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From the 9/10/2021 release of VAERS data:

Found 14,925 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 89 out of 150

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VAERS ID: 1161365 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / OT

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: 2021-03-09
   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: SPIRONOLACTONE; ELIQUIS; LEVOTHYROX; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrhythmia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333566

Write-up: Sudden death; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NC20211009. An 80-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot: EP9605), intramuscular on 06Mar2021 as single dose for covid-19 immunisation. Medical history included cardiac arrhythmia. Concomitant medications included spironolactone; apixaban (ELIQUIS); levothyroxine sodium (LEVOTHYROX) and furosemide. It was reported that the patient did not show any symptoms after vaccination. On 09Mar2021, the patient was sitting and was on the phone, her husband heard a noise of shock. He ran immediately and found his wife unconscious. He called for help and tried to do a cardiac massage. Help arrived 15 minutes later. They began cardiopulmonary resuscitation with cardiac massage, intubation of the patient and they performed 5 to 6 external electric shocks. Unfortunately, the patient died on the spot after 45 minutes of cardiac massage. The emergency services transmitted that it was a sudden death. The patient died due to sudden death on 09Mar2021. It was unknown if autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1161366 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Face oedema, Hypotension, Oedema peripheral, Polymerase chain reaction positive, Pyrexia, Tachycardia, Vaccination site oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: BISOPROLOL; FUROSEMIDE; KARDEGIC; METFORMIN; ALFUSIN; SILODOSIN; FINASTERIDE; PANTOPRAZOLE; ROPINIROLE; ALPRAZOLAM; OXAZEPAM; ZOPICLONE; MIRTAZAPINE; OLANZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Covid-19 infection confirmed on 04Oct2020 (positive PCR test)); Ischemic stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20201004; Test Name: PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021311874

Write-up: fever of 38.5 ? C; Edema upper limb; edema of vaccination arm; Oedema face; Hypotension; Tachycardia; Death unexplained; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The Regulatory Authority report number is FR-AFSSAPS-NT20210622. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 04Mar2021 14:00 (Batch/Lot Number: EP2166) as single dose for Covid-19 immunization. The patient received the first dose of Comirnaty on an unspecified date for Covid-19 immunization (unremarkable). Medical history included Covid-19 infection confirmed with positive PCR on 04Oct2020; ischaemic stroke, and type 2 diabetes mellitus: both from an unknown date and unknown if ongoing; No allergic history. Concomitant medications included bisoprolol, furosemide, acetylsalicylate lysine (KARDEGIC), metformin, alfuzosin hydrochloride (ALFUSIN), silodosin, finasteride, pantoprazole, ropinirole, alprazolam, oxazepam, zopiclone, mirtazapine, and olanzapine; all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient was living in an institution (GIR score 3) and vaccinated with a second dose of Comirnaty on 04Mar2021 at 2 pm. There was a post-vaccination surveillance for 20/30 minutes which was unremarkable. The next morning "around 8 a.m." (05Mar2021) when waking up (H + 19), the patient was found with a fever of 38.5 ?C, edema of the face and of the vaccinated arm, "hypotension of 9/5" and tachycardia. It was decided to hospitalize the patient, but the latter dies before the ambulance arrives, that is to say in less than an hour after the discovery of the first symptoms. The outcome of events was fatal. The patient died on 05Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained; Edema upper limb; Fever; Oedema face; Hypotension; Death unexplained; Tachycardia


VAERS ID: 1161367 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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; Epilepsy; Hormone-dependent prostate cancer; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333443

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, Regulatory Authority report number is FR-AFSSAPS-NT20210740. A 77-year-old male patient received the second dose of bnt162b2 (COMIRNATY), intramuscular, administered in the left arm on 16Mar2021 (Batch/Lot Number: EP9605) as SINGLE DOSE for covid-19 immunization. Medical history included arrhythmia from an unknown date and unknown if ongoing, cerebrovascular accident in 2014, epilepsy from an unknown date, type 2 diabetes mellitus from an unknown date, hormone-dependent prostate cancer from an unknown date. The patient''s concomitant medications were not reported. The patient was in long-term care units with loss of autonomy and multiple comorbidities with deterioration of general condition. She received the second dose of the COMIRNATY vaccine on 16Mar2021. The patient suffered from a death unexplained on 18Mar2021. She was found dead in her bed 36 hours after injection of the vaccine. There were no prodromes, the patient had been seen for the last time an hour before the declaration of death. It was not reported if an autopsy was performed. Follow-up attempts are completed. The information on the batch/lot number has already been obtained.; Reported Cause(s) of Death: death unexplained


VAERS ID: 1161370 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-03
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Behaviour disorder, Blood creatinine, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein increased, Circulatory collapse, General physical health deterioration, Haemoglobin, Heart rate, Hypernatraemia, Hyperthermia, Muscle disorder, Oxygen saturation, Procalcitonin, Renal failure, SARS-CoV-2 test, Shock, Urinary tract infection, White blood cell disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Haematopoietic leukopenia (broad), Retroperitoneal fibrosis (broad), 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), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   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: DIAMOX [ACETAZOLAMIDE]; SERESTA; EFFEXOR; OFLOCET [OFLOXACIN]
Current Illness: Dementia Alzheimer''s type
Preexisting Conditions: Medical History/Concurrent Conditions: Acromioplasty; Adenocarcinoma of colon; Anemia microcytic; Asiderotic anaemia; Breast cancer; C-section; Carbon monoxide poisoning; Colectomy; Foreign body in digestive system, unspecified; Hypertension arterial; Lyme disease; Pyelonephritis
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: creatinine; Result Unstructured Data: Test Result:102 umol/l; Comments: with CKD-EPI 45; Test Date: 20210220; Test Name: creatinine; Result Unstructured Data: Test Result:189 umol/l; Comments: with CKD-EPI 21; Test Name: blood pressure; Result Unstructured Data: Test Result:93/62 mmHg; Test Date: 20210210; Test Name: sodium; Result Unstructured Data: Test Result:160 mmol/L; Test Date: 20210220; Test Name: sodium; Result Unstructured Data: Test Result:192 mmol/L; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210210; Test Name: CRP; Result Unstructured Data: Test Result:117.1 mg/l; Test Date: 20210220; Test Name: CRP; Result Unstructured Data: Test Result:60 mg/l; Test Date: 20210210; Test Name: Hb; Result Unstructured Data: Test Result:11.4 g/dl; Test Name: heart rate; Result Unstructured Data: Test Result:99bpm; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 20210210; Test Name: PCT; Result Unstructured Data: Test Result:11.55 ng/ml; Test Date: 20210209; Test Name: PCR Covid-19 test; Test Result: Negative ; Test Date: 20210210; Test Name: leukocytes; Result Unstructured Data: Test Result:10.6 g/l; Test Date: 20210220; Test Name: leukocytes; Result Unstructured Data: Test Result:12.6 g/l
CDC Split Type: FRPFIZER INC2021333461

Write-up: Failure kidney/acute renal failure with creatinine 189 umol/L with CKD-EPI 21; Hypernatremia; General physical health deterioration/altered general condition in the context of hyperthermia; shock with collapse; shock with collapse; urinary tract infection; behavioural problems with hyperthermia; behavioural problems with hyperthermia; retraction of the left lower limb; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB manufacturer report number FR-AFSSAPS-NY20210566. A 81-year-old female patient received first dose of bnt162b2 (COMIRNATY), via intramuscular route on 21Jan2021 (Batch/Lot Number: EJ6788) as single dose for COVID-19 immunization. Medical history included caesarean section from 1967, Breast cancer from 1983, Carbon monoxide poisoning from 2018, colectomy from 19Aug2019, ongoing dementia alzheimer''s type, hypertension arterial, Foreign body in digestive system, unspecified, right shoulder acromioplasty from 2018, Asiderotic anaemia, adenocarcinoma of colon, lyme disease, Anemia microcytic, and pyelonephritis. Concomitant medication included acetazolamide (DIAMOX [ACETAZOLAMIDE]); oxazepam (SERESTA); venlafaxine hydrochloride (EFFEXOR); ofloxacin (OFLOCET [OFLOXACIN]) taken for pyelonephritis from 06Feb2021. Blood test: Hb 11.5 g/dL, platelets 67 G/L, leukocytes 10.3 G/L. Na 155 mmol/L, K 3.61 mmol/L. Plasma protein 60 g/L. Creatinine 136 ?mol/L with CKD-EPI 32. CRP 132.6 mg/L. CT scan: 2 mm micronodule of the anterior segment of the superior right lobe, thin pleural effusion layer, small peripheral ground-glass focus under the anterior pleural of the superior right lobe. Abdominally, left ureterohydronephrosis, pyelone 23 mm upstream of a 4 mm lithiasis embedded in the lumbar ureter 5 cm downstream of the left pyeloureteral junction, bladder in strong repletion. A large rectal faecal impaction was also noted. Patient transferred to specialist department for emergency urinary diversion in the operating theatre. Suspected of COVID-19 infection. Initiation of probabilistic antibiotic therapy with OFLOCET 200 mg IV and hydration, leading to improvement in renal function. Diagnosis of pyelonephritis due to lithiasis of the lumbar ureter 5 cm downstream of the left pyeloureteral junction, requiring urinary diversion. On 09Feb2021, PCR COVID-19 negative. On 10Feb2021, patient transferred. Discharge assessment: Hb 11.4 g/dL, leukocytes 10.6 G/L, Na 160 mmol/L, Creatinine 102 umol/L with CKD-EPI 45, CRP 117.1 mg/L, PCT 11.55 ng/mL. On 20Feb2021, patient hospitalized for major alteration of general condition, shock with collapse and marbling. On examination, hypernatremia 192 mmol/L, acute renal failure with creatinine 189 umol/L with CKD-EPI 21, leukocytes 12.6 G/L, and CRP 60 mg/L. The clinical examination revealed a patient for whom a no-resuscitation indication and comfort sedation were given Presence of a gluteal eschar. Vitals about right but low blood pressure 93/62 mmHg, heart rate 99 BPM, temperature 36.6 C and saturation 96% in ambient air. Cardiac examination: regular heart sounds, no murmurs, no oedema of the lower limbs. Urological examination: no functional signs in the urine, no back pain. Skin mottling. GCS 10, no signs of focus, no conversation possible. The outcome of the other events was unknown. Vascular filling but progress unfavorable: On 21Feb2021, the patient died. It was not reported if an autopsy was performed. Conclusion: Renal failure with hypernatremia at 192 mmol/L amid major alteration of the general state with consciousness disorders during treatment of pyelonephritis on lithiasis of the lumbar ureter in an 81 y. o. patient one month after a first injection of the COMIRNATY vaccine (batch No. EJ6788). Unfavorable progress leading to the death of the patient. Imputability (according to the method): I1 (dubious).NB: Imputability without prejudice to further investigations that could be carried out as part of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Failure kidney; Hypernatremia; General physical health deterioration


VAERS ID: 1161371 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   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: CRESTOR; ALLOPURINOL; JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE MONOHYDRATE]; CHONDROSULF; GLICLAZIDE; KARDEGIC; SPIRONOLACTONE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; PANTOPRAZOLE
Current Illness: Memory disturbance (Beginner memory problems); Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract; Hypertension arterial; Knee prosthesis insertion; Prostatectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333562

Write-up: dyspnea; Sudden death unexplained; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority number FR-AFSSAPS-NY20210571. An 88-year-old male patient received the second dose of bnt162b2 (COMIRNATY), (route as reported pending clarification) on 14Feb2021 [also reported as 13Feb2021] (lot number: EJ6795) as single dose for covid-19 immunisation. Medical history included cataract (not ongoing), prostatectomy (unknown if ongoing), knee prosthesis insertion from 2012 to an unknown date (not ongoing), hypertension arterial (unknown if ongoing), type 2 diabetes mellitus ongoing since 2007, and ongoing memory impairment (beginner memory problems). The patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date (reported as not ongoing) for covid-19 immunisation. Concomitant medications included rosuvastatin calcium (CRESTOR); allopurinol; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET); chondroitin sulfate sodium (CHONDROSULF); acetylsalicylate lysine (KARDEGIC); spironolactone; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); and pantoprazole. There was no recently introduced treatment. The patient experienced sudden death unexplained on 14Feb2021. It was further reported that on 13Feb2021 (also reported as 14Feb2021), the patient received the second vaccination of COMIRNATY. Due to the observation of dyspnea on an unspecified date, a cardiology consultation was scheduled on 10Mar2021.In the evening, the patient ate well. On the night of 13Feb2021 to 14Feb2021, sudden death. There was intervention of emergency services. It was mentioned that there was death of the patient at home. The outcome of the event dyspnea was unknown while the outcome of the other event was fatal. The patient died on 14Feb2021. An autopsy was not performed. Imputability : I1 (dubious). Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Therapy 1985; 40: 111-8 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1161372 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-14
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Rib fracture, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Osteoporosis/osteopenia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   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: Abdominal aortic aneurysm (Sacciform aneurysm of sub-renal abdominal aorta (54 mm) w/ compression of the head of the pancreas)
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Heart disorder; Hepatic disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333459

Write-up: Sudden death unexplained; Chest pain; Broken ribs; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority. Regulatory Authority Report Number : FR-AFSSAPS-NY20210576. A 97-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 12Feb2021 (Lot Number: EJ6795) as single dose for covid-19 immunisation. Medical history included ongoing abdominal aortic aneurysm/sacciform aneurysm of the abdominal aorta under renal (54 mm) with compression of the head of the pancreas (31Aug2020) and an episode of ACFA (Atrial fibrillation) in Jul2020 (unknown if ongoing). Another history noted: cardiac pathology (heart disorder) and hepatic (hepatic disorder) both from unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 14Mar2021, the patient experienced chest pain (life-threatening) and sudden death unexplained ( life-threatening death) on 14Mar2021. Clinical course was reported as follows. On 12Feb2021, second vaccination with COMIRNATY in the left arm. On 14Mar2021, as the patient raised her arms to put on a protective plastic apron for her meal, chest pain occurred. Shortly after, the patient died during the meal. Realization of resuscitation maneuvers by the reanimation crew (IDE) while waiting for emergencies (observation of broken ribs). Death noted between 7.45 p.m. and 8 p.m. Precautionary statement made by the registrant (does not believe in a causal link with the vaccine). Conclusion: chest pain then death of the patient with a history of sacciform aneurysm of the abdominal aorta under renal (54 mm) with compression of the head of the pancreas and an episode of ACFA in July 2020 vaccinated one months earlier by COMIRNATY (lot EJ6795). Thoracic pain then sudden death in a 97 yr old woman more than 4 weeks after a vaccination with COMIRNATY (lot EJ6795). Outcome of the events chest pain and broken ribs was unknown; while Sudden death unexplained was fatal. The patient died on 14Mar2021. Unknown if an autopsy was performed. Imputability (according to the method): I1 (dubious). Notabene: Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1161377 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Confusional state, Death, Hypotension, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arrhythmia; Depression
Preexisting Conditions: Medical History/Concurrent Conditions: Difficulty in walking
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Death unexplained; Confusional state; Hypotension; Asthenia; Pyrexia; This regulatory authority case was reported by a consumer and describes the occurrence of confusional state, hypotension, asthenia and pyrexia in an 89-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Difficulty in walking. Concurrent medical conditions included Arrhythmia and Depression. On 24-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In February 2021, the patient experienced confusional state, hypotension, asthenia and pyrexia. On 09-Mar-2021, the patient died. The cause of death was not reported. It is unknown if an autopsy was performed.; Reporter''s Comments: A case of death of an 89-year-old female patient 13 days post mRNA-1273 administration. Very limited information has been provided about the cause of death hence difficult to assess. However, the patient is of an advanced age. The other events are temporarily associated with the administration of mRNA-1273. Hence causality with mRNA-1273 cannot be excluded; Reported Cause(s) of Death: Death of unknown cause


VAERS ID: 1161379 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, COVID-19, Chills, Culture urine, Culture urine positive, Death, Drug ineffective, General physical health deterioration, Hyperthermia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), 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: 2021-03-16
   Days after onset: 31
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 Alzheimer''s type (severe Alzheimer''s type dementia); Starvation (undernutrition)
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210212; Test Name: CRP; Result Unstructured Data: Test Result:15; Test Date: 20210212; Test Name: ECBU test (Urine culture); Test Result: Positive ; Test Name: COVID 19; Result Unstructured Data: Test Result:contracted
CDC Split Type: FRPFIZER INC2021333510

Write-up: sars-cov-2 test: contracted (positive); sars-cov-2 test: contracted (positive); Death NOS; deterioration of the general condition as well as a progressive loss of autonomy; (Urine culture) positive; chills; hyperthermia at 38 degree C; This is a spontaneous report from a contactable physician reporting for a patient downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-TO20211826. An 88-year-old female patient received bnt162b2 (COMIRNATY), first dose, intramuscular, administered in Arm Right on 11Feb2021 (Batch/Lot Number: EJ6788) as SINGLE DOSE for covid-19 immunisation. Medical history included dementia alzheimer''s type (severe Alzheimer''s type dementia) and starvation (undernutrition) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death nos on 16Mar2021. Clinical course was reported as follows: The patient received the first injection of the COMIRNATY vaccine on 11Feb2021 and presented the following day, i.e. 12Feb2021, with hyperthermia at 38 degree C and chills. She was put on antibiotics, CRP at 15 and ECBU (Urine culture) positive. A deterioration of the general condition as well as a progressive loss of autonomy were reported leading to his death on 16Mar2021, i.e. 33 days after vaccination. The patient underwent lab tests and procedures which included body temperature: 38 centigrade on 12Feb2021, c-reactive protein: 15 on 12Feb2021, sars-cov-2 test: contracted (positive) on an unspecified date, and ECBU test (urine culture): positive on 12Feb2021. The patient died on 16Mar2021 (Death NOS). Outcome of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Lot number has been obtained.; Reported Cause(s) of Death: death NOS


VAERS ID: 1161393 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021337893

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority (RA). Regulatory authority report number GB-MHRA-APPCOVID-20210326113527, Safety Report Unique Identifier GB-MHRA-ADR 25029836. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER1741), via an unspecified route of administration, at single dose on 17Mar2021 for COVID-19 immunization. No relevant medical history was provided. Patient has not had symptoms associated with COVID-19 and he is not enrolled in clinical trial. No relevant concomitant medications were provided. On 24Mar2021, the patient experienced pulmonary embolism. On the same day, a COVID-19 virus test was done and resulted negative. On 26Mar2021, the patient died due pulmonary embolism. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1161399 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Incorrect route of product administration, Pain
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: HUMULIN M3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021334280

Write-up: Pain; Shortness of breath; received bnt162b2 orally; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Agency Regulatory Authority (RA). Regulatory authority report number GB-MHRA-EYC 00244953. A 56-year-old male patient received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), oral on 26Feb2021 as single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medication included insulin human, insulin human injection, isophane (HUMULIN M3). Before the vaccine injection, the patient has shown no fatal illness that would have resulted in the cause of death. The vaccine as coursed illnesses and symptoms, including pain, shortness of breath, problems on 27Feb2021. Outcome of the event pain was reported as not recovered and for the event shortness of breath was reported as fatal. The patient died on 10Mar2021. 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: shortness of breath


VAERS ID: 1161666 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Death, Heart rate, Heart rate decreased, Malaise, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   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: ALZEST; ATORVASTATIN; CO-BENELDOPA; MIDODRINE; AMOXIL
Current Illness: Frailty
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Blood cholesterol increased; Chest infection; Lower respiratory tract infection (in the past few years of his life and each one left him weaker); Orthostatic hypotension; Parkinson''s disease; Pyrexia
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: blood pressure; Result Unstructured Data: Test Result:dropped; Test Date: 20210320; Test Name: pulse; Result Unstructured Data: Test Result:dropped; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021334130

Write-up: passed peacefully; felt more unwell; syncope; dropped blood pressure; dropped pulse; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202103221739360780, Safety Report Unique Identifier GB-MHRA-ADR 25000352. An 83-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: ER1741), via an unspecified route of administration on 19Mar2021 at 10:00 as single dose for COVID-19 immunization. Medical history included back pain, ongoing asthenia, Parkinson''s disease, blood cholesterol increased, orthostatic hypotension, pyrexia, and had many lower respiratory tract infections in the past few years of his life and each one left him weaker. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient had negative COVID-19 virus test on unspecified date. Concomitant medications included rivastigmine (ALZEST) taken for Parkinson''s disease from 05Mar2019; atorvastatin taken for blood cholesterol increased from 04Sep2017; benserazide hydrochloride, levodopa (CO-BENELDOPA) taken for Parkinson''s disease from 24Dec2008; midodrine taken for orthostatic hypotension from 05Jun2018; and amoxicillin (AMOXIL) taken for pyrexia. It was reported that the patient''s wife had declined to allow him to have his first COVID vaccine in early Jan2021, but requested to give him his first one when the reporter visited the home on 19Mar2021 to vaccinate all residents with second doses. They discussed as a clinical team and as he had been afebrile for 4 days, felt best to vaccinate to protect that delay further as now wife consenting to what they (clinical team) felt was in his best interests. Vaccination occurred at 10:00 hrs on 19Mar2021. He was well that day and ate and drank. He awoke on 20th and declined his medication as felt more unwell. He experienced syncope and dropped blood pressure and pulse. The events felt more unwell, syncope, and dropped blood pressure and pulse were considered serious (medically significant) and were reported to be not recovered. And whilst waiting for the clinical team, he passed peacefully. He was not for resuscitated. The reporter thinks this in unlikely to be an immunisation reaction, but the reporter felt it needed to be reported. 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: passed peacefully


