. Infarct); Pulmonary embolism (St p pulmonary embolism)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021242203

Write-up: Cardiovascular failure; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority (AT-BASGAGES-2021-07101). An 81-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number EL1491) via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included ongoing palliative care, ongoing arterial hypertension, ongoing chronic obstructive pulmonary disease (COPD), infarct cerebral (St.p. ischemic. Infarct) on an unspecified date and unknown if ongoing, pulmonary embolism on an unknown date and not ongoing (St p pulmonary embolism) and ongoing atrial fibrillation (VHF). Concomitant medications were not reported. In Jan2021, the patient experienced cardiovascular failure (cardio-respiratory arrest) with fatal outcome; the patient died on 29Jan2021. An autopsy was not performed. The patient was not suffering from COVID-19. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiovascular failure


VAERS ID: 1086548 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOCETIRIZINE; FRAXIPARINE; BURINEX; ATORVASTATIN; D-VITAL CALCIUM; DAFALGAN; CETIRIZIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Dependence on oxygen therapy; Intestinal operation (10 years ago); Pacemaker insertion (cardiac) (since 1 year); Peripheral venous disease (Blood circulation in the legs: was continuously bothered by this; had artificial veins); Surgery (Blood circulation in the legs: was continuously bothered by this; had artificial veins); Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021236712

Write-up: death received vaccine on Thursday 4 February; death on Sunday 7 February afternoon; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority BE-FAMHP-DHH-N2021-78388. An 87-year-old male patient received the first dose of bnt162b2 (COMIRNATY) (Lot # EJ6789), via an unspecified route of administration at single dose on 04Feb2021 for COVID-19 immunisation. Medical history included that the patient was very weak; blood circulation in the legs: was continuously bothered by this; had artificial veins; no more surgery possible; pacemaker since 1 year; bowel surgery: 10 years ago; oxygen dependent; bedridden. Concomitant medication included levocetirizine, nadroparin calcium (FRAXIPARINE), bumetanide (BURINEX), atorvastatin, ascorbic acid, calcium carbonate, colecalciferol, ergocalciferol (D-VITAL CALCIUM) , paracetamol (DAFALGAN), cetirizine hydrochloride (CETIRIZIN). The patient experienced death received on Thursday 4 February; death on Sunday 7 February afternoon The patient died on 07Feb2021. It was not reported if an autopsy was performed. Reporter''s comment: Treatment - Evolution of the ADR - Death ADR description - Death vaccine received on Thursday 4 February; death on Sunday 7 February afternoon. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Treatment - Evolution of the ADR - Death ADR description - Death vaccine received on Thursday 4 February; death on Sunday 7 February afternoon; Reported Cause(s) of Death: death


VAERS ID: 1086549 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-04
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Oxygen saturation abnormal
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021236701

Write-up: COVID-19 16day infection after vaccination; COVID-19 16day infection after vaccination; putting on high flow oxygen, then going to intensive care.; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB BE-FAMHP-DHH-N2021-79019. A 76-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), Lot# EM0477, via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that on 04Feb2021 the patient was put on high flow oxygen due to oxygen saturation abnormal, then he went to intensive care. The following was also reported: "COVID-19 16day infection after vaccination requiring hospitalization with high-flow oxygen". On an unspecified date few days after admission the patient died. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Oxygen saturation abnormal


VAERS ID: 1086550 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-08
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, General physical health deterioration, Renal failure, Respiratory distress
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BELLOZAL; TAMSULOSIN; OLANZAPINE; LORAZEPAM; PARACETAMOL; MELATONINE; PRAZEPAM; DESMOPRESSIN; HALDOL; QUETIAPIN; CALCIFEROL [COLECALCIFEROL]; INDAPAMIDE; L-THYROXINE [LEVOTHYROXINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Chronic renal failure worsened; Mental retardation; Osmolality abnormal NOS; Paranoid schizophrenia; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021236705

Write-up: COVID-19; COVID-19; Respiratory distress; Renal failure; General physical health deterioration; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority BE-FAMHP-DHH-N2021-79023. A 68-year-old male patient received first dose bnt162b2 (COMIRNATY, lot: EM0477), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation. Medical history included Mental retardation, paranoid schizophrenia, potomania, severe chronic renal failure, benign prostatic hyperplasia, heavy smoking. Concomitant medication included bilastine (BELLOZAL), tamsulosin, olanzapine, lorazepam, paracetamol, melatonine, prazepam, desmopressin, haloperidol (HALDOL), quetiapine fumarate (QUETIAPIN), colecalciferol (CALCIFEROL), indapamide, levothyroxine (L-THYROXINE). The patient experienced respiratory distress, renal failure, general physical health deterioration, covid-19, all on 08Feb2021 with fatal outcome. It was reported that severe Covid-19 infection requiring hospitalization for respiratory distress and deterioration of general condition, aggravation of respiratory distress and increase in renal failure requiring intensive care. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. BNT162B2 for all events reported by FAMHP as unlikely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: covid-19; covid-19; respiratory distress; renal failure; general physical health deterioration


VAERS ID: 1086566 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-02-12
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CELLCEPT [MYCOPHENOLATE MOFETIL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myositis
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021236718

Write-up: Covid-19; Covid-19; This is a spontaneous report from a non-contactable physician from the regulatory authority-WEB DE-PEI-PEI2021003038 . A 80-year-old female patient received two doses bnt162b2 (COMIRNATY) , via an unspecified route of administration on 04Jan2021 and 25Jan2021 both at single doses for covid-19 immunisation. Medical history included myositis. Concomitant medication included immunotherapy with mycophenolate mofetil (CELLCEPT) for myositis. On 12Feb2021 after vaccination the patient developed COVID-19 and death on 12Feb2021. Diagnosis was confirmed by COVID-19 PCR test (result: positive) in Feb2021. Death cause was reported as COVID-19. The patient died on 12Feb2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1086568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Coronavirus test, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: routine rapid test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021241865

Write-up: routine rapid tests was positive; routine rapid tests was positive; This is a spontaneous report from a contactable physician. A 94-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The 94-year-old woman who died in the days that followed in 2021, routine rapid tests was positive 2021. The patient underwent lab tests and procedures which included coronavirus test: positive on 2021. The patient died in 2021. It was not reported if an autopsy was performed. It was reported that: residents and staff in a nursing home were administered the first dose of Comirnaty on 27Jan2021. During routine rapid tests in the days that followed, a large number of residents and staff were positive. Most of these were asymptomatic or with only minor symptoms of illness, and none required hospitalization. In the end, there was a 94-year-old woman who died in the days that followed. The physician assume that the germ was already in the house in the run-up to the vaccination. In his/her opinion, the vaccination had the effect that there were no severe courses. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information available, a causal association between BNT162b2 and the reported event cannot be excluded. The patient''s immunocompromised state due to age and the current pandemic may provide an alternative explanation for the events. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: there was a 94-year-old woman who died in the days that followed; there was a 94-year-old woman who died in the days that followed


VAERS ID: 1086569 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-24
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, C-reactive protein, Dyspnoea, Microbiology test, Oropharyngeal pain, Pneumonia, Pyrexia, Respiratory failure, SARS-CoV-2 test, Transplant failure, X-ray
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOL SANDOZ; PRAVASTATIN STADA; MYFENAX [MYCOPHENOLATE MOFETIL]; FELODIPIN ACTAVIS; PREDNISOLONE; SULFAMETHOXAZOLE; PREGABALIN KRKA; CIQORIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung transplant; Nephropathy
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: C-reactive protein; Result Unstructured Data: Test Result:400 mg/l; Test Date: 202101; Test Name: Microbiology test; Test Result: Negative ; Comments: Microbiology test after BAL, negative; Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 202101; Test Name: X-ray; Result Unstructured Data: Test Result:infiltrates on a chest radiograph
CDC Split Type: DKPFIZER INC2021241783

Write-up: Mechanical ventilator-dependent respiratory failure; ARDS; fever; OBS pneumonia.; over one day, the patient developed progressive breathing difficulty; Sore throat; Graft failure; This is a spontaneous report downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0035761. The case was received from a contactable physician via The Danish Medicines Agency (DKMA). A 49-years-old male patient started to receive first dose of bnt162b2 (COMIRNATY) , from lot number: EM0477 Expiration date :30APR2021 via intramuscular on 07Jan2021 at single dose for covid-19 immunisation . Medical history included lung transplant on 15Aug2020 (not ongoing) and nephropathy (not ongoing) Failure.Patient has no concurrent conditions. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOL SANDOZ) for Gastroesophageal reflux prophylaxis from 15Aug2020, pravastatin sodium (PRAVASTATIN STADA) for Hypercholesterolaemia from 15Aug2020, mycophenolate mofetil (MYFENAX [MYCOPHENOLATE MOFETIL]) for Prophylaxis against lung transplant rejection from 15Aug2020 , felodipine (FELODIPIN ACTAVIS) for Cardiac disorder prophylaxis from 08Dec2020, prednisolone (Prednisolon "DAK") for Steroid therapy from 15Aug2020 , sulfamethoxazole for Infection prophylaxis from 23Sep2020, pregabalin (PREGABALIN KRKA) for Pain prophylaxis from 15Aug2020, ciclosporin (CIQORIN) Prophylaxis against lung transplant rejection from 15Aug2020. All concomitant drugs are given prophylactically in connection with lung transplantation.On 24Jan2021 the patient developed ARDS, graft failure, fever, pneumonia, difficulty breathing and sore throat. On 26Jan2021 the patient developed respiration failure. As a consequence of Respiration failure, the patient needed mechanic respiratory therapy on the 26Jan2021. The ADRs, fever, pneumonia, difficulty breathing and sore throat, were by the physician reported as resulting in hospitalization (on 25Jan2021). The ADRs ARDS, graft failure and respiration failure were reported as fatal. The patient was treated with antibiotic (drug name or substance not specified) and empiric antifungal therapy (drug name or substance not specified) due to the ADRs. The patient was connected to a respirator (26Jan2021) and was connected to an ECMO the 28Jan2021 in 4 days due to the ADRs. After the patient came off the ECMO, mechanical ventilator was still needed. The outcome for the ADRs; fever, pneumonia, Difficulty breathing, difficulty breathing and sore throat was unknown. The outcome for the ADRs; ARDS and graft failure and respiration failure was fatal (date of death: 12Feb2021). Reported cause of death: Respiration failure (date of death (12Feb2021). Post mortem examination was performed: Comments of autopsy findings (24Feb2021): The lung tissue showed severe changes (areas of black discoloration). No Abnormal findings on other organs. The physician assumes that the lung disease could explain the cause of death. Microscopic examination of lung tissues. Result: NA. TEST: C-reactive protein (test date: Jan2021). Test result: 400 mg/L.COVID-19 virus test (test date: Jan2021). Test result: Negative. X-ray (test date: Jan2021). Test result: infiltrates on a chest radiograph. Microbiology test (test date: Jan2021). Test result: Microbiology test after BAL, negative. Causality: No signs of transplant rejection after the transplantation. This was biopsy-confirmed (biopsy scores: 0-3), where all the biopsies were scored as grade 0. The patient had no concomitant conditions in the time around the transplantation and until the patient was hospitalized (25Jan2021). The physician informs that he suspects that the COVID-19 vaccine has triggered the immune system to trigger an inappropriate immune response which eventually lead to the patient''s death. If the Danish Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted. ADDITIONAL INFORMATION ON DRUG PROVIDED IN PRODUCT NOTES Product notes for Comirnaty: Previous given: No No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ARDS; Graft failure; Respiration failure


VAERS ID: 1086572 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-12
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Oxygen saturation, Oxygen saturation decreased, Petit mal epilepsy
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive deterioration; Colon diverticulitis; COVID-19; Dysthymic disorder; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:90/50; Test Name: saturation; Test Result: 71 %
CDC Split Type: ESPFIZER INC2021236711

Write-up: Absence seizure; Arterial oxygen saturation decreased; Hypotension; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB (Regulatory Authority number ES-AEMPS-756661). A 90-year-old female patient received BNT162B2 (COMIRNATY, lot number EK9788), intramuscularly on 03Feb2021 at single dose for COVID-19 immunisation. It was reported the patient received another dose of BNT162B2 (COMIRNATY, lot number EM0477) on 13Feb2021 at single dose (clarification pending). Medical history included hypertension arterial, dysthymic disorder, COVID-19 from Dec2020, colon diverticulitis, cognitive deterioration. The patient''s concomitant medications were not reported. The patient previously took alopurinol, enalapril, torasemide (TORASEMIDA), donezepil hydrochloride (ARICEPT), trazodone hydrochloride (DEPRAX), simvastatin (SIMVASTATINA). It was reported that on 12Feb2021 the patient experienced absence seizure, arterial oxygen saturation decreased, hypotension. The patient died from the events on an unspecified date. It was not reported if an autopsy was performed. Clinical course was reported as follows: an 88-year-old patient (as reported) with the history described that this morning is taken to the nursing consultation for presenting episodes (in number of 3) of absence, with significant desaturation and increased work of breathing, presenting hypotension in episodes (90/50) cold sweating and desaturation (71%) in pulse oximetry. They do not report fever or cough, or respiratory distress in the previous days. Upon arrival at the hospital, the patient was admitted as a corpse.; Reported Cause(s) of Death: Absence seizure; Arterial oxygen saturation decreased; Hypotension


VAERS ID: 1086583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Blood glucose, Body temperature, C-reactive protein increased, Chest X-ray, Culture urine, Escherichia infection, Heart rate, Leukocytosis, Miosis, Oxygen saturation, SARS-CoV-2 test, Sepsis, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VIPDOMET; GALANTAMINE; DEPRAX [FLUOXETINE HYDROCHLORIDE]; LORMETAZEPAM; ADIRO; PARACETAMOL; ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Recurrent UTI; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: Blood culture; Result Unstructured Data: Test Result:Negative x 3; Comments: Negative x 3; Test Date: 20210203; Test Name: blood glucose; Test Result: 241 mg/dl; Test Name: Temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Name: chest x-ray; Result Unstructured Data: Test Result:infiltrate in the right lung base is observe; Test Name: C-reactive protein increased; Test Result: 13.2 mg/dl; Test Date: 20210203; Test Name: C-reactive protein increased; Test Result: 13.1 mg/dl; Test Date: 20210203; Test Name: Culture urine; Result Unstructured Data: Test Result:Escherichia Coli; Comments: Escherichia Coli; Test Date: 20210203; Test Name: HR; Result Unstructured Data: Test Result:158; Test Name: leukocytosis; Result Unstructured Data: Test Result:17200; Test Date: 20210203; Test Name: miotic pupils; Result Unstructured Data: Test Result:miotic pupils; Test Date: 20210203; Test Name: Oxygen saturation; Test Result: 72 %; Test Date: 20210203; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210203; Test Name: WBC; Result Unstructured Data: Test Result:17.2; Comments: Units:10*3/uL
CDC Split Type: ESPFIZER INC2021236713

Write-up: Escherichia coli infection; Sepsis/sepsis of respiratory origin; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB, regulatory authority report number: ES-AEMPS-768748. A contactable physician reported that a 93-year-old female patient received second dose of bnt162b2 (COMIRNATY solution for injection; lot number: EK9788; expiry date: unknown) intramuscular, on 29Jan2021, at 0.3 mL, single, for COVID-19 immunisation. Medical history included hypertension arterial, type 2 diabetes mellitus (DM), and recurrent urinary tract infections (UTIs). Concomitant medications included alogliptin benzoate, metformin hydrochloride (VIPDOMET), galantamine, fluoxetine hydrochloride (DEPRAX), lormetazepam, acetylsalicylic acid (ADIRO), paracetamol, and enalapril. The patient previously received first dose of bnt162b2 (COMIRNATY; lot number: EM0477) intramuscular on 08Jan2021 at 0.3 mL, single, for COVID-19 vaccination. The patient has already received the 2 doses of Pfizer''s SARS-CoV2 vaccine, the 2nd dose was on 29Jan2021. She has had no other changes in situation or treatments. On 03Feb2021, patient was referred from the residence, with suspicion of acute stroke, because around 8:00 p.m. they find that she does not react to stimuli, with respiratory rhonchi, saturation of 72% baseline, HR: 158, miotic pupils and blood glucose of 241 mg / dL. Exploration: Temperature 36.2 centigrade poor general condition, stuporous, cold sweating, tachypneic. AP: crackles in bases. Neurological examination: miotic pupils, remove limbs to pain. Evolution: A 100% KMV was placed, a bladder catheter with a clear urine outlet without objectifying. Acute retention of urine and a complete blood count, biochemistry, coagulation, portable and elemental chest X-ray, and urine sediment and urine culture are requested. 1 ampoule of furosemide was administered. In laboratory tests, hyperglycemia was observed, so patient was prescribed 6 IU of rapid insulin, and elevated RFA (CRP of 13.2 and leukocytosis of 17200). In chest x-ray, infiltrate in the right lung base was observed. Requested blood cultures and start empirical antibiotic therapy with piperacillin / tazoabactam. SARS-CoV2 nasopharyngeal swab requested as admission protocol. On 03Feb2021, patient was diagnosed with was sepsis of respiratory origin and escherichia coli infection. On 04Feb2021, the patient was admitted for sepsis of respiratory origin, who has not responded to antibiotic therapy and shows clear signs of claudication with rattling breathing, work of breathing. The patient died on 04Feb2021 due to escherichia coli infection and sepsis. Autopsy information was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis/sepsis of respiratory origin; Escherichia coli infection


VAERS ID: 1086584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Echocardiogram, Ischaemic cerebral infarction, Ischaemic stroke, Pneumonia aspiration, Ultrasound Doppler
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUPHALAC [LACTULOSE]; ALDACTONE [SPIRONOLACTONE]; CARDYL; OPIREN; KEPPRA; DEPRAX [FLUOXETINE HYDROCHLORIDE]; DUODART; ESCITALOPRAM; FOLI-DOCE; TARDYFERON
Current Illness: Living in nursing home (Partially dependent)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial therapeutic procedure; Arteriopathy (peripheral artery disease with complete occlusion of left popliteal artery to distal trunks); Atrial fibrillation (chronic complete arrhythmia due to atrial fibrillation anticoagulated with Sintrom.); Atrial fibrillation with slow ventricular response; Cardiac failure chronic aggravated; Carotid artery stenosis; Chronic iron deficiency anemia; Cognitive deterioration (mild-moderate cognitive impairment); Cor pulmonale; Dyslipidaemia; Hypertension arterial; Post herpetic neuralgia; Pulmonary arterial hypertension; Sinus node dysfunction; Syncope vasovagal (Vaso-vagal/orthostatic syncope, admission to hospital in 2017); TIA (with asymptomatic bilateral carotid stenosis)
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: Brain CT; Result Unstructured Data: Test Result:Acute ischemic infarction in the left temporal lob; Comments: Acute ischemic infarction in the left temporal lobe; Test Date: 2018; Test Name: Echocardiography; Result Unstructured Data: Test Result:Severe binaural dilatation; Comments: Mild-moderate AoS. LVEF 55-60%. Moderately dilated RV. Moderate-severe TR.; Test Date: 2017; Test Name: TSA Doppler; Result Unstructured Data: Test Result:no significant stenosis
CDC Split Type: ESPFIZER INC2021236704

Write-up: Aspiration pneumonia; Ischaemic stroke; Acute ischaemic infarction in the left temporal lobe; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (Regulatory Authority number ES-AEMPS-769325). An 84 years old male patient received the second dose of BNT162B2 (COMIRNATY; lot EK9788) intramuscular, on 30Jan2021, 0.3 ml single, for COVID-19 immunization. The patient was institutionalised in a nursing home (partially dependent). Medical history included syncope vasovagal from 2017 (vaso-vagal/orthostatic syncope, admission to hospital in 2017), cognitive deterioration (mild-moderate cognitive impairment), dyslipidaemia, hypertension arterial, arteriopathy in 1993 (peripheral artery disease with complete occlusion of left popliteal artery to distal trunks with posterior tibial and fibula recanalization in 1993, cardiac failure chronic aggravated from Oct2020, chronic iron deficiency anemia from Oct2020, atrial fibrillation (in 2018 slow AF), cor pulmonale with PAH, TIA in 2006 with asymptomatic bilateral carotid stenosis, sinus dysfunction, postherpetic neuralgia. The patient had chronic complete arrhythmia due to atrial fibrillation anticoagulated with acenocoumarol (SINTROM) from2014 until 2019. The first dose of Comirnaty was given on 08Jan2021, batch/lot number EM0477, intramuscular, for COVID-19 immunization. Echocardiogram 2018: severe biauricular dilatation. Mild-moderate AoS. LVEF 55-60%. Moderately dilated RV. Moderate-severe TR. Last TSA Doppler 2017: no significant stenosis. Concomitant medications included oral lactulose (DUPHALAC) one for breakfast and another for lunch, oral spironolactone (ALDACTONE; 25 mg film-coated tablet) 25 mg, 1x/day, oral atorvastatin calcium (CARDYL; 20 mg film-coated tablet), oral lansoprazole (OPIREN; 15 mg capsule) 15 mg, 1x/day, oral levetiracetam (KEPPRA; 500 mg film-coated tablet), 500 mg, 1x/day, oral fluoxetine hydrochloride (DEPRAX; 100 mg film-coated tablet) 50 mg, 1x/day (1/2 tablet for dinner), dutasteride, oral tamsulosin hydrochloride (DIODART) one tablet during supper, oral escitalopram (10 mg tablet) 10 mg, 1x/day (1-0-0 ), oral cyanocobalamin, folic acid (FOLI-DOCE) 1 tablet during breakfast and ferrous sulfate (TARDYFERON) once daily (1-0-0). On 07Feb2021 the patient experienced ischaemic stroke with a fatal outcome. The patient referred to the emergency department for clonus in EESS and right EEII, deviation of the labial commissure to the right and constant blinking of the OD since 08Feb2021 morning. The nurse of the Residence also reported hypotonia and that he was not very reactive. On 08Feb2021 brain CT revealed acute ischaemic infarction in the left temporal lobe. He was assessed by personnel: ischaemic stroke in the left MCA territory with cardioembolic profile in the context of non-anticoagulated AF + acute symptomatic focal crises. Given the situation of baseline dependence, and having decided to withdraw anticoagulation, it was decided to maintain a conservative approach. On 09Feb2021: high fever and increased respiratory secretions were reported. Diagnostic impression: possible bronchoaspiration. The patient died on 11Feb2021. It was unknown if an autopsy was done. Aspiration pneumonia was reported as cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Aspiration pneumonia; Ischaemic stroke; Acute ischaemic infarction in the left temporal lobe


