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From the 9/17/2021 release of VAERS data:

Found 15,386 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 73 out of 154

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VAERS ID: 976486 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Drug ineffective, Headache, Malaise, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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: FOSTAIR; LOPERAMIDE; OMEPRAZOLE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Diarrhea; Frontotemporal dementia (frontotemporal dementia with some motor neurone disease (MND) features); Motor neurone disease (frontotemporal dementia with some motor neurone disease (MND) features); Reflux gastritis; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive
CDC Split Type: GBPFIZER INC2021053511

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; Headache; Nausea; Unwell; Death; This is a spontaneous report received by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101181401032020 and Safety Report Unique Identifier GB-MHRA-ADR 24609241. A contactable physician reported that an 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1688), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunisation. Medical history included frontotemporal dementia with some motor neurone disease (MND) features, chronic obstructive pulmonary disease, diarrhea, reflux gastritis. Concomitant medications included beclometasone dipropionate, formoterol fumarate (FOSTAIR) from 20Oct2020 for chronic obstructive pulmonary disease, loperamide from 29Dec2014 for diarrhoea, omeprazole from 01Feb1996 for reflux gastritis, and salbutamol from 19Jun1998 for chronic obstructive pulmonary disease. Patient previously received SEQIRUS VACCINES INFLUENZA on 27Oct2020 for influenza immunization. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient had been feeling well. He attended for his COVID-19 vaccination on 6th January 2021 and when he returned home began to feel unwell, with nausea and headache. That evening his carers were concerned so they called an ambulance. The patient tested positive for COVID-19 (SARS-CoV-2 infection) on 7th January 2021 and unfortunately died on 11th January 2021 in the hospital. It was unclear if vaccine could have been contributing factor. Reporter was unsure if the vaccine and death could be connected. The cause of death was unknown. It was unknown if an autopsy was performed. The outcome of SARS-CoV-2 infection was not recovered, while for the other events was unknown.; Reported Cause(s) of Death: Death


VAERS ID: 976487 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT.KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, Drug ineffective, Dyspnoea, Malaise, SARS-CoV-2 test, Vital signs measurement, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 9
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: RIVASTIGMIN [RIVASTIGMINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cold (had colds before and always got through them); Heart rate low; Parkinson''s disease; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive; Test Date: 20210113; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Name: Vital signs; Result Unstructured Data: Test Result:vitals were giving up
CDC Split Type: GBPFIZER INC2021053413

Write-up: Death; SARS-CoV-2 infection; SARS-CoV-2 infection; Malaise; Dyspnoea; Vomiting; This is a spontaneous report received from a contactable consumer by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101181625023630 and Safety Report Unique Identifier GB-MHRA-ADR 24610617. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 vaccination. Medical history included Parkinson''s disease, heart rate decreased, nasopharyngitis (had colds before and always got through them); all unknown if ongoing. Concomitant medication included rivastigmine (RIVASTIGMIN) from 30Dec2020 for Parkinson''s disease. It was reported that the patient had the vaccine on 30Dec2020 and within 4 days (as reported), the patient felt really unwell on 04Jan2021. He then had trouble breathing and also started vomiting 04Jan2021 . He was taken to hospital on 06Jan2021 and then informed and told to expect the worse. His vitals were giving up on an unspecified date. It was reported that the patient was quite strong for his age despite his Parkinson''s disease. It was reported that the patient tested positive for COVID-19 virus test on 05Jan2021 and 13Jan2021. The patient died on 13Jan2021 (also reported as 05Jan2021). An autopsy was not performed. It was reported that the patient was hospitalized due to the events. The outcome of the event SARS-CoV-2 infection was not recovered, while unknown for the events vomiting, dyspnoea and malaise. No follow up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 976492 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BNT162B2 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, 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: 2021-01-17
   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: ACLIDINIUM BROMIDE; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: CT head; Result Unstructured Data: Test Result:results not provided
CDC Split Type: GBPFIZER INC2021052072

Write-up: Subarachnoid hemorrhage; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101191508083250, Safety Report Unique Identifier GB-MHRA-ADR 24615904 An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: BNT162b2, expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Concomitant medication included aclidinium bromide and salbutamol sulfate (VENTOLIN); both for chronic obstructive pulmonary disease. The patient experienced subarachnoid hemorrhage on 14Jan2021. The patient underwent lab tests and procedures which included computerised tomogram head: results not provided on an unspecified date. The patient died on 17Jan2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Subarachnoid hemorrhage