VAERS ID: 1161667 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: Clinical trial participant (RECOVERY, REGN monoclonal antibodies)
Allergies:
Diagnostic Lab Data: Test Name: CXR; Result Unstructured Data: Test Result:Unknown result; Test Name: PCR; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210126; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021333924

Write-up: SARS-CoV-2 infection; This is a spontaneous report from a contactable other hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202103230953268490, Safety Report GB-MHRA-ADR 25004289. A 93-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. Medical history included clinical trial participant from an unknown date and unknown if ongoing (RECOVERY, REGN monoclonal antibodies), It was unsure if patient has had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection on 26Jan2021. The patient underwent lab tests included Covid-19 virus test: positive on 26Jan2021 (Yes - Positive COVID-19 test), polymerase chain reaction (PCR) and chest x-ray (CXR): unknown results. Therapeutic measures were taken as a result of sars-cov-2 infection. The patient died on 31Jan2021. It was not reported if an autopsy was performed. Additional information: Patient received covid vaccine 14Jan2021, admitted to hospital and tested positive for COVID 26Jan2021. Patient treated with REGN monoclonal antibodies covid vacs as part of RECOVERY trial. Also treated with dexamethasone and antibiotics as part of usual treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1161668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-31
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, 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: 2021-02-08
   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:
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210131; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021334014

Write-up: SARS-CoV-2 infection/Vaccine breakthrough infection; SARS-CoV-2 infection/Vaccine breakthrough infection; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202103231247133620, Safety Report Unique Identifier is GB-MHRA-ADR 25005489. An 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 31Jan2021, the patient experienced SARS-CoV-2 infection/vaccine breakthrough infection. It was reported that the patient received COVID vaccine on 07Jan2021. Tested positive for COVID on 31Jan2021 and was admitted to hospital. Treated with antibiotics and dexamethasone. The reporter assessed the events as serious (hospitalization and death). The patient underwent lab tests and procedures which included chest x-ray: unknown results on an unspecified date and COVID-19 virus test: positive (yes/positive COVID-19 test) on 31Jan2021. The outcome of the events was fatal. The patient died on 08Feb2021 due to SARS-CoV-2 infection/vaccine breakthrough infection. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection/Vaccine breakthrough infection; SARS-CoV-2 infection/Vaccine breakthrough infection


VAERS ID: 1161670 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-17
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cerebral haemorrhage, Cognitive disorder, Computerised tomogram, Headache, Hypertension, SARS-CoV-2 test, Scan
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: ADOPORT; AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; BISOPROLOL; CALCIUM ACETATE; NEORECORMON; OMEPRAZOLE; PREDNISOLONE; SODIUM BICARBONATE
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Chronic kidney disease stage 5; Hyperoxaluria (type 2); Ligament tear; Osteoporosis; Renal transplant; Suprapubic catheter insertion; Suprapubic pain; Urethral obstruction; Walking aid user; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown result; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown result; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Other scans; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: GBPFIZER INC2021336480

Write-up: Hypertension; Headache; Cognitive impairment; Haemorrhage brain; 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-202103240916286910, Safety Report Unique Identifier GB-MHRA-ADR 25010803. A 38-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included suprapubic pain, ligament rupture, osteoporosis, anaemia, ongoing hypertension, end stage renal disease, renal transplant, hyperoxaluria (type 2), bladder catheterisation, urethral obstruction, walked with crutches/Zimmer frame, and was a wheelchair user. The patient has not had symptoms associated with COVID-19 and was not enrolled in a clinical trial. Concomitant medications included tacrolimus monohydrate (ADOPORT); amlodipine; aspirin (acetylsalicylic acid); bisoprolol; calcium acetate; epoetin beta (NEORECORMON); omeprazole; prednisolone; and sodium bicarbonate. On an unspecified date, the patient experienced headaches since having the vaccine approximately 3 weeks prior to death. Stated that it also caused cognitive impairment later on. Prior to death, she was admitted to the hospital with severe hypertension. Scans showed intracerebral haemorrhage on 17Mar2021. The patient died soon after. The patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement, computerised tomogram, and other scans on an unspecified date with unknown results; and SARS-CoV-2 test: negative on an unspecified date: No - Negative COVID-19 test. Outcome of the events hypertension, headache, and cognitive impairment was not recovered. The patient died on 17Mar2021. Cause of death was reported as haemorrhage brain. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.; Reported Cause(s) of Death: Intracerebral haemorrhage


VAERS ID: 1161672 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, 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: 2021-03-22
   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: CLOPIDOGREL; LEVOTHYROXINE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia (lewy body dementia); Hypertension; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021334187

Write-up: Aspiration; Seizures; This is a spontaneous report from a contactable physician received from the Agency Regulatory authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202103241113075810, Safety Report Unique Identifier is GB-MHRA-ADR 25011905. A 91-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not known, expiry date not reported), via an unspecified route of administration on 18Mar2021 at single dose for COVID-19 immunization. Medical history included dementia (Lewy body dementia), hypertension, atrial fibrillation, and hypothyroidism, all from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. Concomitant medications included clopidogrel taken for atrial fibrillation, levothyroxine taken for hypothyroidism, and ramipril taken for hypertension. The patient experienced seizures on 19Mar2021, and aspiration on 22Mar2021. It was reported that 24 hours after vaccine, prolonged seizures started from which she never recovered, felt that she aspirated and died on 22Mar2021 due to the events. 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; Seizure


VAERS ID: 1161673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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: ASPIRIN; ATORVASTATIN; CRESTOR; FERROUS FUMARATE; GLICLAZIDE; LOSARTAN POTASSIUM; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Cholesterol; Diabetes; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021334101

Write-up: Death sudden; Slight sore arm; Feeling little tired; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202103241552045050, Safety Report Unique Identifier GB-MHRA-ADR 25014031. A 75-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 (lot number not known), at single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol, and diabetes. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included acetylsalicylic acid (ASPIRIN); atorvastatin taken for blood pressure high; rosuvastatin calcium (CRESTOR) taken for cholesterol; ferrous fumarate; gliclazide taken for diabetes; losartan potassium taken for blood pressure high; metformin taken for diabetes. On 20Jan2021, the patient experienced slight sore arm and feeling little tired with outcome of recovered. The patient also experienced death sudden on 29Jan2021. The patient had a Covid-19 virus test: negative No - Negative COVID-19 test on 03Feb2021 (as reported). Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 29Jan2021. It was not reported if an autopsy was performed. Additional information: After taking the vaccine he had a slight sore arm and feeling little tired for the first day or two and then was absolutely fine with no complains. He was tested negative COVID-19 at death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1161675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   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: AMLODIPINE; EDOXABAN; LANSOPRAZOLE; RAMIPRIL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Chronic kidney disease stage 3 (3a); Deep vein thrombosis (Reported again in 2019.); Dementia; Hypertension; Pulmonary embolism; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021334057

Write-up: Died in sleep; 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-202103241811231940, Safety Report Unique Identifier GB-MHRA-ADR 25015377. An 88-years-old female patient received BNT162B2 (PFIZER-BIONTECH, COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Mar2021 (Lot Number: ER1741) dose 2, as single dose, for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19, did not have a COVID-19 test, and is not enrolled in clinical trial. Medical history included breast cancer from 2007, hypertension from 2012, dementia from 2018, stroke from 2014, deep vein thrombosis (DVT) from 2012, and reported again in 2019, chronic kidney disease stage 3 (3a) from 2018, pulmonary embolism from 2019. Concomitant medications included amlodipine, edoxaban, lansoprazole, ramipril and sertraline, all taken for an unspecified indication, start and stop date were not reported. The patient died in sleep on 23Mar2021, five days post vaccination. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Died in sleep


VAERS ID: 1161676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Malaise, Pulmonary embolism, SARS-CoV-2 test, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANASTROZOLE; VITAMIN D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast adenocarcinoma; Deep vein thrombosis; Pulmonary thromboembolism
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021336325

Write-up: thrombosis; Pulmonary thromboembolism; Breathlessness; feeling unwell; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202103250735507320, Safety Report Unique Identifier is GB-MHRA-ADR 25017646. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN3924, expiry date not reported), via an unspecified route of administration at single dose on 29Jan2021 for COVID-19 immunization. Medical history included breast cancer, pulmonary embolism, and deep vein thrombosis. Previous low stage breast adenocarcinoma, grade 1. There was no detectable residual disease at post mortem. Patient was unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included anastrozole taken for breast cancer, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced thrombosis, pulmonary thromboembolism, breathlessness, and feeling unwell. Narrative case summary and further information: Death occurred due to pulmonary thromboembolism following deep vein thrombosis. Breathlessness and feeling unwell since vaccine received. Died 4th February 2021. When thrombosis started is unclear as was not diagnosed in life. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05Feb2021 No-Negative COVID-19 test. The patient died on 04Feb2021 due to the events. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Breathlessness; feeling unwell; thrombosis; Pulmonary thromboembolism


VAERS ID: 1161678 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Computerised tomogram, Constipation, Intestinal ischaemia, Laparoscopy, Multiple organ dysfunction syndrome, SARS-CoV-2 test, Sepsis syndrome
SMQs:, Acute pancreatitis (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 23
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: ATORVASTATIN; DEPO-MEDRONE; DIAZEPAM; FINASTERIDE; HYDROXYCHLOROQUINE; IMIPRAMINE; LEFLUNOMIDE; LITHIUM CARBONATE; METHOTREXATE; PROPRANOLOL; SULPHADIAZINE [SULFADIAZINE]; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar affective disorder; Bowel ischaemia; Chronic kidney disease stage 3; Depression; Enlarged prostate (benign); Hypercholesterolaemia; Immunodeficiency (medicines to lower the immune response/illness or condition, which reduces the immune response); Rheumatoid arthritis (trialled and not tolerated medicinal options/regular medicines for RA or other types of arthritis); Sepsis syndrome
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: CT scan; Result Unstructured Data: Test Result:possible oedematous bowel; Test Date: 202102; Test Name: Laparoscopy; Result Unstructured Data: Test Result:Negative for bowel ischaemia; Test Date: 202102; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021337579

Write-up: Abdominal pain; Constipation; Sepsis syndrome; Bowel ischaemia; multi-organ failure; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202103251120266870, Safety Report Unique Identifier GB-MHRA-ADR 25019311. A 70-year-old male patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EK4243) as single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, previously trialled and not tolerated medicinal options; taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr), sepsis syndrome, bowel ischaemia, enlarged prostate (benign), immunodeficiency, taking other treatments or medicines, not listed above, known to lower the immune response and i...; had an illness or condition, not listed above, which reduced the immune response (e.g. immunodef), bipolar affective disorder, chronic kidney disease stage 3, depression, hypercholesterolaemia. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included atorvastatin taken for hypercholesterolaemia, start and stop date were not reported; methylprednisolone acetate (DEPO-MEDRONE) taken for rheumatoid arthritis from an unspecified start date to 28Aug2020; diazepam taken for bipolar disorder, start and stop date were not reported; finasteride taken for enlarged prostate, start and stop date were not reported; hydroxychloroquine taken for rheumatoid arthritis, start and stop date were not reported; imipramine taken for depression, start and stop date were not reported; leflunomide taken for rheumatoid arthritis, start and stop date were not reported; lithium carbonate taken for bipolar disorder, start and stop date were not reported; methotrexate taken for rheumatoid arthritis, start and stop date were not reported; propranolol taken for bipolar disorder, start and stop date were not reported; sulphadiazine (sulfadiazine) taken for rheumatoid arthritis, start and stop date were not reported; tamsulosin taken for enlarged prostate (benign), start and stop date were not reported. The patient experienced bowel ischaemia and multi-organ failure in Feb2021, sepsis syndrome on 10Feb2021, constipation on 05Feb2021, abdominal pain on 09Feb2021. It was reported that the patient had COVID vaccination 6 days prior to hospital attendance. Admitted in Feb2021 with abdominal pain and constipation. Suspected for bowel ischaemia and had very extensive investigations and treatment to cover for sepsis syndrome and ischaemia. No overt bowel ischaemia found at surgery. Patient developed progressive multi-organ failure and care was withdrawn. The patient underwent lab tests and procedures in Feb2021 which included CT scan: possible oedematous bowel; laparoscopy: negative for bowel ischaemia; COVID-19 virus test: negative. Patient had not tested positive for COVID-19 since having the vaccine. The patient died on 24Feb2021. The outcome of the event bowel ischemia was fatal, the patient had recovered from the event constipation on 11Feb2021, the outcome of the other events was unknown. Following death of the patient, post-mortem had found bowel ischaemia to be the cause of death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Bowel ischaemia


VAERS ID: 1161682 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-22
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH COCO138186NEMIS / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Chest X-ray, Chills, Computerised tomogram thorax, Confusional state, Erythema, Feeling hot, Hypotension, Malaise, Pain in extremity, Peripheral circulatory failure, Pulmonary embolism, Respiratory distress, SARS-CoV-2 test, Sepsis, Tachypnoea
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 4
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: AMITRIPTYLINE; BISOPROLOL; FERROUS FUMARATE; FUROSEMIDE; DOCUSATE SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Hypertension; Ischaemic heart disease; Lower respiratory tract infection; Osteoarthritis; Peripheral vascular disease
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown Results; Test Date: 202103; Test Name: computerised tomography pulmonary angiogram (CTPA; Result Unstructured Data: Test Result:patient not well enough; Test Date: 20210219; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021337894

Write-up: sepsis; respiratory distress; hypotension; confusion; tachypnoea; Peripheral shutdown; Suspected chest/cellulitis sepsis; Pulmonary embolism; Unilateral leg pain; Localised erythema; Localised feeling of warmth; Rigors; Generally unwell; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202103260645588980, Safety Report Unique Identifier GB-MHRA-ADR 25024762. An 85-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Mar2021 (Batch/Lot Number: COCO138186NEMIS) as SINGLE DOSE for COVID-19 immunisation. Medical history included ischaemic heart disease, peripheral vascular disease, lower respiratory tract infection from Feb2021 to 2021, osteoarthritis, hypertension, constipation. Unsure if patient had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Concomitant medications included amitriptyline; bisoprolol; ferrous fumarate; furosemide; docusate sodium taken for constipation. The patient experienced sepsis, respiratory distress, hypotension, confusion, tachypnoea, peripheral shutdown, cellulitis and pulmonary embolism on 25Mar2021; patient experienced generally unwell and rigors on 22Mar2021; unilateral leg pain, localised erythema and localised feeling of warmth on 23Mar2021. The patient was hospitalized for the events on 25Mar2021. It was reported that the patient was generally unwell for 3 days from 22Mar2021 including ''shaking'' which seemed clinically descriptive of rigors. Admitted to hospital evening of 25Mar2021 in-extremis with tachypnoea, respiratory distress, hypotension, peripherally shut-down and confusion. Patient also developed unilaterally erythematous, hot and tender right leg on 23Mar2021; clinically suspicious of cellulitis but could not rule out deep vein thrombosis (DVT). Patient rapidly deteriorated and sadly died in the early hours of 26Mar2021. Impression: suspected chest/cellulitis sepsis. Pulmonary embolism (PE) although unclear and patient not well enough for computerised tomography pulmonary angiogram (CTPA). Given STAT treatment dose of dalteparin for pulmonary embolism (PE) (along with treatment for sepsis). The patient underwent lab tests and procedures which included chest x-ray: unknown results; on 19Feb2021 COVID-19 virus test: negative; patient was not well enough for computerised tomography pulmonary angiogram (CTPA) in Mar2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event sepsis was fatal, patient had not recovered from generally unwell and rigors, the outcome of the other events was unknown. The patient died on 26Mar2021 due to sepsis. It was unknown if an autopsy was performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1161684 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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: ALLOPURINOL; ASPIRIN [ACETYLSALICYLIC ACID]; BISOPROLOL; CO-CARELDOPA; FINASTERIDE; MEMANTINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021338014

Write-up: Death; This is a spontaneous report from a contactable physician. Regulatory authority report number GB-MHRA-WEBCOVID-202103261711241100, Safety Report Unique Identifier GB-MHRA-ADR 25029636. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Mar2021 at 11:40 (Lot Number: ER1741), at the age of 86-year-old as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included allopurinol from 16Sep2020; acetylsalicylic acid (ASPIRIN) from 16Sep2020; bisoprolol from 16Sep2020; carbidopa, levodopa (CO-CARELDOPA) from 16Sep2020; finasteride from 16Sep2020; memantine from 24Feb2021. The patient experienced died on 25Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: no - negative COVID-19 test on 05Mar2021. Cause of death was unknown. It was not reported if an autopsy was performed. Additional information included that second vaccine was given in care home at approximately 11:40. The patient was observed for 15 minutes and had no issues, had lunch and seemed his usual self. He collapsed in chair and staff realized he was not breathing, not for resuscitation and passed away. It was referred to coroner as unexpected death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1161686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   Days after onset: 30
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: AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Cardiac arrest; Osteopenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021337419

Write-up: cardiac arrest; Difficulty breathing; Double vision; This is a spontaneous report from a contactable consumer or other non hcp received from the Agency Regulatory Authority(RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202103262024103070. A 81-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Dec2020 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac arrest from an unknown date and unknown if ongoing, osteopenia from an unknown date and unknown if ongoing, blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) taken for blood pressure abnormal, start and stop date were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced double vision on 20Dec2020, difficulty breathing on 11Jan2021 and cardiac arrest on 12Jan2021. The patient was admitted to hospital on 11Jan2021 due to breathing problems. He experienced cardiac arrest 12Jan2021 and placed on ventilator. Ventilator turned off on 18Jan2021 and the patient died on 19Jan2021. Cardiac arrest and dyspnea were considered life-threatening adverse events. Clinical outcome of the events cardiac arrest and dyspnea was fatal, while outcome of diplopia was unknown. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: cardiac arrest; Difficulty breathing


VAERS ID: 1161698 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-02
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: 2021-02-13
   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: GBPFIZER INC2021313395

Write-up: died; This is a spontaneous report from a contactable consumer (patient''s wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that the reporter''s husband had his first dose of the COVID vaccine on the 10Feb2021, he died on the 13Feb2021. 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: died


VAERS ID: 1161716 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6790 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac failure, Dyspnoea, Heart rate, Hypotension, Oxygen saturation
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: ATROVENT; QUAMATEL; ZYLLT; TENSIOMIN; TRENTAL; MILURIT; DORMICUM [MIDAZOLAM HYDROCHLORIDE]; FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; FRONTIN; XETER; TALLITON; DIAPREL; CORDAFLEX
Current Illness: Carotid artery stenosis; Cerebral circulatory disorder; Emphysema; Hypertension; Peripheral arterial disease; Pulmonary fibrosis; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspnoea (general state was persisting during the last year;dyspnoea under loading which ceased during rest); Helicobacter pylori infection
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: blood pressure; Result Unstructured Data: Test Result:126/100 mmHg; Test Date: 20210305; Test Name: heart rate; Result Unstructured Data: Test Result:100; Comments: 100/min; Test Date: 20210305; Test Name: saturation; Test Result: 92 %
CDC Split Type: HUPFIZER INC2021335347

Write-up: heart failure; blood pressure decreased; dyspnoea; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority HU-OGYI-149821. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular in the left upper arm on 05Mar2021 at 10:49 (Lot Number: EJ 6790; Expiration Date: May2021) as 0.3 mL, single for covid-19 immunisation. After the first vaccination with COMIRNATY, no adverse event occurred. Medical history included ongoing hypertension, type 2 diabetes mellitus from 2004 and ongoing, ongoing peripheral arterial disease, ongoing carotid artery stenosis, helicobacter pylori infection (not ongoing), ongoing cerebral circulatory disorder, ongoing emphysema, ongoing pulmonary fibrosis. The patient''s general state was persisting during the last year. He had dyspnoea under loading which ceased during rest. Concomitant medications included ipratropium bromide (ATROVENT); famotidine (QUAMATEL); clopidogrel bisulfate (ZYLLT); captopril (TENSIOMIN); pentoxifylline (TRENTAL); allopurinol (MILURIT); midazolam hydrochloride (DORMICUM [MIDAZOLAM HYDROCHLORIDE]); beclometasone dipropionate, formoterol fumarate (FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]); alprazolam (FRONTIN); rosuvastatin calcium (XETER); carvedilol (TALLITON); gliclazide (DIAPREL); and nifedipine (CORDAFLEX). On 05Mar2021 at 10:49 am, the patient received the second dose of COMIRNATY. Three hours later (13:49), the patient experienced blood pressure decreased and dyspnoea at his home and died several hours later after transportation to hospital. During vaccination, the patient was cardiorespiratory compensated (blood pressure: 126/100 Hgmm, heart rate 100/min, saturation: 92%), he had no reactions during the half-hour observation period. The patient died on 05Mar2021. Autopsy was done, autopsy result was not available. Cause of death was heart failure, which resulted by his pulmonary fibrosis. Sender Comment: Blood pressure decrease and dyspnoea are not expected adverse events of COMIRNATY. These symptoms might have rather occurred due to the concurrent cardiorespiratory diseases of the patient. Time to onset was three hours. Causality between the adverse events and COMIRNATY is unlikely. The case is serious because the patient died. No further information is expected.; Reported Cause(s) of Death: blood pressure decreased; dyspnoea; heart failure