VAERS ID: 1086591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Antimicrobial susceptibility test, Asthenia, Bacterial test positive, Blood glucose, Blood glucose increased, Blood pressure measurement, Body temperature, C-reactive protein, Culture urine, Death, Fatigue, Glomerular filtration rate, Heart rate, Hypertension, Infection, Malaise, Muscle twitching, Nausea, Pyelonephritis, Pyrexia, SARS-CoV-2 test, Urine analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARA-TABS; FURESIS; TRAJENTA; PEGORION; NORSPAN [BUPRENORPHINE]; IMOVANE; MINIFOM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Dementia; Flatus; Insomnia; Mild mental retardation; Pain; Swelling; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: susceptibility test; Result Unstructured Data: Test Result:Ciprofloxacin is a suitable drug for its treatment; Test Date: 20210215; Test Name: Blood sugar; Result Unstructured Data: Test Result:high, around 33; Test Date: 20210216; Test Name: Blood sugar; Result Unstructured Data: Test Result:high; Test Date: 20210218; Test Name: Blood sugar; Result Unstructured Data: Test Result:still high, about 20; Comments: even on fasting; Test Date: 20210219; Test Name: Blood sugar; Result Unstructured Data: Test Result:around 20-25; Comments: high; Test Date: 20210220; Test Name: Blood sugar; Result Unstructured Data: Test Result:high; Test Date: 20210221; Test Name: Blood sugar; Result Unstructured Data: Test Result:high; Test Date: 20210222; Test Name: Blood sugar; Result Unstructured Data: Test Result:high; Test Date: 20210215; Test Name: Blood pressure; Result Unstructured Data: Test Result:184/96; Test Date: 20210216; Test Name: Body temperature; Result Unstructured Data: Test Result:up to 39.4 Centigrade; Test Date: 20210218; Test Name: Body temperature; Result Unstructured Data: Test Result:maximum of 39 Centigrade; Test Date: 20210215; Test Name: CRP; Result Unstructured Data: Test Result:5; Test Date: 20210216; Test Name: CRP; Result Unstructured Data: Test Result:11; Comments: low; Test Date: 20210218; Test Name: CRP; Result Unstructured Data: Test Result:remains low; Test Date: 20210219; Test Name: CRP; Result Unstructured Data: Test Result:2; Test Date: 20210222; Test Name: CRP; Result Unstructured Data: Test Result:38; Test Date: 20210219; Test Name: urine culture; Result Unstructured Data: Test Result:in urine grows coliform rodent bacteria; Test Date: 20210216; Test Name: glomerular filtration rate (GfR); Result Unstructured Data: Test Result:40; Comments: fall; Test Date: 20210215; Test Name: heart rate; Result Unstructured Data: Test Result:96; Test Date: 20210216; Test Name: Covid test; Test Result: Negative ; Test Date: 20210216; Test Name: urine; Result Unstructured Data: Test Result:erythrocytes ++, nitrite +, leukocytes ++.
CDC Split Type: FIPFIZER INC2021236702

Write-up: Death; Fatigue; Muscle twitching; weakened; Bacteria urine identified; Pyrexia; Pyelonephritis; the focus of the infection is unclear; Nausea; Malaise; vomiting; Blood glucose increased; Blood pressure 184/96; This is a spontaneous report from a contactable nurse downloaded from the Medicines Agency (MA) WEB FI-FIMEA-20210954. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot: EL0725), intramuscular on 10Feb2021 at 0.3 mL, single for covid-19 immunization. Medical history included type 2 diabetes, mild mental retardation, dementia, pain, constipation, insomnia, Flatus, swelling. Concomitant medication included paracetamol (PARA-TABS) for Pain from Sep2016, furosemide (FURESIS) for Swelling from Oct2020, linagliptin (TRAJENTA) for Diabetes from Oct2020, macrogol 4000 (PEGORION) for Constipation from Oct2017, buprenorphine (NORSPAN) for pain from Dec2015, zopiclone (IMOVANE) for Insomnia from Nov2018, simeticone (MINIFOM) for Flatus from Jan2019. The patient experienced death on 22Feb2021 18:20; nausea, malaise, vomiting, blood glucose increased, blood pressure 184/96 on 15Feb2021; pyrexia, pyelonephritis, the focus of the infection is unclear on 16Feb2021; bacteria urine identified on 19Feb2021; fatigue, muscle twitching, weakened on 20Feb2021. The events were reported as serious as death. On 15Feb2021 at breakfast and lunch malaise and vomiting. High blood sugar around 33 observed at 3 p.m., Blood pressure 184/96, heart rate 96, rapid CRP 5. Received Novorapid and Paracetamol as adviced by a physician, however, no clear response. 16Feb blood sugar still high, fever up to 39.4, , however rapid CRP low: 11. Consumer relatively well-being, urine with precipitation, no upper respiratory or skin symptoms, no abdominal symptoms. Clean-catch urine taken: erythrocytes ++, nitrite +, leukocytes ++. Started treatment for a incipient pyelonephritis : Ciprofloxacin 250 mg x 2, a reduced dose was decided because glomerular filtration rate (GfR) in the fall approximately 40, now possibly even lower. Blood tests could not be taken very easily from the consumer. However, the focus of the infection is unclear, that is why a Covid sample was taken and found to be negative. On 18Feb The fever continued, with a maximum of 39. Condition relatively good, cheerfully chatted. Sugars were still high, about 20 even on fasting, received Novorapid. Decided to temporarily take Lantus 10 IU (this dose was also before), in addition to blood sugar further corrected with Novorapid x 3 / day (morning + lunch + dinner). The idea arose as to whether fever could be associated with a covid vaccine received on 10Feb because CRP remains low. On 19Feb fever still and high blood sugar values ??(around 20-25), continued despite paracetamol and insulin treatment, CRP 2. Urine culture result and susceptibility test completed, found that in urine grows coliform rodent bacteria and Ciprofloxacin is a suitable drug for its treatment. But clear focus of infection still not found. A hospice care decision has been made. More painkillers prescribed : BuTrans ad 10 micrograms, and whenever needed. Oxynorm 5-10 mg at a time without upper limit. Paracetamol extended orally / rectally. It was agreed that regular medication will be given as soon if the consumer takes it. On 20-21Feb the consumer condition has remained the same, despite insulin treatment, blood sugar values ??remained high and fever despite receiving paracetamol. consumer tired and weakened, meals have gone variably. She did not appear suffering, with occasional twitching in the upper body. On 22Feb CRP 38, consumer eating significantly reduced, was really weakened, fever and high blood sugar values still despite paracetamol and insulin use. Looks painless, twitching from time to time in the upper body. At 18.20 the consumer died. The outcome of the events was fatal. The patient died on 22Feb2021 18: 20 due to events. 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: Vomiting; Bacteria urine identified; Fatigue; Muscle twitching; weakened; Nausea; Malaise; Blood glucose increased; Blood pressure 184/96; Pyrexia; Pyelonephritis; the focus of the infection is unclear; death


VAERS ID: 1086592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Cough, Death, General physical health deterioration, Pneumonia, Secretion discharge
SMQs:, Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease (Alzheimer''s disease with frontal features); Cognitive disorders (progressing cognitive symptoms since 1997)
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Respiratory tract infection; Swallowing difficult
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:70; Test Name: CRP; Result Unstructured Data: Test Result:50
CDC Split Type: FIPFIZER INC2021236721

Write-up: Death; Pneumonia; General physical health deterioration; Mucus; cough; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FI-FIMEA-20210957. A 80-years-old male patient started to receive bnt162b2 (COMIRNATY), Lot #EL1491 intramuscular on 28Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included progressing cognitive symptoms from 1997 and ongoing, dementia alzheimer''s type Alzheimer''s disease with frontal features ongoing, respiratory tract infection, epilepsy, dysphagia. The patient''s concomitant medications were not reported. On 04Feb2021 the patient experienced mucus and cough, pneumonia treated with intravenous antibiotics, general physical health deterioration, and death. The patient underwent lab tests and procedures which included c-reactive protein:70 and 50. The patient died on 08Feb2021. Expected death, but chronological connection to the vaccine. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Pneumonia; General physical health deterioration; Death


VAERS ID: 1086607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021242206

Write-up: Died in sleep; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-BR20210421. An 89-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EP9598), intramuscular at arm left on 24Feb2021 at single dose for COVID-19 immunisation. Medical history included cardiac failure on an unspecified date. The patient''s concomitant medications were not reported. The patient died in sleep on 25Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Died in sleep


VAERS ID: 1086624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Blood pressure diastolic decreased, Blood pressure measurement, Body temperature, Coma scale, Crepitations, Death, Electrocardiogram, Heart rate, Heart rate decreased, Investigation, Laboratory test, Oxygen saturation, Renal function test, SARS-CoV-2 test, Scan brain, Therapeutic response unexpected
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NADOLOL; OXAZEPAM; CARBIMAZOLE; PARACETAMOL; NEBIVOLOL; FUROSEMIDE [FUROSEMIDE SODIUM]; COLECALCIFEROL; BROMAZEPAM; RENUTRYL BOOSTER; OPTIVE
Current Illness: Asthenia; Cachexia
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Aortic stricture (Tight RA (aortic stenosis) w/ global cardiac decompensation at the end of 2019, stable in June 2020 (LVEF) 45%, HVG conce); Cognitive impairment (Unexplored neurocognitive disorder); Dehydration; Disorientation; Fall (impossibility of getting up.); Hematoma; Hospitalization (hospitalized in this context of repeated falls and difficult home maintenance); Hyperthyroidism (on carbimazole); Left ventricular hypertrophy; Oral rehydration; Papillitis (Pseudopapillite vasculaire en 2000); Tachycardia paroxysmal; Varicose veins (compression stockings); Walking aid user
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: blood culture; Test Result: Negative ; Test Date: 20210215; Test Name: BP; Result Unstructured Data: Test Result:102/77; Test Date: 20210216; Test Name: BP; Result Unstructured Data: Test Result:165/72; Test Date: 20210217; Test Name: BP; Result Unstructured Data: Test Result:108/57; Test Date: 20210217; Test Name: BP; Result Unstructured Data: Test Result:110/56; Test Date: 20210218; Test Name: BP; Result Unstructured Data: Test Result:107/59; Test Date: 20210218; Test Name: BP; Result Unstructured Data: Test Result:112/55; Test Date: 20210218; Test Name: BP; Result Unstructured Data: Test Result:107/59; Test Date: 20210217; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210218; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210215; Test Name: Coma Scale; Result Unstructured Data: Test Result:15; Comments: small temporo-spatial disorientation; Test Date: 20210215; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm at 65 bpm, a left axis and le; Comments: regular sinus rhythm at 65 bpm, a left axis and left ventricular hypertrophy.; Test Date: 202102; Test Name: Pulse rate; Result Unstructured Data: Test Result:between 52 and 68 bpm; Comments: no fever, eupneic in ambient air.; Test Date: 20210215; Test Name: Pulse rate; Result Unstructured Data: Test Result:63 bpm; Test Date: 20210215; Test Name: investigation; Result Unstructured Data: Test Result:Presence of a hematoma localized to the right zygo; Test Date: 20210215; Test Name: clinical examination; Result Unstructured Data: Test Result:unremarkable; Comments: no neurological deficit; Test Date: 20210218; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:96; Test Date: 20210215; Test Name: renal clearance; Result Unstructured Data: Test Result:28 ml/min; Comments: 28 ml / min / 1.73m2 (usual clearance at 47 ml / min / 1.73m2) in favor of dehydration (dry tongue).; Test Date: 20210218; Test Name: renal clearance; Result Unstructured Data: Test Result:48 ml/min; Comments: 1.73m2; Test Date: 20210215; Test Name: covid-19 pcr test; Test Result: Negative ; Test Date: 20210215; Test Name: Brain scan; Result Unstructured Data: Test Result:scheduled
CDC Split Type: FRPFIZER INC2021232837

Write-up: few sub-crackles located in the 2 fields, without functional repercussions; Death unexplained; Renal function improved with an estimate of GFR (Glomerular filtration rate) by the Agency formula at 48 ml / min / 1.73m2; values of 108/57 and 110/56 on 17Feb2021 and 112/55 then 107/59 on 18Feb2021; pulse oscillated between 52 and 68 bpm during the stay; This is a spontaneous report from a contactable physician reporting for a patient downloaded from the regulatory authority FR-AFSSAPS-DJ20210313. An 87-year-old female patient received bnt162b2 (COMIRNATY; Lot number EM6950), intramuscular on 17Feb2021 at SINGLE DOSE for covid-19 immunisation. Medical history included anxiety; hyperthyroidism on carbimazole; Aortic stricture, described as Tight RA (aortic stenosis) with global cardiac decompensation at the end of 2019, stable in June 2020 (LVEF ( Left ventricular ejection fraction) 45%, HVG (left ventricular hypertrophy) conce; Cognitive impairment, Unexplored neurocognitive disorder; and tachycardia paroxysmal from an unknown date and unknown if ongoing, papillitis, Pseudopapillite vasculaire en 2000 on 2000, unknown if ongoing; and ongoing asthenia; ongoing cachexia; walk with a cane / walker from an unknown date. The patient was reported as asthenic cachetic patient, and lives alone at home. The patient would have fallen twice, on February 14 and 15 (2021) in the evening with the impossibility of getting up. On 15Feb2021, she was hospitalized in this context of repeated falls and difficult home maintenance. BP emergencies was at 102/77 (15Feb2021), pulse at 63 bpm; no fever, eupneic in ambient air. Presence of a hematoma localized to the right zygomatic bone, no other complaint. CS (Coma Scale) at 15, small temporo-spatial disorientation. The rest of the clinical examination is unremarkable, no neurological deficit is observed. On 15Feb2021, the biology shows a clearance at 28 ml / min / 1.73m2 (usual clearance at 47 ml / min / 1.73m2) in favor of dehydration (dry tongue). Blood cultures are negative and COVID-19 PCR is negative. The ECG taken on 15Feb2021 shows a regular sinus rhythm at 65 bpm, a left axis and left ventricular hypertrophy. On 15Feb2021, a brain scan was scheduled for 19Feb2021. In view of the clinical and biological elements, furosemide is suspended (15Feb2021), oral hydration and by G (dextrose) 5% in sc at night is prescribed (15Feb2021), compression stockings are prescribed for varicose veins and bromazepam is discontinued (15Feb2021) in favor of oxazepam. Concomitant medication included nadolol, oxazepam, paracetamol, nebivolol, furosemide sodium, colecalciferol, bromazepam, carbohydrates nos, fats nos, minerals nos, proteins nos, vitamins nos (RENUTRYL BOOSTER), carmellose sodium, glycerol (OPTIVE), therapy dates and indication unspecified; and carbimazole for hyperthyroidism. On 17Feb2021, the patient received a first dose of COMIRNATY vaccine (batch EM6950). It was reported the patient died of death unexplained on 18Feb2021. On 18Feb 2021, the doctor was the last to see the patient at 3 PM (15:00). He mentions a few sub-crackles located in the 2 fields, without functional repercussions felt by the patient (does not complain of anything) and furosemide is prescribed for the next day at a dosage of 40 mg per day. The BP is 107/59, the 02 saturation in ambient air is 96%. The temperature is 37 deg C. At 6:45 PM (18:45), the nurse enters the room and finds the patient in the process of wasting, then death was declared. The patient is found in a semi-seated position in her bed. There is no sign of a struggle. On the semiological level, the patient did not present any sign of PAO (acute lung edema) before her death. She did not show any sign of reactogenicity after vaccination (no fever: t DEG C at 37 DEG C on February 17 at 3 p.m. and at 37 DEG C at 3 p.m. on 18Feb2021). The highest blood pressure during his stay was 165/72 on 16Feb2021 with values of 108/57 and 110/56 on 17Feb2021 and 112/55 then 107/59 on 18Feb2021, the last blood pressure having was taken at 3 p.m., 4 hours before his death. The pulse oscillated between 52 and 68 bpm during the stay, the lowest value having been found before vaccination. Renal function improved with an estimate of GFR (Glomerular filtration rate) by the Agency formula at 48 ml / min / 1.73m2 on 18Feb2021, the day of his death. The doctor thinks first of a death related to the severe aortic stenosis of the patient. However, due to the context of the COVID-19 vaccination the day before death, a pharmacovigilance declaration was also made. Outcome of Death unexplained was fatal while unknown for all other events. It was unknown if an autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1086633 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-24
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood albumin, Blood count, Blood electrolytes, Liver function test, Renal function test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM; OMEPRAZOLE; DEPAKOTE; ACEBUTOLOL; MODOPAR; MACROGOL; ZYMA; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar disorder; Normal pressure hydrocephaly; Phlebitis; Tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 202009; Test Name: albumin; Result Unstructured Data: Test Result:44 g/l; Test Date: 202009; Test Name: blood count; Result Unstructured Data: Test Result:Normal; Test Date: 202009; Test Name: ion balance; Result Unstructured Data: Test Result:Normal; Test Date: 202009; Test Name: liver assessment; Result Unstructured Data: Test Result:Normal; Test Date: 202009; Test Name: renal function; Result Unstructured Data: Test Result:Normal
CDC Split Type: FRPFIZER INC2021242187

Write-up: Death sudden; This is a spontaneous report downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LM20210366. A contactable physician reported that a 76 years old female patient received the second dose of BNT162B2 (COMIRNATY, Lot. EJ6788) intramuscularly, at single dose, on 09Feb2021, for COVID-19 immunisation. Relevant medical history included bipolar disorder, phlebitis, tachycardia and normal pressure hydrocephaly, all from an unspecified date and unknown if ongoing. Past drug event included facial edema due to cortisone. Concomitant medications included escitalopram 10 (unit unspecified) once daily; omeprazole 20 (unit unspecified) once daily; valproate semisodium (DEPAKOTE) 500 (unit unspecified) once daily; acebutolol 200 (unit unspecified) 1/2 / day; benserazide hydrochloride, levodopa (MODOPAR) 125 (unit unspecified), thrice daily, for stiffness; macrogol; enzymes nos (ZYMA) 80000 (unit unspecified), 1 dose / month and paracetamol if needed. On 24Feb2021, death sudden was reported (resident found dead in bed this morning at 5:30 a.m). No current acute pathology, no complaints or grievances during previous visits by the IDE. She did not call or ring the bell. Last organic assessment Sep2020 normal in terms of blood count, ion balance and renal function albumin 44 g/l normal liver assessment. Attending physician selected sudden death as the reason for death. No autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1086634 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Coma scale, Exercise electrocardiogram, Heart rate, Loss of consciousness, Oxygen saturation, Pain assessment, Sensory disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IRBESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High weight; Hypertension arterial (treated with ATACAND 8mg, stopped 1 month ago)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:10; Test Name: body temperature; Result Unstructured Data: Test Result:afebrile; Test Name: Glasgow score; Result Unstructured Data: Test Result:15; Test Name: ETT; Result Unstructured Data: Test Result:didn''t show dilation of the ascending thoracic; Comments: aorta, absence of flaps and tamponades, no pericardial effusion and dilation of the right ventricle; Test Name: heart rate; Result Unstructured Data: Test Result:90; Comments: 90 bpm with heavy sweating; Test Name: oxygen saturation; Test Result: 99 %; Test Name: VAS pain scale; Result Unstructured Data: Test Result:9/10
CDC Split Type: FRPFIZER INC2021242198