VAERS ID: 976493 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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: ACICLOVIR; ALLOPURINOL; APIXABAN; ATORVASTATIN; BISOPROLOL; BUMETANIDE; CO-TRIMOXAZOLE; GLYCERYL TRINITRATE; ISOSORBIDE MONONITRATE; OMEPRAZOLE; PARACETAMOL; TAMSULOSIN; VITAMIN B12 NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; B-cell lymphoma (diagnosed in Dec2020 and had had 2 rounds of chemotherapy with R-GCVP before Shia vaccination); Blood cholesterol abnormal; Deficiency anaemia; DVT (required platelet transfusion on his last admission); Frailty (very frail); Gout; Heart failure; Ischaemic heart disease; Pain; Platelet transfusion; Renal disease; Retention urinary; Comments: This patient had a history of ischaemic heart disease and heart failure and chronic renal disease . In December 2020 he was diagnosed with B cell lymphoma and had had 2 rounds of chemotherapy with R-GCVP before Shia vaccination . He was very frail . He had a DVT and had required platelet transfusion on his last admission . He was fairly well the weekend of his vaccination and appeared to have no ill effects from it . His death was sudden , found collapsed 6:15 am 11/1/21.I do not think his death was connected to vaccination . Cause of death thought to be likely MI on a background of IHD , DVT , CKD and lymphoma . Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021056801

Write-up: Death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202101200910191490, Safety Report Unique Identifier GB-MHRA-ADR 24619194. A 80-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EK1768, via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. In Dec2020 he was diagnosed with B cell lymphoma and had had 2 rounds of chemotherapy with R-GCVP (rituximab, gemcitabine, cyclophosphamide, vincristine, prednisolone) before Shia vaccination. He was very frail with ischaemic heart disease (IHD) and chronic renal disease (CKD). He had a Deep vein thrombosis (DVT) and had required platelet transfusion on his last admission. Additional medical history included gout, angina pectoris, pain, Retention urinary, and Deficiency anaemia, Blood cholesterol abnormal. Concomitant medication included aciclovir from Dec2020 for Prophylaxis, allopurinol from 27Jun2019 for gout, apixaban from Dec2020 for Deep vein thrombosis, atorvastatin from Nov2008 for Blood cholesterol, bisoprolol from Jul2012 for Cardiac failure, bumetanide for Cardiac failure, co-trimoxazole from Dec2020 for Prophylaxis, glyceryl trinitrate for Angina pectoris, isosorbide mononitrate from 2018 for Myocardial ischaemia, omeprazole, paracetamol from 2014 for pain, tamsulosin from 2020 for Urinary retention, vitamin b12 nos from 03Nov2020 for Deficiency anaemia.The patient previously received influenza vaccine (INFLUENZA VIRUS) on 15Sep2020. The patient experienced death on 11Jan2021. He was fairly well the weekend of his vaccination and appeared to have no ill effects from it. His death was sudden, found collapsed 6:15 am 11Jan2021.it was unknown if autopsy was done. The reporter did not think his death was connected to vaccination. Cause of death thought to be likely MI on a background of IHD, DVT , CKD and lymphoma. The reporter was reporting because his death was soon after vaccination but had no reason to think death was connected in any way to the vaccine. He had had no apparent reaction or ill effects from the vaccine. Vaccination was not entered as having any part in cause of death on death certificate. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial.; Sender''s Comments: Based on the information currently available, the Company handles the death as related to BNT162B2 vaccine for reporting purpose. Multiple comorbidities including B cell lymphoma, ischaemic heart disease, chronic renal disease and deep vein thrombosis were significant risk factors for death in this elderly patient.; Reported Cause(s) of Death: Death