VAERS ID: 1161726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 1 - / -

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: 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: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330246

Write-up: Cardiac arrest passed away at home; This is a spontaneous report from a contactable healthcare professional (HCP) via health authority (HA). The regulatory authority report number is unspecified. An 85-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK4238), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced cardiac arrest and passed away at home. 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: Cardiac arrest passed away at home


VAERS ID: 1161727 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4175 / 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: Diabetes; Hyperlipidemia (with no medical treatment); Hypertension; Microalbuminuria
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330265

Write-up: Death; This is a spontaneous report received from a contactable other HC via Agency Regulatory Authority. A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch Number: EK4175) as single dose for COVID-19 immunisation. Medical history included unbalanced diabetes, microalbuminuria from 2016, hypertention, and hyperlipidemia with no medical treatment. The patient''s concomitant medications were not reported. The report was received in the epidemiology department division by medical staff. It was reported that on an unspecified date with time range of 9 days there was circumstances of death. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information and with the medical history of unbalanced diabetes, hypertension, and hyperlipidemia with no medical treatment, the event Death is considered unrelated to the suspected drug. The case will be reassessed if 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: 1161728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4175 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Myocardial infarction, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Hypertension; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330273

Write-up: pulmonary edema; myocardial infarction; shortness of breath; This is a spontaneous report from a contactable healthcare professional (HCP) via health authority. The regulatory authority report number is unspecified. A 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4175) as single dose for COVID-19 immunisation. The patient''s medical history included hypothyroid, hypertension, and Alzheimer''s disease. The patient''s concomitant medications were not reported. The patient experienced " Circumstances of death: pulmonary edema, myocardial infarction, arrived to the emergency room with shortness of breath" on an unspecified date. Time range of 12 days was reported. The patient died on an unspecified date due to pulmonary edema, myocardial infarction, and shortness of breath. 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: Pulmonary edema; myocardial infarction; shortness of breath


VAERS ID: 1161729 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), 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: 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: Asthma; Barrett''s esophagus; Morbid obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330278

Write-up: Loss of consciousness; myocardial infarction; This is a spontaneous report from a contactable health care professional. A 52-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4238, expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included Barrett esophagus, morbidly obese (BI-58) and asthma all from an unknown date. The patient''s concomitant medications were not reported. It was reported that the circumstances of death loss of consciousness at home and myocardial infarction on an unspecified date (reported time frame was 6 days). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected; Sender''s Comments: Based on the information provided, the reported events are likely intercurrent medical condition and unrelated to BNT162B2. Case will be reassess once 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Loss of consciousness; myocardial infarction


VAERS ID: 1161730 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 2 - / -

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: Asthma; Diabetes; Hashimoto''s disease; Ischemic heart disease; Lipids abnormal; Orthopedic procedure (In the days before recipient of the vaccine); Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330288

Write-up: unknown cause of death; This is a spontaneous report received from healthcare professional via Health Authority. A 85-year-old female patient received the second dose of bnt162b2 (BNT162B2; batch/lot number: EK4240), at unknown vaccination age via an unspecified route of administration on an unspecified date (reported time range of 1 day) as a single dose for covid-19 immunisation. Medical history included asthma, diabetes, lipids in the blood (lipids abnormal), osteoporosis, Hashimoto, ischemic heart disease (IHD), and orthopedic procedure in the days before recipient of the vaccine. It was unknown if the patient was pregnant at the time of vaccination. The patient received the first dose of bnt162b2 (BNT162B2; unknown lot number and expiration date), at unknown vaccination age via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient''s concomitant medications were not reported. The patient experienced a circumstance of unknown cause of death on an unspecified date. The outcome of the event was fatal. This case is a report for deaths in the vicinity of receiving a vaccine against Corona. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow up attempts are possible. No further information is expected.; Sender''s Comments: A reasonable possibility that the event unknown cause of death is related to vaccination with BNT162B2 cannot be completely excluded until further information regarding clinical course and death cause is provided. Underlying comorbidities in this elderly patient may be contributory. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1161731 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4241 / 2 - / -

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: ILPFIZER INC2021330313

Write-up: death; This is a spontaneous report from a contactable other healthcare professional via Agency Regulatory Authority. A 59-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot Number: EK4241), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced death on an unknown date. The patient died (due to an unknown cause) on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded. However, there was no information provided regarding autopsy results, specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. This case will be reassessed once additional information is available. 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-2020517122 same correspondence reporter, same product, other patient, other events (master case); Reported Cause(s) of Death: death


VAERS ID: 1161732 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Osteoporosis; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330315

Write-up: death certificate states that he died of an acute myocardial infarction (STEMI); This is a spontaneous report from a contactable other hcp received via the Agency Regulatory Authority. A 60-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch Number: EK4238) as single dose for COVID-19 immunisation. Medical history included schizophrenia, hypertension and osteoporosis from unspecified dates. The patient''s concomitant medications were not reported. The report was received in the epidemiology department division by medical staff. It was reported that on an unspecified date, 16 days from the vaccine, patient was brought to the emergency room anesthetized and respirated after collapsing in the shower. A death certificate states that he died of an acute myocardial infarction (STEMI). Circumstances of death was collapse at home underwent CPR in emergency room. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information, the event Acute myocardial infarction is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if 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: Adeath certificate states that he died of an acute myocardial infarction (STEMI)


VAERS ID: 1161733 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Malaise, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: Congestive heart failure (Background : CHF and additional diseases)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330350

Write-up: Difficulty breathing difficulty including an event of choking and loss of consciousness. Emergency Service invited to the scene determined his death; Peripheral edema began to appear in limbs which worsened.; A day after the second dose started to feel bad, general bad feeling.; This is a spontaneous report from a contactable other HCP received from Regulatory Authority (Attached is a file of reports of hospitalizations and deaths in the vicinity of receiving a vaccine against Corona, updated to 25Mar2021. The reports were received in the epidemiology department division by medical staff. Please note that the file has 2 tabs: hospitalizations, deaths.Patient number.) A male patient of an unspecified age (89, units unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK4240), second dose via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. Medical history included Congestive Heart Failure from an unknown date, Background : CHF and additional diseases. The patient''s concomitant medications were not reported. Difficulty breathing difficulty including an event of choking and loss of consciousness. Emergency Services invited to the scene determined his death. A day after the second dose, patient started to feel bad, general bad feeling. Peripheral edema began to appear in limbs which worsened. The patient refused to hospitalization or receiving medical treatment. The events were assessed as serious, fatal outcomes, cause of deaths. Patient died on an unspecified date. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Difficulty breathing difficulty including an event of choking and loss of consciousness; Peripheral edema began to appear in limbs which worsened.; A day after the second dose started to feel bad, general bad feeling.


VAERS ID: 1161734 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Face injury, Fall, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: Dementia; Heart failure (heart failure with incidents of lung congestion); Hypertension; Lung congestion (heart failure with incidents of lung congestion); Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330424

Write-up: died at home after a fall and lots of bleeding from the face; fell on the face; died at home after a fall and lots of bleeding from the face; This is a spontaneous report from a contactable other healthcare professional received from Agency Regulatory Authority. An 85-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EK4242) as single dose for covid-19 immunisation. Medical history included hypertension, heart failure with incidents of lung congestion, osteoporosis and dementia, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient died at home after a fall and lots of bleeding from the face on an unspecified date. Clinical course was reported as follows. The patient went to sleep without any complaint. In the course of the night, she got up from her bed, did not speak and did not complain and then immediately fell on the face. She got injured and bled a lot from the face. Emergency services was called. The family attempted to resuscitate until the ambulance arrived. When the emergency service arrived the resuscitation continued but unsuccessfully. The patient died on an unspecified date. It was not reported if an autopsy was performed.Outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fell on the face; died at home after a fall and lots of bleeding from the face; died at home after a fall and lots of bleeding from the face


VAERS ID: 1161735 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0203 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, General physical health deterioration, Leukocytosis, Oxygen saturation, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Chronic bronchitis; Hypertension; Osteoporosis; Smoker
Allergies:
Diagnostic Lab Data: Test Name: oxygen saturation; Result Unstructured Data: Test Result:96; Test Name: leukocytes; Result Unstructured Data: Test Result:17000; Comments: leukocytosis
CDC Split Type: ILPFIZER INC2021330471

Write-up: decrease in general state; weakness; leukocytosis 17000; Died in the hospital; This is a spontaneous report from a contactable other healthcare professional received via the Agency Regulatory Authority, Regulatory Authority report number is unspecified. An 85-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EL0203) as single dose for COVID-19 immunization. Medical history included, hypertension, heavy smoker in the past, chronic bronchitis, osteoporosis, anemia. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: unknown) as single dose for COVID-19 immunization. The patient "came to the emergency room as a of decrease in the general state and weakness for a week now. Saturation with oxygen 96, lab tests- leukocytosis 17000- started empirical antibiotic treatment. Died in the hospital." The patient was hospitalized for events decrease in the general state, weakness, leukocytosis. Emergency room visit for "decrease in the general state" and weakness (for a week now). The patient underwent lab tests and procedures which included oxygen saturation: 96, white blood cell count: 17000 (leukocytosis) on an unspecified date. Therapeutic measures were taken as a result of leukocytosis 17000 which included empirical antibiotic treatment. The outcome of the events decrease in the general state, weakness, leukocytosis was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Batch/lot number already provided.; Reported Cause(s) of Death: Died in the hospital


VAERS ID: 1161736 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-19
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL7834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Decreased appetite, Dizziness, Fall
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (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: ILPFIZER INC2021330479

Write-up: Died at home; he was weak, without appetite and with dizziness; he was weak, without appetite and with dizziness; he was weak, without appetite and with dizziness; fell; This is a spontaneous report from a contactable healthcare professional (HCP) via Regulatory authority. The regulatory authority report number is unspecified. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL7834) as SINGLE DOSE for covid-19 immunisation. The patient received first dose of COMIIRNATY on an unspecified date for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. According to the report after the second vaccine he was weak, without appetite and with dizziness, could not get up in bed. On the morning of 19Feb2021, he got up to go to the bathroom and apparently fell. Association staff(rescue team) performed resuscitation the patient died. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events weak, without appetite, dizziness, and fell was unknown. No follow-up attempts possible. No further information expected. Batch/lot number already provided.; Reported Cause(s) of Death: Died at home


VAERS ID: 1161737 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

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: Dementia; Diabetes; Hyperlipidemia; IHD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330491

Write-up: Collapsed near the car; This is a spontaneous report from a contactable other healthcare professional via Agency Regulatory Authority. An 84-year-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, Lot Number: EK4242), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history included dementia, diabetes, hyperlipidaemia, and IHD which were all ongoing. The patient''s concomitant medications were not reported. On an unspecified date, the patient collapsed near the car. It was further reported as 7 days after a second dose, according to the team (rescue team) patient was found unconscious near the street with no breathing and no pulse, the monitor showed an asystolic line, CPR was performed, arrived to the emergency room and was respirated, in US heart without movements, CPR was performed with no success and his death was determined. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number was obtained.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded for the event of Unknown cause of death. However, there was no information provided regarding autopsy results, specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. . Of note, the underlying conditions of dementia, diabetes, hyperlipidaemia and IHD may have possibly contributed to the death of this elderly patient. This case will be reassessed once additional information is available. 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-2020517122 same correspondence reporter, same product, other patient, other events (master case); Reported Cause(s) of Death: Collapsed near the car


VAERS ID: 1161738 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL7834 / 2 - / -

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

Life Threatening? Yes
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: Diabetes; Obesity (BMI 46.4)
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident (CVA in his past.); Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330500

Write-up: died in his home from cardiac arrest; Ventricular fibrillation; This is a spontaneous report from a contactable other healthcare professional. A 51-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL7834) as SINGLE DOSE for covid-19 immunisation. Medical history included: ongoing diabetes, ongoing obesity (BMI 46.4), smokes and cerebrovascular accident in his past from an unknown date and unknown if ongoing. The patient previously took bnt162b2 first dose on unspecified date for covid-19 immunisation. The patient''s concomitant medications were not reported. It was reported that the patient collapsed in his home, they note that he did not complain of pains before the collapse. The family members started chest massage before the emergency service came. The patient was found lying on the floor, unconscious, without pulse and without breathe, in the monitor (there was) Ventricular fibrillation. It was noted that the patient died in his home from cardiac arrest (reported as Time range: same day, unspecified). The patient died on an unspecified date. It was not reported if an autopsy was performed.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Cardiac arrest with fatal outcome due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient with medical history of diabetes, obesity, tobacco use and cerebrovascular accident. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including autopsy results and EKG at baseline, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: died in his home from cardiac arrest


VAERS ID: 1161739 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6017 / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330501

Write-up: Was found dead in her home; This is a spontaneous report from a contactable healthcare professional via Regulatory Authority line listing and was referring to patient number in the file. A female patient of an unspecified age (73, age unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EP6017), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Circumstances of death was the patient was found dead in her home. The patient died of an unknown cause on an unspecified date. It was unknown if autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded for the death NOS. However, there was no information provided regarding autopsy results, specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. This case will be reassessed once additional information is available. 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-2020517122 Same source (Regulatory Authority), similar event, different patient and reporter (patient number); Reported Cause(s) of Death: Was found dead in her home


VAERS ID: 1161740 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 2 - / -

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: Diabetes; Dyslipidemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330508

Write-up: Collapsed during physical activity; This is a spontaneous report from a contactable healthcare professional (HCP) via Regulatory authority. The regulatory authority report number is unspecified. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (lot number: EK4240) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus and dyslipidaemia. The patient''s concomitant medications were not reported. The patient collapsed during physical activity on an unspecified date (reported as 3 weeks from the vaccine). His friends performed CPR, until the rescue team came. His death was determined at the hospital. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Collapsed during physical activity


VAERS ID: 1161741 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Facial paralysis, Hypothermia, Septic shock, Slow speech
SMQs:, Toxic-septic shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hearing impairment (broad), Sepsis (narrow), Opportunistic infections (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: Colon operation (20 years ago due to a tumor background)
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia (with TAMSULOSIN); Colon neoplasm NOS; GERD; Hypertension; Paroxysmal atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021331664

Write-up: Hypothermia; weakness; slowness of speech; drooping at the corner of the mouth; septic shock; This is a spontaneous report from a contactable healthcare professional via Regulatory Authority line listing and was referring to patient number in the file. A 98-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included benign prostatic hyperplasia (BPH), hypertension, gastrooesophageal reflux disease (GERD), paroxysmal atrial fibrillation (PAF) and resection of the colon (in 2001) 20 years ago due to a tumor background. The patient''s concomitant medications were not reported. The patient previously took tamsulosin for BPH. Circumstances of death were hypothermia, weakness, slowness of speech, drooping at the corner of the mouth and septic shock all on an unknown date. The patient died due to hypothermia, weakness, slowness of speech, drooping at the corner of the mouth and septic shock on an unknown date. It was unknown if autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the current available information, the events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if 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.,Linked Report(s) : IL-PFIZER INC-2020517122 Same source (Regulatory Authority),similar event, different patient and reporter (master case); Reported Cause(s) of Death: Hypothermia; weakness; slowness of speech; drooping at the corner of the mouth; Septic shock


VAERS ID: 1161742 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (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: Diabetes; Hypertension; Leg ulcer; Macular corneal dystrophy; Nephropathy; Peripheral vascular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021344846

Write-up: Tachycardia; Shortness of breath; died; This is a spontaneous report from a contactable other healthcare professional. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included Diabetes with complications (nephropathy and MCD-Macular corneal dystrophy), ulcer in the leg, Suspicion of OM, hypertension and Peripheral vascular disease. The patient''s concomitant medications were not reported. The patient experienced tachycardia and shortness of breath on an unspecified date and was hospitalized on an unspecified date due to the events. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events tachycardia and shortness of breath was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: A reasonable possibility that the event unknown cause of death is related to vaccination with BNT162B2 cannot be completely excluded until further information regarding clinical course and death cause is provided. The events tachycardia and shortness of breath are considered unrelated to BNT162B2; the patient''s advanced age, as well as history of diabetes with complications, nephropathy, peripheral vascular disease and other comorbidities provide an explanation for these 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 1161743 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: ILPFIZER INC2021347056

Write-up: IUFD; IUFD; This is a spontaneous report received from a contactable other healthcare professional (HCP). Regulatory report number is not provided. This other hcp reported information for both mother and fetus. This is the fetus report. Only this case is serious. A fetus patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EK4240, expiry date not reported) dose 1, transplacental on an unspecified date at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s mother is a 39-year old female who was at risk pregnancy because of twins. On an unspecified date, the patient experienced IUFD (intrauterine fetal death), which was reported as serious with criteria as hospitalization as the patient''s mother was hospitalized on unknown dates with diagnosis as IUFD, and as medically significant. Event description was provided as IUFD of one of the fetuses (time range of events was reported as 11 days). The patient died on an unspecified date. The cause of death was IUFD. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2021349377 Maternal report; Reported Cause(s) of Death: IUFD; IUFD


VAERS ID: 1161744 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal heart rate abnormal, Foetal movement disorder, Histology, Laboratory test, Prenatal screening test, Syndactyly, X-ray
SMQs:, Congenital, familial and genetic disorders (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (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: Test Name: histological check of the placenta; Result Unstructured Data: Test Result:unknown; Test Name: genetic test; Result Unstructured Data: Test Result:unknown; Test Name: integrated test; Result Unstructured Data: Test Result:normal; Test Name: x- ray; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: ILPFIZER INC2021348948

Write-up: IUFD; did not feel fetal movement; no fetal heart beat; syndactyly in fingers 4-5 in the right leg; This is a spontaneous report received from a contactable other HCP via Regulatory Authority. This other hcp reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose transplacental on 17Feb2021, single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The day before injection on 17Feb2021 received the first injection of the vaccine for COVID 19 in a community setting. When mother was given it there was no fetal heart beat. In an ultrasound check it showed a fetus with no heartbeat and no movement, IUFD. PCR test for COVID 19 when she was admitted was negative. The mother gave birth on date in the evening and the fetus was without external birth defects except for syndactyly in fingers 4-5 in the right leg. Even with request and repeated explanation, the woman refused an autopsy but agreed to a genetic test, x-rays, medical photographs and histological check of the placenta in addition to a corona test from the placenta and from the fetus.The outcome of the event IUFD was fatal, unknown for other events. No follow-up attempts possible. No further information expected.; Sender''s Comments: The reported events IUFD, fetal movement disorder, fetal heart rate absent and syndactyly are likely an intercurrent condition and not related to bnt162b2 .; Reported Cause(s) of Death: IUFD


VAERS ID: 1161759 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Hyperpyrexia
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: 2021-03-07
   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: TERAPROST; BISOPROLOL FUMARATE; RAMIPRIL; LASIX [FUROSEMIDE]; XARELTO; ROLUFTA
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No provide medical history
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Death; Il A regulatory authority report was received from a physician concerning a 79-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced hyperpyrexia and death. The patient''s medical history was not provided. Concomitant medications included terazosin hydrochloride, bisoprolol fumarate, ramipril, furosemide, rivaroxaban, and umeclidium bromide. On 04 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 300042723) intramuscularly for prophylaxis of COVID-19 infection. On 05 Mar 2021, the patient experienced hyperpyrexia. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. On 07 Mar 2021, the patient died. The event of hyperpyrexia was considered fatal. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 79-year-old male patient who experienced hyperpyrexia and death. Very limited information regarding this event has been provided at this time. The event of hyperpyrexia was considered fatal. Plans for an autopsy were not provided.; Sender''s Comments: 12-Mar-2021, the sender is asked to activate the clinical report follow-up procedure.; Reported Cause(s) of Death: hyperpyrexia


VAERS ID: 1161786 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166-12-026 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: LEVOTHYROXINE; ENALAPRIL; AMLODIPINE; SIMVASTATIN; NEBIVOLOL; SILODOSIN; RIVAROXABAN; OMEPRAZOLE
Current Illness: AFib; Artificial cardiac pacemaker wearer (total BAV pacemaker); Atrioventricular block; Hypercholesteremia; Hypertensive heart disease; Hypothyroidism (hypothyroidism in replacement treatment); Overweight
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021311573

Write-up: The patient died on 10Mar2021 , on 07Mar2021 had been subjected to the second dose of the Pfizer vaccine; This is a spontaneous report from contactable physician downloaded from the Regulatory Authority. The regulatory authority number is IT-MINISAL02-699985. An 83-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: EP2166-12-026) at the age of 83-years-old, intramuscular on 07Mar2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included ongoing hypertensive heart disease, atrial fibrillation (AFib), atrioventricular block, artificial cardiac pacemaker wearer (total BAV pacemaker), hypercholesterolemia, hypothyroidism in replacement treatment, and overweight. Concomitant medications included levothyroxine, enalapril, amlodipine, simvastatin, nebivolol, silodosin, rivaroxaban, and omeprazole. The patient passed away on 10Mar2021. The patient was living alone. The corpse was found sitting in an armchair in front of the television in the late morning of 10Mar2021. At the arrival of the doctor, around 1 pm, the patient already had signs of rigor mortis therefore presumably death occurred early in the morning of Wednesday, 10Mar2021. The patient died on 10Mar2021. The cause of death was unknown. Autopsy was not performed. Reporter''s comment: Mr. PRIVACY was suffering from hypertensive heart disease, atrial fibrillation, total BAV pacemaker, hypercholesterolemia, hypothyroidism in replacement treatment, overweight. Mr. PRIVACY , born on PRIVACY, passed away on March 10, 2021. On March 7, he received the second dose of the Pfizer vaccine. The patient, who lived alone, was already found dead, sitting in an armchair in front of the television, in the late morning of 10 March. Upon my arrival, around 1 pm, the deceased present. Sender''s comments: On 16Mar21, the clinical report is attached, the fields updated with new information, the death field privacy filled in. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Mr. PRIVACY was suffering from hypertensive heart disease, atrial fibrillation, total BAV pacemaker, hypercholesterolemia, hypothyroidism in replacement treatment, overweight. Mr. PRIVACY , born on PRIVACY, passed away on March 10, 2021. On March 7, he received the second dose of the Pfizer vaccine. The patient, who lived alone, was already found dead, sitting in an armchair in front of the television, in the late morning of 10 March. Upon my arrival, around 1 pm, the deceased present.; Reported Cause(s) of Death: The patient died on 10Mar2021 , on 07Mar2021 had been subjected to the second dose of the Pfizer vaccine