Write-up: Cardio-respiratory arrest; Loss of consciousness; Hyperalgesic lumbar pain; Sensory disorders; Severe abdominal pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB Regulatory Authority number FR-AFSSAPS-LY20211088. A 49-years-old male patient (firefighter) received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), batch # EK9788, via intramuscular route in the left arm on 10Feb2021 at single dose for COVID-19 immunization. Medical history included hypertension from an unknown date treated with candesartan cilexetil (ATACAND) 8 mg, stopped 1 month before this report and being overweight. It was reported that hypertension was stabilized but still a little high. In Jan2021 the patient had received the first injection of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via intramuscular route (batch unknown). The doctor didn''t report any adverse event between the first and second dose. Concomitant medication included irbesartan. On 20Feb2021 the patient was taken care of by the fire brigade for hyperalgesic lumbar pain with notion of irradiation in the legs with sensory disorders. On the same date he had 99% oxygen saturation and 9/10 VAS pain scale. The patient was afebrile with a blood pressure of "10" (no units provided) and a heart rate of 90 bpm with heavy sweating. Glasgow score of 15. During transport, the patient presented with severe abdominal pain with discomfort and loss of consciousness. He went in cardiopulmonary arrest (ACR) 2 minutes before arriving to the emergency room. In emergencies (arrival at 9:30 am): ACR with rhythm in electromechanical dissociation was found then asystole after 30 minutes of cardiopulmonary resuscitation (CPR) occurred (no shockable rhythm). In total 10 mg of adrenaline (1mg every 3 to 5 minutes in IV) were administered and the patient was intubated (Cormack and Lehane score of 1). No concept of inhalation, no "CE"; ETT (performed during CPR) didn''t show dilation of the ascending thoracic aorta, absence of flaps and tamponades, no pericardial effusion and dilation of the right ventricle. Cardiopulmonary resuscitation was continued for a total of 45 minutes. The cardio-respiratory arrest was fatal and patient''s death was declared at 10:15 am the same day. Concerning the cause of death, strong anamnestic presumption of a rupture of the abdominal aorta or a dissection of the descending thoracic aorta was done. 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: Cardio-respiratory arrest


VAERS ID: 1086637 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Hypotension
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: End stage renal failure ((GFR 23ml / min)); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021242193

Write-up: Cardio-respiratory arrest; Hypotension; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-MA20210654. A 77-years-old male patient received the second dose bnt162b2 (COMIRNATY) from lot EM6950 left arm intramuscular on 16Feb2021 at single dose for covid-19 immunisation . Age at vaccination :77 years. Medical history included hypertension unknown if ongoing , end stage renal disease (GFR 23ml / min) unknown if ongoing. The patient''s concomitant medications were not reported. The patient received the second anticovid19 vaccination COMIRNATY vaccine and was unwell following moderate hypotension and then 48 hours later, cardiopulmonary arrest resulting in death.Clincial course was reported as follows: On 17Feb2021, the patient presented discomfort with moderate hypotension (no numerical value). His relatives take him to a doctor near his home, on 19Feb2021, where he will suffer cardiopulmonary arrest, not recovered after an attempt at resuscitation by the SMUR.The patient died on 19Feb2021. It was not reported if an autopsy was performed.The otucome of the other event was unknown.Covid 19 PCR test performed: no covid19 history: no No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1086641 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure measurement, Body temperature, Cardiac arrest, Chest pain, Heart rate, Pain, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (breast cancer G); Dyslipidaemia (dyslipidemia); Hypertension; Peripheral arterial occlusive disease (PAD with femoral angioplasty (2012)); Peripheral artery angioplasty
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: Blood pressure; Result Unstructured Data: Test Result:138/86 mmHg; Test Date: 20210211; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210211; Test Name: Heart rate; Result Unstructured Data: Test Result:84; Test Date: 20210125; Test Name: COVID-19 test; Result Unstructured Data: Test Result:No
CDC Split Type: FRPFIZER INC2021232980

Write-up: Cardiac arrest; Chest pain; body aches; anxiety; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-NT20210435. A 93-year-old female patient received first dose of bnt162b2 (COMIRNATY, Batch number: EJ6789), intramuscular on 11Feb2021 10:00 (at 93-year-old) at single dose (right arm) for COVID-19 immunization. Medical history included Peripheral artery angioplasty, Hypertension, Breast cancer (breast cancer G) from 1994, Dyslipidaemia/dyslipidemia, Peripheral arterial occlusive disease from 2012 (PAD with femoral angioplasty); all unknown if ongoing. The patient returned to nursery home at the end of Jan2021 (also reported as 25Jan2021), the COVID-19 screening PCR test/ COVID-19 test at the entrance was negative (No). The patient has not developed COVID-19. The patient is considered eligible for vaccination on 09Feb2021, therefore she received first dose of the bnt162b2 vaccine against COVID-19 on 11Feb2021 at 10:00 am (temperature at 36.6?C, blood pressure at 138/86 mmHg, heart rate at 84, cardiopulmonary auscultation without particularity). Within hours of the vaccination, she complained about body aches and anxiety (11Feb2021), which subsided in the evening. Nothing special was noticed the following days until 16Feb2021, on day 5 of the vaccination, at 13:00, she experienced chest pain with cardiac arrest. The workers initiated an attempt at resuscitation (oxygen + external electric shock + cardiac massage) until the arrival of the SAMU (emergency medical aid service) which, despite their intervention, was unable to revive the flat path of heart rate. Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. The outcome of the events body aches and anxiety was recovering. Chest pain and cardiac arrest were reported as fatal. Death was on 16Feb2021 at 14:00. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest; Chest pain


VAERS ID: 1086668 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-05
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Decreased appetite, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Diabetes; Hypertension arterial; Hypothyroidism; Iron deficiency anemia; Psychosis
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: Oxygen saturation; Test Result: 91 %; Test Date: 20210205; Test Name: Fever; Result Unstructured Data: Test Result:38 and 39 Centigrade
CDC Split Type: FRPFIZER INC2021232907

Write-up: COVID-19 aggravated; fever between 38 and 39 C; desaturation (91%); loss of appetite; isolated cough; This is a spontaneous report from a contactable physician from the Medicines Agency (MA)WEB. The Regulatory Authority report number is FR-AFSSAPS-RS20210256. A 71-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6788, expiration date not reported), intramuscular in the left arm on 27Jan2021 at a single dose for COVID-19 immunisation. Medical history included Hypertension arterial, Iron deficiency anemia, arrhythmia, Diabetes, Delusional psychosis, and hypothyroidism. The patient''s concomitant medications were not reported. The patient is considered to be at risk of developing a severe form of COVID19 disease (diabetes, heart disease). The patient experienced COVID-19 aggravated on 05Feb2021. It was further reported that on 05Feb2021, onset of fever between 38 and 39 C, desaturation (91%), loss of appetite and isolated cough. The patient was hospitalized on an unspecified date in Feb2021 due to the events. On 13Feb2021, death of the patient due to complicated COVID following according to the declaring doctor. 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: isolated cough; COVID-19 aggravated; fever between 38 and 39 C; desaturation (91%); loss of appetite


VAERS ID: 1086669 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, Blood creatinine, Blood gases, Blood potassium, Blood sodium, Brain natriuretic peptide, Bronchitis, C-reactive protein, COVID-19 pneumonia, Carbon dioxide, Coma scale, Computerised tomogram, Discomfort, Drug ineffective, Dyspnoea, Exposure to SARS-CoV-2, Fibrin D dimer, Fraction of inspired oxygen, Haemoglobin, Heart rate, Muscular weakness, Oxygen saturation, PO2, Pyrexia, Respiratory disorder, SARS-CoV-2 test, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 40
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ALPRAZOLAM; SMECTA [ALUMINIUM HYDROXIDE-MAGNESIUM CARBONATE GEL;ALUMINIUM MAGNESIUM SILICATE;GLUCOSE MONOHYDRATE; TAMSULOSIN; UVEDOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pancreatitis; Colorectal adenocarcinoma (operated in 2009 with ostomy since this intervention); Hypotension orthostatic (with venous retention); Operation NOS; Pneumopathy (Right lung pneumopathy in 1956, 2002, 2005 and 2011); Pneumopathy; Prostatic adenoma (with urinary leaks since 2007); Stoma care; Urinary incontinence
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Creatinine level; Result Unstructured Data: Test Result:76; Test Date: 20210207; Test Name: Creatinine level; Result Unstructured Data: Test Result:76; Test Date: 20210207; Test Name: Creatinine level; Result Unstructured Data: Test Result:116; Comments: increase from 76; Test Date: 20210206; Test Name: Gasometry; Result Unstructured Data: Test Result:7.43 pH units; Test Date: 20210206; Test Name: Potassium level; Result Unstructured Data: Test Result:4.2; Test Date: 20210206; Test Name: Sodium level; Result Unstructured Data: Test Result:136; Test Date: 20210206; Test Name: BNP; Result Unstructured Data: Test Result:86; Test Date: 20210206; Test Name: Carbon dioxide pressure; Result Unstructured Data: Test Result:34.6; Test Date: 20210206; Test Name: GCS; Result Unstructured Data: Test Result:15; Test Date: 20210206; Test Name: CT scan; Result Unstructured Data: Test Result:ground-glass opacity; Comments: no sign favouring a pulmonary embolism but a large zone of ground-glass opacity spread across the ensemble of the pulmonary parenchyma with Crazy-Paving pattern and a strip of parenchymatous condensation; Test Date: 20210206; Test Name: CRP; Result Unstructured Data: Test Result:204.9; Test Date: 20210206; Test Name: CRP; Result Unstructured Data: Test Result:80.9; Test Date: 20210206; Test Name: D dimers; Result Unstructured Data: Test Result:1806; Test Date: 20210206; Test Name: FiO2; Test Result: 85 %; Test Date: 20210207; Test Name: FiO2; Test Result: 50 %; Test Date: 20210208; Test Name: FiO2; Test Result: 100 %; Test Date: 20210209; Test Name: FiO2; Test Result: 100 %; Test Date: 20210206; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14.8; Test Date: 20210206; Test Name: Heart rate; Result Unstructured Data: Test Result:100/min; Test Date: 20210206; Test Name: Heart rate; Result Unstructured Data: Test Result:32/min; Test Date: 20210206; Test Name: Saturation; Test Result: 60 %; Test Date: 20210207; Test Name: Saturation; Result Unstructured Data: Test Result:100 with high flow O2 %; Test Date: 20210209; Test Name: Saturation; Test Result: 90 %; Test Date: 20210206; Test Name: Oxygen pressure; Result Unstructured Data: Test Result:72; Comments: with a flow of 70/min; Test Date: 20210208; Test Name: Oxygen pressure; Result Unstructured Data: Test Result:50; Test Date: 20210209; Test Name: Oxygen pressure; Result Unstructured Data: Test Result:60; Test Date: 20210208; Test Name: Fever; Result Unstructured Data: Test Result:38.3; Test Date: 202101; Test Name: COVID-19 PCR test; Test Result: Negative ; Comments: during hospitalization 26-29Jan2021, patient had been contact with a COVID case; Test Date: 202101; Test Name: COVID-19 PCR test; Test Result: Negative ; Comments: during hospitalization 26-29Jan2021, patient had been contact with a COVID case; Test Date: 20210224; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: post-mortem RT-PCR; no sequencing was available; Test Date: 20210206; Test Name: Leucocytes; Result Unstructured Data: Test Result:9.700
CDC Split Type: FRPFIZER INC2021232944

Write-up: Discomfort; Acute renal insufficiency; severe COVID-19 pneumopathy/ post-mortem RT-PCR on 24Feb2021 came back positive; severe COVID-19 pneumopathy/ post-mortem RT-PCR on 24Feb2021 came back positive; Acute respiratory failure; Respiratory problems; patient has been in contact with a COVID case; Weakness in the lower limbs; Dyspnoea; Bronchitis; This is a spontaneous report from a contactable other healthcare professional (also reported as physician) downloaded from the Medicines Agency (MA) WEB; the Regulatory Authority Report Number is FR-AFSSAPS-RS20210310. An 86-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiry date were unknown), intramuscular on 21Jan2021 at a SINGLE DOSE for COVID-19 immunisation. The patient''s medical history included right lung pneumopathy in 1956, 2002, 2005 and 2011; Chronic pancreatitis in 1995; Prostatic adenoma with urinary leaks since 2007; Orthostatic hypotension with venous retention; Colorectal adenocarcinoma operated in 2009 with ostomy since this intervention. Concomitant and patient''s usual medications included allopurinol (ALLOPURINOL), alprazolam (ALPRAZOLAM ) at 0.75mg, daily; aluminium hydroxide-magnesium carbonate gel, aluminium magnesium silicate, glucose monohydrate, glycyrrhiza glabra (SMECTA), tamsulosin (TAMSULOSIN), and colecalciferol (UVEDOSE); all from an unknown date for an unspecified indication. It was reported that patient had no signs of intolerance immediately after vaccination on 21Jan2021. Then, patient was admitted to the hospital geriatric unit from 26Jan2021 to 29Jan2021 for weakness in the lower limbs and dyspnoea. Patient was diagnosed with bronchitis on an unknown date in Jan2021 leading to a prescription of Augmentin, 3g/day. During the hospitalization, the patient has been in contact with a COVID case on an unknown date in Jan2021 but since that date, 2 PCR tests have come back negative. The situation deteriorated again on 04Feb2021, with respiratory problems that required hospital admittance on 06Feb2021. Upon admittance, no signs of cardiac insufficiency, regular rhythm at 100/min, Glasgow (GCS scale) at 15, no sensory-motor deficit, and no abnormal abdominal pains. Regarding respiratory issues, patient had frequency at 32/min, saturation at 60%, labored respiration, paradoxical breathing, and blockage sounds in the two sites of auscultation. Gasometry carried out under Optoflow showed pH at 7.43, pCO2 (Carbon dioxide pressure) at 34.6, PO2 (Oxygen pressure) at 72 with a flow of 70/min, and FiO2 (Fraction of inspired oxygen) at 85%. C-reactive protein (CRP) was at 204.9 down to a value at 80.9. BNP (brain natriuretic peptide) was at 86, and D dimers at 1806. FBC (full blood count) showed: leukocytes at 9,700, Hb (Haemoglobin) at 14.8. Ionogram with Na (sodium) was at 136, K (potassium) at 4.2, and Creatinine at 76. An injected CT scan showed that there was no sign favouring a pulmonary embolism, but a large zone of ground-glass opacity spread across the ensemble of the pulmonary parenchyma with Crazy-Paving pattern and a strip of parenchymatous condensation. On 06Feb2021, hypothesis of a severe COVID pneumopathy was referred to because it reached 50 to 75% of the parenchyma. Treatment included non-invasive means with initiation of a primary treatment with Dexamethasone 6 mg/d, Lovenox 40mg twice a day, Rocephin 1g, and Spiramycin 1.5M three times a day. On 07Feb2021: the situation remained worrying but with a stable hemodynamic. Patient had superficial polypnea and draw, diffuse bruits in the 2 fields; the P/F ratio (Horowitz index) was at 100 on high flow O2 with FiO2 at 50%. On 07Feb2021, start of acute renal insufficiency with creatinine went from 76 to 116. Dose of spiramycin was increased to 3M three times a day. On 08Feb2021, the patient was exhausted, dyspnoea was mostly exhalation with labored respiration and paradoxical breathing and blockage sounds in the two sites of auscultation. Oxygen was at a flow of 50 and FiO2 (fraction of inspired oxygen) at 100%. Low fever was at 38.3 and Ceftriaxone was replaced with Taxocilline. On 09Feb2021, patient had new worsening of the respiratory state with motricity agitation. Optiflow was at a flow of 60 and FiO2 at 100%, enabling O2 saturation at 90%. Significant discomfort was experienced by the patient on 09Feb2021, who agreed to be sedated with midazolam 0.5mg/hour. On 10Feb2021, the patient died. It was unknown if an autopsy was performed. The post-mortem RT-PCR on 24Feb2021 came back positive; no sequencing was available. No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: severe COVID-19 pneumopathy/ post-mortem RT-PCR on 24Feb2021 came back positive; severe COVID-19 pneumopathy/ post-mortem RT-PCR on 24Feb2021 came back positive


VAERS ID: 1086678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Blood pressure measurement, Brain natriuretic peptide, C-reactive protein, Cardiac failure, Echocardiogram, Fibrin degradation products, Heart rate, Investigation, Oxygen saturation, Oxygen saturation decreased, Pulmonary function test, Pulmonary sepsis, Renal function test, Respiratory distress, SARS-CoV-2 test, Supraventricular tachyarrhythmia, Troponin, Weight, White blood cell count, pH body fluid
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Aortic valve disease (Tight calcified aortic stenosis with retained LVEF); Cardiac valve disease; Chronic atrial fibrillation (under Cordarone treatment); Chronic renal insufficiency; Cognitive disorder (probably of a MMS 20/30 vascular origin); COVID-19; Dyslipidemia; Hypertension arterial; TAVI (2016)
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: lactic acid; Result Unstructured Data: Test Result:3.8 mmol/L; Test Date: 20210211; Test Name: BP; Result Unstructured Data: Test Result:106/62 mmHg; Test Date: 20210212; Test Name: BP; Result Unstructured Data: Test Result:240/120 mmHg; Test Date: 20210212; Test Name: BNP; Result Unstructured Data: Test Result:7647 pg/mL; Test Date: 20210212; Test Name: CRP; Result Unstructured Data: Test Result:238 mg/l; Test Date: 20210212; Test Name: CRP; Result Unstructured Data: Test Result:247 mg/l; Test Date: 20210212; Test Name: heart ultrasound; Result Unstructured Data: Test Result:bable sequelae of the anteroseptal MI concordant w; Comments: bable sequelae of the anteroseptal MI concordant with the EG, increased left and right pressure, ultrasound subject to respiratory distress with tachycardia at 150min.; Test Date: 20210212; Test Name: D-dimer; Result Unstructured Data: Test Result:1150 ng/ml; Test Date: 20210211; Test Name: pulse; Result Unstructured Data: Test Result:94/min; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:110/min; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:150/min; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:116; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:122; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:133; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:120; Test Date: 20210212; Test Name: pulse; Result Unstructured Data: Test Result:140; Test Date: 20210208; Test Name: routine consultation; Result Unstructured Data: Test Result:complained of brief thoracic pains; Comments: complained of brief thoracic pains that stopped spontaneously; Test Date: 20210211; Test Name: saturation; Test Result: 89 %; Test Date: 20210212; Test Name: saturation; Result Unstructured Data: Test Result:desaturation on 3l/min of O2 %; Test Date: 20210212; Test Name: saturation; Test Result: 87 %; Test Date: 20210212; Test Name: pH; Result Unstructured Data: Test Result:7.29; Test Date: 20210208; Test Name: pulmonary bases; Result Unstructured Data: Test Result:bruits; Test Date: 20210212; Test Name: renal function; Result Unstructured Data: Test Result:40; Test Date: 20210212; Test Name: PCR Sars-CoV-2; Test Result: Negative ; Test Date: 20210212; Test Name: troponin; Result Unstructured Data: Test Result:150; Test Date: 20210208; Test Name: weight; Result Unstructured Data: Test Result:increase in weight of 2kg in 1 month; Comments: increase in weight of 2kg in 1 month; Test Date: 20210208; Test Name: WBC; Result Unstructured Data: Test Result:5250; Test Date: 20210212; Test Name: WBC; Result Unstructured Data: Test Result:11460/mm3; Test Date: 20210212; Test Name: WBC; Result Unstructured Data: Test Result:17500
CDC Split Type: FRPFIZER INC2021232976

Write-up: Pulmonary sepsis; Supraventricular tachyarrhythmia; Arterial oxygen saturation decreased; Distress respiratory; Decompensation cardiac; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-ST20210446. An 88-year-old female patient received second dose of bnt162b2 (COMIRNATY; lot EJ6789), intramuscular on 11Feb2021 at 0.3 mL, single (left arm) for COVID-19 immunisation. Medical history included valvular cardiopathy with severe aortic stenosis, Transcatheter aortic valve implantation (TAVI) in 2016, post TAVI chronic atrial fibrillation (under Cordarone treatment), chronic renal insufficiency, chronic arterial dyslipidemia, mild cognitive disorder (probably of a MMS 20/30 vascular origin), aortic valve disease (tight calcified aortic stenosis with retained LVEF), Hypertension arterial, and COVID-19 on 27Apr2020. The patient''s concomitant medications were not reported. The patient received first dose of bnt162b2 for COVID-19 immunisation on an unspecified date. The patient had a routine consultation on 08Feb2021, she complained of brief thoracic pains that stopped spontaneously. Upon examination, bruits at the pulmonary bases and evidence of an increase in weight of 2kg in 1 month, the white blood cell (WBC) was at 5250, no dosage of the cardiac enzymes available at that moment. On 11Feb2021, the patient experienced arterial oxygen saturation decreased, distress respiratory, and decompensation cardiac. On 12Feb2021, the patient experienced pulmonary sepsis, and supraventricular tachyarrhythmia. The patient was hospitalized due to the events on an unspecified date. She had the second injection of bnt162b2 vaccine on 11Feb2021 and patient was not febrile before vaccination and did not have dyspnea. Then 15 minutes after the vaccination, during post-vaccination monitoring, saturation was at 89%, blood pressure was at 106/62mmHg, with pulse at 94bpm, apyretic, and no dyspnoea. The desaturation persisted without any fever or pulmonary indications. On 12Feb2021, she had a consultation with her general practitioner, persistent desaturation on 3 L/min of O2, BP maintained, apyretic at the auscultation of the bruits, and pulse at 110bpm. The lab test of 12Feb2021 showed CRP at 238mg/l, WBC at 11,460/mm3, BNP: 7647pg/ml (NV<125), and D dimers at 1150ng/ml (NV<500). The general practitioner suggested the start of cardiac decompensation or a pulmonary infection or a pulmonary embolism. Patient was put on Lasilix and Augmentin started on 12Feb2021 with an increase in the flow of O2. Rapid deterioration in the evening with polypnea and cyanosis. Patient was transferred to accident and emergency: patient had tachycardia at 116-122-133-120-140, saturation to 87% put on a Boussignac. Specialist''s opinion included heart ultrasound was probable sequelae of the anteroseptal myocardial infarction (MI), concordant with the EG, increased left and right pressure, ultrasound subject to respiratory distress with tachycardia at 150 minutes. The emergency staff refer to recent-onset cardiac decompensation on atrial fibrillation with rapid ventricular response on pneumopathy and probable unexplored prior MI. The patient was put on LOVENOX 0.8*2/d, Digoxin, Cordarone, Boussignac then NIV, Risordan, Lasilix and tazocilline. Desaturation at 82% on positive-pressure airflow 15 L, renal function at 40, draw, BP at 240/120mmHg, Boussignac CPAP + risordan was given. Patient had polypnea, bruits in the totality of the two field and predominantly on the right. PCR Sars-CoV-2 was negative, CRP at 247mg/L, troponin 150, NT$g11,000, WBC at 17,500, and lactic acid at 3.8mmol/L. There was deterioration of the patient at pH: 7.29, hypoxia and lactic acid at 3.8. The physician reported a completely unexpected and brutal death. The patient presented 3 entangled sign with: an acute respiratory distress syndrome (ARDS) within the context of an infectious pneumopathy with a CRP at 238 on D1 post-vaccination which does not argue in favour of the imputability of the vaccine; probable sequelae of an unrecognized MI; and rapid-onset cardiac decompensation on atrial fibrillation. The patient died on 13Feb2021. An autopsy was not performed. No follow-up attempts are possible, information on batch number already obtained.; Reported Cause(s) of Death: Decompensation cardiac; Pulmonary sepsis; Supraventricular tachyarrhythmia; Arterial oxygen saturation decreased; Distress respiratory