VAERS ID: 976494 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; BETOPIC [BETAMETHASONE]; BISOPROLOL; CETRABEN [PARAFFIN]; LAXIDO ORANGE; OMEPRAZOLE; ATORVASTATIN; SUKKARTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction (with likely LVF and mild post infarct angina); Cardiac pacemaker insertion; Cholesterol high; Constipation; Dehydration; Epididymitis; Glaucoma; Intervertebral disc operation; Intervertebral disc prolapse; Intraocular lens implant; Ischaemic heart disease; Lens capsulotomy; Open-angle glaucoma; Phacoemulsification; Sciatica; Thyroidectomy partial; Thyrotoxicosis ([with or without goitre]); Type II diabetes mellitus; Comments: 14 Jun 1955~Thyrotoxicosis (XE104) ~THYROTOXICOSIS [with or without goitre] 02 Apr 1960~Partial thyroidectomy NEC (71105) ~PARTIAL THYROIDECTOMY 12 Sep 1975~Epididymitis (K241.) ~EPIDIDYMITIS [exc. mumps] 02 Mar 1998~Open-angle glaucoma (F451.) 08 Apr 1998~Sciatica (XE1FC) 23 Apr 1998~Prolapsed lumbar intervertebral disc (N122.) 21 May 1998~Excision of thoracic intervertebral disc NEC (7J239) 29 Mar 1999~Phacoemulsification of lens (72631) 21 May 1999~Acute myocardial infarction (XE0Uh) ~with likely LVF and mild post infarct angina 07 Apr 2000~Phacoemulsification of lens (72631) 29 Nov 2001~Laser capsulotomy of lens capsule (X00XM) 05 Mar 2002~[V]Has artificial eye lens (ZV431) 05 Sep 2013~Type II diabetes mellitus (X40J5) Ischaemic heart disease (XE2uV) Insertion of permanent cardiac pacemaker (Xa1nT) 14 Sep 2020~Aspirin 75mg dispersible tablets~1 EVERY DAY~56 tablet~23 Nov 2020 ~Issues: 2~Review: 14 Sep 2021 ~Indication: Ischaemic heart disease (XE2uV) 14 Sep 2020~Betoptic 0.5% eye drops (Novartis Pharmaceuticals UK Ltd)~ONE DROP TWICE DAILY~10 ml~18 Aug 2020, Issue from previous template, Reauthorised ~Issues: 0~Review: 14 Sep 2021 ~Indication: Glaucoma (F45..) 14 Sep 2020~Bisoprolol 1.25mg tablets~take one daily~56 tablet~23 Nov 2020 ~Issues: 2~Review: 14 Sep 2021 14 Sep 2020~Cetraben cream (Thornton & Ross Ltd)~use as a soap substitute and moisturiser~500 gram~23 Nov 2020 ~Issues: 1~Review: 14 Sep 2021 14 Sep 2020~Laxido Orange oral powder sachets sugar free (Galen Ltd)~Take ONE or TWO sachets dissolved in water (125ml per sachet) daily as needed to treat constipation~30 sachet~08 Oct 2020 ~Issues: 1~Review: 14 Sep 2021 14 Sep 2020~Omeprazole 20mg gastro-resistant capsules~take one daily~56 capsule~23 Nov 2020 ~Issues: 2~Review: 14 Sep 2021 06 Oct 2020~Atorvastatin 20mg tablets~Take ONE daily at night to lower cholesterol levels~56 tablet~23 Nov 2020 ~Issues: 2~Review: 06 Oct 2021 06 Oct 2020~Sukkarto SR 500mg tablets (Morningside Healthcare Ltd)~take FOUR tabletes once daily with food for diabetes~224 tablet~23 Nov 2020 Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021056597