VAERS ID: 1161789 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood count, Blood test, Cardio-respiratory arrest, Cerebral haemorrhage, SARS-CoV-2 test, SARS-CoV-2 test negative, Troponin I
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210318; Test Name: blood count; Result Unstructured Data: Test Result:no results reported; Test Date: 20210318; Test Name: clinical chemistry; Result Unstructured Data: Test Result:no results reported; Test Date: 20210319; Test Name: COVID-19 molecular test; Result Unstructured Data: Test Result:no result reported; Comments: result is not declared on ADR Form; Test Date: 20210319; Test Name: SARS-CoV-2 PCR test negative; Test Result: Negative ; Test Date: 20210318; Test Name: troponin I; Result Unstructured Data: Test Result:no results reported
CDC Split Type: ITPFIZER INC2021334273

Write-up: cardio-respiratory arrest; massive Cerebral haemorrhage; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB, regulatory authority number IT-MINISAL02-703639. An 82-year-old female patient received the second dose of bnt162b2 (vaccine, Lot Number: ET3620), intramuscular, administered in Deltoid Left on 18Mar2021 as a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of vaccine on 25Feb2021 in the left deltoid for covid-19 immunisation. The patient experienced massive cerebral haemorrhage on 18Mar2021. It was further reported that patient was serious in coma immediately in the emergency room. Clinical picture was compatible with probably hemorrhagic stroke. Brady-arrhythmic cardiac action MV, harsh snoring breath, abdomen treatable. On 19Mar2021 at 01:27 patient had cardio-respiratory arrest. Urgency code changed from red to black. Th patient''s final diagnosis was Massive cerebral haemorrhage, ACR (ACR Appropriateness Criteria for Cerebrovascular Disease). From intervention card 118, reported vomiting episode with subsequent loss of consciousness Home therapies from card of emergency 118 were Zarelis 37, 5 mg, Triptych; from the Emergency Room report Entact 10 mg, another drug not better specified. Quick swab with negative result; molecular swab performed and notification sent to health management; result was not declared on ADR Form; complete blood count , clinical chemistry and Troponin I (unknown result). Therapeutic measures were taken as a result of massive cerebral haemorrhage. The outcome of the events was fatal. The patient died on 19Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number already obtained; Reported Cause(s) of Death: Massive cerebral haemorrhage; cardio-respiratory arrest


VAERS ID: 1161845 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: Medical History/Concurrent Conditions: Cervical spondylosis
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination; Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7-35.9 Centigrade; Comments: on workdays
CDC Split Type: JPPFIZER INC2021346954

Write-up: Death; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v20102376. A 65-year-old male (age at vaccination was 65 years) patient on 09Mar2021 at 12:00, received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EP2163, Expiration date 31May2021) via an unspecified route of administration at 0.3 mL, single for COVID-19 immunization. Body temperature before vaccination (on 09Mar2021) was 35.9 degrees Centigrade. The patient had no family history. The patient had a relevant medical history of cervical spondylosis in 2012 and was examined in the reporter''s hospital. The patient worked normally after vaccination and had no absence and no physical deconditioning. The working days of the patient were 09Mar2021, 11Mar2021, 13Mar2021, 14Mar2021, 16Mar2021, 17Mar2021, 19Mar2021, 20Mar2021, 21Mar2021, 22Mar2021, 24Mar2021, 25Mar2021, 27Mar2021. The body temperature on workdays was 35.7-35.9 degrees Centigrade. On 29Mar2021 (20 days after the vaccination), the police contacted the reporting hospital that he was found dead at home. The details were unknown. The death date was around 28Mar2021 to 29Mar2021. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (fatal) and assessed that the causality between the patient''s death and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: though the causality between the patient''s death and BNT162b2 was unknown, there was no positive doubt about the causal relationship between the patient''s death and BNT162b2. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1161850 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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:
CDC Split Type: MTPFIZER INC2021343748

Write-up: had died from COVID-19 (despite being fully vaccinated) within 14 days; had died from COVID-19 (despite being fully vaccinated) within 14 days; This is a spontaneous report from a contactable physician via corporation sales representative. This physician reported similar events for 6 patients. This is the second of 6 reports. A 9-decade (over 80 years old) patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were not reported) at single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had died from COVID-19 (despite being fully vaccinated) within 14 days of taking the second dose. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : MT-PFIZER INC-2021338126 same reporter, same drug, same events, different patient; Reported Cause(s) of Death: had died from COVID-19 (despite being fully vaccinated) within 14 days; had died from COVID-19 (despite being fully vaccinated) within 14 days


VAERS ID: 1161851 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC2021343749

Write-up: had died from COVID-19 (despite being fully vaccinated) within 14 days; had died from COVID-19 (despite being fully vaccinated) within 14 days; This is a spontaneous report from a contactable physician via sales representative. This physician reported similar events for 6 patients. This is the third of 6 reports. A 9-decade-old (over 80 years old) patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date (batch/lot number and expiration date were not reported) at single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had died from COVID-19 (despite being fully vaccinated) within 14 days of taking the second dose. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : MT-PFIZER INC-2021338126 same reporter, same drug, same events, different patient; Reported Cause(s) of Death: had died from COVID-19 (despite being fully vaccinated) within 14 days; had died from COVID-19 (despite being fully vaccinated) within 14 days


VAERS ID: 1161852 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
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: Cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC2021343750

Write-up: had died from COVID-19 (despite being fully vaccinated) after 14 days of taking the second dose; had died from COVID-19 (despite being fully vaccinated) after 14 days of taking the second dose; This is a spontaneous report from a contactable physician via sales representative. This physician reported similar events for 6 patients. This is the fourth of 6 reports. An 9-decade-old (over 80-years-old) patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date (batch/lot number and expiration date were not reported) at single dose for COVID-19 immunisation. Medical history included cancer. The patient''s concomitant medications were not reported. The patient had died from COVID-19 (despite being fully vaccinated) after 14 days of taking the second dose. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : MT-PFIZER INC-2021338126 same reporter, drug, and events, different patient; Reported Cause(s) of Death: had died from COVID-19 (despite being fully vaccinated), 14 days after the second dose; had died from COVID-19 (despite being fully vaccinated), 14 days after the second dose


VAERS ID: 1161853 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
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: Cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC2021343751

Write-up: had died from COVID-19 (despite being fully vaccinated) after 14 days of taking the second dose; had died from COVID-19 (despite being fully vaccinated) after 14 days of taking the second dose; This is a spontaneous report from a contactable physician. This physician reported similar events for 6 patients. This physician reported similar events for 6 patients. This is the fifth of 6 reports. A 9-decade (over 80 years old) patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were not reported) at single dose, for COVID-19 immunisation. The patient''s medical history included cancer. Concomitant medications were not reported. On an unspecified date, the patient had died from COVID-19 (despite being fully vaccinated) after 14 days of taking the second dose. It was not reported if an autopsy was performed. Information on the batch/lot number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : MT-PFIZER INC-2021338126 same reporter, same drug, same events, different patient; Reported Cause(s) of Death: had died from COVID-19 (despite being fully vaccinated) after 14 days of taking the second dose; had died from COVID-19 (despite being fully vaccinated) after 14 days of taking the second dose


VAERS ID: 1161854 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC2021343752

Write-up: had died from COVID-19 (despite being fully vaccinated) within 14 days; had died from COVID-19 (despite being fully vaccinated) within 14 days; This is a spontaneous report from a contactable physician via Agency Regulatory Authority. This physician reported similar events for 6 patients. This is the 6th of 6 reports. A 9-decade (over 80 years old) patient of an unspecified gender received the first and second doses of BNT162B2 (COMIRNATY), both via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were not reported) at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had died from COVID-19 (despite being fully vaccinated) within 14 days of taking the second dose on unknown date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : MT-PFIZER INC-2021338126 same reporter, same drug, same events, different patient; Reported Cause(s) of Death: had died from COVID-19 (despite being fully vaccinated) within 14 days; had died from COVID-19 (despite being fully vaccinated) within 14 days


VAERS ID: 1161868 (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: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction
SMQs:, Ischaemic 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: 2021-02-16
   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: DICLOFENAC POTASSIUM; INDERAL; OMEPRAZOLE; CALCIUM CARBONATE/VITAMIN D3; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Osteoporosis; Vertebral lesion
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021311625

Write-up: major cerebral infarction (death); This is a spontaneous report downloaded from the Regulatory Authority-WEB [NL-LRB-00478646] and Safety Report Unique Identifier [NL-LRB-00480220]. A contactable physician reported that a 90-year-old female patient received bnt162b2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration on 15Feb2021 as a single dose for COVID-19 immunization and acenocoumarol (manufacturer unknown, strength: 1mg), via an unspecified route of administration from an unspecified date to an unspecified date, at 1 DF and 2 DF alternate day for an unspecified indication. Medical history included atrial fibrillation, osteoporosis and vertebral lesion all from an unknown date and unknown if ongoing. Concomitant medications included diclofenac potassium (manufacturer unknown); propranolol hydrochloride (INDERAL); omeprazole (manufacturer unknown); calcium carbonate, colecalciferol (manufacturer unknown) and paracetamol (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. It was reported that the dose of acenocoumarol had been lowered right before vaccination to reduce the risk of haematoma. Normally the patient received 1 and 2 tablets alternately but on 11-13Feb2021 the patient received 1 tablet and on 14-15Feb2021, the patient did not receive any tablet. On 16Feb2021, the patient experienced a major cerebral infarction (death) one day after the vaccination of bnt162b2. The patient died on 16Feb2021. An autopsy was not performed. Reporter''s comments: BioNTech / Pfizer vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no, Patient died the next day, Additional information ADR: She had a major cerebral infarction COVID-19. Previous COVID-19 infection: No. 17Mar2021: Follow up : Is cerebral infarction the registered cause of death? Clinical Diagnosis. What was the patient''s situation before vaccination? Was this an independent living? How was your health? Home care? Nursing home resident, if so, for which indication? Pacient lived in a private nursing home. The pacient was actually quite stable. Her memory did deteriorate a bit, but otherwise she was not critically ill or likewise. What was the patient''s condition in the weeks / days up to vaccination? Was there deteriorating health? So, yes, what was the scenery? See above. Was a corona test taken around the time of the vaccination? If so, on what date and what was the result? No, no reason for that. What was the medical history? Pacient had AF- atrial fibillation with rate control and blood thinners. Osteoporosis. Was temporarily (primary care residence) hospitalized because of many back pain due to vertebral collapse. Were there risk factors for cerebral infarction? See above. What medication did the patient use? (if more than just the reported diclofenac): omeprazole. Acenocoumarol. Propanolol. Calc / Vit D. Paracetamol. Was there an adjustment in medication around the time of the vaccination? Called thrombosis service. Dosing schedule has been adjusted. Normally patient received 1 and 2 tablets alternately. On 11-12-13Feb2021 1tablet, on 14-15Feb2021 0 tablet. (I requested this from the technical service of PRIVACY). What is your estimate of the contribution that (side effects of) the vaccine may have made to the death? (none / very unlikely / vaccine side effects may have accelerated death / vaccine side effects are highly likely to accelerate death / it is extremely unlikely that without these side effects this patient would have died in the short term) Pacient had no fever, not deathly ill from vaccine or likewise. So straight through the vaccine I think is unlikely. A possible lowering of the acenocoumarol does play a role. Because we don''t want a muscle hematoma, we risk a CVA-cerebralvascular accident. Immediately after vaccination, did the patient have side effects such as fever, chills, malaise, headache, nausea, vomiting, muscle pain, joint pain or injection site reactions? No. Was autopsy done? No. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Patient died the next day Additional information ADR: She had a major cerebral infarction COVID-19 Previous COVID-19 infection: No. 17Mar2021: Follow up : - Is cerebral infarction the registered cause of death? Clinical Diagnosis - What was the patient''s situation before vaccination? Was this an independent living? How was your health? Home care? Nursing home resident, if so, for which indication? Pacient lived in a private nursing home. The pacient was actually quite stable. Her memory did deteriorate a bit, but otherwise she was not critically ill or likewise. - What was the patient''s condition in the weeks / days up to vaccination? Was there deteriorating health? So, yes, what was the scenery? See above. - Was a corona test taken around the time of the vaccination? If so, on what date and what was the result? No, no reason for that. - What was the medical history? Pacient had AF- atrial fibillation with rate control and blood thinners. Osteoporosis. Was temporarily (primary care residence) hospitalized because of many back pain due to vertebral collapse. - Were there risk factors for cerebral infarction? See above - What medication did the patient use? (if more than just the reported diclofenac): omeprazole. Acenocoumarol. Propanolol. Calc / Vit D. Paracetamol. - Was there an adjustment in medication around the time of the vaccination? Called thrombosis service. Dosing schedule has been adjusted. Normally patient received 1 and 2 tablets alternately. On 11-12-13Feb2021 1tablet, on 14-15Feb2021 0 tablet. (I requested this from the technical service of PRIVACY) - What is your estimate of the contribution that (side effects of) the vaccine may have made to the death? (none / very unlikely / vaccine side effects may have accelerated death / vaccine side effects are highly likely to accelerate death / it is extremely unlikely that without these side effects this patient would have died in the short term) Pacient had no fever, not deathly ill from vaccine or likewise. So straight through the vaccine I think is unlikely. A possible lowering of the acenocoumarol does play a role. Because we don''t want a muscle hematoma, we risk a CVA-cerebralvascular accident. - Immediately after vaccination, did the patient have side effects such as fever, chills, malaise, headache, nausea, vomiting, muscle pain, joint pain or injection site reactions? No - Was autopsy done? No; Reported Cause(s) of Death: major cerebral infarction (death)


VAERS ID: 1161869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-25
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

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: CLOPIDOGREL; PANTOPRAZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021311689

Write-up: Mrs was found dead; myocardial infarction; This is a spontaneous report received via Regulatory Authority NL-LRB-00479771. A 90-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medication included clopidogrel at 75 mg, taken for an unspecified indication, start and stop date were not reported; pantoprazole at 40 mg, taken for an unspecified indication, start and stop date were not reported. The patient (Mrs) was found dead on 25Feb2021. The general practioner had mentioned that this was a myocardial infarction (a serious heart attack). It was unknown if autopsy was performed. The patient died on 25Feb2021. The outcome of the events was fatal. No follow-up attempts are possible, Information on batch number cannot be obtained.; Reported Cause(s) of Death: major myocardial infarction according to the GP (reporter is not the GP)


VAERS ID: 1161870 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Epilepsy, Lung disorder, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Generalised convulsive seizures following immunisation (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 31
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 Name: COVID 19 infection; Result Unstructured Data: Test Result:no COVID 19 infection diagnosed; Comments: no COVID 19 infection diagnosed, no corona detected
CDC Split Type: NLPFIZER INC2021311681

Write-up: Epileptic seizure; pulmonary function worsened/lungs deteriorated in function; Stroke; This is as spontaneous report received from a contactable health professional downloaded from the Regulatory Authority (RA). The regulatory authority report number is NL-LRB-00479852. An 87-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at a single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced epileptic seizure, stroke, and pulmonary function impairment following administration of covid-19 vaccine; all were serious (death, life threatening, caused or prolonged hospitalization). The patient had an epileptic seizure, 3 hours after vaccination on 06Feb2021. He was admitted to the hospital. The next day (07Feb2021), he again experienced epileptic seizures and had a stroke. The duration of the seizures was 3 days. His pulmonary function worsened/lungs deteriorated in function, but there was no COVID 19 infection diagnosed, no corona detected. Patient was put to sleep and died on 09Mar2021, 31 days after vaccination after passive euthanasia. Epileptic seizure was treated with Midozalam. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Epileptic seizures Additional information ADR: Received epileptic seizures a few hours after the injection, examined in hospital. Next day seizures and stroke seizures lasted for 3 days, lungs deteriorated in function, no corona detected. Patient put to sleep passive euthanasia died on 09MAR2021. Previous COVID-19 infection: No. Other diagnostic procedures: No, patient was 87 years old; Reported Cause(s) of Death: epileptic seizure; stroke; pulmonary function impairment


VAERS ID: 1161871 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? Yes
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: TAMSULOSINE [TAMSULOSIN]; ACENOCOUMAROL; FINASTERIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Pneumonia
Allergies:
Diagnostic Lab Data: Test Name: Hb; Result Unstructured Data: Test Result:5.7
CDC Split Type: NLPFIZER INC2021333819

Write-up: Cerebral infarction; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority The regulatory authority number NL-LRB-00482146. An 85-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 09Feb2021 as a single dose for covid-19 immunization. The patient''s medical history included anaemia from an unknown date and pneumonia from 2021. Concomitant medications included tamsulosine; acenocoumarol; and finasteride, all taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebral infarction on 14Feb2021. It was further reported that the patient had a cerebral infarction out of nowhere on Sunday evening on 14Feb2021. During the day there was no sign of him. Per hospital information there was left-sided paralysis, incontinent, inability to swallow properly, neglect. confounding factors are low HB 5.7 / gain strength after pneumonia (not coronavirus related). Patient has no previous Covid-19 infection. The outcome of the event was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: cerebral infarction


VAERS ID: 1161872 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Circulatory collapse, Hypertension, Malaise, Retching, SARS-CoV-2 test positive, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypersensitivity (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: COLECALCIFEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Dementia; Mitral valve insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: blood pressure; Result Unstructured Data: Test Result:180/120 mmHg; Test Date: 20201222; Test Name: Corona confirmed by test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021333786

Write-up: gagging; Hypertension was diagnosed by care in COs (180/120), after which in the room on the bed, the tension dropped and the pulse remained high, and then died shortly afterwards (around 7 pm).; Not feeling well; vomited; Shortly afterwards she had collapsed in the living room and was not approachable.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. A 77-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EP9598), via an unspecified route of administration on 02Mar2021 at a single dose for COVID-19 immunisation. Medical history included COVID-19 from 22Dec2020 (Corona confirmed by test), mitral valve insufficiency, dementia. Concomitant medications included colecalciferol. The patient previously received the first dose of BNT162B2 (COMIRNATY), on 02Feb2021 for COVID-19 immunisation and experienced no adverse reaction. The patient experienced vomiting (death), not feeling well (death), collapse vascular (death), hypertension (death) on 09Mar2021 following administration of covid-19 vaccine pfizer injection fluid for covid 19 immunisation. It was reported that the patient was gagging around 5:30 pm on 09Mar2021 and had vomited. According to the patient there was nothing wrong. She had walked around the department again. Shortly afterwards she had collapsed in the living room and was not approachable. Hypertension was diagnosed (180/120), after which in the room on the bed, the tension dropped and the pulse remained high, and then died shortly afterwards at around 07:00 pm. The outcome of the events was fatal. The patient died on 09Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No information is expected. ; Reported Cause(s) of Death: Hypertension was diagnosed by care in COs (180/120), after which in the room on the bed, the tension dropped and the pulse remained high, and then died shortly afterwards (around 7 pm).; Not feeling well; Vomited; Shortly afterwards she had collapsed


VAERS ID: 1161874 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chronic obstructive pulmonary disease
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: 2021-03-19
   Days after onset: 14
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 obstructive pulmonary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021333814

Write-up: died of hypoxic cardiac arrest 19Mar2021 (15 days after vaccination); According to her husband her COPD got worse after she received the second dose of the vaccine; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NO-NOMAADVRE-FHI-2021-U4n93r, Sender''s (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00023697. An 89-year-old female patient received the second dose of bnt162b2 (COMIRNATY) at the age of 89-year-old, intramuscular on 04Mar2021 (Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). The patient''s concomitant medications were not reported. The patient was previously vaccinated with the first dose of bnt162b2 on 10Feb2021 for COVID-19 immunisation. According to the husband, the patient''s COPD got worse after she received the second dose of the vaccine on 04Mar2021 and died of hypoxic cardiac arrest 19Mar2021 (15 days after vaccination). The patient died on 19Mar2021 due to both events reported. It was unknown if an autopsy was performed. The reporter is a physician. The reactions were serious and fatal. The causality assessment was possible. Reporter''s comment: The reporter was called out to the patient as an emergency doctor and has no further information on this case. Sender Comment: Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register in this country, 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. When vaccinating patients who are ill with serious 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. Rare side effects are generally difficult to detect. Even with large studies, one will never be able to completely insure oneself against rare side effects. There should therefore be a low threshold for reporting unexpected reactions that occur after vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another random, concurrent cause that has nothing to do with the vaccination in question. Causality assessment: On the basis of the information in the report and in accordance with international criteria, the causal relationship with vaccination is assessed as possible. By possible causal connection is meant a reaction, including pathological laboratory tests, which occurs in temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Response to discontinuation may be absent or unclear. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. As the report contains sparse information, and it concerns a fatal outcome, we will consider trying to obtain a little more information about the patient, medical history, as well as results from any examinations, from the patient''s GP. In that case, the report will be updated with this additional information. Information about the batch/lot number was requested.; Reporter''s Comments: The reporter was called out to the patient as an emergency doctor, and has no further information on this case.; Reported Cause(s) of Death: died of hypoxic cardiac arrest 19Mar2021 (15 days after vaccination); According to her husband her COPD got worse after she received the second dose of the vaccine