VAERS ID: 1086681 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Babinski reflex test, Blood potassium, Blood pressure measurement, C-reactive protein, Computerised tomogram, Failure to thrive, Fall, Haemorrhagic stroke, Hypertension, Orbital haematoma, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Accidents and injuries (narrow), Hypertension (narrow), Optic nerve disorders (broad), Retinal disorders (broad), Neonatal disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GARDENAL [PHENOBARBITAL]; ZOLPIDEM; LACTULOSE; TEGRETOL; KEPPRA; RISPERDAL; TARDYFERON
Current Illness: Epilepsy (sequelae epilepsy of absence type (focal epilepsy involving the temporal regions)); Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Consciousness disturbed; Hypokalaemia (hospitalized for hypokalaemia from 30 to 31Jan2021); Ischemic stroke; Memory disturbance (memory disorders (disorder of access to lexical stock) sequelae); Meningoencephalitis bacterial (due to Mycoplasma pneumonia); Pneumonia mycoplasmal; Psychiatric decompensation; Refusal of treatment by patient
Allergies:
Diagnostic Lab Data: Test Name: Babinski; Result Unstructured Data: Test Result:bilateral positive; Test Name: potassium; Result Unstructured Data: Test Result:2.94; Test Date: 20210201; Test Name: blood pressure (BP); Result Unstructured Data: Test Result:115/80 mmHg; Test Date: 20210203; Test Name: blood pressure (BP); Result Unstructured Data: Test Result:195/110 mmHg; Test Date: 20210204; Test Name: blood pressure (BP); Result Unstructured Data: Test Result:160/90 mmHg; Test Name: CT scan; Result Unstructured Data: Test Result:hematoma; Comments: Left 5 cm capsulolenticulo-thalamic intra-parenchymal hematoma causing a local mass effect and intraventricular contamination in the left lateral ventricle; no hydrocephalus and no sign of engagement; Test Name: C-reactive protein (CRP); Result Unstructured Data: Test Result:80; Test Name: leukocytes (leuco); Result Unstructured Data: Test Result:10.6
CDC Split Type: FRPFIZER INC2021232924

Write-up: Haemorrhagic stroke; Hypertensive episode; hematoma around the left orbit of yellow color (possible fall?); hematoma around the left orbit of yellow color (possible fall?); Syndrome de glissement; This is a spontaneous report from a contactable physician, downloaded from the regulatory authority-WEB (regulatory authority number: FR-AFSSAPS-ST20210479). An 83-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection; lot number: EJ6788, expiration date was unknown), intramuscularly (IM) in the left arm on 01Feb2021 at 0.3 mL, single for COVID-19 immunization and acetylsalicylate lysine (KARDEGIC; lot number and expiration date were unknown), orally from an unspecified date to an unspecified date at 75 mg, once a day for cerebrovascular accident prophylaxis. Relevant medical history included a history of 2 ischemic strokes (May2014 and May2020); meningoencephalitis bacterial due to mycoplasma pneumonia in 1973 with ongoing epilepsy from 1973, further described as sequelae epilepsy of absence type (focal epilepsy involving the temporal regions) and memory disorders (disorder of access to lexical stock) sequelae; she was hospitalized for hypokalaemia from 30Jan2021 to 31Jan2021; impaired consciousness; refusal to take her anti-epileptic drugs; and behavioral decompensation. Concomitant medications included phenobarbital (GARDENAL, 100 mg tablet); zolpidem; lactulose; carbamazepine (TEGRETOL, 400 mg tablet); levetiracetam (KEPPRA, 500 mg film-coated tablet); risperidone (RISPERDAL, 1 mg film-coated tablet); and ferrous sulfate (TARDYFERON, 80 mg coated tablet). The patient had no history of COVID-19. On 03Feb2021, the patient experienced haemorrhagic stroke and hypertensive episode, which were considered life threatening, and had led to hospitalization and death. It was further reported that two (2) days after vaccination on 03Feb2021, the patient was hospitalized for right hemiplegia, trismus. On 03Feb2021, she has had "Syndrome de glissement" for 2 days, but appeared to be in her normal state at 12 noon. At 3 p.m., left facial paralysis as well as hemiparesis, with no verbal response was discovered. The patient was reported to have a concept of refusal of treatment for several days. On physical examination on an unspecified date, the patient''s general condition showed no response to verbal solicitation and apyretic. Neurological examination revealed bilateral positive Babinski. There was left heminegligence, right hemiparesis, grasping to the left, and hematoma around the left orbit of yellow color (possible fall?) on an unspecified date. The patient was reported to have hypertension on admission on 03Feb2021 with blood pressure (BP) of 195/110 mmHg, while at the time of vaccination on 01Feb2021, she had normal BP at 115/80 mmHg. On an unspecified date, biologically, the patient had hypokalaemia with potassium of 2.94, biologic inflammatory syndrome, C-reactive protein (CRP) of 80, and leukocytes (leuco) of 10.6 (hospitalized for hypokalaemia from 30Jan2021 to 31Jan2021). Computed tomography (CT) scan on an unspecified date revealed left 5 cm capsulolenticulo-thalamic intra-parenchymal hematoma causing a local mass effect and intraventricular contamination in the left lateral ventricle with no hydrocephalus and no sign of engagement. On 04Feb2021, the patient was noted to have hypertension at 160/90 mmHg with stable clinical condition, right hemiplegia, mutism, and symmetrical and reactive pupils. "LOXEN discontinuation attempt, patient with blood pressure targets" was reported. The patient died on 04Feb2021, after returning to nursing home. The conclusion of hospitalization was reported as haemorrhagic stroke with hypertensive peak. The reporter specified that the patient had been unstable for several days, particularly before the vaccination, with impaired consciousness, refusal to take her anti-epileptic drugs, behavioral decompensation. The patient was hospitalized for haemorrhagic stroke and hypertensive episode from 03Feb2021 to an unknown date. The action taken in response to the events for acetylsalicylate lysine was permanently withdrawn on an unspecified date. Therapeutic measures were taken as a result of hypertensive episode. The patient died on 04Feb2021. An autopsy was not performed. The outcome of the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; Hypertensive episode


VAERS ID: 1086690 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haematoma, Cerebral haemorrhage, Hemiplegia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral amyloid angiopathy; Haematoma (Right and left occipitals); Knee prosthesis insertion (left); Status epilepticus
Allergies:
Diagnostic Lab Data: Test Date: 20200908; Test Name: COVID-19 test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021232935

Write-up: Cerebral haemorrhage; Left hemiplegia; large right fronto parietal hematoma; This is a spontaneous report downloaded from the regulatory authority-WEB FR-AFSSAPS-TO20210803. A contactable physician reported that an 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscular in the left arm on 02Feb2021 at a single dose for COVID-19 immunisation. The patient''s medical history included status epilepticus from Mar2018, knee prosthesis insertion (left), cerebral amyloid angiopathy, right and left occipital hematomas in 2004 and 2017, all unknown if ongoing. Concomitant medications were not reported. On 04Feb2021, the patient experienced left hemiplegia on cerebral hemorrhage with large right fronto parietal hematoma. The patient underwent lab tests and procedures which included COVID-19 test with unknown results on 08Sep2020. The patient died on 04Feb2021 due to the events. It was not reported if an autopsy was performed. The events left hemiplegia and cerebral hemorrhage were reported as serious with medically significant and death criteria from HA. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Left hemiplegia; Cerebral haemorrhage; large right fronto parietal hematoma


VAERS ID: 1086790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Malaise, Pulmonary oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC2021239067

Write-up: Unable to swallow; malaise; lungs filled up with fluid; This is a spontaneous report received by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202103022224085310, Safety Report Unique Identifier: GB-MHRA-ADR 24865631. A contactable consumer reported that an 81-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. The patient is not enrolled in clinical trial. The patient experienced unable to swallow (also reported as problems swallowing food and chewing) on 27Jan2021. The patient also experienced malaise and lungs filled up with fluid on an unspecified date in 2021. The patient''s general practitioner (GP) had seen him. The patient died on 10Feb2021. It was unknown if an autopsy was performed. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unable to swallow; malaise; lungs filled up with fluid


VAERS ID: 1086793 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Malaise, Pneumonia aspiration, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 48
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUMETHIAZIDE; PERINDOPRIL; SALBUTAMOL; SERTRALINE; SIMVASTATIN; TRELEGY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Aortic aneurysm; BPH; Depression; Fall (admitted to hospital); Hearing impaired; Hospitalization (due to fall); Sarcopenia; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210213; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021244100

Write-up: aspiration pneumonia; Fatigue; unwell; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103031538237850, Safety Report Unique Identifier GB-MHRA-ADR 24869685. A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not known) solution for injection, via an unspecified route of administration on 14Jan2021 at a single dose for Covid-19 immunization. Medical history included fall (admitted to hospital), aortic aneurysm, depression, anxiety, benign prostatic hyperplasia (BPH), steroid therapy (taking regular steroid treatment (e.g. orally or rectally)), type 2 diabetes mellitus from an unknown date and unknown if ongoing, hearing impaired from an unknown date and unknown if ongoing, and sarcopenia from an unknown date and unknown if ongoing. Concomitant medication included bendroflumethiazide for hypertension, perindopril for hypertension, salbutamol for COPD (Chronic obstructive pulmonary disease), sertraline, simvastatin, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY) for COPD (Chronic obstructive pulmonary disease). Unsure if patient has had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. The family stated that the patient became unwell shortly after receiving his Covid vaccine on 14Jan2021. He was fatigued on 15Jan2021. Patient had a fall (prior to vaccination) and was then admitted to hospital. In the hospital he was treated for possible aspiration pneumonia on an unknown date, but he failed to respond to the treatment. Patient died on 03Mar2021 due to aspiration pneumonia. The events caused prolonged hospitalization, considered life-threatening, and medically significant. The patient underwent lab tests which included COVID-19 virus test: no - negative covid-19 test on 13Feb2021. Outcome of the event aspiration pneumonia was fatal while unwell and fatigue was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Aspiration pneumonia


VAERS ID: 1086794 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-02-18
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8492 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Flu; Heart attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021239162

Write-up: Heart attack; Heart attack; Sudden death; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103031624390100, Safety Report Unique Identifier GB-MHRA-ADR 24870125. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EE8492), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included flu and heart attack. Patient had annual flu jabs (INFLUENZA VACCINE) for immunization. Not sure when last one was, possibly within the last three months. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patients concomitant medications were not reported. Patient was talking normally before leaving for an afternoon walk. No signs of illness. The patient had heart attack on an unspecified date and never returned home. The event of heart attack was considered serious (life threatening). The patient had a sudden death on 18Feb2021. Patient has not tested positive for COVID-19 since having the vaccine. An autopsy was carried out. The outcome of the heart attack was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1086796 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-02-25
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Death
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; TILDIEM LA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021244504

Write-up: Death; collapsed; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103041412267780, Safety Report Unique Identifier GB-MHRA-ADR 24875612. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1688) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Relevant medical history was not reported. Unsure if patient has had symptoms associated with COVID-19; the patient has not had a COVID-19 test and he was not enrolled in clinical trial. Concomitant medications included lisinopril and diltiazem hydrochloride (TILDIEM LA). The patient died on 25Feb2021. He went to shopping center, collapsed and died. The cause of death was unknown but could be linked to vaccine that was given month before. 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


VAERS ID: 1086799 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal failure; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021243998

Write-up: diarrhoea; unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority [HU-OGYI-074621]. A 74-year-old male patient received bnt162b2 (COMIRNATY, lot number: EJ6134), intramuscularly on the left arm on 30Jan2021 at 0.3 mL, single dose for COVID-19 immunisation. Medical history included ongoing hypertension and ongoing chronic renal failure. Concomitant medications were not reported. On 01Feb2021, the patient experienced diarrhoea. The outcome of diarrhoea was unknown. The patient was hospitalized in 03Feb2021 for diarrhoea and died due to an unknown cause of death on 06Feb2021. It was not reported if an autopsy was performed. The case was described as follows: This serious, spontaneous case was reported by a physician on 15Feb2020, concerning the occurrence of diarrhoea after the use of Comirnaty concentrate for dispersion for injection (MAH: BioNTech Manufacturing GmbH). On 30Jan2021, the 74-year-old male patient received 0.3 ml Comirnaty concentrate for dispersion for injection (tozinameran; batch number: EJ6134, expiry date: not reported, intramuscularly, in the left upper arm) for COVID-19 immunisation.On 01Feb2021, the patient experienced diarrhoea. The patient was treated with unknown medicinal therapy but his medical condition did not improve. On 03Feb2021, the patient was hospitalized. On 06Feb2021, the patient died. The patient''s medical condition was hypertension and chronic renal failure. The patient''s concomitant medicinal products were not reported. Senders comment: According to the SmPC of Comirnaty concentrate for dispersion for injection, diarrhoea is not listed but expected. TTO is 1 day. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered possible. The case is considered serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1086800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VEROSPIRON; TALLITON; TORVALIPIN; ASTRIX
Current Illness: Dilated cardiomyopathy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Decompensation cardiac; Helicobacter pylori infection; Retrosternal pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021244003

Write-up: death; brief loss of consciousness; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [HU-OGYI-083821]. An 89-year-old female patient received the first dose of bnt162b2 (COMIRNATY) lot number: EJ6134, via an unspecified route of administration on 30Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included COVID-19 from 09Dec2020 to 22Dec2020, helicobacter pylori infection from 2000, decompensation cardiac on 2012, dilated cardiomyopathy from 2011 and ongoing, retrosternal pain from 2005. Concomitant medication included spironolactone (VEROSPIRON), carvedilol (TALLITON), atorvastatin calcium (TORVALIPIN) and acetylsalicylic acid (ASTRIX). The patient previously took syncumar from 2006 to 2011. On 07Feb2021, eight days after vaccination, the patient experienced brief loss of consciousness and after the patient had basic life support then advanced resuscitation but both failed, the patient died. At the time of death, the outcome of the event brief loss of consciousness was unknown. The patient died on 07Feb2021. An autopsy was performed, and results were not provided. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1086801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-18
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anal incontinence, Asthenia, Death, Hyperhidrosis, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CITROKALCIUM; TAMSULOSIN; FURON [FUROSEMIDE]; KALIUM-R; DOXAZOSIN; NOVORAPID; SORBIFER DURULES [ASCORBIC ACID;FERROUS SULFATE]; TRESIBA; BISOPROLOL; MEZITAN; CO VALSACOR; METFORMIN
Current Illness: Atherosclerosis of arteries of the extremities; Atrial fibrillation; Benign prostatic hyperplasia; Gastroesophageal reflux; Hypertension; Non-insulin-dependent diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021244011

Write-up: pale; sweating; unable to keep stool; very poor condition; death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority -WEB [HU-OGYI-085221]. This spontaneous, serious case was reported by an other health care professional on 18Feb2021 concerning death after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). On 31Jan2021, the 88-year-old male patient, who was a resident of a social care institute, received the first dose of Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)/Tozinameran) concentrate for dispersion for injection (strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, left arm, batch number: EJ6134). (Date of admission to the hospital: 16Feb2021). On 16Feb2021, the patient was transported to the hospital in a very poor condition, he was pale, sweating, unable to keep stool. On 18Feb2021 the department of infectious diseases of the hospital reported the patient''s death to the social care institute. No documentation was available. Medical history included atherosclerosis of arteries, atrial fibrillation, benign prostatic hyperplasia, gastroesophageal reflux, hypertension, and non-insulin-dependent diabetes mellitus, all ongoing. Concomitant medication was CO-VALSACOR 160 mg/25 mg film-coated tablet (valsartan; hydrochlorothiazide, once daily), CITROKALCIUM tablet (calcium citrate, once daily), MEZITAN 35 mg modified-release film-coated tablet (trimetazidine, twice daily), NovoRapid (insulin aspart, 22-20-20 IU daily), Tresiba (Insulin degludec, 30 IU daily, SORBIFER DURULES 320 mg film-coated tablet (ferrous sulphate, dried, ascorbic acid, once daily), Furon (furosemide, once daily), KALIUM-R tablet (potassium chloride, once daily), unknown tamsulosin 0.4 mg daily, unknown bisoprolol 5 mg daily, unknown metformin 1000 mg daily, and unknown doxazosin 2 mg daily. The outcome of the events very poor condition, he was pale, sweating, unable to keep stool was unknown. Senders comment: The 88- year-old patient died 18 days after Comirnaty vaccination. There is no information about whether autopsy was performed and what cause of death was. The causal relationship between the event and Comirnaty is unassessable due to lack of information. The case is serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1086802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-01-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Condition aggravated, Dysphagia, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEN-U-RON; ATORVASTATIN; AMLODIPINE; ASACTAL; CLEXANE
Current Illness: Aphasia motor; Cerebral ischaemia; Hemiparesis (right); Hyperlipidaemia; Hypertension; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic alcoholism
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021244005

Write-up: dysphagia; Loss of consciousness; His state was gradually worsening; fever/febrile several times; weakness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is HU-OGYI-098221. A 71-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot: EL1484, expiry date: Apr20210), intramuscular at 0.3ml single in the left upper arm on 30Jan2021 for covid-19 immunization. The patient''s medical history included ongoing hemiparesis and motor aphasia due to cerebral ischaemia since 2014 resulted of chronic alcoholism from unknown date an unknown if ongoing. The patient had ischaemic heart disease, hypertension and hyperlipidaemia all from unknown date and ongoing. He was in a nursing home since 2014, and his general state was reported to be satisfactory. He was able to sit in a wheelchair and could eat without help. Concomitant medication included paracetamol (BEN-U-RON), atorvastatin, amlodipine, acetylsalicylic acid (ASACTAL) and enoxaparin sodium (CLEXANE). On the next day, 31Jan2021, the patient experienced weakness, he became febrile several times/fever, for which he received ALGOPYRIN. His state was gradually worsening, he developed dysphagia and loss of consciousness. The patient died on 03Feb2021 at 9:15 a.m. An autopsy was not performed. Senders comment: Weakness and fever are expected adverse events of COMIRNATY, listed in the product information. Dysphagia and loss of consciousness were presumably the result of the worsening of the patient''s state. Time to onset is reasonable. Causality between weakness, fever and COMIRNATY is probable. The case is serious because the patient died. No further information is expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: weakness; fever/febrile several times; dysphagia; loss of consciousness; His state was gradually worsening


VAERS ID: 1086803 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021240115

Write-up: got sick with Corona ,one of them also died; got sick with Corona ,one of them also died; This is a spontaneous report from a contactable physician. The physician reported same event for four patients, this is the first of four reports. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE of first dose, via an unspecified route of administration on an unspecified date at SINGLE DOSE of second dose for covid-19 immunisation. Medical history included kidney transplant. The patient''s concomitant medications were not reported. The patient received 2 doses of BNT162b2 and got sick with Corona and died. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about Batch/Lot number has been requested.; Sender''s Comments: Based on the limited information provided, the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported events in this patient. Additional information regarding onset dates of drug administration/ events and concomitant medications will aid in comprehensive assessment of the case. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : IL-PFIZER INC-2021240116 same drug/event in different patients;IL-PFIZER INC-2021240117 same drug/event in different patients;IL-PFIZER INC-2021240118 same drug/event in different patients; Reported Cause(s) of Death: got sick with Corona ,one of them also died; got sick with Corona ,one of them also died


VAERS ID: 1086814 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Sopor
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aneurysm (Abdominal aneurysm operated (2013)); Fracture multiple (hosp. for accidental fall resulting in fracture of the femur and rib fractures with mild ir type i.); Heart disease, unspecified (HYPOKINETICODILATORY HEART DISEASE); Heart failure NYHA class IV (cardiac insufficiency EF(ejection fraction) 31%); Hemorrhage cerebral (post traumatic brain hemorrhage (2017)); Laparocele; Monoclonal gammopathy; Paroxysmal supraventricular tachycardia (associated with hemodynamic instability undergoing slow pathway cryoablation surgery); Prosthesis user (Wearer of right knee prosthesis (2003), left knee prosthesis (2002) and shoulder prosthesis (2000)); Thrombopenia (plateletopenia in monoclonal gammopathy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021242209