Write-up: Death; fall; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101200930136640, Safety Report Unique Identifier GB-MHRA-ADR 24619489. A 94-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included thyrotoxicosis from 14Jun1955 (with or without goitre), Partial thyroidectomy NEC on 02Apr1960, Epididymitis from 12Sep1975, Open-angle glaucoma (F451.) from 02Mar1998, Sciatica (XE1FC) from 08Apr1998, Prolapsed lumbar intervertebral disc (N122.) from 23Apr1998, Excision of thoracic intervertebral disc NEC (7J239) from 21May1998, Phacoemulsification of lens (72631) on 29Mar1999 and 07Apr2000, Acute myocardial infarction (XE0Uh) from 21May1999 (with likely LVF and mild post infarct angina), Laser capsulotomy of lens capsule (X00XM) on 29Nov2001, has artificial eye lens (ZV431) from 05Mar2002, Type II diabetes mellitus (DM, (X40J5)) from 05Sep2013, Ischaemic heart disease (IHD, (XE2uV)) and Insertion of permanent cardiac pacemaker (Xa1nT), glaucoma, constipation, dehydration, cholesterol high. Concomitant medications included acetylsalicylic acid (ASPIRIN) 75mg dispersible tablets for Ischaemic heart disease, betamethasone (BETOPIC) 0.5% eye drops (Novartis Pharmaceuticals UK Ltd) for Glaucoma, bisoprolol 1.25mg tablets from 23Nov2020, paraffin (CETRABEN ) cream (Thornton & Ross Ltd), use as a soap substitute and moisturiser, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO ORANGE) oral powder sachets sugar free (Galen Ltd) to treat constipation, omeprazole 20mg gastro-resistant capsules, atorvastatin 20mg tablets to lower cholesterol levels, metformin hydrochloride (SUKKARTO) SR 500mg tablets (Morningside Healthcare Ltd) for diabetes. Patient has not had symptoms associated with COVID-19, didn''t have a COVID-19 test. Patient was not enrolled in clinical trial. Patient was slow decline since Christmas. Unwell from 06Jan2021 with constipation and dehydration. Covid Vaccine (Pfizer) was on 08Jan2021. The patient fell on 09Jan2021. Seen by GP on 11Jan2021. Non specifically unwell. No temp. Chest and urine all OK. Abdominal soft and non tender. Slow decline over the following week. Died over the weekend on 16Jan2021. The physician personally doesn''t think this was related to the Covid Vaccine as he was unwell before he received it but was reporting it as it was a death within 2 weeks of the vaccine. Reported to Coroner and Death certified, frailty of old age, IHD, DM type 2. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of fall was unknown. No follow-up attempts possible; information regarding batch/lot cannot be obtained.; Sender''s Comments: The 94-year-old patient had medical history included acute myocardial infarction, Type II diabetes mellitus, ischaemic heart disease and insertion of permanent cardiac pacemaker, and cholesterol high. The company concurs with the reporting physician that the patient''s death within 2 weeks of the vaccine was unrelated to the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).; Reported Cause(s) of Death: Death


VAERS ID: 976498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

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: 2021-01-20
   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:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021055910

Write-up: Sudden death; This is a spontaneous report from a contactable Physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101202046007970, Safety Report Unique Identifier GB-MHRA-ADR 24623410. A 101-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0739) via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial. Patient is 101 years old so sudden death not surprising. Had been completely well the day before but was found to have died by carer & family. This was 11 days after the vaccination. Son reports that she had not experienced any side effects from the vaccination, not even a sore arm. "I do not think the death was related to the vaccine but given it is a novel vaccine I felt it improtant to report this death in case of epidemiological significance." Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 20Jan2021. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 976503 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-09
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Coronary disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021017388

Write-up: aortic aneurysm; The initial case was missing the following minimum criteria: no first-hand knowledge. Upon receipt of follow-up information on 21Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report downloaded from the regulatory authority with cae identifier. A contactable other healthcare professional reported that an 87-year-old female patient received bnt162b2 (COMIRNATY) lot no: EJ6796, expiration date 30Apr2021, via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included Alzheimer''s disease, hypertension, and coronary disease all from unknown dates. The patient''s concomitant medications were not reported. The patient did not experience any obvious side effects after the vaccination, the patient passed away on 09Jan2021 after sudden illness. Based on the patient''s symptoms on 09Jan2021 aortic aneurysm is listed as the cause of death. It was unknown if autopsy was performed. Outcome of the event aortic aneurysm was fatal.; Reported Cause(s) of Death: Aortic aneurysm


VAERS ID: 976504 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebellar haemorrhage, Coma scale, Coma scale abnormal, Hemiparesis, Respiratory arrest, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: GCS; Result Unstructured Data: Test Result:5/15
CDC Split Type: ITPFIZER INC2021043387