VAERS ID: 1161876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 13
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: METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; ZOPIKLON MYLAN; PARACET [PARACETAMOL]; FLECAINID SANDOZ; CANDESARTAN SANDOZ; TRANSIDERM-NITRO; AZARGA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart rate abnormal; Insomnia
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021333817

Write-up: CEREBRAL BLEEDING; This is a spontaneous report from a contactable nurse from the Regulatory Authority (RA) NO-NOMAADVRE-FHI-2021-Uee29y, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00023253. An 86-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: EP9598), intramuscular on 25Feb2021 10:15 at single dose for COVID-19 vaccination. The patient medical history included insomnia and heart rate abnormal. Concomitant medication included metoprolol succinate (METOPROLOL SANDOZ) from 09Mar2021 to 14Mar2021; zopiclone (ZOPIKLON MYLAN) taken for insomnia from 22Dec2020 to 14Mar2021; paracetamol (PARACET) from 09Mar2021 to 14Mar2021; flecainide acetate (FLECAINID SANDOZ) taken for heart rate abnormal from 11Mar2020 to 14Mar2021; candesartan cilexetil (CANDESARTAN SANDOZ) from 09Mar2021 to 14Mar2021; glyceryl trinitrate (TRANSIDERM-NITRO) from 09Mar2021 to 14Mar2021; brinzolamide, timolol maleate (AZARGA) from 23Oct2019 to 14Mar2021. The patient previously received the first dose of bnt162b2 (COMIRNATY) on unspecified date for COVID-19 vaccination. On 01Mar2021, the patient developed cerebral bleeding and was admitted to hospital on unspecified date in Mar2021. On the 09Mar2021 the patient was discharged from hospital to a nursing home. On the 14Mar2021 the patient died. The patient outcome was Fatal, at the time of the report. The case was considered to be serious. Cause of death was cerebral bleeding. It was unknown if an autopsy was performed. Sender Comment: Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register (the Regulatory Authority), 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. This vaccine is marked with a black triangle because it is a new vaccine. This means that the vaccine is subject to special monitoring in order to detect new safety information as quickly as possible. Healthcare professionals are encouraged to report suspected adverse reactions. It is especially important that serious and / or unusual side effects are reported. If you have further information, you can in this dialogue send journal notes / epicrisis / laboratory answers and / or other reports. In addition, you can provide your birth number, name or other info that is relevant to the event. The information is processed securely in this dialog, and is automatically deleted after 4 months. Processing and storage of personal data takes place in accordance with the Act Causal assessment: The studies on which the temporary approval of the vaccine is based included very few people over the age of 85. We therefore know little about how any side effects will affect the very elderly. However, we assume that the side effects will largely be the same in the elderly as in those over 65 years of age. The large clinical studies have shown that most people who receive mRNA vaccines experience discomfort a few days after vaccination; such as stab wound pain, lethargy, headache, muscle and joint pain, nausea and fever. For most people, the ailments are just unpleasant and go away in a couple of days. Cerebral haemorrhage is not one of the known side effects of this vaccine. Data from use in frail patients with comorbidity are also limited, and such lack of information will be obtained in post-marketing studies, among others (1). When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including cerebral haemorrhage, may occur shortly after vaccination without any connection to vaccination. However, this cannot be ruled out. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else accidental, at the same time a cause that has nothing to do with the vaccination in question. 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 (2). Since the patient''s death, the message is classified as serious, although a causal link between the vaccine and cerebral haemorrhage has not been established. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: 22-mar-2021: requested additional information regarding cerebral incident. If new medical information is received, report will be updated.; Reported Cause(s) of Death: cerebral bleeding


VAERS ID: 1161882 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   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: Arterial hypertension; Coronary heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021333820

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number PL-URPL-3-400-2021. An 82-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Mar2021 15:35 (Batch/Lot Number: ER7812; Expiration Date: 14Mar2021) as single dose for COVID-19 immunisation. Medical history included ongoing chronic arterial hypertension and was burdened with coronary heart disease. The patient''s concomitant medications were not reported. The patient experienced death on 11Mar2021 06:15. The patient did not wake up in the morning, death was confirmed on 11Mar2021 at 6:15 AM by a physician. On the day of vaccination, the patient showed no contraindications to vaccination. It was not reported if an autopsy was performed. Health Authority Comment: Comirnates- vaccine against COVID-19 (mRNA). The immediate cause of death is unknown, and based on the patient''s medical history, it cannot be determined whether the vaccine contributed to this outcome. There is a time relationship between vaccination and death. The person reporting post-vaccinal reaction qualified it as serious. HA assessed the post-vaccinal reaction as serious. Relatedness of drug to reaction/event: Found dead; Source of assessment: regulatory authority; Method of assessment: WHO scale; Result of Assessment: Conditional. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1161898 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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:
CDC Split Type: ROPFIZER INC2021329830

Write-up: Number of newly confirmed persons with COVID-19 vaccinated prior to the confirmation, from the beginning of the year and until 15 March 2021: at national level: 6.376 (P); infection with the virus SARS-CoV-2; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that "until 15 March 2021, a number of 89 persons from the persons deceased due to the infection with the virus SARS-CoV-2 has been vaccinated prior to their death". The patient was deceased due to the infection with the virus SARS-CoV-2 has been vaccinated prior to their death. It was reported that the patient has been previously vaccinated with Pfizer. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected. The information about lot number and expiration date cannot be obtained. The case was closed for follow-up activities.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 infection and drug ineffective due to temporal relationship. Case will be re-assessed upon the additional information provided. 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: SARS-COV-2 infection


VAERS ID: 1161904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, General physical health deterioration, Investigation, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 59
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OFTAGEL; IMDUR; OMEZYL; DIVISUN; DUROFERON; OPTIMOL [TIMOLOL MALEATE]; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; CIRCADIN; CILAXORAL; PARACETAMOL; ENALAPRIL; TROMBYL; METOPROLOL; OXASCAND; MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Glaucoma; Myocardial infarct; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: test; Result Unstructured Data: Test Result:didn''t show anything
CDC Split Type: SEPFIZER INC2021311821

Write-up: Death; vomiting; Diarrhoea; General physical health deterioration; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is SE-MPA-2021-018588. A 94-year-old female patient received her first dose of BNT162B2 (COMIRNATY) on Jan2021 (lot number: EJ6796) and her second dose on Feb2021 (lot number: EJ6790), both via an unspecified route of administration at single dose for COVID-19 immunisation. Medical history included Alzheimer''s disease, glaucoma, myocardial infarction, and renal failure, all from an unspecified date and unknown in ongoing. Concomitant medications included carbomer (OFTAGEL) from 29May2019, isosorbide mononitrate (IMDUR) from 20Feb2019, omeprazole (OMEZYL) from 04Feb2021, colecalciferol (DIVISUN) from 05Sep2019, ferrous sulfate (DUROFERON) from 04Feb2021, timolol maleate (OPTIMOL) from 25Jul2019, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) from 25Jul2019, melatonin (CIRCADIN) from 12Jan2021, sodium picosulfate (CILAXORAL) from 30Dec2019, paracetamol from 03Jan2020, enalapril from 29May2019, acetylsalicylic acid (TROMBYL) from 05Sep2019, metoprolol from 05Sep2019, oxazepam (OXASCAND) from 09Jul2020, mirtazapine from 05Jun2020. The patient previously took mirtazapine and experienced confusional state. On Jan2021, five days after vaccination of first dose, the patient developed vomiting and diarrhoea. Tests (unspecified) done on Jan2021 didn''t show anything. Five weeks later (Feb2021), the patient received the second dose and three days later, the reporter was informed that the patient''s general health had deteriorated further, and she had ongoing diarrhoea. The patient died 14 days after the second dose on Mar2021. The reporter stated that a deterioration could be seen after each dose, but that it''s difficult to assess whether it''s related. The patient died on Mar2021. The cause of death was vomiting, diarrhoea and general physical health deterioration. It was not reported if an autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; Vomiting; Diarrhoea; General physical health deterioration


VAERS ID: 1161905 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Computerised tomogram head, Heart rate, Physical examination, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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: ALVEDON; CANODERM; CANDESARSTAD; FLUTIDE [FLUTICASONE PROPIONATE]; INOLAXOL N [STERCULIA URENS GUM]; METOPROLOL; SALURES; HIRUDOID; VENTOLINE [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension; Lung sarcoid; Middle cerebral artery aneurysm; Sleep apnea
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: CT brain scan; Result Unstructured Data: Test Result:confirmed a large parenchymal hemorrhage; Comments: confirmed a large parenchymal hemorrhage frontotemporal left side and large amounts of subarachnoid hemorrhage and significant mass effect with midline excess; Test Date: 202103; Test Name: heart rate; Result Unstructured Data: Test Result:weak peripherals pulses; Test Date: 202103; Test Name: Assessment; Result Unstructured Data: Test Result:Had stable vital parameters but RLS 8 and did not; Comments: Had stable vital parameters but RLS 8 and did not respond to pain stimulation, large dilated pupils that did not respond to light/Renewed clinical examination showed that the patient had no cerebral activity
CDC Split Type: SEPFIZER INC2021333859

Write-up: Intracerebral haemorrhage; Subarachnoid haemorrhage; This is a spontaneous report from contactable physicians downloaded from the Agency Regulatory Authority, regulatory authority number SE-MPA-2021-019656. Other unique identifier SE-MPA-1615884879618. A 74-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on Mar2021 (Batch/Lot Number: EP2166) as single dose for COVID-19 immunization. Medical history included hypertension, lung sarcoid, sleep apnea, asthma, and middle cerebral artery aneurysm from an unknown date. Concomitant medication included paracetamol (ALVEDON) from 20Mar2018 to an unspecified date; urea (CANODERM) from 09Oct2019 to an unspecified date; candesartan cilexetil (CANDESARSTAD) from 06Jun2020 to an unspecified date; fluticasone propionate (FLUTIDE) from 19Mar2018 to an unspecified date; sterculia urens gum (INOLAXOL N) from 20Mar2018 to an unspecified date; metoprolol from 29May2020 to an unspecified date; bendroflumethiazide (SALURES) from 27Feb2021 to an unspecified date; mucopolysaccharide polysulfuric acid ester (HIRUDOID) from 19Mar2018 to an unspecified date; and salbutamol sulfate (VENTOLINE) from 19Mar2018 to an unspecified stop date. The patient previously took doxazocin and experienced unspecified previous drug reaction. In Mar2021, it was reported that three days after the vaccination with Comirnaty the patient arrived at the emergency room with RLS 8, no spontaneous breathing, had a laryngeal mask and weak peripherals pulses. The patient was found unconscious in her home after an alert from a friend. She had stable vital parameters but RLS 8 and did not respond to pain stimulation, large dilated pupils that did not respond to light. High suspicion of cerebral event why the patient went directly to the CT brain scan which confirmed a large parenchymal hemorrhage frontotemporal left side and large amounts of subarachnoid hemorrhage and significant mass effect with midline excess. Not considered to be in question for neurosurgical evacuation due to the large intracerebral hemorrhage, already signs of entrapment and poor prognosis. The patient was taken to the Intensive care unit to investigate whether she was possibly a candidate for organ donation, but it appeared later that she had declined this. Relatives were informed of the patient''s condition. Renewed clinical examination showed that the patient had no cerebral activity and was pronounced dead at midnight and the respirator was turned off. The reporter had no/very low suspicion of connection with the vaccination. It was assessed as a large intracerebral bleeding, probable rupture of previously known aneurysm. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Intracerebral haemorrhage; Subarachnoid haemorrhage


VAERS ID: 1161906 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia
SMQs:, 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: 2021-03-01
   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: Medical History/Concurrent Conditions: Esophagitis; Hypertension; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021333868

Write-up: PNEUMONIA - DEAD; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-019659. Other Case identifier number: SE-MPA-1615893378161. A 95-year-old female patient received bnt162b2 (COMIRNATY, lot number: EP2163), intramuscular on an unspecified date in Feb2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included esophagitis, stroke from 2020, and hypertension. The patient''s concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced pneumonia - dead. The event was considered as serious as it led to fatal outcome. The patient died in Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: PNEUMONIA - DEAD


VAERS ID: 1161907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Death, General physical health deterioration, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

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: Medical History/Concurrent Conditions: COVID-19; Hypertension; Multiple system atrophy (Parkinson''s type MSA-P); Myocardial infarction
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:rising; Test Date: 202103; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 202103; Test Name: saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: SEPFIZER INC2021333867

Write-up: Other unspecified not fully defined and not complete cause of death; Sick of fever 39 degrees Celsius a day later; Decreased general condition; wheezing; rising blood pressure; decreased saturation; This is a spontaneous report from a contactable physician regulatory authority number SE-MPA-2021-019693. A 77-year-old male patient received bnt162b2 (COMIRNATY, lot number: EP2166), intramuscular on Mar2021 as 0.3 mL, single for covid-19 immunisation. The patient medical history included multiple system atrophy, Parkinson''s type MSA-P; hypertension and previous myocardial infarction; all from an unknown date and unknown if ongoing. On March 2020, the patient had a Covid-19 infection and unknown if ongoing. The patient''s concomitant medications were not reported. The reported events were other incompletely defined and unspecified causes of death on Mar2021. Clinical course reported as the patient was vaccinated with Comirnaty on March 2021. Sick of fever 39 degrees Celsius a day later. Decreased general condition, wheezing, rising blood pressure and decreased saturation. Died at night between days 4 and 5 after the vaccine was given. The outcome of sick of fever 39 degrees Celsius a day later, decreased general condition, wheezing, rising blood pressure and decreased saturation was unknown. Outcome of the unknown cause of death was fatal. Cause of death was unknown. The patient died on Mar2021. Autopsy will not be performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1161910 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Feeling abnormal
SMQs:, Dementia (broad)

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: Medical History/Concurrent Conditions: Cardiac failure; Chronic obstructive pulmonary disease (stage 2); Hypertension; Ulcerative colitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021333838

Write-up: patient was found dead after the 2nd dose of the Pfizer Vaccine; felt weird; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB with regulatory authority number SE-MPA-2021-022325. A 77-year-old female patient received the second dose of bnt162b2 (COMIRNATY also reported as PFIZER COVID-19 VACCINE), intramuscular on Mar2021 (Lot Number: ER7812) as a single dose for covid-19 immunization. Medical history included cardiac failure, hypertension, chronic obstructive pulmonary disease stage 2 and ulcerative colitis, all were unknown if ongoing. The patient''s concomitant medications were not reported. The patient died on Mar2021 after the second injection of Pfizer''s vaccine. It was further reported that the patient received the vaccine in the morning and after lunch (Mar2021), she told a neighbour that she felt weird. The morning after (Mar2021), she was found dead in her house. It was reported that the report was assessed as serious, death. The outcome of the event felt weird was unknown while the outcome of the other event was fatal. The patient died on Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1161911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: SEPFIZER INC2021333834

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable consumer or other non hcp and additional physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-022327. Other case identifier number SE-MPA-1616403276188. A 39-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on Jan2021, single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Reported suspect adverse event was subarachnoid haemorrhage. Vaccination on an unknown date in January 2021 and in February2021, the woman died as a result of a subarachnoid haemorrhage in Feb2021, time to onset is not further specified in the report. The outcome of the event was fatal. Report assessed as serious, death. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1165250 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematoma, Road traffic accident
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   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: CONCOR; TORASEMID; THROMBO ASS; OLEOVIT D3; SPIRONO; METFORMIN; ATORVASTATIN; ACEMIN [ACECLOFENAC]
Current Illness: Heart insufficiency (Heart Failure with Reduced Ejection Fraction - Dilated Cardiomyopathy); Pacemaker insertion (cardiac) (CRT Implantation); Type 2 diabetes mellitus (diabetes mellitus II)
Preexisting Conditions: Comments: DM II, HFrEF - dil. CM?
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021342441

Write-up: Traffic accident without external fault: Resuscitation (NEF); multiple hematomas (before accident): hematomas right and left upper arm, upper abdomen; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-19144. A 62-year-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 12Mar2021 (batch/lot number: ET1831) as a single dose for COVID-19 immunisation. Medical history included ongoing heart insufficiency (heart failure with reduced ejection fraction - dilated cardiomyopathy), pacemaker insertion (cardiac) from 11Mar2021 and ongoing (CRT implantation), and ongoing type 2 diabetes mellitus (diabetes mellitus II). Concomitant medications included bisoprolol fumarate (CONCOR); torasemide (TORASEMID); acetylsalicylic acid (THROMBO ASS); colecalciferol (OLEOVIT D3); spironolactone (SPIRONO); metformin; atorvastatin; aceclofenac (ACEMIN); all taken for unspecified indications, start and stop date were not reported. The patient experienced death on 23Mar2021, traffic accident without external fault: resuscitation (NEF) on 23Mar2021 08:40 (as reported), multiple hematomas (before accident): hematomas right and left upper arm, upper abdomen on 23Mar2021. It was also reported that on 23Mar2021 at 8:30 a.m. (as reported) emergency call due to a traffic accident (no fault of third party) - resuscitation (NEF) - death. Multiple hematomas (BEFORE accident). Hematomas right and left upper arm, upper abdomen; possibly due to the mechanism of HIT and thrombosis discussed in connection with COVID-19 vaccinations. The outcome was fatal for death and road traffic accident, and unknown for hematoma. The patient died on 23Mar2021. An autopsy was not performed. A medical autopsy was refused by the BH. There was a causal connection between the vaccination on 12Mar2021 and the traffic accident on 23Mar2021. The traffic accident was caused by an atypical agreement from the road, most likely through loss of consciousness. The patient was found to have multiple hematomas in the morning on the same day. The patient was vaccinated with BNT162B2 shortly before. Relatedness of drug to events as per reporter was possible. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Traffic accident without external fault: Resuscitation (NEF)


VAERS ID: 1165258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Cerebrovascular accident, Ischaemia, Lung disorder, Renal disorder
SMQs:, Neuroleptic malignant syndrome (broad), 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), Hypertension (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: Medical History/Concurrent Conditions: Coagulation disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC2021354340

Write-up: Stroke; Ischemia; high pressure; lungs affected by cooking with firewood; dry kidney; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports. This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history include coagulation problems. Concomitant medications were not reported. Patient presented small ischemias but did not strokes according to doctors, she suffered from high pressure, lungs affected by cooking with firewood and dry kidney. On an unspecified date, the lady was vaccinated for the first dose and a week later she passed away due to a stroke. It was not reported if an autopsy was performed. The outcome of the events ischemia, high pressure, lungs affected by cooking with firewood, and dry kidney was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : CR-PFIZER INC-2021354341 same reporter, product, and events, different patient.; Reported Cause(s) of Death: Stroke


VAERS ID: 1165260 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-15
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Decreased appetite, General physical health deterioration, Hypophagia, Hypotonia, Pyrexia, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Dementia of the Alzheimer''s type NOS
Preexisting Conditions: Medical History/Concurrent Conditions: Perfume sensitivity
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: body temperature; Result Unstructured Data: Test Result:41.4 Centigrade
CDC Split Type: DEPFIZER INC2021342349

Write-up: Sudden deterioration of the general condition; severe vomiting; massive weakness; drowsiness; fever/massive high fever up to 41.4 degrees C; no appetite; decreased muscle tone; reduced food intake; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB [DE-PEI-CADR2021036837], Safety Report Unique Identifier: DE-PEI-202100024966. A 91-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot: EK9788), intramuscular on 09Feb2021 as single dose for covid-19 immunisation. The patient had first dose of bnt162b2 on an unspecified date for Prophylactic vaccination. Medical history included atrial fibrillation and Dementia of the Alzheimer''s type NOS, both ongoing and fragrances and perfumes allergy. The patient''s concomitant medications were not reported. On 15Feb2021, the patient experienced sudden deterioration of the general condition, decreased muscle tone, severe vomiting, massive weakness, drowsiness, fever/massive high fever up to 41.4 degrees C, no appetite, significantly reduced food intake. The outcome of the events vomiting, asthenia, somnolence, pyrexia, decreased appetite, hypotonia and hypophagia was not recovered. This report was considered serious-death. The patient died on 23Feb2021 due to sudden deterioration of the general condition. In was unknown if autopsy was performed. Senders comment: Are you or the person concerned known of any allergies? If yes, which? yes, fragrances and perfumes Information on risk factors or previous illnesses old age, severe Alzheimer''s dementia Atrial fibrillation/massive high fever up to 41.4 degrees C, could hardly be reduced; extreme weakness, no more food and fluid intake possible. all events/Regulatory Authority/Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden deterioration of the general condition


VAERS ID: 1165261 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Death, Hypotonia, Malaise
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: Medical History/Concurrent Conditions: Atrial fibrillation (with continuous anticoagulant therapy); Chronic renal insufficiency; Heart failure; Hyperthyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021342350