Write-up: after more than 24 hours from administration, patient (already suffering from heart failure class IV NYHA) in a soporous state with worsening of dyspnea. Death after about another 5 hours.; after more than 24 hours from administration, patient (already suffering from heart failure class IV NYHA) in a soporous state with worsening of dyspnea. Death after about another 5 hours.; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority-WEB (Regulatory authority number IT-MINISAL02-687060). A 95-year-old male patient received BNT162B2 (COMIRNATY; Lot number EP9598; expiration date 30Jun2021) intramuscular in the left arm on 24Feb2021 at 10:00 at single dose for COVID-19 immunisation. Relevant medical history included paroxysmal supraventricular tachycardia from an unknown date and unknown if ongoing (associated with hemodynamic instability undergoing slow pathway cryoablation surgery), prosthesis user from an unknown date and unknown if ongoing (wearer of right knee prosthesis (2003), left knee prosthesis (2002) and shoulder prosthesis (2000)), Heart failure NYHA class IV from 2018 to an unknown date (cardiac insufficiency ejection fraction (EF) 31%), cardiac disorder (hypokineticodilatory heart disease) from an unknown date and unknown if ongoing, post traumatic brain hemorrhage (2017), monoclonal gammopathy from an unknown date and unknown if ongoing, thrombocytopenia from an unknown date and unknown if ongoing (plateletopenia in monoclonal gammopathy), laparocele from an unknown date and unknown if ongoing, multiple fractures from Jan2021 to an unknown date (hospitalization for accidental fall resulting in fracture of the femur and rib fractures with mild ir type I; pathologies ascertained: right femur fracture due to accidental fall in a domestic environment subjected to head prosthesis surgery; tsvp associated with haemodynamic instability subjected to cryoblation of the slow pathway; for multiple vertebral somatic collapses, with somatic collapse of d7 d10 and d12) and abdominal aneurysm from 2013 to an unknown date (abdominal aneurysm operated (2013); at the cardiological visit in Dec2020: precarious general clinical compensation; the cardiologist suggested increasing the diuretic therapy bringing to 2 the 25 mg LASIX tablets per day and the need for a reassessment also of the blood tests (BNP, blood counts electrolytes, creatinine, glycemia, holter ECG of 24h for finding frequent extrasystole) and to perform X-ray of the chest)). Concomitant medications were not reported. On 25Feb2021, after more than 24 hours from administration, the patient (already suffering from heart failure class IV NYHA) was in a soporous state with worsening of dyspnea. Death occurred after about another 5 hours on 25Feb2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: dyspnea; sopor


VAERS ID: 1086832 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-18
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Platelet count, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALBYL-E; SOMAC; OMNIC
Current Illness: Myelomatosis (Stable disease)
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Colon cancer (Unknown if this is past or concomittant disease.); Gastrooesophageal reflux disease; Hypothyreosis; Living alone (no home care, and was driving his car); TIA
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:Normal
CDC Split Type: NOPFIZER INC2021236708

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NO-NOMAADVRE-FHI-2021-U97n7 , Safety Report Unique Identifier NO-NOMAADVRE-E2B_00016969. A 94-years-old male patient received the first dose of bnt162b2 (COMIRNATY, lot EM0477), intramuscular at Arm Right on 03Feb2021 09:52 at single dose for covid-19 immunization. Medical history included Hypothyreosis, transient ischaemic attack (TIA), Myelomatosis from 2018 and ongoing (stable disease reported 13Jan2021; 1st line treatment in 2019 with bortezomib and dexamethasone (VELCADE/Dexamethasone, VELDEX); 2nd line treatment in 2020 with melphalan and prednisolone, due to high M-component and anemia. No regress, but stable disease), colon cancer from 2005 (unknown if this was past or concomitant disease), gastrooesophageal reflux disease, benign prostatic hyperplasia. The patient was living at home alone, had no home care, and was driving his car. Concomitant medication included acetylsalicylic acid, magnesium oxide (ALBYL-E) for TIA, pantoprazole sodium sesquihydrate (SOMAC) for gastrooesophageal reflux disease, tamsulosin hydrochloride (OMNIC) for Benign prostatic hyperplasia. The patient experienced sudden death on 18Feb2021. The patient underwent lab tests included Thrombocyte count: normal on 15Feb2021. Clinical course reported as follow: On 18Feb2021, the patient was found dead at home, sitting in his armchair. He had pleny of dried blood on his chin and sweater. This was described as "mors subita". It was stated that the exact cause of death was unknown. Could be hematemesis from gastric ulcer due to thrombocytopenia? The patient had done blood tests on 15Feb2021 and was in good shape that day, no sign of thrombocytopenia. The outcome was Fatal, at the time of the report. The case was considered to be serious. It was not reported if an autopsy was performed. Sender''s comments: Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register (the Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. The report concerns a patient in his 90s who was found dead at home 15 days after the first dose of the Covid-19 vaccine Comirnaty. The patient had plenty of blood on his chin and sweater. Hematemesis from gastric ulcer secondary to thrombocytopenia is mentioned as a possible cause of death, but it is emphasized that the exact cause of death is not known. Two days before the incident, the patient was for blood sampling, was in good shape and samples showed no signs of thrombocytopenia. We understand that it is reported due to an unexpected death with a temporal connection with vaccination. The medical history includes multiple myeloma (in treatment recently, stable disease), cancer coli, TIA and hypothyroidism. The patient lived at home alone without help. Sudden death is not among the adverse reactions reported in participants in the clinical trials at Comirnaty. Elderly patients and patients with underlying diseases were included in the studies, but the data are still limited from use in multi-sick and elderly patients. In the individual case, however, it is difficult to know whether the death is due to a vaccine or another, accidental 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. 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. Since the patient''s death, the message is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SUDDEN DEATH


VAERS ID: 1086834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR [ATORVASTATIN]; SELO-ZOK; OMNIC; ALBYL-E; ZANIDIP
Current Illness: Coronary disease
Preexisting Conditions: Medical History/Concurrent Conditions: BPH; Hypertension; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021236700

Write-up: CARDIAC ARREST; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority Agency-WEB NO-NOMAADVRE-FHI-2021-Upmj9, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00016971. A 90-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: EJ6789), intramuscular at arm left on 10Feb2021 at 10:26 at single dose for COVID-19 immunisation. Medical history included myocardial infarction on an unknown date, ongoing coronary artery disease, benign prostatic hyperplasia (BPH) and hypertension, both from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin (LIPITOR) oral at 80 mg once a day from 2002 to 23Feb2021 for myocardial infarction, metoprolol succinate (SELO-ZOK) oral at 100 mg once a day from 2002 to 23Feb2021, tamsulosin hydrochloride (OMNIC) oral at 0.4 mg once a day for BPH, acetylsalicylic acid/magnesium oxide (ALBYL-E) oral at 75 mg once a day from 2002 to 23Feb2021 for coronary disease, lercanidipine hydrochloride (ZANIDIP) oral from an unknown date to 23Feb2021 at 10 mg once a day. The patient experienced cardiac arrest on 23Feb2021 with fatal outcome. The patient died on 23Feb2021. An autopsy was not performed. Reporter''s comment: from event description, not coded elsewhere in the report: On 23/Feb/2021, the patient developed CARDIAC ARREST. He suddenly fell down in his garden, with his grandchildren present. No symptoms prior to the incident. The death is described as unexpected. The patient has a known coronary disease, and the cardiac arrest could have been caused by a new cardial incident. It is not known if there will be performed an autopsy. Sender''s comment: The report applies to a patient in his 90s who fell asleep at home 13 days after the first dose of the COVID-19 vaccine COMIRNATY. The patient had known coronary heart disease and reports suspected cardiac arrest based on a new cardiac event. We understand that it is reported due to an unexpected death with a temporal connection with vaccination. Cardiac events or sudden death are not among the adverse reactions reported in participants in the clinical trials at COMIRNATY. Elderly patients and patients with underlying diseases were included in the studies, but the data are still limited from use in multi-sick and elderly patients. The safety of use in frail patients with, among other things, underlying cardiovascular diseases is among the areas being examined for the vaccine. In the individual case, however, it is difficult to know whether the death is due to a vaccine or another, accidental 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. 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 relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient''s death, the message is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible, information on batch number already obtained.; Reporter''s Comments: From event description, not coded elsewhere in the report: On 23/Feb/2021, the patient developed CARDIAC ARREST. He suddenly fell down in his garden, with his grand children present. No symptoms prior to the incident. The death is described as unexpected. The patient has a known coronary disease, and the cardiac arrest could have been caused by a new cardial incident. It is not known if there will be performed an autopsy.; Reported Cause(s) of Death: CARDIAC ARREST


VAERS ID: 1086838 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021242211

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB Regulatory Authority number PL-URPL-3-311-2021. A 87-year-old male patient received his first dose of BNT162b2 (COMIRNATY), lot # EL8723, exp.date 12Feb2021 intramuscularly at left arm on 12Feb2021 15:17 (at the age of 87-years-old) for COVID-19 immunization. On 17Feb2021 1:30 p.m the patient died. No other post-vaccination reactions. It was unknown if rdean autopsy was performed and the cause of death. Sender Comment: Comirnaty is a mRNA vaccine against COVID-19 (with modified nucleosides). Given the lack of medical information regarding the death (autopsy result, medical history, etc.), it cannot be excluded that factors other than the vaccine may have contributed to the death. The temporal relationship supports a cause and effect relationship (death 5 days after vaccination). The reporting person classified it as severe. Regulatory authority classified the report as severe due to the reporter''s assessment and the patients death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1089835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Malignant neoplasm of pancreas (stent implantation)
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain (patient was admitted to hospital); Fever (unknown reason); Suspected COVID-19 (two days fever, loss of smell)
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: covid; Test Result: Negative
CDC Split Type: CZPFIZER INC2021250705

Write-up: sudden death/death after vaccination; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB CZ-CZSUKL-21001643. A 78-year-old male patient received his first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history included abdominal pain from 23Dec2020 and patient was admitted to hospital. On 30Dec2020, the patient was diagnosed with pancreatic tumour. It was decided to not operate. Stent was applied instead. Three patients from the same room was tested as Covid-19 positive, the patient was negative on 30Dec2020. He might have been Covid-19 positive in Oct2020 (two days fever, loss of smell), but was not tested that day. On 08Jan2021 the patient had fever, unknown reason. Concomitant drugs were not reported. The patient experienced sudden death/death after vaccination on 12Jan2021. The event was serious for death, hospitalization, medical significant, and life-threatening. The cause of death was unknown. According to a physician, patient was not at terminal stage, preparation for home care with perspective of 3 months. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1089840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021250310

Write-up: Death; This is a spontaneous report from a non-contactable physician, downloaded from the Regulatory Agency-WEB DE-PEI-PEI2021003112. A 77-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 13Feb2021 (Batch/lot no: EJ6789) at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. It was not reported if an autopsy was performed. The cause of death was not reported. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1089902 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-04
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Oxygen saturation
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: desaturation; Test Result: 80 %
CDC Split Type: FRPFIZER INC2021250318

Write-up: COVID-19 respiratory infection; COVID-19 respiratory infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (FR-AFSSAPS-MA20210612). A 98-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EM0477), intramuscularly, on 19Jan2021 (at the age of 98-years-old) at a single dose for COVID-19 immunisation. Medical history included living in nursing home. The patient''s concomitant medications were not reported. The patient experienced COVID-19 respiratory infection on 04Feb2021, which was reported as fatal. It was reported that on day 16 of vaccination (day 1), there was appearance of a COVID-19 infection with 80% desaturation on 04Feb2021. The patient died on an unspecified date. The cause of death was assessed as COVID-19. 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: COVID-19


VAERS ID: 1093103 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-03-07
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Eating disorder, Fatigue, Hypersomnia, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drowsiness; Excessive eating
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021251539

Write-up: tiredness; stopped eating; felt asleep/She hasn''t really woken properly since. Awake for a minute or so only; death; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-APPCOVID-20210307110917, Safety Report Unique Identifier GB-MHRA-ADR 24894109. A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0739) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included hyperphagia and somnolence. Concomitant medications were not reported. On an unspecified date, the patient experienced tiredness with fatal outcome and died (cause of death was unknown) on 07Mar2021. It was unknown if an autopsy was performed. The patient underwent a COVID-19 virus test on an unspecified date with negative result. The patient experienced extreme immediate tiredness for over six weeks to death. Nothing else changed. The patient went from quite well and happy to drastic change immediately. She stopped eating and drastic downward spiral. It was also specified that the patient was well for a year in reporter''s home. The patient had a few aged problems, but enjoying life, happy and eating well. Immediately after her jab she came home, refused her favorite meal and felt asleep. She hasn''t really woken properly since. Awake for a minute or so only. She Stopped walking, talking etc . The doctor was aware, and bloods were taken. There was no change in medications. The patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1093284 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anal sphincter atony, Death, Seizure, Sopor
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Convulsive seizure; Anal sphincter atony; Sopor; Death; A spontaneous report was received from a Healthcare professional concerning a 94-year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273), experienced convulsive seizure, anal sphincter atony and sopor (profound or lethargic sleep), and while hospitalized, the patient died. The patient''s medical history was not reported. No concomitant medications were provided. On 18-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 300042721) intramuscularly for prophylaxis of COVID-19 infection. On 18-Feb-2021, the patient was presented with conclusive seizure, anal sphincter atony and sopor that resulted in hospitalization. Treatment provided to the patient was unknown. Action taken with mRNA-1273 in response to the events was not reported. Follow-up for the case was received and the patient was reported to be dead on 20-FEB-2021. Autopsy details were unknown.; Reporter''s Comments: Very limited information regarding the death of the patient has been provided at this time. Patient''s advanced age may have been contributory for the occurrence of the death. No further follow-up information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1093285 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast carcinoma; CVA; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021250336

Write-up: Four days after the first dose of VOC-2 vaccination with Pfizer suspected Acute Myocardial Infarction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority IT-MINISAL02-689629. A 95-year-old female patient received bnt162b2 (COMIRNATY), Lot EP9598, Expiration date 30May2021, first dose, via an unspecified route of administration on 24Feb2021 at 0.3 mL, single for covid-19 immunisation. Medical history included cerebrovascular accident from 01Jan2016 to an unknown date, breast cancer from 01Jan2014 to an unknown date, hypertension from 01Jan2016 to an unknown date. The patient''s concomitant medications were not reported. On 28Feb2021, four days after the first dose of vaccination, the patient experienced suspected acute myocardial infarction. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1093352 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; SINTROM; TARDYFERON; FOLIC ACID; SPIRONOLACTONE; FUROSEMIDE; QUETIAPINE; CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Cardiac valve prosthesis user (wearer of mechanical mitral prosthesis); Chronic hepatitis C (liver disease); Chronic renal failure; Femur fracture; Fracture repair; Living in residential institution; Peripheral vascular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021212888

Write-up: Death; Fever; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB. Regulatory authority report number is ES-AEMPS-762104. An 84-year-old male patient received second dose of BNT162B2 (COMIRNATY; Solution for injection, lot number: EK9788, unknown expiration), intramuscular in arm on 28Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included institutionalised, chronic complex of Alzheimer''s disease, chronic hepatitis C virus (liver disease), mitral prosthesis carrier (wearer of mechanical mitral prosthesis), peripheral vascular disease, chronic renal failure, and right pertrochanteric fracture operated on 02Mar2020. Concomitant medications included omeprazole, acenocoumarol (SINTROM), ferrous sulfate (TARDYFERON), folic acid, spironolactone, furosemide, quetiapine, and calcium, colecalciferol (CALCIUM & VITAMIN D). The patient also received first dose of COMIRNATY (lot number: EJ6796, unknown expiration) on 07Jan2021 for COVID-19 vaccination. On the same day of administration of the second dose on 28Jan2021, fever and death were reported. No information is available on the circumstances of death. Outcome of the event fever was unknown. The patient died due to unknown cause on 28Jan2021. 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


VAERS ID: 1094029 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Oxygen saturation
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: Body temperature; Result Unstructured Data: Test Result:39.6 Centigrade; Comments: 20 days after a first dose of COMIRNATY; Test Date: 20210208; Test Name: Oxygen saturation; Test Result: 70 %; Comments: 20 days after a first dose of COMIRNATY
CDC Split Type: FRPFIZER INC2021250314

Write-up: COVID-19 respiratory infection; on D20 of vaccination (D1), appearance of a COVID-19 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency -WEB. This is a report received from the Regulatory Authority. The regulatory authority report number is FR-AFSSAPS-MA20210613. An 89-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EM0477), intramuscularly on 19Jan2021 at 89-years-old at a single dose for COVID-19 immunization. The patient''s medical history included living in nursing home from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 08Feb2021, the patient experienced: COVID-19 respiratory infection, on D20 of vaccination (D1), appearance of a COVID-19 infection. The clinical course was reported as follows: the 89-year-old patient, who was a resident in a nursing home, received the first dose of the COMIRNATY vaccine on 19Jan2021. On 08Feb2021, day 20 (D20) after receiving the first dose (D1) of the COMIRNATY vaccine, the patient displayed the "appearance of a COVID-19 infection with 70% desaturation. and fever at 39.6 Centigrade." The patient underwent lab tests and procedures which included oxygen saturation: 70 %, body temperature: 39.6 Centigrade; both on 08Feb2021, 20 days after a first dose of COMIRNATY. The clinical outcome of the events, COVID-19 respiratory infection and drug ineffective, was fatal. The patient died on an unspecified date due to COVID-19 respiratory infection. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1094268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Confusional state, Drug ineffective, Dyspnoea, Heart rate, Heart rate decreased, SARS-CoV-2 test, Seizure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 62
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:decreased; Test Date: 20210304; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021246577

Write-up: Confusion; shortness of breath; seizure; SARS-CoV-2 infection; SARS-CoV-2 infection; Seizures; Heart rate drop; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202103061608463700. Safety Report Unique Identifier GB-MHRA-ADR 24889457. An 85-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# Ek4243), via an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19, did not have a COVID-19, was not enrolled in clinical trial. The patient experienced seizure in Jan2021 with outcome of unknown , sars-cov-2 infection (death) on 04Mar2021 with fatal outcome on 04Mar2021, confusion (non-serious) on 23Jan2021 with outcome of unknown, seizures (non-serious) on 23Jan2021 with outcome of unknown. It was reported that the patient had a seizure overnight in Jan2021, ended up confused (on 23Jan2021) and short of breathe. He was admitted to hospital and treated with antibiotics. Patient had 2nd seizure and was treated for further infection. 3rd seizure just over a week later with continued confusion. Heart rate dropped. Patient tested positive and passed away. 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: SARS-CoV-2 infection; SARS-CoV-2 infection


VAERS ID: 1094665 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX [FUROSEMIDE]; BISOPROLOL; NITRODERM; PLAVIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer (Colon, liver & possibly bowel); Congestive heart failure; Dementia; Diabetes; Fall; Palliative care; Skull fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021252679

Write-up: had passed a way; This is a spontaneous report from a contactable consumer. A 83-years-old female patient received the first dose of bnt162b2 (BNT162B2) , via an unspecified route of administration in the right arm on 02Mar2021 12:00 at single dose for covid-19 immunisation . Medical history included cardiac failure congestive , neoplasm malignant (Colon, liver & possibly bowel) , diabetes mellitus , dementia, fall on Jan2021 , skull fracture on Jan2021, palliative care from Nov2020. Concomitant medication included furosemide (LASIX), bisoprolol (BISOPROLOL), glyceryl trinitrate (NITRODERM), clopidogrel bisulfate (PLAVIX). The patient was not diagnosed with Covid-19 before the vaccination. The patient was not tested positive to Covid-19 after the vaccination The patient passed a way on 08Mar2021. The action taken in response to the event(s) for bnt162b2 was not applicable. An autopsy was not performed. Course of the event: the patient fell at home in her bedroom. She was conscious when speaking with her daughter, but then was unresponsive when a family member came to help her up off the floor and had passed a way. Information about Lot/Batch number has been requested.; Reported Cause(s) of Death: had passed away


VAERS ID: 1094669 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; XARELTO; IMOVANE; DIFFU K; PREGABALIN; FUROSEMIDE; TRIMEBUTINE; VENTOLINE [SALBUTAMOL SULFATE]; SERESTA; RAMIPRIL; BISOPROLOL HEMIFUMARATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cataract; Coxarthrosis; Erysipelas; Fall; Hand osteoarthritis; Osteoarthritis knee; Venous peripheral insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210213; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021250323

Write-up: a positive SARS COVID 19 PCR test; COVID-19 aggravated; COVID-19 pneumonitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB (FR-AFSSAPS-AM20210427). A 96-year-old female received BNT162B2 (COMIRNATY), intramuscularly, first dose on 19Jan2021 (Lot number: EJ6788) and second dose on 09Feb2021 (Lot number: EK9788) in the left deltoid, both at a single dose for COVID-19 immunisation. Medical history included osteoarthritis knee, coxarthrosis, cataract, venous peripheral insufficiency, erysipelas, atrial fibrillation (AFib), hand osteoarthritis, and recurrent fall. The patient was not previously diagnosed with COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO), zopiclone (IMOVANE), potassium chloride (DIFFU K), pregabalin (MANUFACTURER UNKNOWN) , furosemide (MANUFACTURER UNKNOWN), trimebutine (MANUFACTURER UNKNOWN), salbutamol sulfate (VENTOLINE), oxazepam (SERESTA), ramipril (MANUFACTURER UNKNOWN), and bisoprolol hemifumarate (MANUFACTURER UNKNOWN). The patient experienced a positive SARS COVID 19 PCR test and COVID-19 aggravated on 13Feb2021, which caused hospitalization on 13Feb2021 and were reported as fatal. The patient also experienced COVID-19 pneumonitis in Feb2021, which was reported with hospitalization and fatal. The clinical course was reported as follows: On 11Feb2021, the patient had an onset of fever and was hospitalized on 13Feb2021 before a positive SARS COVID-19 PCR test. There was clinical degradation thereafter, initiation of oxygen therapy and unspecified corticosteroid therapy on 14Feb2021. It was also reported that the patient experienced behavioral disorder and hallucinations from the first dose of the vaccine. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test: positive on 13Feb2021. The patient died on 22Feb2021. The cause of death was reported as COVID-19 pneumonitis. 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: COVID-19 pneumonitis


VAERS ID: 1094671 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, CSF white blood cell count, Coma, Computerised tomogram head, Diarrhoea, Oxygen saturation, Pyrexia, Red blood cell count, Respiratory fatigue, White blood cell count
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GAVISCON [ALGELDRATE;ALGINIC ACID;MAGNESIUM TRISILICATE;SODIUM BICARBONATE]; LYRICA; KARDEGIC; NIFEDIPINE; SOTALOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Age-related macular degeneration; Hypertension arterial; Ischaemic heart disease; Osteoporosis; Spinal operation
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Test Name: Brain CT; Result Unstructured Data: Test Result:normal, no bleeding; Test Name: CRP; Result Unstructured Data: Test Result:54.8 mg/l; Test Name: leucocytes; Result Unstructured Data: Test Result:2 /mm3; Comments: Lumbar puncture; Test Name: oxygen saturation; Test Result: 81 %; Test Name: oxygen saturation; Test Result: 98 %; Test Name: red blood cells; Result Unstructured Data: Test Result:750 /mm3; Comments: Lumbar puncture; Test Name: leucocytes; Result Unstructured Data: Test Result:11.3 x10 9/l; Comments: Lumbar puncture
CDC Split Type: FRPFIZER INC2021250331

Write-up: Respiratory fatigue; Fever; Coma; Diarrhea; This is a spontaneous report from a contactable physician. This is a report received from the Agency-WEB. Regulatory authority or other manufacturer number FR-AFSSAPS-TS20210515. A 94-years-old female patient received the second dose of bnt162b2 (COMIRNATY) vaccine , intramuscular 15Feb2021 at single dose for Covid-19 immunisation . Medical history included hypertension , myocardial ischaemia, age-related macular degeneration , spinal operation , osteoporosis. Concomitant medication included algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON), pregabalin (LYRICA), acetylsalicylate lysine (KARDEGIC), nifedipine (NIFEDIPINE), sotalol (SOTALOL). The patient received the first dose of BNT162b2 on an unspecified date. The patient died from coma febrile on 18Feb2021 (day 3) after vaccination. The cause of death was mentioned to be respiratory fatigue. Course of the event: on 16 and 17Feb2021: Appearance of asthenia and diarrhea. Prescription of loperamide. Diarrhea recovered on 17Feb2021. On 18Feb2021, at 10:05 am, the patient was found in a GCS3 coma, dyspneic with 81% ambient air saturation, a fever of 39.2 ? C; unresponsive pupils. The patient is taken care of by the emergency medical and resuscitation service . Put under oxygen therapy immediately (Sa02 98% under 15l / min). Management: Initiation of treatment with ceftriaxone 3g / day in the event of suspicion of inhalation pneumopathy + IV aciclovir. Oxygen therapy continued. Beginning of comfort care in the face of desaturation and signs of respiratory exhaustion. The patient underwent lab tests and procedures which included body temperature: 39.2 centigrade, computerised tomogram head: normal, no bleeding , C-reactive protein: 54.8 mg/l, oxygen saturation: 81 % , white blood cell count: 11.3 x10^ 9/l. Lumbar puncture: slightly hemorrhagic appearance. Count: 750 red blood cells / mm3 and 2 leucocytes / mm3. An autopsy was not performed. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Pyrexia; Coma; Respiratory fatigue


VAERS ID: 1094681 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1194 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Asthenia, Blood pressure measurement, Fatigue, Heart rate, Vaccination site pain
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic alcoholism (years of evolution until reaching the state of drunk, even the days that he was vaccinated)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Diabetes mellitus (for more than 20 years uncontrolled); Gastric cancer (8 years of evolution with no treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210303; Test Name: Blood pressure; Result Unstructured Data: Test Result:without blood pressure; Test Date: 20210303; Test Name: pulse; Result Unstructured Data: Test Result:without pulse
CDC Split Type: MXPFIZER INC2021253671

Write-up: Acute myocardial infarction; Asthenia/Fatigue; Asthenia/Fatigue; pain on the application site; This is a spontaneous report from a non-contactable healthcare professional received from Regulatory Authority. Regulatory authority number 10501. A 57-year-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN1194, expiration date: 01Jun2021) intramuscular, in left arm, on 25Feb2021, for COVID-19 immunisation. Medical history included arterial hypertension, diabetes mellitus for more than 20 years uncontrolled, gastric cancer (8 years of evolution with no treatment), chronic alcoholism (years of evolution until reaching the state of drunk, even the days that he was vaccinated). Allergies: no. Treatment: metoprolol, metformin, glibenclamide. Concomitant medications were not reported. The patient experienced pain on the application site on 25Feb2021. The patient experienced acute myocardial infarction and asthenia/fatigue on 03Mar2021. The family members referred that after the administration of the first dose on 07Feb2021, the patient presented pain on the application site and mild headache, and that same day, drank alcoholic beverages until drunkenness, that leaded to visual hallucinations, on the second day of the application only said that felt tired on the 3rd day without symptomatology. About the administration of the second dose on 25Feb2021, the family members only referred that the patient had pain on the application site and that lasted only one day without another symptoms. The patient went to his work activities without any symptoms on 01Mar2021 and 02Mar2021, without clinical manifestations. On 03Mar2021, he was carrying out his activities in the health center normally, mentioned going to the restroom, around 12.00, approximately at 20 min, a companion also entered the bathroom when realizing that he was busy, spoke to him on repeated occasions, for which he went to the authorities of the health center. The door was opened, finding him unconscious with mydriasis and pupils without response to luminous stimulations, with cold skin, without pulse or blood pressure. Basic resuscitation maneuvers were performed without positive result. Patient with a history of arterial hypertension and diabetes mellitus for more than 20 years uncontrolled. The family members corroborated that he had been diagnosed with gastric cancer of 8 years of evolution with no treatment, besides of chronic alcoholism with years of evolution until reaching the state of drunk, even the days that he was vaccinated. The patient died on 03Mar2021. Myocardial infarction was reported with a fatal outcome. Pain on the application site resolved on 26Feb2021. Asthenia/fatigue outcome was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021257759 Same patient/vaccine, different dose and AE; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1099516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, General physical health deterioration, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: ATPFIZER INC2021242192

Write-up: Reduced general condition; COVID-19 respiratory infection; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority-WEB. Regulatory authority number AT-BASGAGES-2021-04874. An 88 years old female patient received the first dose of BNT162B2 (COMIRNATY, Lot. EL1491) at single dose, on 15Jan2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. Post the vaccination, the patient has been tested for COVID-19 and resulted positive on 19Jan2021. On 22Jan2021, the patient experienced reduced general condition and died on 30Jan2021. Clinical outcome of reduced general condition and death was fatal. Cause of death was reported as COVID-19 respiratory infection. It was unknown if autopsy was done. Relatedness of drug to reaction(s)/event(s) for Comirnaty to all events, reported as Unassessable/Unclassifiable by BASGAGES. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 respiratory infection; Reduced general condition


VAERS ID: 1099517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chemotherapy NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: ATPFIZER INC2021242190

Write-up: COVID-19 PCR test positive; Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-04884. A 76-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (Lot # EL1491), via an unspecified route of administration at single dose on 15Jan2021 for COVID-19 immunisation. Medical history included ongoing chemotherapy NOS. Concomitant medications were not reported. The patient experienced death NOS on 01Feb2021, COVID-19 PCR test positive on 26Jan2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 26Jan2021. The patient died on 01Feb2021 from COVID-19 respiratory infection. It was not reported if an autopsy was performed. Missing info on cause of death and possible underlying diseases. Clinical course was reportrd as follows: Since 01Jan2021 a COVID infection was circulated in the retirement home. All 12/14 deceased were tested positive for Sars-CoV2 by means of PCR. The patient of this AE report was also positive. Tested for Sars-CoV2 by means of PCR (26Jan2021), on 29Jan2021 in the hospital due to deterioration, died there on 01Feb2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1099525 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021241061

Write-up: Passed away; This is a spontaneous report from a contactable Health Care Professional. A male patient of an unspecified age received BNT162B2 (COMIRNATY) at single dose, on 03Mar2021, at 09:14 AM, for COVID-19 immunisation. Relevant medical history included multiple chronic conditions from an unspecified date. Concomitant medications were unknown. The patient was observed for 15 mins post injection and did not exhibit any untoward side effects or adverse events. The patient was reported to have been fine for the rest of 03Mar2021. It was reported that the patient died on 04Mar2021 (last observation 23:45) and was declared dead at 00:33 on 05Mar2021. No immediate adverse reactions noted in the lead up to the time of death. It was unknown if autopsy was done. No death certificate has been issued at this time and no further information was available at this time. No follow up attempts are needed. No further information is expected.; Sender''s Comments: The patient was observed for 15 mins post injection and did not exhibit any adverse events. The patient was reported to have been fine for the rest of 03Mar2021. It was reported that the patient died on 04Mar2021 (last observation 23:45) and was declared dead at 00:33 on 05Mar2021. There was no evidence that the patient''s death was causally related to the BNT162B2 (COMIRNATY). The case will be reassessed should additional information become 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: passed away


VAERS ID: 1099540 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-05
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: Covid-19 test; Result Unstructured Data: Test Result:Postive
CDC Split Type: BEPFIZER INC2021249391

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first single dose of BNT162B2 (COMIRNATY, lot number EM0477) on 18Jan2021, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was positive on 05Feb2021 with fatal outcome. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The cause of death was not reported. The patient only received the first dose as was too sick for the second dose. Follow-up attempts are not possible. No further information is expected.; Sender''s Comments: Based on the information available as reported at this point, a possible contributory role of the suspect product cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to only the vaccine first dose is given. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1099541 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-05
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: Covid-19 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: BEPFIZER INC2021249392

Write-up: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of bnt162b2 (COMIRNATY, lot number EM0477, expiration date not reported) , via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was positive COVID-19 testo on 05Feb2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. The cause of death was not reported. The patient only received the first dose as the patient was too sick for the second dose. Follow-up attemtps are not possible. No further information is expected.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive and drug ineffective due to temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: positive COVID-19 test; positive COVID-19 test


VAERS ID: 1099542 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-11
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: BEPFIZER INC2021249393

Write-up: COVID-19; COVID-19; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the 1st dose of bnt162b2 (COMIRNATY, lot# EM0477), via an unspecified route of administration, on 18Jan2021, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced COVID-19 on 11Feb2021 with fatal outcome on an unspecified date in 2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 11Feb2021. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event COVID-19 leading to fatal outcome based on the known safety profile. However considering the relatively short duration since the vaccine first dose is given, it is unlikely the patient would have fully developed immunity. 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: COVID-19; COVID-19


VAERS ID: 1099567 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arterial thrombosis, Gastrointestinal necrosis, Hepatic failure, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Ischaemic colitis (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COPD; House dust allergy; Pollinosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021242210

Write-up: small intestinal necrosis; small bowel necrosis due to suspected arterial thrombosis; increasing liver failure; kidney failure; This is a spontaneous report from a non-contactable other health professional downloaded from the Agency DE-DCGMA-21188222. A 56-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection) lot number EJ6788 and expiry date unknown, intramuscular at the arm (deltoid muscle) on 12-Feb-2021 at single dose for Covid-19 immunization. Medical history included COPD, asthma, pollinosis, house dust allergy; all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical vaccine included first dose of Comirnaty on 22-Jan-2021 for Covid-19 immunization and had been tolerated. On 16-Feb-2021, the patient experienced small intestinal necrosis (gastrointestinal necrosis), small bowel necrosis due to suspected arterial thrombosis (arterial thrombosis), increasing liver failure (hepatic failure), kidney failure (renal failure). The patient was hospitalized due to the events on unspecified date. The patient died on an unspecified date due to the events. It was not reported if an autopsy was performed. Reporter''s comment: Measures: OP on February 16, 2021 and relaparotomy on February 17, 2021. PEI: event assessment for all events/D. unclassifiable. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Measures: OP on February 16, 2021 and relaparotomy on February 17, 2021.; Reported Cause(s) of Death: small bowel necrosis due to suspected arterial thrombosis; increasing liver failure; kidney failure; small intestinal necrosis


VAERS ID: 1099568 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; House dust mite allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021250304

Write-up: Death; Aspiration; This is a spontaneous report from a non-contactable physician. This is a report received from the regulatory authority-WEB. Regulatory authority or other manufacturer number DE-DCGMA-21188243. A 32-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot/batch number not provided), via an unspecified route of administration on 12Feb2021(at 32-year-old)at single dose for COVID-19 immunisation. Medical history included: Asthma, House dust mite allergy, both were unknown if ongoing. The patient''s concomitant medications were not reported. 13 hours after vaccination (12Feb2021) the patient developed Aspiration and Death, lasting for unknown. The patient is dead on 12Feb2021. Death cause was reported as Aspiration. An autopsy was performed and results were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Aspiration


VAERS ID: 1099576 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-12
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas; Apoplexy; Atrial fibrillation; Dementia; Hypertension arterial; Immobilization syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021242197

Write-up: stroke/apoplexy; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number DE-PEI-PEI2021003066. An 89-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number: EM0477, expiry date was not reported) (at 89 years of age), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunisation. Medical history included apoplexy, hypertension arterial, immobilization syndrome, atrial fibrillation, dementia and adipositas, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced stroke on 12Feb2021. On 12Feb2021, after vaccination the patient developed stroke. The patient is dead. Death cause was reported as Apoplexy. The patient died on 21Feb2021. It was not reported if an autopsy was performed. Event Assessment: Stroke/PEI/ D. Unclassifiable. Stop date for stroke reported as 21Feb2021. No follow-up attempts possible. No further information expected.; Sender''s Comments: A causal association between BNT162B2 and the event stroke cannot be excluded based on a compatible temporal relation. Underlying medical conditions and advanced age should however, be considered as contributory factors to stroke. 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 RAs, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Apoplexy; stroke


VAERS ID: 1099577 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Disseminated intravascular coagulation, Hepatic failure, Intestinal gangrene, Visceral venous thrombosis
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021242188

Write-up: Hepatic failure; Gangrene intestine; Disseminated intravascular coagulation; Visceral venous thrombosis; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-PEI2021003069. A 56-year-old female patient received the second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ6788), intramuscular on 12Feb2021 at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took COMIRNATY for covid-19 immunisation on 22Jan2021. On 15Feb2021 (after vaccination), the patient developed disseminated intravascular coagulation, visceral venous thrombosis, gangrene intestine and hepatic failure lasting for unknown. The patient died on an unspecified date. The outcome of the events was fatal. Further information awaited. 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: hepatic failure; gangrene intestine; disseminated intravascular coagulation; visceral venous thrombosis


VAERS ID: 1099578 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypothermia
SMQs:, Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: Body temperature; Result Unstructured Data: Test Result:decrease
CDC Split Type: DEPFIZER INC2021242201

Write-up: Hypothermia (Body temperature decrease); This is a spontaneous report from a non-contactable physician downloaded from the Agency, regulatory authority number DE-PEI-PEI2021003071. An 87-years-old female patient received the second dose of bnt162b2 (COMIRNATY, lot number unknown), intramuscular on 30Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated with the first dose of bnt162b2 on 31Dec2020 for COVID-19 immunization. On 01Feb2021, after vaccination the patient developed hypothermia (body temperature decrease), lasting for unknown. The patient died on 06Feb2021 due to the event. It was not unknown if an autopsy was performed. Event Assessment: Hypothermia / PEI / C. Inconsistent causal association. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Hypothermia (Body temperature decrease)


VAERS ID: 1099579 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-02-21
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021242204

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authoirty-WEB, regulatory authority number DE-PEI-PEI2021003073. An 85-year-old male patient received the first dose of BNT162B2 (COMIRNATY; lot number: EM0477), via an unspecified route of administration on 14Jan2021 at single dose, then received the second dose (lot number: EM0477) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced exitus letalis on 21Feb2021. It was also reported that on 21Feb2021 after vaccination the patient developed death, lasting for unknown. It was not reported if an autopsy was performed. Event assessment of the event Death as per PEI was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1099582 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Disturbance in attention, Dyspnoea, Pneumonia bacterial
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021256441

Write-up: Dyspnoea; Vigilance decreased; Pneumonia bacterial; Exsiccosis; This is a spontaneous report from a non-contactable physician received from regulatory authority, downloaded from the Agency, DE-PEI-PEI2021003160. A 98-year-old female patient received BNT162B2 (COMIRNATY, batch/lot number: EM0477) via an unspecified route of administration on an unspecified date (unknown age at vaccination) at single dose for COVID-19 immunization. The patient''s medical history included dementia and unknown if ongoing. Before vaccination there are no typical symptoms of infections; the patient was stable. Concomitant medications were not reported. After vaccination, on 01Feb2021 the patient developed dyspnea, vigilance decreased, exsiccosis, and pneumonia bacterial, lasting for unknown. The condition was life threatening. The patient died on 05Feb2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death:


VAERS ID: 1099593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-23
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FENTANYL B. BRAUN; EUTHYROX; LANSOPRAZOL KRKA; KLORZOXAZON DAK; TOUJEO SOLOSTAR; CLORIOCARD; ROBINUL; MIRTAZAPIN "2CARE4"; LOSARSTAD; KEPPRA; KALIUMKLORID ORIFARM
Current Illness: Loss of consciousness (For 3 years. Sometimes opened eyes and reacted a litle but contact was not possible); Unwell
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Depression; Diabetes mellitus; Epilepsy; Hypertension; Metabolic disorder; Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021249334

Write-up: Death; This is a spontaneous report downloaded from the Agency [DK-DKMA-WBS-0042948]. The case was received from a contactable nurse via The Agency. An 89-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly on 22-Jan-2021 (Lot number: EJ6134, Expiration Date: 30-Apr-2021) at single dose for COVID-19 immunisation. Patient medical history included Apoplexy and concurrent conditions included Metabolic disorder, pain, Epilepsy, Hypertension, Depression, Diabetes mellitus, ongoing loss of consciousness for 3 years. Sometimes opened eyes and reacted a little but contact was not possible, and ongoing Unwell. Concomitant medication included fentanyl citrate (FENTANYL B. BRAUN) from 03-Mar-2020 for pain, levothyroxine sodium (EUTHYROX) from 13-Jul-2020 for Metabolic disorder, lansoprazole (LANSOPRAZOL KRKA) from 20-Apr-2020 for Gastric ulcer prophylaxis, chlorzoxazone (KLORZOXAZON DAK) from 02-Dec-2020 for Muscle relaxant therapy, insulin glargine (TOUJEO SOLOSTAR) from 12-Feb-2019 for Diabetes mellitus, clopidogrel hydrochloride (CLORIOCARD) from 20-Apr-2020 for Thrombosis prophylaxis, glycopyrronium bromide (ROBINUL) from 13-Jul-2020 for Airway secretion clearance therapy, mirtazapine (MIRTAZAPIN "2CARE4") from 20-Apr-2020 for Depression, losartan potassium (LOSARSTAD) from 24-Mar-2020 for Hypertension, levetiracetam (KEPPRA) from 20-Apr-2020 for Epilepsy, potassium chloride (KALIUMKLORID ORIFARM) from 04-Mar-2020 for Calcium supplementation. The patient previously took the first dose of BNT162B2 (COMIRNATY), on 22-Jan-2021 (Lot number: EJ6797, expiry date: 30-Apr-2021) at single dose for COVID-19 immunisation. The patient experienced death on 23-Feb-2021. The event was reported as serious for being fatal and life-threatening. An autopsy was not performed. The patient is buried. There is no information regarding test results. Causality: The reporter stated that the patient''s condition was mainly stationary until receiving the vaccine. If the Agency receives supplemental significant information regarding this case the case will be re-submitted. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1099617 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Depressed level of consciousness, Heart rate, SARS-CoV-2 antibody test, Suicide attempt
SMQs:, Suicide/self-injury (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYMBALTA; LORAZEPAM; FUROSEMIDA [FUROSEMIDE]; ALMAX FORTE; OMEPRAZOLE; PARACETAMOL; SIMVASTATIN; FENTANYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker wearer (cardiovascular disease (excluding hypertension)); AV block; Constipation; COVID-19; Dyslipidemia; Gonarthrosis (bilateral, more severe on the right); Hiatus hernia; Hip arthrodesis (left hip, when he was 18 years old, due to a tumor); Hip surgery; Hyperplasia of prostate (benign); Hypoacusis; Inguinal hernia repair; Intracerebral hematoma (post-traumatic, right fronto-basal); Left cataract extraction; Macular degeneration; Normochromic normocytic anemia; Prostate cancer (adenoma); Prostatectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: blood pressure; Result Unstructured Data: Test Result:156/76; Test Date: 20210111; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210130; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210111; Test Name: heart rate; Result Unstructured Data: Test Result:76; Test Date: 202008; Test Name: COVID-19 serology test; Test Result: Positive ; Comments: IgG
CDC Split Type: ESPFIZER INC2021251541