Write-up: Floppy; Ill feeling; Floppy; Chills; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB Regulatory Authority number DE-PEI-CADR2021037277, Safety Report Unique Identifier DE-PEI-202100024653. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Mar2021 (Lot Number: ER7812) as single dose for COVID-19 immunization. Medical history included chronic kidney disease, atrial fibrillation with continuous anticoagulant therapy, heart failure, hyperthyroidism. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: unknown) as single dose for COVID-19 immunization. The patient had chills at noon, weakness, ill feeling , then was put to bed and found dead in the early evening on 21Mar2021. The outcome of chills, weakness, ill feeling was unknown. The patient died on 21Mar2021. It was not reported if an autopsy was performed. This report is serious - death. "summary (full translation available upon request)." Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? - Information on risk factors or previous illnesses: chron. Renal insufficiency, Atrial fibrillation with continuous anticoagulant therapy, Heart failure, Hyperthyroidism / had chills at noon, weakness, ill feeling , then was put to bed and found dead in the early evening. No changes/deterioration noticed beforehand. Comirnaty/ Ill feeling, Unknown cause of death, Floppy, Chills/PEI/D. Unclassifiable No follow-up attempts possible. No further information expected. Batch/lot number already provided.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1165264 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
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: Benign prostatic hyperplasia; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021342340

Write-up: Seizures; Trembling; Syncope; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-PEI2021003710. A 92-year-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 18Feb2021 at a single dose for COVID-19 immunisation. Medical history included dementia and benign prostatic hyperplasia. The patient''s concomitant medications were not reported. The patient also received first dose of Comirnaty (unknown lot number and expiration) on unspecified date for COVID-19 immunisation. The patient experienced syncope, trembling, and seizures on 24Feb2021. The patient died following events syncope, trembling, and seizures on unspecified date. It was unknown if an autopsy was performed. The events were assessed as serious (hospitalization, life threatening, and death). The events trembling, syncope, seizures were assessed as unclassifiable by Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Seizures; Trembling; Syncope


VAERS ID: 1165270 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram head
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: 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 Name: CCT; Result Unstructured Data: Test Result:Diagnosis of unknown result was confirmed by CCT
CDC Split Type: DEPFIZER INC2021342346

Write-up: Apoplexy; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB Regulatory Authority number DE-PEI-PEI2021003752. A 93-year-old female patient received BNT162b2 (COMIRNATY), dose 1 via an unspecified route of administration, at age 93 years, on 01Feb2021 (Batch/Lot number was not reported) as singled dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 09Feb2021, 8 day(s) after vaccination the patient developed apoplexy, lasting for unknown. Diagnosis of unknown result was confirmed by CCT (cranial computed tomography) on an unspecified date. The patient is dead 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. No further information is expected.; Reported Cause(s) of Death: Apoplexy


VAERS ID: 1165272 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / 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: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PAMOL; ENALAPRIL; GABAMED [GABAPENTIN]; IRON; BETNOVAT [BETAMETHASONE]; XAGRID; CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]
Current Illness: Polycythaemia vera; Smoker''s lung (The patient is also a smoker.)
Preexisting Conditions: Medical History/Concurrent Conditions: Blood disorder; Hypertension; Pain; Wound treatment
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021340785

Write-up: patient found dead 04Mar2021; This is a spontaneous report downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0049767. The case was received from a contactable physician via Medicines Agency (MA). A 66-year-old female patient received bnt162b2 (COMIRNATY), First dose intramuscular on 25Feb2021 (Batch/Lot Number: ep9598) as SINGLE DOSE for covid-19 immunisation. Medical history included polycythaemia vera and Smoker''s lung (The patient is also a smoker) both ongoing; pain, blood disorder, hypertension and wound treatment from an unknown date and unknown if ongoing. There is no information regarding past medication. Concomitant medications included paracetamol (PAMOL) taken for pain from 15Jun2018 to an unspecified stop date; enalapril (ENALAPRIL) taken for hypertension from 23Oct2020 to an unspecified stop date; gabapentin (GABAMED [GABAPENTIN]) taken for pain from 04Sep2018 to an unspecified stop date; iron (IRON) taken for mineral supplementation from 15Oct2020 to an unspecified stop date; betamethasone (BETNOVAT [BETAMETHASONE]) taken for wound treatment from 31May2018 to an unspecified stop date; anagrelide hydrochloride (XAGRID) taken for blood disorder from 24Aug2018 to an unspecified stop date; calcium, colecalciferol (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) taken for Vitamin D supplementation from 04Mar2019 to an unspecified stop date. On 25Feb2021 the patient was vaccinated with first dose of Comirnaty (Batch number: ep9598) for COVID-19 immunisation. It was reported occurrence of Found dead (patient found dead 04Mar2021). The physician reported the event Found dead to be Fatal. No treatment due to the ADR was reported. The patient died on Mar2021. An autopsy was not performed. Reported cause(es) of death: Polycythaemia vera, Smoker''s lung, found dead. Only inquest was performed. Findings Polycythaemia vera, and Smoker''s lung, time of death is unknown. No post mortem was performed as the authorities were not aware of the vaccination with Comirnaty. Information about inquest and cause of death was received from regulatory authorities, listed as other reporter, from a requested follow-up. There is no information regarding test results. Causality: The physician is unsure about causality between death and vaccination with Comirnaty. The physician is contacted by a caretaker after the patient was found death in patients own home and is later made aware of that the patient was vaccinated with Comirnaty. The patient was not in contact with own physician in relation to vaccination with Comirnaty or death. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Found dead; Polycythaemia vera; Smoker''s lung


VAERS ID: 1165279 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Computerised tomogram, Neoplasm, Pneumonia, Pulmonary thrombosis, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (narrow), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: chest X-ray; Result Unstructured Data: Test Result:Extensive bilateral interstitial alveolar opacitie; Comments: Extensive bilateral interstitial alveolar opacities that occupy all lung fields, more accentuated on the left side, suggestive in the current context of significant evolutionary inflammatory involvement (with fibrotic pattern) of a viral type. Increased cardiothoracic index. Free costophrenic angle; Test Date: 202102; Test Name: CT scan; Result Unstructured Data: Test Result:chronic thromboembolism; Test Date: 202012; Test Name: Ab; Test Result: Positive ; Test Date: 20210211; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210211; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021342298

Write-up: neoplasm; Bilateral pneumonia; Pulmonary thrombosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority ES-AEMPS-799829. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Feb2021 (Lot Number: EK9788) as single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient''s concomitant medications were not reported. The patient previously received the first dose of COMIRNATY on 12Jan2021 (lot no: EM0477) for COVID-19 immunisation. The patient experienced bilateral pneumonia and pulmonary thrombosis on 10Feb2021. Both events required were reported as serious (death). Clinical course was reported as follows. On 02Feb2021, began to have fever and progressive deterioration so was referred to the emergency room. Laboratory tests and radiography compatible with an inflammatory-thrombotic process similar to covid, with poor evolution despite empirical antibiotic therapy and high-dose corticosteroids, dying on 16Feb2021. Autopsy with pulmonary thrombosis and acute inflammatory changes, similar to those found in autopsies- covid. Also, neoplastic infiltration of the cervical ganglion (pending final report). Negative antigen and PCR detection test (11Feb2021). Chest X-ray (Feb2021): Extensive bilateral interstitial alveolar opacities that occupy all lung fields, more accentuated on the left side, suggestive in the current context of significant evolutionary inflammatory involvement (with fibrotic pattern) of a viral type. Increased cardiothoracic index. Free costophrenic angle. Chest CT showed: X-ray bilateral infiltrates. Covid in Nov2020 (Ab positive in Dec2020) with vaccination at the end of Jan2021. Description: Sufficiently enhanced pulmonary arterial vascularization, with basal motion artifact, with doubtful eccentric linear filling defect in the segmental branch of the right lower lobe, which could correspond to chronic thromboembolism. Pulmonary artery of normal caliber. Normally positioned interventricular septum. Aorta and cardiothoracic index within normal limits. Small bilateral pleural effusion. Diffuse, multilobar and bilateral parenchymal involvement, with increased density of the ground glass parenchyma, which in some areas respects the peripheral location. The pattern of involvement is nonspecific but by distribution it could correspond to interstitial edema, and less likely infectious process (non-typical COVID pattern), although the patient had previous COVID infection, unknown pneumonic involvement during the episode and/or residual lesions. Small increase in focal density in posterior aspect of T9, possible bone islet. Conclusion: Given that the CT scan (Feb2021) shows chronic thromboembolism, it cannot be ruled out that it is a sequel to COVID-19 that occurred 4 months ago (Nov2020). Also note that at autopsy it appears that he had a neoplasm. The patient died on 16Feb2021. Autopsy was done, unknown if results are available. Outcome of the events bilateral pneumonia and pulmonary thrombosis was fatal; while outcome of event neoplasm was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: bilateral pneumonia; pulmonary thrombosis


VAERS ID: 1165280 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-07
Onset:2021-03-17
   Days after vaccination:100
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Breast haematoma, Coma scale, Culture urine, International normalised ratio, Melaena
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: BISOPROLOL FUMARATE; DEPRAX [FLUOXETINE HYDROCHLORIDE]; VALSARTAN + HIDROCLOROTIAZIDA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dyslipidaemia; Ischaemic stroke; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210317; Test Name: blood pressure; Result Unstructured Data: Test Result:10/60; Test Date: 20210317; Test Name: GCS; Result Unstructured Data: Test Result:8; Test Date: 20210308; Test Name: urine culture; Test Result: Negative ; Test Date: 20210218; Test Name: INR; Result Unstructured Data: Test Result:5.4
CDC Split Type: ESPFIZER INC2021342599

Write-up: Melaena; Breast haematoma; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number ES-AEMPS-800382. A 98-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Mar2021 (lot number: EP2163) as 0.3 mL, single for COVID-19 immunisation; and acenocoumarol (SINTROM), oral from 07Dec2020 (Batch/Lot number was not reported) to 17Mar2021, at unspecified dose for atrial fibrillation. Medical history included ischaemic stroke from 2009 to an unknown date, urinary tract infection from 21Feb2020 to an unknown date, atrial fibrillation from an unknown date and unknown if ongoing, and dyslipidaemia from an unknown date and unknown if ongoing. Concomitant medications included bisoprolol fumarate taken for atrial fibrillation from 01Aug2012 to 17Mar2021; fluoxetine hydrochloride (DEPRAX) taken for an unspecified indication from 29Nov2019 to 17Mar2021; hydrochlorothiazide, valsartan (VALSARTAN + HIDROCLOROTIAZIDA) taken for an unspecified indication from 18May2012 to 17Mar2021. On 18Feb2021, patient''s INR= 5.4. On 04Mar2021, the patient received the first dose of Comirnaty. On 08Mar2021, urine culture negative. 09Mar2021, patient had lesions/wounds on both lower limbs, treatment with EII with betatul + velban + crepe, and EID povidone iodine + aquacel foam. On 17Mar2021, sudden deterioration in general condition with difficulty swallowing in the last 24 hours, and black stools (melaena). Patient bedridden, sleepy, calm. Still on 17Mar2021, patient had spontaneous opening of eyes, no speech; GCS (Glasgow Coma Scale): 8. BP: 10/60; generalized crackles. Patient had no respiratory distress. Extensive haematoma in the left mammary and inframammary region (breast haematoma on 17Mar2021). Sintron and other medication were suspended except paracetamol if necessary. The patient died on 18Mar2021. Causes of death were melaena and breast hematoma. An autopsy was not performed. Time interval between beginning of Comirnaty administration and start of both events was 14 days; between beginning of Valsartan + Hydrochlorothiazide administration and start of both events was 1 day; between beginning of Sintrom administration and start of both events was 101 days; between beginning of Deprax administration and start of both events was 475 days; between beginning of Bisoprolol administration and start of both events was 3151 days; and time interval between last dose of Deprax, Bisoprolol, Sintrom, Valsartan+Hydrochlorothiazide and start of both events was 1 day. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Breast haematoma; Melaena


VAERS ID: 1165283 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-28
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: LOSARTAN; RILUTEK; RISPERIDON; METFORMIN; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Agitation; ALS (still goes without treatment.); Continuous positive airway pressure; Dysphasia; Hyperlipidemia; Hypertension; Mood disorder; Sleep apnea (with Continuous positive airway pressure (CPAP) at night.); Smoker; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021342468

Write-up: Death/Vomiting; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB FI-FIMEA-20211451. A 63-years-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EJ6134, expiry date not reported), intramuscular on 09Feb2021 at a single dose for covid-19 immunisation. Medical history was reported as follows: In the anamnesis, patient had ALS (amyotrophic lateral sclerosis) diagnosis form Apr2020, and still goes without treatment, dysphasia, sleep apnea with continuous positive airway pressure (CPAP) at night, was a smoker (reported as he smokes), hypertension, hyperlipidemia, type 2 diabetes, agitation and mood disorder. Patient received the first vaccine dose of Comirnaty (lot number: EJ6795) as COVID-19 vaccination on 19Jan2021. Concomitant medications included oral losartan at 50 mg, daily taken for hypertension; oral riluzole (RILUTEK) taken for amyotrophic lateral sclerosis at 50 mg, daily; oral risperidone (RISPERIDON) taken for agitation at 1 mg, daily; oral metformin taken for diabetes mellitus at 500 mg, daily; and oral sertraline taken for mood disorder at 50 mg, daily. Start and stop date were not reported for all concomitant drugs. On 28Feb2021, the patient experienced death/vomiting. Course of event was reported as: Resident staff at the department met patient no later than 28Feb2021 at 00:40, then measured as usual. Looking at patient about 02:45, then he lied lifeless on the floor next to the bed, stiffness of death, is on the right side, and has vomited. Patient had no recent change in the month; no recent trauma. The patient died on 28Feb2021. The cause of death was death/vomiting (as reported). At autopsy, patient had no visible signs of trauma and was referred to forensic autopsy. Given the connection in time between vaccination with Comirnaty and the subsequent sudden death, the death is hereby reported as a suspected / possible vaccine side effect. The result of the forensic autopsy is currently not available to the reporter. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: death/vomiting


VAERS ID: 1165286 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Blood pressure systolic, Blood pressure systolic decreased, Blood sodium, C-reactive protein, C-reactive protein increased, Circulatory collapse, Coma scale, Decreased appetite, Decubitus ulcer, Dehydration, Extrapyramidal disorder, Fall, Hypernatraemia, Hypovolaemic shock, SARS-CoV-2 test, White blood cell count, White blood cell count increased
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), 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), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GALANTAMINE [GALANTAMINE HYDROBROMIDE]; MODOPAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of prostate; Alzheimer''s disease; Dementia with Lewy bodies; Parkinson''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210208; Test Name: blood pressure; Result Unstructured Data: Test Result:73/35 mmHg; Test Date: 20210203; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:64 mmHg; Test Date: 20210203; Test Name: Hypernatremia; Result Unstructured Data: Test Result:170 mmol/L; Test Date: 20210203; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:9; Test Date: 20210208; Test Name: CRP; Result Unstructured Data: Test Result:430 mg/l; Test Date: 20210202; Test Name: RT-PCR for SARS-Cov 2; Result Unstructured Data: Test Result:no - negative; Test Date: 20210208; Test Name: Leucocytes; Result Unstructured Data: Test Result:17680 /mm3
CDC Split Type: FRPFIZER INC2021342450

Write-up: CARDIOVASCULAR COLLAPSE; bedsores on the foot; ASTHENIA; ANOREXIA; DEHYDRATION; fell twice; Hypovolemic shock; Leucocytes at 17680/mm3; CRP at 430 mg/l; systolic blood pressure was 64 mmHg; Hypertonie extrapyramidale/ worsening of his extrapyramidal syndrome; Hypernatremia 170 mmol/l; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-AM20210702. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Deltoid Left on 23Jan2021 (at the age of 76-years-old) (Batch/Lot Number: EM0477) as single dose for covid-19 immunisation. Medical history included prostate cancer, dementia with lewy bodies, Parkinson''s syndrome, and Alzheimer''s disease. The patient''s concomitant medications include galantamine hydrobromide (GALANTAMINE [GALANTAMINE HYDROBROMIDE]), oral from an unspecified date (Batch/Lot Number: Unknown) to 09Feb2021, for dementia alzheimer''s type; and benserazide hydrochloride, levodopa (MODOPAR), oral from an unspecified date (Batch/Lot Number: Unknown) to 09Feb2021, at for parkinsonism. On 23Jan2021, the patient quickly developed asthenia with anorexia and hydration problems/dehydration. In the afternoon, he fell twice from his height with no cause found. Thereafter, the patient condition continued to deteriorate, requiring two consultations with his attending physician. On 31Jan2021 at D7, the appearance of bedsores on the foot and on 01Feb2021 on the sacrum. On 02Feb2021 at D9, an RT-PCR for SARS-Cov 2 was negative. The patient was hospitalized on 03Feb2021 at D10, for deterioration of the general state. On admission, the systolic blood pressure was 64 mmHg, Glasgow coma scale 9, signs of global dehydration, Hypertonie extrapyramidale in lead pipe position with cogwheel sign, Hypernatremia 170 mmol/l. Collegial decision not to undertake resuscitative measures, nor dialysis. Implementation of hydration and increase of MODOPAR. Cardiovascular collapse was also reported. On 05Feb2021 at D13, worsening of his extrapyramidal syndrome, he is painful despite analgesics. On 08Feb2021 at D18, the patient is apyretic BP 73/35mmHg, Leucocytes at 17680/mm3, CRP at 430 mg/l. Antibiotic therapy with CEFOTAXIME 1g 3x/d. Hypovolemic shock was also reported. On 09Feb2021 at D19, the patient died. The patient was hospitalized for the events asthenia, anorexia, dehydration, cardiovascular collapse, fall, bedsores on the foot. The events Leucocytes at 17680/mm3 and CRP at 430 mg/l were assessed as serious (medically significant). The events asthenia, anorexia, dehydration, cardiovascular collapse, and hypovolemic shock were considered as fatal. The outcome of the other events was unknown. The patient underwent lab tests and procedures which included blood pressure measurement: 73/35 mmhg on 08Feb2021, blood pressure systolic: 64 mmhg on 03Feb2021, blood sodium: 170 mmol/l on 03Feb2021, coma scale: 9 on 03Feb2021 , c-reactive protein: 430 mg/l on 08Feb2021, sars-cov-2 test: no - negative on 02Feb2021, white blood cell count: 17680 /mm3 on 08Feb2021. Therapeutic measures were taken as a result of dehydration, cardiovascular collapse, asthenia, anorexia. The patient died on 09Feb2021. It was not reported if an autopsy was performed. NB: The score(s) of imputability established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Regulatory Authority nr 84/50, 24 January 1985; Reported Cause(s) of Death: Hypovolemic shock; ASTHENIA; ANOREXIA; DEHYDRATION; CARDIOVASCULAR COLLAPSE


VAERS ID: 1165287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Basophil count, Blood calcium, Blood creatinine, Blood potassium, Blood sodium, Bradycardia, Coma scale, Computerised tomogram abnormal, Electrocardiogram, Haemoglobin, Haemorrhagic stroke, Hypertension, International normalised ratio, International normalised ratio increased, Lymphocyte count, Monocyte count, Neutrophil count, Oxygen saturation decreased, Platelet count, Protein albumin ratio, White blood cell count
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Hypertension (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   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: Cane user; Fibrillation atrial (Treated with Previscan)
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: Polynuclear basophils; Result Unstructured Data: Test Result:0.1 g/l; Test Date: 20210319; Test Name: Calcium level; Result Unstructured Data: Test Result:2.41 mmol/L; Test Date: 20210319; Test Name: Creatinine; Result Unstructured Data: Test Result:82 umol/l; Test Date: 20210319; Test Name: Potassium level; Result Unstructured Data: Test Result:2.9 mmol/L; Test Date: 20210319; Test Name: Sodium level; Result Unstructured Data: Test Result:144 mmol/L; Test Date: 20210319; Test Name: Bradycardia; Result Unstructured Data: Test Result:49bpm; Test Date: 20210319; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:4; Test Date: 20210319; Test Name: CT scan cerebral; Result Unstructured Data: Test Result:large intra parenchymal hematoma; Comments: large intra parenchymal hematoma of the right fronto-parieto-temporo-occipital brain parenchyma roughly extended in the sagittal plane over about 12 cm surrounded by a significant perilesional edema. Ventricular flooding in the lateral ventricles, the V3 and V4. Important sub-factorial engagement with left deviation of the median line of about 17 mm. Right temporal engagement. Edema extended to the bridge, no aneurysmal image, no obvious bone fracture.; Test Date: 20210319; Test Name: ECG; Result Unstructured Data: Test Result:atrial fibrillation, normoaxed; Comments: no conduction disorder, inferolateral flat T waves; Test Date: 20210319; Test Name: Hemoglobin; Result Unstructured Data: Test Result:10.8 g/dl; Test Date: 20210319; Test Name: Arterial hypertension; Result Unstructured Data: Test Result:250/90 mmHg; Test Date: 20210319; Test Name: INR; Result Unstructured Data: Test Result:3.48; Test Date: 20210319; Test Name: Lymphocytes; Result Unstructured Data: Test Result:2.7 g/l; Test Date: 20210319; Test Name: Monocytes; Result Unstructured Data: Test Result:0.4 g/l; Test Date: 20210319; Test Name: Polynucelates neutrophils; Result Unstructured Data: Test Result:10.1 g/l; Test Date: 20210319; Test Name: Desaturation; Test Result: 92 %; Test Date: 20210319; Test Name: Platelets; Result Unstructured Data: Test Result:166 g/l; Test Date: 20210319; Test Name: Proteins; Result Unstructured Data: Test Result:81 g/l; Test Date: 20210319; Test Name: Leucocytes; Result Unstructured Data: Test Result:13.4 g/l
CDC Split Type: FRPFIZER INC2021342446