Write-up: suicide attempt; stuporous picture; This is a spontaneous report from a contactable physician reporting different events for same patient and drug. This is second of two reports. The first report was downloaded from Regulatory Authority-WEB [ES-AEMPS-755248]. A 90-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot#: EJ6796) at single dose in left arm on 08Jan2021 for COVID-19 immunisation. Medical history included COVID-19; artificial cardiac pacemaker wearer from 2016, cardiovascular disease (excluding hypertension); dyslipidemia; atrioventricular (AV) block; intraparenchymal hematoma from 2015, post-traumatic, right fronto-basal; hiatus hernia; constipation; normochromic normocytic anemia; hip arthrodesis, left hip, when he was 18 years old, due to a tumor; gonarthrosis, bilateral, more severe on the right; benign prostate hyperplasia; prostate cancer, adenoma; macular degeneration; hypoacusia; prostatectomy from 2010; cataract removal; left hip surgery; inguinal hernia surgery. Concomitant medications included duloxetine hydrochloride (CYMBALTA, 30 mg) at 1-0-0; lorazepam (1 mg) at 0-0-2; furosemide (FUROSEMIDA, 40 mg) at 0-0-1; almagate (ALMAX FORTE, 1.5 g) at 0-1-0; omeprazole (20 mg) at 1-0-0; paracetamol (1 mg); simvastatin (20 mg) at 0-0-1; fentanyl at 25 mg/h 1/72 hrs. The patient experienced stuporous picture on 09Jan2021, suicide attempt on an unspecified date. Therapeutic measures were taken as a result of stuporous picture. The patient underwent lab tests and procedures which included blood pressure: 156/76 on 11Jan2021; body temperature: 36.7 Centigrade on 11Jan2021 and 36.3 Centigrade on 30Jan2021; heart rate: 76 on 11Jan2021; COVID-19 serology test: positive in Aug2020, IgG. The outcome of events was unknown. The patient died on 30Jan2021 due to acute respiratory distress syndrome and cardio-respiratory arrest (refer to AER 2021208062). It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Acute respiratory distress syndrome; Cardio-respiratory arrest


VAERS ID: 1099627 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hyperthermia, Physical examination, SARS-CoV-2 test positive
SMQs:, Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; MIANSERIN; LORAZEPAM; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arteritis; COVID-19 (Covid-19 test positive on 03Apr2020); Cyst; Embolism pulmonary; Hypercholesterolemia; Hysterectomy; Meningioma
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: Physical examination; Result Unstructured Data: Test Result:asymptomatic except hyperthermia; Test Date: 20200403; Test Name: COVID 19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021242189

Write-up: Hyperthermia; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB (regulatory authority number FR-AFSSAPS-AN20210623). A 95 years old female patient received the second single dose of BNT162B2 (COMIRNATY; lot EK9788) intramuscular, on 09Feb2021, for COVID-19 immunisation. Medical history included hypercholesterolemia, meningioma, embolism pulmonary, hysterectomy, arteritis, arterial hypertension, cyst, all from an unknown date and unknown if ongoing. The patient had COVID-19 in 2020 (COVID-19 test positive on 03Apr2020). The patient was at risk of developing a severe form of COVID-19 disease. The patient received the first dose of Comirnaty on an unspecified date (batch/lot number EM0477). Usual treatment included clopidogrel 75 mg/day, mianserin 60 mg/J, lorazepam 1 mg/day and paracetamol. On 12Feb2021, the patient presented with hyperthermia. Physical examination: asymptomatic except hyperthermia. On 12Feb2021: initiation of amoxicillin 3 g/day. On 15Feb2021: initiation of cefixime 400 mg/day. On 18Feb2021: persistent hyperthermia on D4 of antibiotic therapy with cefixime. Switch for ceftriaxone (ROCEPHINE). Hospitalization 14 days after the 2nd vaccination. On 24Feb2021 death on the 15th day after the second dose of COMIRNATY. Both death unexplained and hyperthermia were reported with a fatal outcome. It was unknown if an autopsy was done. Conclusion: hyperthermia occurring in a patient 3 days after vaccination with the second dose of COMIRNATY, then death 15 days after injection. NB: Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry of Health. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hyperthermia


VAERS ID: 1099628 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA; Dementia; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: COVID-19 PCR; Test Result: Negative ; Test Date: 20210216; Test Name: COVID-19 PCR; Test Result: Positive
CDC Split Type: FRPFIZER INC2021232809

Write-up: COVID-19 aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The Regulatory Authority report number is FR-AFSSAPS-BR20210398. A 93-year-old male patient received the first dose of BNT162B2 (COMIRNATY, batch number: EK9788, expiration date not reported), intramuscular on 11Feb2021 at a single dose for COVID-19 immunisation. Medical history included Type 2 diabetes mellitus, cerebrovascular accident (CVA), and dementia. The patient''s concomitant medications were not reported. The declaration was made by a domestic hospitalisation physician for a resident of a facility for dependent elderly people. Note the absence of a coordinating physician in this facility. On 01Feb2021, this patient left a Pneumology department which was the center of a large cluster on that date. PCR negative at the exit. He was admitted to facility for dependent elderly people. On 03Feb2021, his state of health began to deteriorate and this was initially attributed to frustration at leaving his home. On 11Feb2021, first injection of the COMIRNATY was administered with continued deterioration of the general condition. On 16Feb2021, the patient experienced bronchial congestion, stopping hydration and PCR COVID positive. On 17Feb2021, the patient experienced COVID-19 aggravated. On 18Feb2021, intervention by the domestic hospitalisation physician for respiratory deterioration (distress) with agitation and pain which appeared the day before which included introduction of hyoscine butylbromide (SCOBUREN) and midazolam. On 19Feb2021, death of the patient. In total, the patient probably infected with COVID before his first vaccine injection, which deteriorated in the days that followed. The domestic hospitalisation physician cannot rule out a severe form of COVID following vaccination. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1099629 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Decreased appetite, Lung disorder
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD; Emphysema; Fibrosis NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021250308

Write-up: WATER IN LUNGS; Pain chest; Appetite lost; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB Regulatory Authority number FR-AFSSAPS-BS20210274. A 81-years-old male patient received the first dose of bnt162b2 (COMIRNATY, lot#unknown), via an unspecified route of administration single dose on 25Jan2021 for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease, ongoing emphysema, ongoing fibrosis. The patient''s concomitant medications were not reported. The patient experienced water in lungs (lung disorder) (death) on 29Jan2021, appetite lost (decreased appetite) (death) on 25Jan2021, pain chest (chest pain) (death) on 28Jan2021. They punctured the water out of his lungs so that he wouldn''t suffer so much. They put him in a room sitting up and secured him with pillows. He had a coherent speech and seemed calm. An hour later, they found him dead in the bed. He died in the emergency room on Friday 29Jan2021 at 3:15 am. An autopsy was not performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: water in lungs; appetite lost; pain chest


VAERS ID: 1099635 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-23
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Coma scale, Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colonoscopy (a history of general anesthesia for a colonoscopy on heredity (father died of colon cancer)); Coronary heart disease (NSTEMI (non-ST segment elevation myocardial infarction) at the age of 70 years); General anesthesia; Pre-diabetic (fasting glycemia pre-diabetic treated by diet and a little triglycerides); Supplementation therapy (no long-term treatment apart from taking herbal medicine, vitamins and food supplements)
Allergies:
Diagnostic Lab Data: Test Date: 20210224; Test Name: CT angiography; Result Unstructured Data: Test Result:brain death; Test Date: 20210224; Test Name: Glasgow scale; Result Unstructured Data: Test Result:3; Comments: no sign of waking up with a Glasgow at 3 and pupils in bilateral mydriasis, reactive in the afternoon with a transcranial Doppler in bilateral reverse flow; Test Date: 20210223; Test Name: PCR-Covid-19; Test Result: Negative
CDC Split Type: FRPFIZER INC2021232792

Write-up: Infarct myocardial; This is a spontaneous report downloaded from the regulatory authority-WEB regulatory authority FR-AFSSAPS-DJ20210353. A contactable physician (specialist doctor who was the patient''s companion) reported that a 57-year-old male patient received second dose of BNT162B2 (COMIRNATY; lot number: EM0477), intramuscular on 03Feb2021 at single dose for COVID-19 immunisation. The patient had no medical history in particular no cardiac history (no history of angina). It was reported by his companion a fasting glycemia pre-diabetic treated by diet and a little triglycerides. It was also noted a history of general anesthesia for a colonoscopy on heredity (father died of colon cancer) as well as a coronary heart (NSTEMI (non-ST segment elevation myocardial infarction) at the age of 70 years). The patient had no long-term treatment apart from taking herbal medicine, vitamins and food supplements. The patient''s concomitant medications were not reported. On 13Jan2021, the patient received his first injection of the BNT162B2 vaccine (batch no. EM0477) without any adverse effects. On 03Feb2021, he received his 2nd injection of the BNT162B2 vaccine (batch no. EM0477). It did not present any adverse effects in the aftermath (no sign of reactogenicity such as fever, etc.). On 23Feb2021, the patient, who was a general practitioner, was returning to lunch by bike from his doctors office which was 3 km from his house (flat journey) with a notion of effort but not major (usually doing this trip 3 times a day). According to the testimony of the children who were present, he experienced radiating chest pain in the jaw as well as tachycardia. He lost consciousness while on the phone with the (emergency services) and presented with cardiopulmonary arrest. The children immediately began heart massage. Upon arrival of the emergency services within seconds, he received several external electric shocks (CEE) and amiodarone (CORDARONE) due to an initial ventricular fibrillation. He was taken to the emergency room for the placement of venous-arterial ECLS. The pump started and at this point it shows a no flow at 0 minutes and a low flow at 53 minutes. He again received two CEEs on probable ventricular tachycardia, without result. Norepinephrine therapy was started due to low blood pressure on ECLS. Coronary angiography was performed due to the initial symptomatology. It resumes sinus rhythm at this time. The coronary angiography found bitronascular lesions with tight stenosis on the anterior ventricular vein at 2 levels as well as an acute occlusion of the circumflex treated with an active stent. He receives aspirin and heparin in the room. On 24Feb2021, the sedation was stopped but he showed no sign of waking up with a Glasgow at 3 and pupils in bilateral mydriasis, reactive in the afternoon with a transcranial Doppler in bilateral reverse flow. In the evening, brain death was confirmed by CT angiography. Therapeutic limitation with comfort care was decided. On the semiological level, an infectious assessment was taken. The PCR-Covid-19 was negative on February 23, 2021. According to the cardiologist who performed the coronary angiography, the diagnosis was a myocardial infarction by rupture of a plate with occlusion of the circumflex and it was the myocardial infarction which was the cause of arrhythmias. Note that the patient was an active general practitioner, cycling and doing a lot of mountain climbing (hiking, skiing, climbing). He had stopped his sports activities for a year due to COVID-19. Possible context of professional overwork, he had not taken leave for 18 months (4-day week). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1099638 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (NOS); Breast cancer (considered cured); CVA; Hemiplegia; Hypertension arterial (HTA); Malnutrition NOS (weight 50 kg); Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021242191

Write-up: Sudden death; feeling tired; This is a spontaneous report from a contactable physician via the Agency downloaded from the Regulatory Agency -WEB FR-AFSSAPS-LM20210367. A 84-year-old female patient received second dose of bnt162b2 (COMIRNATY;lot EJ6788) intramuscular in right arm on 09Feb2021 at single dose for covid-19 immunisation. Medical history included hypertension arterial (HTA) unknown if ongoing, cerebrovascular accident (CVA) unknown if ongoing , breast neoplasia considered cured, undernutrition (weight 50 kg), unspecified arrhythmias and stroke in 2013 with sequelae hemiplegia. The patient''s concomitant medications were not reported. The patient experienced sudden death on 18Feb2021. The patient was found dead in bed in the morning on 18Feb2021; she had been seen by the nurse shortly before, had complained of feeling tired (unknown outcome) but had not described any other symptoms. The patient died on 18Feb2021. 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


VAERS ID: 1099639 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-03
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cognitive impairment; Fall; Ischaemic heart disease (ETT (Transthoracic echocardiography) revealing ischemic heart disease); Osteoporosis with fracture; Parkinson''s disease (Parkinsonian syndrome with repeated falls and moderate cognitive impairment,)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bronchiectasis; Cardiac insufficiency (myocardial insufficiency that went unnoticed with LVEF (left ventricular ejection fraction) 35%); COVID-19 pneumonia (COVID-19 infection complicated by right posterior pulmonary embolism); Deep vein thrombosis; Hospitalization; Interstitial lung disease (Dilation of the bronchi at the lower lobe level and interstitial syndrome); Orthostatic hypertension; Pulmonary embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021232843

Write-up: Heart arrest/cardiac arrest; This is a spontaneous report downloaded from the Medicines Agency (EMA) EudraVigilance-WEB. The regulatory authority report number is FR-AFSSAPS-LY20210917. A contactable pharmacist reported that an 85-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EJ6795), on the left arm, intramuscularly on19Jan2021 at single dose for COVID-19 immunisation. Medical history included dilation of the bronchi at the lower lobe level and interstitial syndrome in 2013, ongoing parkinsonian syndrome with repeated falls and moderate cognitive impairment from an unspecified date, bilateral distal deep vein thrombosis with bilateral pulmonary embolism in 2018, arterial hypertension and orthostatic hypertension in 2020, ongoing osteoporosis with fractures on Apr2020, COVID-19 infection complicated by right posterior pulmonary embolism on 13Apr2020, ongoing ischemic heart disease on 15Apr2020 due to myocardial insufficiency that went unnoticed (anteroapical and anterolateral negative T wave) with LVEF (left ventricular ejection fraction) 35% via ETT (Transthoracic echocardiography). No antiaggregant because of the significant risk of falling. Hospital admission on 17Aug2020. The patient''s concomitant medications were not reported. The patient had a flu vaccination on 31Oct2020. The patient received the first dose of BNT162B2 on 19Jan2021. From 19Jan2021 to 03Feb2021 no particular symptom or deterioration of the patient''s general condition. On 03Feb2021, patient goes into cardiac arrest requiring urgent care. Eventually he died. The patient died on 03Feb2021. 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


VAERS ID: 1099640 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatinine, Coma scale, Haemoglobin, Investigation, Oxygen saturation, Platelet count, Respiratory distress, SARS-CoV-2 test negative, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIANSERINE HCL; ZYMAD; DAFALGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Choked on food; Dementia; Living in nursing home; Osteoarthritis; Pneumonia aspiration (Repeated false routes with aspiration pneumonia); Pneumopathy (inhalation pneumopathy on probable false route, having led to respiratory decompensation); Respiratory failure (inhalation pneumopathy on probable false route, having led to respiratory decompensation); Starvation (Severe undernutrition)
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: bicarbonate; Result Unstructured Data: Test Result:35 mmol/L; Test Date: 20210208; Test Name: creatinine; Result Unstructured Data: Test Result:65 umol/l; Test Date: 20210215; Test Name: glasgow; Result Unstructured Data: Test Result:3; Comments: Glasgow 3, with significant pauses in breathing, muffled heart sound, but seemed regular, there was foam in the mouth; Test Date: 20210208; Test Name: Hb; Result Unstructured Data: Test Result:12.8 g/l; Test Date: 20210208; Test Name: DFG CKD EPI; Result Unstructured Data: Test Result:70ml / min / 1.73m2; Test Date: 20210215; Test Name: saturation; Result Unstructured Data: Test Result:50% %; Comments: desaturation; Test Date: 20210208; Test Name: platelets; Result Unstructured Data: Test Result:295 g/l; Test Date: 202012; Test Name: PCR COVID; Test Result: Negative ; Comments: PCR COVID; Test Date: 20210208; Test Name: leukocytes; Result Unstructured Data: Test Result:4.26 g/l
CDC Split Type: FRPFIZER INC2021242194

Write-up: Distress respiratory; This is a spontaneous report from a contactable pharmacist downloaded from the Agency-WEB FR-AFSSAPS-LY20211066. A 94-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY, Lot # EJ6788) intramuscular at single dose on 02Feb2021 for COVID-19 immunisation. Medical history included pneumonia aspiration (repeated false routes with aspiration pneumonia), starvation/severe undernutrition, osteoarthritis, dementia, choking, lived in a facility for the elderly. 17Nov2020: inhalation pneumopathy on probable false route, having led to respiratory decompensation. PCR COVID negative in early Dec2020. Concomitant medication included mianserin hydrochloride (manufacturer unknown, 10mg) oral 2 in the evening, colecalciferol (ZYMAD) every 3 months, paracetamol (DAFALGAN) if needed. The patient previously received dbnt162b2 (COMIRNATY, Lot # EM0477) on 12Jan2021 for COVID-19 immunisation and experienced no adverse effects. The patient experienced no adverse effects in the aftermath of the 2nd dose. On 08Feb2021 (last report): Hb 12.8g/l, platelets 295g/L, leukocytes 4.26g/l, bicarbonate 35mmol/l, creatinine 65?mol/l, DFG CKD EPI 70ml/min/1.73m2. On 15Feb2021 the patient experienced distress respiratory. The event distress respiratory was considered fatal. Clinical course of events was as follows: On 15Feb2021 patient was found in 50% desaturation, then 45% under 1L O2, put under 5L O2. At treatment, patient Glasgow 3, with significant pauses in breathing, muffled heart sound, but seemed regular, there was foam in the mouth. Evolution of events included therapeutic limitation and O2 withdrawal. Quickly, patient reactive to the foix maneuver, auscultatory silence, reactive mydraise pupils: death. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. No further information available. No follow-up attempts are possible.; Reported Cause(s) of Death: distress respiratory


VAERS ID: 1099643 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-10
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Dehydration, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Guillain-Barre syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021250322

Write-up: SARS-CoV-2 infection; a COVID-19 infection, 22 days after a first dose of COMIRNATY; severe asthenia; major dehydration; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from the Regulatory Authority. The regulatory authority report number is FR-AFSSAPS-MA20210609. A 91-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EM0477), intramuscularly on 19Jan2021 at 91-years-old at a single dose for COVID-19 immunization. The patient''s medical history included living in nursing home from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 10Feb2021, the patient experienced: SARS-CoV-2 infection, a COVID-19 infection, 22 days after a first dose of COMIRNATY, severe asthenia, and major dehydration. The clinical course was reported as follows: The 91-year-old patient, who was a resident in a nursing home, was vaccinated with the first dose of the COMIRNATY vaccine on 19Jan2021. On 10Feb2021, appearance of a COVID-19 infection with severe asthenia and major dehydration, lead to the death of the patient. The clinical outcome of the events was fatal. The patient died on an unspecified date due to SARS-CoV-2 infection, severe asthenia, and major dehydration. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: severe asthenia; major dehydration; SARS-CoV-2 infection


VAERS ID: 1099645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021232850

Write-up: COVID-19 PCR test positive; COVID-19 aggravated/fever, rapidly worsening; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority FR-AFSSAPS-MP20210279. A 101-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot: EJ6788), intramuscular on left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history included cerebrovascular accident (CVA) from 2013 to 2013 (not ongoing). The patient''s concomitant medications were not reported. On 22Jan2021, the patient experienced fever, rapidly worsening and COVID-19 aggravated. On 25Jan2021 with PCR test for COVID-19: positive, no variant testing. The patient died on 27Jan2021 due to COVID-19 and COVID-19 PCR test positive (reported as severe COVID leading to death). It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 aggravated/fever, rapidly worsening; COVID-19 PCR test positive


VAERS ID: 1099646 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dyspnoea, Electrocardiogram, Fatigue, Heart rate, Myocardial infarction, Pain
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: Blood pressure; Result Unstructured Data: Test Result:13/8; Test Date: 20210219; Test Name: ECG; Result Unstructured Data: Test Result:over-shift in the lateral territory; Test Date: 20210219; Test Name: Pulse; Result Unstructured Data: Test Result:good
CDC Split Type: FRPFIZER INC2021242205