Write-up: Hypertension arterial; International normalised ratio increased; Haemorrhagic stroke; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority. Regulatory Authority Report Number : FR-AFSSAPS-AN20211054. An 89-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; candesartan cilexetil, oral from an unspecified date to 19Mar2021, at unspecified dose for an unspecified indication; hydrochlorothiazide, oral from an unspecified date to 19Mar2021, at unspecified dose for an unspecified indication; fluindione (PREVISCAN), oral from an unspecified date to 19Mar2021, at unspecified dose for atrial fibrillation. Medical history included atrial fibrillation and walking with canes from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced hypertension arterial, international normalised ratio increased and haemorrhagic stroke on 19Mar2021. On 19Mar2021, the patient was taken to the emergency room for a coma. She was found on the ground around 11:20 am unconscious, with vomiting. At 10:00, there had been the passage of home helpers: no anomaly at that time. No sign of recent fall. Patient living alone at home with only help at home, walking with canes. On arrival at the hospital at 12:00, she has Glasgow (coma test) at 4, anisocoria, arterial hypertension at 250/90, has an episode of bradycardia at 49 beats per minute, with noisy breathing with 92% desaturation under 6L of oxygen to the mask. Recurrent vomiting. Irregular heart sounds, without breath. ECG showed atrial fibrillation, normoaxed, no conduction disorder, inferolateral flat T waves. Cerebral CT on 19Mar2021: large intra parenchymal hematoma of the right fronto-parieto-temporo-occipital brain parenchyma roughly extended in the sagittal plane over about 12 cm surrounded by a significant perilesional edema. Ventricular flooding in the lateral ventricles, the V3 and V4. Important sub-factorial engagement with left deviation of the median line of about 17 mm. Right temporal engagement. Edema extended to the bridge, no aneurysmal image, no obvious bone fracture. Patient with a massive hemorrhagic stroke, probably hypertensive, leading to death 48 hours after a dose of COMIRNATY vaccine against COVID-19, in a context of overdose of AVK (antivitamines K). The patient underwent lab tests and procedures on 19Mar2021 which included Leucocytes: 13.4 G / L (N: 4-10 G / L), Hemoglobin 10.8 g / dl (N: 12-16), Platelets 166 G / L (N: 150-400 G / L), Polynucelates neutrophils: 10.1 G / L (N: 1.7-7 G / L), Polynuclear basophils: 0.1 G / L (N: 0-0.1), Lymphocytes: 2.7 G / L (N: 1-4 G / L), Monocytes: 0.4 G / L (N: 0.2-0.8 G / L), Sodium: 144 mmol / l (N: 136-145), Potassium 2.9 mmol / l (N: 3.4-4.5), Proteins 81 g / l (N: 64-83), Calcium 2.41 mmol / l (N: 2.20-2.55), Creatinine 82 ?mol / l (N: 45-84) and INR 3.48. The patient died on 19Mar2021 at 06:50 pm (18:50). It was not reported if an autopsy was performed. The action taken in response to the events for candesartan cilexetil, hydrochlorthiazide and fluinidione was not applicable. The outcome of the events was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1165288 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Blood pressure measurement, Blood pressure systolic, Computerised tomogram, Confusional state, Death, Disorientation, Electrocardiogram, Electroencephalogram, Epilepsy, Hypotension, Malaise
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Thrombosis venous deep
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: blood pressure; Result Unstructured Data: Test Result:113/80; Test Date: 202103; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:90 mmHg; Test Date: 202103; Test Name: CT scan; Result Unstructured Data: Test Result:No bleeding; Test Date: 202103; Test Name: ECG; Result Unstructured Data: Test Result:sinus ECG; Test Date: 202103; Test Name: EEG; Result Unstructured Data: Test Result:Standby trace rather well organized for age; Comments: Standby trace rather well organized for age, correctly reactive. Collection of a slow fluctuating focus that is correctly reactive under the temporal, central and left parietal regions. Post-critical origin uncertain.
CDC Split Type: FRPFIZER INC2021342404

Write-up: patient was found dead in his sleep; malaise; hypotension; disoriented; confused; total amnesia of the facts, last memory goes back to the descent of his car; epileptic seizure; This is a spontaneous report from a contactable physician from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BR20210892. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 19Mar2021 (Batch/Lot Number: ET3620) as single dose for covid-19 immunisation. Medical history included deep vein thrombosis, hypertension. Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Back from the vaccination around 3 p.m on 19Mar2021, patient found by witnesses, on the ground, disoriented and confused. Total amnesia of the facts, last memory goes back to the descent of his car with trace of bite of the tongue compatible with a probable epileptic seizure. No bleeding on CT scan, sinus ECG, first-line non-contributory blood assessment. Clinically in a state of post-critical confusion. No signs of neurological focus. Electroencephalography (EEG): Standby trace rather well organized for age, correctly reactive. Collection of a slow fluctuating focus that is correctly reactive under the temporal, central and left parietal regions. Post-critical origin uncertain. No epileptic figure. Transfer to short-term hospitalization unit for monitoring. On 20Mar2021, in the afternoon, the patient presented with malaise with hypotension without tachycardia, prolonged hypotension, having responded to a 500 ml of NaCl. No complaints expressed, no abnormality on neurological or cardiopulmonary examination. Decision to extend the 24-hour surveillance with a blood check scheduled for the morning of the 21st. Hourly blood pressure monitoring until midnight: no tachycardia; systolic blood pressure 90 mm Hg. Felt better after sleeping, discussion with the nursing team at 1:30 (last blood pressure check, BP 113/80), no discomfort expressed, eupneic, no pain, normal vigilance. Passage at 4:00: slept. On 21Mar2021, at 6 a.m., the patient was found dead in his sleep. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: patient was found dead in his sleep


VAERS ID: 1165290 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Asthenia, Cardiac arrest, Constipation, Dehydration, Fatigue, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; General physical health deterioration; Weight loss
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021342419

Write-up: Cardiac arrest; Asthenia; malaise/feeling unwell; Abdominal pain/lower pelvic abdominal pain; constipation; exhaustion; dehydration; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20212258. A 75-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 16Mar2021 (Lot Number: EJ6789) as SINGLE DOSE for COVID-19 immunization. Medical history included constipation, weight loss and deterioration of the general condition from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient presented on day 1 after the 1st injection, had abdominal pain, then on day 2 asthenia, malaise and death following cardiac arrest, in a context of deterioration of the general condition which began 3 weeks before the vaccination and constipation 5 days before vaccination. The patient has not had COVID-19, and has not been tested. The patient had no medical follow-up for 10 years. No treatment in progress. Concept of deterioration of general condition with weight loss for 3 weeks before vaccination. On day 1 17Mar2021, the patient contacts his sister and informs her that he is suffering from abdominal pain. On day 2 18Mar2021, the patient goes to his sister because he feels bad. Call from doctor done. Per doctor consultation, the patient had lower pelvic abdominal pain, constipation for 7 days (therefore beginning 5 days before vaccination), no tachycardia or respiratory failure and no sign of major severity. The patient had notion of dehydration (signs not specified) in Mar2021, asthenia and exhaustion noted on the report card. Prescription of a symptomatic treatment for digestive purposes and a biological assessment to be done the next day. In the evening, the sister calls back on the 15th: because patient is very tired, can no longer climb the stairs, feeling unwell on 18Mar202. Mobilization of a team of ambulance attendants who observe gasp, then perform 4 electric shocks. Mobilization of an emergency service which arrives at around 1 am (night from day 2 to day 3): patient was in cardiac arrest on 19Mar2021. Has already benefited for 15 min from resuscitation maneuvers. Death noted. It was proposed to the family to perform an autopsy for scientific purposes, not immediately accepted (possible delay 72 hours). The patient died on 19Mar2021 due to cardia arrest. An autopsy was not performed. The outcome of the rest of the events was unknown. No follow-up attempts are possible; information about lot/batch number already obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1165291 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, General physical health deterioration, Rectal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 31
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: Bedridden (placed in palliative care); Palliative care
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021342455

Write-up: Deterioration of the general state; rectal bleeding; Diarrhea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. Regulatory authority report number FR-AFSSAPS-LM20210585. A 78-year-old female patient received BNT162B2 (COMIRNATY), first dose on 28Jan2021 (Lot Number: EJ6795, unknown expiration) and second dose on 18Feb2021 (Lot Number: EM6950, unknown expiration), both via intramuscular in left arm as a single dose for COVID-19 immunisation. Medical history included bedridden and placed in palliative care. No history of COVID. The patient''s concomitant medications were not reported. It was reported that the patient experienced diarrhea on 29Jan2021 the day after the 1st dose, without real improvement until the 2nd dose when a rectal bleeding was associated on 19Feb2021. The patient had deterioration of the general state on 01Mar2021. The patient died following events diarrhea, bleeding rectal, and deterioration of the general state on 01Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: Diarrhea; rectal bleeding; Deterioration of the general state


VAERS ID: 1165292 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, General physical health deterioration, Rectal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   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: Medical History/Concurrent Conditions: Bedridden; Diabetes; Phlebitis; Stroke; Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021342453

Write-up: Bleeding rectal; Diarrhea; Progressive degradation of the general state; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number FR-AFSSAPS-LM20210588. A 97-year-old female patient received the first dose of bnt162b2 (COMIRNATY,Lot Number: EM6950), intramuscular, administered in the left arm on 18Feb2021 as a single dose for covid-19 immunisation. The patient''s medical history included phlebitis, stroke, diabetes and bedridden all from an unknown date and unknown if ongoing and dementia from unknown date. The patient''s concomitant medications were not reported. Patient was living in an institution, refusal of hospitalization by the family, patient placed in palliative care. On 19Feb2021, the patient had diarrhea and rectal bleeding and on unspecified date in 2021, the experienced progressive degradation of the general state with death on 02Mar2021. The outcome of the events was fatal as the patient died on 02Mar2021. It was unknown if autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Progressive degradation of the general state; diarrhea; rectal bleeding


VAERS ID: 1165294 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Ischaemic stroke, Peripheral ischaemia
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 15
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: Anticoagulant therapy
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:24
CDC Split Type: FRPFIZER INC2021342459

Write-up: Acute limb ischemia/acute ischemia of the 2 legs; Ischemic stroke/left sylvian cerebrovascular accident; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20210608. A 75-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477), intramuscular, administered in arm left on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history included that he was on well-balanced anticoagulation. The patient''s concomitant medications were not reported. On 26Jan2021, the patient experienced acute ischemia of the 2 legs (appearance of thrombus in the 2 legs)/ acute limb ischemia and left sylvian cerebrovascular accident/ischemic stroke. The events led to patient''s hospitalization. The duration of effects was 15 days. The outcome of the events was fatal. Cause of death was acute ischemia of the 2 legs (appearance of thrombus in the 2 legs)/ acute limb ischemia and left sylvian cerebrovascular accident/ischemic stroke. The patient died on 10Feb2021. It was unknown if the an autopsy was performed. The patient underwent lab tests and procedures which included body mass index: 24 on an unspecified date. NB: Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Regulatory Authority no 84/50, Acute limb ischemia, Ischemic stroke /start date 26jan2021/ stop date 10Feb2021/outcome fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ischemic stroke/left sylvian cerebrovascular accident; Acute limb ischemia/acute ischemia of the 2 legs


VAERS ID: 1165295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Coma scale, Investigation, PCO2, SARS-CoV-2 test, pH body fluid
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 13
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: ESIDREX; TANAKAN [GINKGO BILOBA]; COZAAR; ATENOLOL; FUROSEMID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve calcification; Carotid artery atheroma; Decompensation cardiac; Hypertension; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210303; Test Name: glasgow scale; Result Unstructured Data: Test Result:14; Test Date: 20210303; Test Name: investigation; Result Unstructured Data: Test Result:Sym and bilateral vesicular murmur, bilateral crac; Comments: Sym and bilateral vesicular murmur, bilateral crackles, irregular heart noise, calcified aortic stenosis murmur,edema of the lower limbs, soft and painless abdo,; Test Name: pCO2; Result Unstructured Data: Test Result:52; Test Date: 20210303; Test Name: pCO2; Result Unstructured Data: Test Result:87; Test Name: pH; Result Unstructured Data: Test Result:7.344; Test Date: 20210303; Test Name: pH; Result Unstructured Data: Test Result:7.17; Test Date: 20210301; Test Name: covid-19 test; Result Unstructured Data: Test Result:positive; Comments: variant
CDC Split Type: FRPFIZER INC2021342423

Write-up: COVID-19 aggravated; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-NC20211060. An 80-year-old female patient received her first dose of BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via intramuscular route in the arm on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history included cardiac decompensation, and hypertension in July 2019, obesity, calcified aortic valve, and DTE carotid atheroma (55%). Concomitant medications included hydrochlorothiazide (ESIDREX), ginkgo biloba (TANAKAN), losartan potassium (COZAAR), atenolol, and furosemide. Since 27Feb2021, the patient has presented chills, cough, dyspnea-orthopnea, two episodes of vomiting, loss of appetite, two coughing up blood (one red and one black). Cardiology consultation recently does not mention his calcified aortic stenosis in the report of 26Nov. The patient tested positive for COVID-19 (variant) on 01Mar2021 while going to the emergency room and then returned home. The patient consulted again on 02Mar2021 because his condition deteriorated during the day. Acidosis and hypercapnia were corrected by non-invasive ventilation. The next day, patient had respiratory deterioration. On 03Mar2021, the patient was referred by his doctor in emergency. On 03 Mar2021, PH was 7.17 and PCO2 was 87. Patient was put under non-invasive ventilation. Initial clinical examination showed "Sym and bilateral vesicular murmur, bilateral crackles, irregular heart noise, calcified aortic stenosis murmur, edema of the lower limbs, soft and painless abdo, confused glasgow scale GSC 14." CARDIO ADVICE: decompensation which seems to be more due to COVID than to acute lung edema. CAR BNP (Btype natriuretic peptide) very high. Summary of management and evolution: Respiratory decompensation on COVID and acute lung edema (for cardio). Effectiveness of the non-invasive ventilation following a session of one more hour, control gas PH 7.344, PCO2 52. Patient was still confused after refusal of care. Serious opinion was made, comfort care. During the first week of hospitalization, patient was relatively stationary. However, there was clear deterioration of the disease in the second week of hospitalization. Unfavorable changes with the death on 15Mar2021. It was not reported if an autopsy was performed. Conclusion: Covid-19 possibly aggravated by vaccination. Indeed, all her family circle has tested positive for COVID19 (variant): woman (57 years old, co-morbidities with cancer right cardiac decompensation, COPD(Chronic obstructive pulmonary disease), neurodegenerative disease) and the young girl (24 years old). They did not benefit from the vaccination and remained asymptomatic, except for the patient. This obviously remains a hypothesis. 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 on batch number cannot be obtained.; Reported Cause(s) of Death: Covid-19 aggravated


VAERS ID: 1165300 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795/EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Myocardial infarction, Oxygen saturation, Respiratory distress, Venous oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: KARDEGIC; CORDARONE; PAROXETINE; LEVOTHYROX; ESOMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Hypertension arterial; Ischaemic heart disease; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210218; Test Name: ECG; Result Unstructured Data: Test Result:shift D2-D3-VF mirror in D1, VL; Test Date: 20210218; Test Name: Desaturation; Test Result: 80 %
CDC Split Type: FRPFIZER INC2021342442

Write-up: Venous oxygen saturation decreased; Infarct myocardial; Distress respiratory; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-PC20210362. A 95-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6795/EK9788), dose 2 intramuscular on 17Feb2021 (at the age of 95years) as single dose for Covid-19 immunization. The patient received the first dose of Comirnaty on an unspecified date for Covid-19 immunization (prophylactic vaccination). Medical history included hypertension arterial, bedridden, ischemic heart disease, renal failure; all from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylate lysine (KARDEGIC); amiodarone hydrochloride (CORDARONE), paroxetine, levothyroxine sodium (LEVOTHYROX), and esomeprazole; all taken for an unspecified indication, start and stop date were not reported. On 18Feb2021 (the day after vaccination), the patient experienced sudden respiratory distress in nursery home 80% desaturation. Call of the emergency aid services: major congestion, draft, crackles; ECG: shift D2-D3-VF mirror in D1, VL. Put on oxygen and brought to the emergency room. The patient had a posterior myocardial infarction and respiratory distress leading to death before arrival to the emergency room. The patient died on 18Feb2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Infarct myocardial; respiratory distress; Venous oxygen saturation decreased


VAERS ID: 1165301 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain hypoxia, Coma, Hemiplegia, Lung disorder, Pneumonia, Pyrexia, Respiratory distress, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   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: Leukoencephalopathy; Pulmonary embolism; Stroke; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: COVID-19 test; Result Unstructured Data: Test Result:unknown
CDC Split Type: FRPFIZER INC2021342434

Write-up: Distress respiratory; Pneumopathy; coma; left hemiplegia; cerebral hypoxemia; bibasal pneumonia; Fever; This is a spontaneous report from a contactable physician from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PC20210598. A 93 year old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 18Feb2021 (Lot Number: EM6950) as single dose for COVID-19 immunization. Medical history included vascular dementia, stroke 2005, marked leukopathy and pulmonary embolism 2016. The patient''s concomitant medications were unspecified. The patient previously had first dose of COMIRNATY for COVID-19 immunization. On 19Feb2021 24 hours after the second injection, the patient experienced fever and bibasal pneumonia. The patient had antibiotic treatment. On 23Feb2021, the patient experienced coma, left hemiplegia, respiratory distress. Per radiological, there was a disappearance of the pneumopathy, persistent coma probably due to cerebral hypoxemia). The patient died on 23Feb2021 due to the events. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Distress respiratory; Fever; Pneumopathy; bibasal pneumonia; coma; left hemiplegia; cerebral hypoxemia


VAERS ID: 1165302 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-27
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788, EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood creatine phosphokinase, Blood creatinine, Depressed level of consciousness, Dermo-hypodermitis, Dyspnoea, Erysipelas, Renal failure, Rhabdomyolysis, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemic heart disease; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: creatine kinase; Result Unstructured Data: Test Result:12000; Test Date: 20210227; Test Name: creatinine; Test Result: 219 umol; Test Date: 20210227; Test Name: Covid-19 test; Result Unstructured Data: Test Result:unknown
CDC Split Type: FRPFIZER INC2021342440

Write-up: Dyspnoea; disturbance of consciousness; Consciousness clouding; Rhabdomyolysis; Kidney failure; Erysipelas; dermohypodermitis lower right limb; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PC20210600. A 96-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 18Feb2021 (at the age of 96-years-old) (reported Lot numbers: EJ6788 and EJ6789; pending clarification) as single dose (reported as 1 DF) for covid-19 immunisation. Medical history included Type 2 diabetes mellitus, and Ischaemic heart disease. The patient''s concomitant medications were not reported. The patient received first dose of COMIRNATY on 28Jan2021 for COVID-19 immunization. On 27Feb2021: Dyspnoea, disturbance of consciousness/ Consciousness clouding, rhabdomyolysis major (creatine kinase 12000) renal failure (creatinine 219 uM), dermohypodermitis lower right limb. The patient was hospitalized from 27Feb2021 to 04Mar2021 (date of death). The patient underwent lab tests and procedures which included blood creatine phosphokinase: 12000 on 27Feb2021, blood creatinine: 219 umol on 27Feb2021, sars-cov-2 test: unknown on 27Feb2021. The outcome of the event Erysipelas was recovered while unknown for the event dermohypodermitis lower right limb. The events dyspnea, Consciousness clouding/ disturbance of consciousness, Rhabdomyolysis, Kidney failure, and Dyspnoea were considered as fatal. The patient died on 04Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Consciousness clouding; disturbance of consciousness; Rhabdomyolysis; Kidney failure; Dyspnoea


VAERS ID: 1165304 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Adrenal mass, Brain natriuretic peptide, Cardio-respiratory arrest, Chest pain, Computerised tomogram, Hepatic infarction, Intestinal ischaemia, Renal infarct, Splenic infarction, Troponin T, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (narrow), Cardiomyopathy (broad), Renovascular disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Hepatic metastases
Allergies:
Diagnostic Lab Data: Test Name: NT-proBT; Result Unstructured Data: Test Result:300 pg/mL; Comments: (Normal Value (NV) <300 pg/mL); Test Name: NT-proBT; Result Unstructured Data: Test Result:9235 pg/mL; Comments: (Normal Value (NV) <300 pg/mL); Test Date: 20210321; Test Name: brain Ct scan; Result Unstructured Data: Test Result:no post-anoxic abnormality was visible; Comments: At the cerebral level, no post-anoxic abnormality was visible on the CT scan; Test Date: 20210321; Test Name: thoracic-abdominopelvic CT scan; Result Unstructured Data: Test Result:ileal, right and transverse colonic ischaemia; Comments: ileal, right and transverse colonic ischaemia. In the abdominopelvic region, ileal, right and transverse colonic ischaemia and a moderate amount of intraperitoneal haematic density effusion. Bilateral hepatic, splenic and renal infarction. Left adrenal nodule. Hepatic segment VII hyper-arterial lesion probably related to one of the secondary hepatic locations, the others are hardly visible.; Test Name: Cardiac Troponin T hs; Result Unstructured Data: Test Result:15492 ng/L; Comments: (Normal Value (NV) <15 ng/L); Test Name: Cardiac Troponin T hs; Result Unstructured Data: Test Result:38999 ng/L; Comments: (Normal Value (NV) <15 ng/L); Test Name: Cardiac Troponin T hs; Result Unstructured Data: Test Result:32856 ng/L; Comments: (Normal Value (NV) <15 ng/L)
CDC Split Type: FRPFIZER INC2021342443

Write-up: ileal, right and transverse colonic ischaemia; Bilateral hepatic, splenic and renal infarction; Bilateral hepatic, splenic and renal infarction; Bilateral hepatic, splenic and renal infarction; Left adrenal nodule; STEMI; Cardiorespiratory arrest; ventricular fibrillation; onset of chest pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RE20210822. A 61-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 18Mar2021 (Batch/Lot Number: ET3620) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer, and Hepatic metastases. The patient''s concomitant medications were not reported. On 19Mar2021: Onset of chest pain, electrocardiogram showing inferolateral ST segment elevation with anterior mirror. Cardiorespiratory arrest due to ventricular fibrillation, the patient received 6 external electric shocks with recovery of a sinus rhythm. Initiation of treatment with CORDARONE 150 mg/3 mL, 3 ampoules then 6 ampoules per 24 hours and sodium heparin (laboratory unknown) 25000 IU per 24 hours. The patient presented with a recurrence of cardiorespiratory arrest with asystole recovered after 7 mg adrenaline (laboratory results unknown). Patient intubated urgently. Emergency coronary angiography using the right femoral artery approach, demonstrating a single-vessel lesion with acute occlusion of the proximal right coronary and stenosis of the middle right coronary treated with an active stent. Successful re-canalisation of the proximal right coronary artery and angioplasty of the middle right coronary artery. During the operation the patient was shocked twice on ventricular fibrillation. Therapeutic hypothermia is applied at 8:09 pm. On 20Mar2021: Ultrasound stability with biventricular dysfunction $g left ventricular ejection fraction about 45%, hypokinetic right ventricle with uncomplicated 25 mm inferior vena cava dilation. Continued sedation, curarisation and hypothermia until 8:00 pm then neurological assessment. On 21Mar2021: New episode of cardiorespiratory arrest recovered after external electric shock. At median laparotomy, purulent fluid and ischaemia of the right colon associated with omental ischaemia of the last 80 centimetres were discovered. On return from the block, pupils in bilateral reactive mydriasis with pathological transcranial doppler with telediastolic velocity $g80 on both sides. ADDITIONAL TESTS of 21Mar2021: Conclusive brain and thoracic-abdominopelvic scans. At the cerebral level, no post-anoxic abnormality was visible on the CT scan. At the abdominopelvic level, ileal, right and transverse colonic ischaemia. In the abdominopelvic region, ileal, right and transverse colonic ischaemia and a moderate amount of intraperitoneal haematic density effusion. Bilateral hepatic, splenic and renal infarction. Left adrenal nodule. Hepatic segment VII hyper-arterial lesion probably related to one of the secondary hepatic locations, the others are hardly visible. CONCLUSION: The patient presented with a ST-segment elevation myocardial infarction, but the diagnosis was not clearly established at this time. On 22Mar2021: The patient died/also reported as sudden death at 12:12 AM. The patient underwent lab tests and procedures which included brain natriuretic peptide: 300 pg/ml on (Normal Value (NV) <300 pg/mL) , brain natriuretic peptide: 9235 pg/ml on (Normal Value (NV) <300 pg/mL) , computerised tomogram: no post-anoxic abnormality was visible on 21Mar2021 At the cerebral level, no post-anoxic abnormality was visible on the CT scan , computerised tomogram: ileal, right and transverse colonic ischaemia on 21Mar2021 ileal, right and transverse colonic ischaemia. In the abdominopelvic region, ileal, right and transverse colonic ischaemia and a moderate amount of intraperitoneal haematic density effusion. Bilateral hepatic, splenic and renal infarction. Left adrenal nodule. Hepatic segment VII hyper-arterial lesion probably related to one of the secondary hepatic locations, the others are hardly visible , troponin t: 15492 ng/l on (Normal Value (NV) <15 ng/L) , troponin t: 38999 ng/l on (Normal Value (NV) <15 ng/L) , troponin t: 32856 ng/l on (Normal Value (NV) <15 ng/L). The patient died on 22Mar2021. It was not reported if an autopsy was performed. The outcome of the event STEMI was fatal, while unknown for the other events. The patient received treatment for the events STEMI, Cardiorespiratory arrest, and ventricular fibrillation. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: STEMI


VAERS ID: 1165305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: Medical History/Concurrent Conditions: Aortic stenosis; Arthrosis; Decompensation cardiac; Dementia NOS; Hypertension arterial; Senile macular degeneration
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021342463

Write-up: Asthenia; Epigastric pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-RE20210850. A 90-year-old female patient received bnt162b2 (COMIRNATY, lot number ET3620 and expiration date not provided), intramuscular, administered in Arm Right first dose on 17Mar2021 at single dose for Covid-19 immunization. The patient''s medical history included Hypertension arterial, Dementia NOS, Senile macular degeneration, Arthrosis, Aortic stenosis, and Decompensation cardiac. The patient''s concomitant medications were not reported. On 17Mar2021, twelve hours after injection the patient presented epigastric pain and asthenia. The patient died 2 hours after the onset of symptoms (without further details). 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: Asthenia; Epigastric pain


VAERS ID: 1165307 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-15
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 LA / OT

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: 2021-03-15
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021342466

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-TO20211924. An 84-year-old male patient received the second dose of BNT162B2 (COMIRNATY Solution for injection, lot number: ER2659, expiry date: unknown), intramuscular in the left arm, on 03Mar2021, as single dose, for covid-19 immunisation. There were no medical history and concomitant medications. Historical vaccine included the first dose of BNT162B2 (COMIRNATY Solution for injection, lot number: EM 0477, expiry date: unknown), intramuscular in the left arm, on 05Feb2021, for COVID 19 immunisation. The patient experienced sudden death on 15Mar2021. Discovery of the body at home and declaration of death was on 15Mar2021. The patient was in excellent general condition, was a marathon runner, was an active athlete despite his age, was totally independent and lived alone. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1165308 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-03-16
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
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: 2021-03-01
   Days after onset: 14
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: 20210312; Test Name: Covid-19 PCR test; Result Unstructured Data: Test Result:absence of SARS COV 2 in the sample; Test Date: 20210316; Test Name: Covid-19 PCR test; Result Unstructured Data: Test Result:weak positive, probable indicator of moderate vira; Comments: weak positive, probable indicator of moderate viral excretion
CDC Split Type: FRPFIZER INC2021342462

Write-up: Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-TO20211956. A 50-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot: ER0641), intramuscular on 19Feb2021 as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (lot: EJ6788) on 26Jan2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. PCR test on 12Mar2021 with absence of SARS COV 2 in the sample. On 16Mar2021, the patient had vaccination failure and COVID-19 pneumonia. PCR test on 16Mar2021 with weak positive, probable indicator of moderate viral excretion. The patient died in Mar2021 due to vaccination failure and COVID-19 pneumonia. 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 pneumonia; Vaccination failure


VAERS ID: 1165315 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-18
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   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: GABAPENTIN; LANSOPRAZOLE; SIMVASTATIN; SITAGLIPTIN; METFORMIN; CO-CARELDOPA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemic heart disease; Osteoporosis; Perforated duodenal ulcer repair; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210218; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021343890

Write-up: Drug ineffective; confirmed COVID-19 positive result; Sepsis; This is a spontaneous report from a contactable pharmacist received from a regulatory authority. The regulatory authority report number is GB-MHRA-MIDB-ece38980-a6e9-4449-af5e-f32722a8a8ea, Safety Report Unique Identifier GB-MHRA-ADR 25042533. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 22Jan2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included Type 2 Diabetes Mellitus, Angina (Ischeamic Heart Disease), perforated duodenal ulcer requiring surgery and osteoporosis. Concomitant medications included gabapentin, lansoprazole, simvastatin, sitagliptin, metformin, carbidopa, and co-careldopa. The patient experienced drug ineffective, confirmed covid-19 positive result, and sepsis, all from 18Feb2021, which were reported as fatal outcome and causing hospitalization. The patient was hospitalized for drug ineffective, confirmed covid-19 positive result, and sepsis from 18Feb2021. Therapeutic measures were taken as a result of drug ineffective/confirmed covid-19 positive result included treatment Palliated on 26Feb2021 post admission. The patient died on 26Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: drug ineffective; confirmed covid-19 positive result; sepsis


VAERS ID: 1165492 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, 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), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
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: Diabetes; Hypertension; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021343456

Write-up: cardiac arrest; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202103270909463110. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes, immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...), and hypertension. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 19Mar2021. The patient died on 24Mar2021. It was not reported if an autopsy was performed and the reported cause of death was cardiac arrest. The clinical course was reported as: "Vaccine caused cardiac arrest which caused death. Postmortem samples sent for confirmation" No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1165506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Chest pain
SMQs:, Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   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: Diabetes mellitus insulin-dependent; Hypertension; OA knee (knee arthrosis)
Preexisting Conditions: Medical History/Concurrent Conditions: Weakness; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: blood pressure; Result Unstructured Data: Test Result:140/80 mmHg; Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade
CDC Split Type: HUPFIZER INC2021354240

Write-up: weakness; chest pain; This is a spontaneous report from a contactable physician downloaded from a regulatory authority- WEB. E2B Authority Number is HU-OGYI-145721. An 81-year-old female patient received her 1st dose of BNT162B2 (COMIRNATY, lot number ET1831, expiry date: unknown) at 0.3 ml single dose intramuscular in left upper arm on 05Mar2021 for COVID-19 immunisation. Medical history included knee arthrosis, hypertension, and diabetes mellitus insulin-dependent, all ongoing. Before vaccination, the patient was already very weak; she could be travelled by wheelchair although her diseases were balanced by her current pharmacotherapy. Based on the vaccinating doctor, there was no contraindication of vaccination, she was cardio-pulmonary compensated, her blood pressure and body temperature were normal (140/80 Hgmm and 36.4 degree C, respectively). Concomitant drug was not provided. During the half-hour observation period, no reaction was observed. On the next day in the afternoon, the patient became weak, later, she experienced chest pain and died at her home. Based on the opinions of the patient''s vaccinating physician and family doctor, the death was not related to the vaccination but could be due to a cardiac event. Autopsy has been done, the result is unknown. Sender Comment: Weakness is an expected adverse event of COMIRNATY, however, the patient was already reported to be weak before vaccination. Time to onset was one day. Causality between the weakness, and resulting death and COMIRNATY is not assessable. The case is serious because the patient has died. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: weakness; chest pain


VAERS ID: 1165507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood pressure measurement, Body temperature, Cardiac disorder, Choking, Circulatory collapse, Condition aggravated, Dyspnoea, Specialist consultation
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Supraventricular tachyarrhythmias (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   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: KALDYUM; FUROSEMIDE; TALLITON; XETER; CO-PRENESSA; ACETYLSALICYLIC ACID; OLICARD
Current Illness: Colon cancer; Decompensation cardiac (persisting between NYHA stage I and stage II); Dilated cardiomyopathy; Extrasystoles; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiopulmonary failure; Chemotherapy; Colectomy; COVID-19; Hospitalization
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: blood pressure; Result Unstructured Data: Test Result:130/80 mmHg; Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Test Date: 20210311; Test Name: cardiological examination; Result Unstructured Data: Test Result:worsening circulatory failure,; Comments: and atrial fibrillation which could have caused his worsening condition
CDC Split Type: HUPFIZER INC2021354241

Write-up: dyspnoea; worsening cardiac condition; worsening cardiac condition; circulatory failure; atrial fibrillation; choking; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority- WEB [HU-OGYI-149521] received via Regulatory Authority. A 75 years old male patient received BNT162B2 (COMIRNATY) on 05Mar2021via Intramuscular to the right upper arm at 0.3 mL, single (batch: ET1831) for COVID-19 immunisation. The patient''s medical history included ongoing hypertension, ongoing extrasystoles, ongoing Decompensation cardiac persisting between NYHA stage I and stage II, ongoing dilated cardiomyopathy, ongoing colon cancer, colectomy (no ongoing) and consequent chemotherapy (no ongoing). He has been hospitalized and he had chemotherapy several times during the last 6 years (no ongoing). In Dec2020, he had COVID-19 (no ongoing), that time he had not have significant asphyxia, chest X-ray has not been prepared. On the examination before vaccination, he was reported to be cardio-pulmonary compensated. His blood pressure and body temperature were normal (130/80 mmHg and 36.1 degree C, respectively) on 05Mar2021. Concomitant medicines were acetylsalicylic acid, indapamide, perindopril erbumine (CO-PRENESSA), furosemide, potassium chloride (KALDYUM), isosorbide mononitrate (OLICARD), carvedilol (TALLITON) and rosuvastatin calcium (XETER). There was no contraindication of vaccination. During the half-hour observation period, no adverse event has occurred. On 11Mar2021, the patient has been sent to the medical service by his family doctor, because he had dyspnoea for several days. He experienced choking on 11Mar2021 and hospitalization. Cardiological examination has found worsening circulatory failure, and atrial fibrillation which could have caused his worsening condition. He was kept in the hospital, then died on the same day at 11Mar2021 14:00. Based on the opinions of the patient''s vaccinating physician and family doctor, the death is not related to the vaccination but could be due to a cardiac event. Autopsy has been done. The result is not yet received. Sender Comment: Dyspnoea is not expected adverse event of COMIRNATY. It might be a symptom caused by the worsening cardiac condition on 11Mar2021 of the patient. Time to onset was 6 days. Causality between the adverse events and COMIRNATY is not assessable. The case is serious because the patient died.; Sender''s Comments: Based on information provided, the event dyspnea is more likely related to underlying diseases of Decompensation cardiac persisting between NYHA stage I and stage II, ongoing dilated cardiomyopathy but unrelated to BNT162B2 (COMIRNATY).; Reported Cause(s) of Death: dyspnoea; choking; worsening cardiac condition; worsening cardiac condition


VAERS ID: 1165508 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: QUETIAPINE; NU-SEALS; PANTOPRAZOLE; ZOPICLONE; ELTROXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Agitation; Atrial fibrillation; Cognitive impairment; Dementia; Frailty; Gastritis; Hypothyroidism; Insomnia; Living in residential institution; Respiratory symptom (it was outlined that the patient tended to be chesty without any formal lung diagnosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021342366

Write-up: ACUTELY SHORT OF BREATH; APPEARED TO DEVELOP ACUTE RESPIRATORY DISTRESS; This is a report received from Health Products Regulatory Agency Regulatory authority report number IE-HPRA-2021-068085 with Safety Report Unique Identifier IE-HPRA-2021-068085. A 98-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: ER0641) at a single dose for COVID-19 immunisation. The patient was reportedly living in a residential institution and was on grade 2 fluids and minced diet. Medical history included atrial fibrillation, dementia, Cognitive impairment, asthenia, respiratory symptom (it was outlined that the patient tended to be chesty without any formal lung diagnosis), hypothyroidism, gastritis, insomnia, and agitation; all from an unknown date and unknown if ongoing. The patient previously took the first dose of BNT162B2 (COMIRNATY) vaccine on 19Jan2021 (Lot number: EM4077) for COVID-19 immunisation. Concomitant medications included quetiapine taken for agitation; acetylsalicylic acid (NU-SEALS) taken for atrial fibrillation; pantoprazole taken for gastritis; zopiclone taken for insomnia; and levothyroxine sodium (ELTROXIN) taken for an unspecified indication. The patient experienced acutely short of breath and appeared to develop acute respiratory distress on 18Feb2021. The seriousness criteria of the events were death and outcomes of the events were fatal. The patient was transferred to hospital via ambulance and died within an hour of arrival on an unspecified date in Feb2021. It was not reported if an autopsy was performed and the reported causes of death were shortness of breath and respiratory distress. Reportedly, the coroner was informed. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Shortness of breath; Respiratory distress


VAERS ID: 1165509 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-09
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Syncope
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), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: COMBODART; PRAVASTATIN; BETMIGA; SALBUTAMOL; BISOPROLOL; RIVAROXABAN; SPIRIVA RESPIMAT; LACTULOSE; ESOMEPRAZOLE; SPIRONOLACTONE; BURINEX; SERETIDE EVOHALER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COPD; Heart failure; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021342353

Write-up: COLLAPSE; CARDIAC ARREST; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-068553. An 84-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Mar2021 (at the age of 84-years-old) (Batch/Lot Number: ER2659) as 0.3 ml single for covid-19 immunisation. Medical history included cardiac failure, chronic obstructive pulmonary disease, hypertension, atrial fibrillation. Concomitant medications included dutasteride, tamsulosin hydrochloride (COMBODART); pravastatin; mirabegron (BETMIGA); salbutamol; bisoprolol; rivaroxaban; tiotropium bromide (SPIRIVA RESPIMAT); lactulose; esomeprazole; spironolactone; bumetanide (BURINEX); fluticasone propionate, salmeterol (SERETIDE EVOHALER); all taken for unspecified indications, start and stop dates were not reported. On 09Mar2021, the patient collapsed at home/also reported as syncope. The patient was brought by ambulance to the Emergency Department (ED). The patient experienced cardiac arrest and standard resuscitation was performed. The reporter outlined that it was unclear if the event was in any way related to vaccine administration, but the reporter was reporting as per protocol. In Mar2021, the patient died. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Batch/lot number already provided.; Reported Cause(s) of Death: Syncope; Cardiac arrest


VAERS ID: 1165511 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-12
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   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: LERCANIDIPINE; BISOPROLOL; AMITRIPTYLINE; ZESTORETIC; ELIQUIS; BROMAZEPAM; METFORMIN; ATORVASTATIN; ASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cholecystitis (patient was noted to have declined surgery for in 2011); Diabetes; Hypertension; Macular degeneration
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021342361

Write-up: ABDOMINAL PAINS EXTENDED TO BACK; ABDOMINAL PAINS EXTENDED TO BACK; This is a spontaneous report from a contactable physician reporting for a patient downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-069716. A 90-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: ER2659; Expiration Date: Jun2021) as SINGLE DOSE for covid-19 immunisation, at 90 years old. Medical history included atrial fibrillation from an unknown date, cholecystitis from an unknown date (patient was noted to have declined surgery for in 2011), macular degeneration from an unknown date, hypertension from an unknown date, diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included lercanidipine; bisoprolol; amitriptyline; hydrochlorothiazide, lisinopril (ZESTORETIC); apixaban (ELIQUIS); bromazepam; metformin; atorvastatin; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced abdominal pains extended to back on 12Mar2021 17:00. Clinical course was reported as follows: On 02Mar2021, the patient was vaccinated with her first dose of COMIRNATY (batch no: ER2659, exp: Jun/2021). It was reported that the patient had no side effects at all following vaccination and had no gastrointestinal symptoms. On 12Mar2021, at 17.00, the patient experienced sudden onset of abdominal pains that extended into her back. It was reported that the patient did not want to attend a clinic at this time. At 21:00, the patient''s abdominal pain had progressed and became so bad that an ambulance was called. At approximately 22:00, before the ambulance arrived, the patient passed away. Outcome of the events was fatal. The patient died on an unspecified date. It was outlined that a post-mortem would be performed.; Reported Cause(s) of Death: Back pain; Abdominal pain


VAERS ID: 1165513 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-22
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, SARS-CoV-2 test, Sopor
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), Dementia (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: 2021-02-24
   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: METOPROLOL; XARELTO; FUROSEMIDE; QUETIAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cognitive deterioration; CVA (stroke); Embolism pulmonary; Hypertensive heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: ITPFIZER INC2021342295

Write-up: worsening soporific state; drowsy; unconscious; This is as spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-704426. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 12Feb2021 (Lot Number: EL0725) as 0.3 mL, single for SARS-CoV-2 vaccination at age 89 years old. Medical history included hypertensive heart disease, embolism pulmonary, cognitive deterioration, CVA/stroke, and AFib, all from unknown dates and unknown if ongoing. Concomitant medications included metoprolol taken for Hypertension arterial, start and stop date were not reported; rivaroxaban (XARELTO) taken for thrombosis prophylaxis from 24May2016 to an unspecified stop date; furosemide taken for Hypertension arterial, start and stop date were not reported; and quetiapine taken for an unspecified indication, start and stop date were not reported. Performed the first dose of covid vaccine on 12Feb2021. Patient who had never contracted the virus. The patient died on 24Feb2021 after becoming drowsy and unconscious on 22Feb2021. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test: negative on 15Feb2021. The patient died on 24Feb2021. An autopsy was not performed. Outcome of the events was fatal. Reporter comment: The patient was given the first dose of COVID vaccine on 12Feb2021 host who had never contracted the virus. She died on 24Feb2021, having developed a worsening soporific state 10 days after the vaccine, leading to loss of consciousness and then death. Sender comment: Concomitant diseases and medications were included after contacting the reporter. Update 23Mar2021: report sent by the reporter is attached. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The patient was given the first dose of COVID vaccine on 12Feb2021 host who had never contracted the virus. She died on 24Feb2021, having developed a worsening soporific state 10 days after the vaccine, leading to loss of consciousness and then death.; Reported Cause(s) of Death: worsening soporific state; drowsy; unconscious


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