Write-up: myocardial infarction; aches and pains; fatigue; little more dyspnea; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB. Regulatory Authority number FR-AFSSAPS-MP20210336. A 77-year-old male patient received second dose of BNT162B2 (COMIRNATY), intramuscularly in arm on 17Feb2021 as a single dose (1 DF) for covid-19 immunisation, lot number: unknown. Medical history included hypertension arterial and renal failure chronic, both unknown if ongoing. Concomitant medications were not provided. First vaccine dose of BNT162B2 (COMIRNATY) was administered on unknown date for COVID-19 immunisation, first injection without undesirable effect, lot number: unknown. Patient considered to be at risk of developing a severe form of COVID-19. Background to COVID-19 was reported as no. It was not reported (NR) if patient was tested. On 18Feb2021, the next day, the patient presented aches and pains, fatigue and a little more dyspnea. On 19Feb2021 on waking up he did not feel very well and had difficulty breathing, he consulted a general practitioner around 9.45 am. Blood pressure (BP) was 13/8, pulse was good when suddenly at 11.30 he had a cardiorespiratory arrest. The doctor gave him an external massage, help arrived at about 11:45. Injection of adrenaline: resumption of the heartbeat. Post a cardiorespiratory arrest (ACR) electrocardiogram (ECG) showed over-shift in the lateral territory. At about 11:50 a.m. second cardiorespiratory arrest (RCA) recovered again. Around 12 noon third (3 rd) cardiorespiratory arrest (ARC) not recovered. Resuscitation stopped at 12.30 pm. On 19Feb2021 patient died due to infarct myocardial. No autopsy was performed. Outcome of the other events was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1099648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Albuminuria, Blood immunoglobulin G, Body temperature normal, Heart rate, Malnutrition, Oxygen saturation, Oxygen saturation decreased, Polymerase chain reaction positive, Respiratory rate, SARS-CoV-2 test negative, Weight, Weight increased
SMQs:, Acute renal failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PAROXETINE MESILATE; MOVICOL PLAIN; UVEDOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colorectal cancer NOS (colonic neoplasm in 2014 (total remission after treatment)); Constipation chronic; COPD; COVID-19; Depression; Respiratory infection (A second infectious respiratory episode in May2020.)
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: albuminuria; Result Unstructured Data: Test Result:33.5 g/l; Comments: The day of the second dose, the patient was asymptomatic from a respiratory perspective, but malnourished with albuminuria at 33.5g/l; Test Date: 20201229; Test Name: A Sars Cov2 serology; Result Unstructured Data: Test Result:65.5; Comments: A Sars Cov2 serology done on 29Dec found Ig totals of 65.5); Test Date: 20210210; Test Name: apyretic; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210210; Test Name: apyretic; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: at 17:00 after vaccination; Test Name: cardiac frequency; Result Unstructured Data: Test Result:100/min; Comments: Heartbeat was regular with cardiac frequency at 100/min with no murmur or racing; Test Name: heartbeat; Result Unstructured Data: Test Result:regular; Test Name: blood gas with PO2; Result Unstructured Data: Test Result:45 mmHg; Comments: blood gas with PO2 at 45mmHg (SAMU at 11:00).; Test Name: saturation; Test Result: 64 %; Comments: The patient saturation was at 64% in ambient air measured before the arrival of the SAMU.; Test Date: 20210212; Test Name: saturation; Result Unstructured Data: Test Result:decreased %; Comments: acute desaturation; Test Date: 20200417; Test Name: Positive PCR test; Result Unstructured Data: Test Result:positive; Comments: Positive PCR test on 17Apr (carried out on 15); Test Date: 20200527; Test Name: Positive PCR test; Result Unstructured Data: Test Result:positive; Comments: Positivity of the PCR on 27May; Test Date: 20200622; Test Name: Positive PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20201002; Test Name: Positive PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20201113; Test Name: Positive PCR test; Result Unstructured Data: Test Result:negative; Test Name: respiratory rate; Result Unstructured Data: Test Result:32/min; Comments: respiratory rate at 32/min, no bruits or sibilants at the cardiac auscultation; Test Date: 20210212; Test Name: Sars Cov2 antigen test; Result Unstructured Data: Test Result:negative; Comments: An Sars Cov2 antigen test was carried out on 12Feb by the SAMU doctor and was found to be negative.; Test Date: 20210210; Test Name: weight; Test Result: 38.2 kg; Comments: a weight of 38.2 (-0.8kg in 1 month but with a weight gain in the days that preceded the vaccination); Test Date: 202102; Test Name: weight; Result Unstructured Data: Test Result:gain
CDC Split Type: FRPFIZER INC2021232892

Write-up: Oxygen saturation decreased/acute desaturation; malnourished with albuminuria at 33.5g/l; malnourished with albuminuria at 33.5g/l; weight gain in the days that preceded the vaccination; This is a spontaneous report from a contactable physician from the WEB F-AFSSAPS-PA20210280. An elderly female patient (reported as 85-year-old and 84-year-old, pending clarification) received the second dose of bnt162b2 (COMETARY, lot number: EJ6795), intramuscular at the right arm on 10Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included colorectal cancer NOS (colonic neoplasm in 2014 with total remission after treatment) from 2014 to an unspecified date; chronic obstructive pulmonary disease (COPD) and depression from an unspecified date and unknown if ongoing; infected with Covid 19 in Apr2020 (the first symptoms of Covid 19 appeared around the 10Apr2020 with fever + respiratory symptoms such as phlegmy cough + change in general state. The patient had been treated with AUGMENTIN + low molecular weight heparin on 15Apr2020. Positive PCR test on 17Apr2020 (carried out on 15). Positivity of the PCR on 27May2020. A second infectious respiratory episode in May2020 and unknown if ongoing. The PCR tests carried out on 22Jun2020, 02Oct2020, and 13Nov2020 were all negative. A Sars Cov2 serology done on 29Dec2020 found Ig totals of 65.5). Medical history also included constipation chronic from an unspecified date and unknown if ongoing. Concomitant medication included paroxetine mesilate (PAROXETINE MESILATE), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL PLAIN) for chronic constipation, and colecalciferol (UVEDOSE). The patient was vaccinated with the first dose of bnt162b2 on 20Jan2021 for Covid-19 immunisation and experienced bronchial episode with fever at 5 PM. The day of the second dose, the patient was asymptomatic from a respiratory perspective, but malnourished with albuminuria at 33.5g/l and a weight of 38.2 (-0.8kg in 1 month but with a weight gain in the days that preceded the vaccination); she was apyretic with a T degress at 36.7 C before vaccination and 36.6 C at 17:00 after vaccination. On 12Feb2021 at around 10:00 the patient experienced oxygen saturation decreased/acute desaturation. Following opinion of the hospital, decision for end of life palliative care. The patient died on 13Feb2021 at 22:30 due to oxygen saturation decreased/acute desaturation. An autopsy was not performed. A SARS Cov2 antigen test was carried out on 12Feb2021 by the doctor and was found to be negative. The patient saturation was at 64% in ambient air measured before the arrival of the hospital. Heartbeat was regular with cardiac frequency at 100/min with no murmur or racing, respiratory rate at 32/min, no bruits or sibilants at the cardiac auscultation, blood gas with PO2 at 45mmHg hospital at 11:00. The outcome of the events malnourished with albuminuria at 33.5g/l and a weight gain in the days that preceded the vaccination was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Oxygen saturation decreased/acute desaturation


VAERS ID: 1099659 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Coma scale, Extensor plantar response
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; METFORMIN
Current Illness: AFib; Diabetes mellitus non-insulin-dependent (non-insulin-dependent diabetes)
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Anticoagulant therapy; Dementia Alzheimer''s type; Hemorrhage of digestive tract; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Name: Babinski; Result Unstructured Data: Test Result:positive sign; Test Name: Glasgow; Result Unstructured Data: Test Result:Glasgow at 10 / 11
CDC Split Type: FRPFIZER INC2021242200

Write-up: Stroke; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB (Regulatory Authority number FR-AFSSAPS-TS20210501). A 91-years-old male patient received the second dose of BNT162B2 (COMIRNATY; lot number EJ6789), intramuscularly in left arm on 11Feb2021 at 0.3 mL single dose for COVID-19 immunisation. Medical history included ongoing non-insulin-dependent diabetes, ongoing atrial fibrillation (ACFA), Alzheimer''s type dementia, ischaemic heart disease. The patient had no history of COVID-19 and no COVID-19 test was performed. The patient was a person at risk of developing a severe form of the COVID-19 disease for age, cardiac history and diabetes. Concomitant medications included amlodipine (AMLODIPINE), and probably (as reported) metformin (METFORMIN). It was reported the statin was stopped the day before D2 due to the patient''s age. Anticoagulants stopped several months ago in case of anaemia and digestive bleeding. On 11Feb2021, the patient received the second injection of Comirnaty. RAS (nothing to report) within 30 minutes after vaccination. Sudden onset, 2 days later (on 13Feb2021), of a complete deficit of the right upper limb, a partial deficit of the right lower limb, vigilance disorders, decreased reactivity (Glasgow at 10/11), Babinski positive sign. The diagnosis of a probably ischaemic stroke was made, without further exploration in view of age. The state of the patient deteriorated rapidly with oxygen dependency and reduced communication and finally died on 19Feb2021 (D8 of vaccination) as a result of the stroke. In total, probably ischaemic stroke (no imaging performed) complicated by death in a 91 year old patient with cardiac comorbidities 2 days after the 2nd injection of the Comirnaty vaccine. 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: Stroke


VAERS ID: 1099663 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Advanced cancer (Patient was under last resort treatment as well as strong pain medication (likely opioids).); Hospitalization
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021250736

Write-up: Patient hospitalized with terminal cancer and received his first shot of COMIRNATY but passed away the day he was due for second shot; This is a spontaneous report from a contactable consumer via a Pfizer colleagues. A 78-year-old male patient (a childhood friend of the reporter) received his first dose of BNT162B2(COMIRNATY, Lot/batch number was not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included hospitalized with terminal cancer. Patient had terminal cancer and was under last resort treatment as well as strong pain medication (likely opioids). Concomitant medications were not reported. He received his first shot of Pfizer vaccine but passed away the day he was due for second shot. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: Patient hospitalized with terminal cancer and received his first shot of COMIRNATY but passed away the day he was due for second shot


VAERS ID: 1100051 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 RL / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Product administered at inappropriate site
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEXANE; TIAPRIDAL; CAVINTON FORTE; FRONTIN; COVEREX AS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia; Femoral neck fracture; Flutter atrial; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021244072

Write-up: death; intramuscular at 0.3 mL, single in the right thigh; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-096021. An 83-year-old female patient received the second dose of bnt162b2 (COMIRNATY) (Lot # EJ6790), intramuscular at 0.3 mL, single in the right thigh on 17Feb2021 for COVID-19 immunisation. Medical history included atrial fibrillation and flutter, dementia, hypertension, and bilateral femoral neck fracture in 2014 and in 2017. Concomitant medication included enoxaparin sodium (CLEXANE), tiapride hydrochloride (TIAPRIDAL), vinpocetine (CAVINTON FORTE), alprazolam (FRONTIN), perindopril arginine (COVEREX AS). Previously the patient received the first dose of Comirnaty (Lot # EJ6134) intramuscular in the left arm on 27Jan2021 for COVID-19 immunisation. The patient experienced death on 20Feb2021. The patient died on 20Feb2021. It was not reported if an autopsy was performed. Sender Comment: The 83 year-old patient died 3 days after Comirnaty vaccination. There is no information about the cause of death or whether autopsy was done. The causal relationship between the reported death and Comirnaty was unassessable. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1100098 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021256454

Write-up: Death from unspecified cause; This is a spontaneous report from a contactable physician (General Practitioner) downloaded from the regulatory authority-WEB, IT-MINISAL02-689813. A 95-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6136), intramuscularly in left deltoid on 26Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died on 01Mar2021 from unspecified cause. It was not reported if an autopsy was performed. Reporter Comment: On 03Mar2021 request for clinical report, on 04Mar2021 insertion of the reporter''s clinical report. Sender Comment: Spontaneous reporting form inserted in the regional vaccination register received following access by the local regulatory authority manager. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: On 03Mar2021 request for clinical report, on 04Mar2021 insertion of the reporter''s clinical report.; Reported Cause(s) of Death: Death from unspefied cause


VAERS ID: 1100137 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021250339

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [Regulatory Authority number PL-URPL-3-291-2021]. An 82-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EP9598, expiration date: 20Feb2021), intramuscularly in left arm at 82-year-old, on 18Feb2021 at 12:56 at 0.3 mL, single for COVID-19 immunisation. Medical history included ongoing heart insufficiency. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, Solution for injection, unknown batch/lot number and expiration date) via an unspecified route of administration at an unspecified age on an unspecified date at single dose for COVID-19 immunisation. She did not report any distressing symptoms after the first dose of vaccination and she also felt well at the time of vaccination qualification. On 22Feb2021 at 11:00 a.m. a post-vaccination reaction occurred. The reaction was reported as death of the patient 5 days (as reported) after receiving vaccination against COVID-19. The patient reported no complaints both immediately after vaccination and in the period between vaccination and death. The patient was found in the morning with no signs of life. The doctor declared death. At the time of reporting the undesirable post-vaccination reaction, the cause of death was unknown. The patient died on 22Feb2021. It was unknown if an autopsy was performed. Additional information: Information was obtained that the patient was single. The reporter classified the report as severe. Sender Comment: Death on the fifth post-vaccination day is an unexpected side effect of COMIRNATY. There is a time relationship between the administration of the vaccine and the occurrence of the reaction. Due to insufficient information, a causal relationship between the administration of the vaccine and the occurrence of death has not been assessed. The reporting person classified them as severe. URPL also classified the application as severe. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1100154 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; METFORMIN; PRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021246882

Write-up: 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


VAERS ID: 1101613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-02-07
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19; Palliative care
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210207; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Test Date: 20210204; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: ATPFIZER INC2021242199

Write-up: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms with fatal outcome/died on 10Feb2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB AT-BASGAGES-2021-04888. A 90-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EL1491), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing palliative care palliative and COVID-19 from 07Feb2020 and ongoing. The patient''s concomitant medications were not reported. On 07Feb2021, the patient experienced positive COVID-19 test with symptoms with fatal outcome. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 07Feb2021 and COVID-19 virus test negative on 04Feb2021. The patient died on 10Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, batch number already obtained. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1103586 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EM04777 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy, General physical health deterioration, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (no medical history reported)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20210

Write-up: Epileptic seizure; Convulsions; General physical health deterioration; A regulatory authority report was received from a pharmacist concerning, a 79 years old female patient who received Moderna (mRNA-1273) vaccine and experienced Epileptic seizure, Convulsions and General physical health deterioration. The patient had no history of epilepsy. Concomitant product use was not provided by the reporter. On 22 Jan 2021, approximately two hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: EM04777) for prophylaxis of COVID-19 infection. Two hours post vaccine the patient experienced Epileptic seizure and was admitted to Emergency room. The patient''s condition stabilized with initiation of depakene and brought to the state of consciousness, but with visible general degradation of patient''s health. The patient was back to nursing home. The patient tested positive for COVID-19 on 26 Jan 2021 and was transferred in Hospital Covid unit. The patient had very degraded output on 3 Feb 2021. Call received from the Nursing home on 4 Feb 2021 for DEG. The patient was readmitted to the hospital. The patient developed the condition of epileptic pain. The patient was given second and then third line of treatment with no success Passage Palliative care. The patient died on 10 Feb 2021. No laboratory information was provided by the reporter. Treatment information for the event Epileptic seizure, provided included: Depakene. Action taken with mRNA-1273 in response to the event(s) was Not applicable. The event(s), Epileptic seizure, Convulsions and General physical health deterioration were considered as Fatal. The cause of death was reported as Epileptic seizure, Convulsions and General physical health deterioration. Plans for an autopsy were unknown.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Case narrative was translated from the source document by the case processor. Errors in translation could be expected. Please refer the source document.; Reported Cause(s) of Death: Epileptic seizure; General physical health deterioration


VAERS ID: 1104877 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Asthenia, Blood pressure measurement, Body temperature, Death, Decreased appetite, Disorientation, Dyspnoea, Dysstasia, Fall, Fatigue, Gait disturbance, Head injury, Headache, Heart rate, Hypersomnia, Pupillary reflex impaired, Pyrexia, Restlessness, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEBIVOLOL 1 A PHARMA; AMLODIPIN 1A FARMA; BURONIL; CALCIDURAN; TOUJEO; ERYCYTOL [HYDROXOCOBALAMIN]; HALCION; RAMIPRIL HCT ACTAVIS; AMLODIPIN [AMLODIPINE]; KREON 25000; OLEOVIT-D3; EUCREAS; NACL; RAMIPRIL ACTAVIS; FORXIGA
Current Illness: Arterial hypertension; Cognitive impairment (Cognitive impairment DD incipient Dementia (Mini-Mental State Examination 22/30)); Dementia (Cognitive impairment DD incipient Dementia (Mini-Mental State Examination 22/30)); Fecal incontinence; Type II diabetes mellitus (not primarily insulin-dependent diabetes / type 2 diabetes)
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration pneumonia; Centrilobular emphysema; Hypokalaemia; Pneumonia (Pneumonia on both sides, more pronounced on the right); Pneumonia; Prostatic hyperplasia (obstructive prostatic hyperplasia); TURP (due to in obstructive prostatic hyperplasia)
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: blood pressure; Result Unstructured Data: Test Result:190/90 mmHg; Test Date: 20210131; Test Name: blood pressure; Result Unstructured Data: Test Result:120/80 mmHg; Test Date: 20210115; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210131; Test Name: pulse; Result Unstructured Data: Test Result:84; Test Date: 20210114; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210117; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: ATPFIZER INC2021250312

Write-up: fell from bed; bloody bump on forehead; difficult breathing; could no longer get up unaided; sluggish pupillary reaction; headache; Death; very weak; cannot find room; eats only a little; increased agitation; restless; sleeps a lot; exhausted/tired; Temperature 37.8 ?C; changed gait pattern; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [AT-BASGAGES-2021-07100]. A 77-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EL1491, expiry date: 30Apr2021), via an unspecified route of administration, on 15Jan2021 13:55 (at the age of 77-year-old), at single dose, for COVID-19 immunization. Medical history included pneumonia from Sep2018 to an unknown date, ongoing arterial hypertension, centrilobular emphysema and unknown if ongoing, TURP (transurethral prostatectomy) from Dec2018 to an unknown date due to in obstructive prostatic hyperplasia, aspiration pneumonia from an unknown date and unknown if ongoing, ongoing cognitive impairment and dementia (Cognitive impairment DD incipient Dementia (Mini-Mental State Examination 22/30)), hypokalaemia from 20Sep2019 and unknown if ongoing, obstructive prostatic hyperplasia from an unknown date to Dec2018, fecal incontinence from 15Oct2019 and ongoing, pneumonia from 20Sep2019 and unknown if ongoing (Pneumonia on both sides, more pronounced on the right), and ongoing type II diabetes mellitus (not primarily insulin-dependent diabetes / type 2 diabetes). The patient''s weight was not reported, and height was not reported. Concomitant medications included nebivolol hydrochloride (NEBIVOLOL 1 A PHARMA) from 01Apr2020, amlodipine (AMLODIPIN 1A FARMA, strength 10 mg) from 27Mar2020, melperone hydrochloride (BURONIL, strength 25 mg) from 07Feb2020, ascorbic acid, calcium phosphate, citric acid, colecalciferol (CALCIDURAN) from 26Sep2019, insulin glargine (TOUJEO) from 24Jan2021, hydroxocobalamin (ERYCYTOL, strength 1 mg, reported as "Erycytol Dep Amp") from 18Jun2020, triazolam (HALCION) from 07Feb2020, hydrochlorothiazide, ramipril (RAMIPRIL HCT ACTAVIS, strength 5/12.5 mg) from 02Sep2019, amlodipine (AMLODIPIN, strength 5 mg, reported as "Amlodipin +Ph") from 07May2020, pancreatin (KREON 25000) from20Jan2021, colecalciferol (OLEOVIT-D3) from18Jun2020, metformin hydrochloride, vildagliptin (EUCREAS, strength 50/1000 mg) from 04Nov2019, NACL (strength 500 mL, reported as "phys NaCl Lsg FRE FREEFL") from 21Jan2021, ramipril (RAMIPRIL ACTAVIS, strength 5 mg) from 02Sep2019, and dapagliflozin propanediol monohydrate (FORXIGA, strength 10 mg) from 02Sep2019. The patient was not sick with COVID. On 15Jan2021 17:06, the patient''s body temperature was 37.8 C, blood pressure was 190/90 mmHg, patient changed gait pattern. Then 2 tablets of paracetamol, 10 mg acetylsalicylic acid (ASPIRIN) were received. On 15Jan2021 18:55, the patient experienced sleeps a lot and exhausted. The patient was feeling better, but since then very tired. It was reported entry of the tiredness in the care log on 15Jan2021, 16Jan2021, 17Jan2021, 19Jan2021, 20Jan2021, 21Jan2021 (+ exhaustion), 22Jan2021, (+ entry delayed reaction), 23Jan2021. On 25Jan2021, it was reported "restless night". On 27Jan2021 the patient experienced increased agitation, it was reported entry in care log that patient looked restless. On 28Jan2021 the patient could not find his room, eat only a little. From 29Jan2021 patient looked calmer again. On 30Jan2021 patient found room only with help. On 31Jan2021 patient was very weak and tired, and patient fell from bed in the room between 19:00 and 22:00: bloody bump on forehead, difficult breathing, patient could no longer get up unaided, blood pressure was 120/80 mmHg, pulse was 84, had sluggish pupillary reaction, headache, and was transferred by ambulance to the hospital. On 02Feb2021, the patient died in the hospital. The patient underwent other lab tests and procedures, which included COVID-19 antigen test was negative on 14Jan2021, and negative on 17Jan2021. The outcome of the event "death" was fatal; of "fever" was recovered on 15Jan2021 21:43; of "gait disorder" was unknown; of other events was not recovered. The cause of death was not reported. 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


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