Write-up: left flaccid hemiparesis; GSC 5/15; respiratory arrest; urticarial rash; vomiting; cerebral haemorrage; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is IT-MINISAL02-651250. A 89-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1484 and expiration date: Apr2021), via an unspecified route of administration on arm left on 05Jan2021 at 0.3 mL, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. About ten minutes after received the Covid comirnaty vaccine, presented left flaccid hemiparesis, GSC 5/15, urticarial rash, vomiting, respiratory arrest. And cardio-pulmonar resuscitation, oxygen therapy, parenteral antihystaminic and cortisonic were received as treatment. Events all caused hospitalization. The patient in the Emergency Urgency and Acceptance Department and found cerebral haemorrage (not better specified) caused patient died. The Patient died on 06Jan2021 at 6.21. It is unknown if the autopsy done. The outcome of the event Cerebellar haemorrhage was fatal, outcome of the other events was unknown. Sender''s comments: The Patient died on 06Jan2021 at 6.21. Attached: clinical report by Dr.; report of Dr. with confirmation of death; first aid report by Dr. I still await confirmation from the hospital if the autopsy will be done. Reporter''s comment: Suspected an acute neurological event (cerebral haemorrhage) not related to vaccination; vaccine-related allergic skin reaction symptoms.; Reporter''s Comments: Suspected an acute neurological event (cerebral haemorrhage) not related to vaccination; vaccine-related allergic skin reaction symptoms.; Sender''s Comments: Based on the information currently provided, a possibly contributory role of suspected vaccine BNT162B2 in the development of the fatal cerebral hemorrhage cannot be completely excluded. Additional information regarding relevant medical history, underlying conditions, concomitant medications and autopsy result will aid in comprehensive assessment of the case.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 978321 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2020-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL SANDOZ; RINGERLACTAT NACH HARTMANN BAXTER VIAFLO; RISPERIDON SANDOZ; MIRTAZAPIN SANDOZ; LAEVOLAC-LAKTULOZ; NOVALGINE; PANTOLOC [PANTOPRAZOLE]; ELIQUIS
Current Illness: Atrial fibrillation (Chronic heart failure in AF); Chronic heart failure (Chronic heart failure in AF; Left ventricular hypertrophy); Dementia aggravated (Advanced dementia); Emphysema pulmonary (highly chronic obstructive pulmonary emphysema); Generalized arteriosclerosis (severe general atherosclerosis); Hemorrhagic cystitis (Hemorrhagic cystitis); Retention cyst (vascular scars and retention cysts up to 1 cm in size on both kidneys); Sigmoid diverticulitis (Sigmoid diverticulosis); Struma nodosa (small nodular goiter nodosa on both sides); Type II diabetes mellitus (Diabetes Typ II)
Preexisting Conditions: Medical History/Concurrent Conditions: Complicated urinary tract infection; Deep vein thrombosis (Z.N. extensive arm vein thrombosis on the right); Hysterectomy (St. p. hysterectomy); Iron deficiency anemia; Left ventricular hypertrophy; Musculoskeletal pain; Nausea (refused to eat &drink, she had nausea & nausea also on particular days(e.g. on 14Dec2020, 23Dec2020)); Nausea (Nausea and vomiting); Pacemaker insertion (cardiac) (Condition after DDDR-PM implantation 1998, change of generator); Prerenal failure (Prerenal kidney failure as part of a urinary tract infection); Renal scarring (vascular scars and retention cysts up to 1 cm in size on both kidneys); Vomiting
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021054547

Write-up: Posterior myocardial infarction; Nausea with vomiting; Nausea with vomiting; This is a spontaneous report from a contactable healthcare professional and physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB AT-BASGAGES-2021-00013. A 92-year-old female patient received bnt162b2 (COMIRNATY; batch/lot: EJ6796, expiration date: unknown), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 vaccination. Medical history included ongoing chronic heart failure in AF(atrial fibrillation); left ventricular hypertrophy, pacemaker insertion (cardiac) from 1998 (condition after DDDR-PM implantation 1998, change of generator), ongoing dementia aggravated (advanced dementia), ongoing hemorrhagic cystitis, hysterectomy (St. p. hysterectomy), ongoing generalized arteriosclerosis (severe general atherosclerosis), ongoing retention cyst (vascular scars and retention cysts up to 1 cm in size on both kidneys), nausea and vomiting, ongoing type II diabetes mellitus, complicated urinary tract infection, prerenal kidney failure as part of a urinary tract infection, iron deficiency anemia, ongoing struma nodosa (small nodular goiter nodosa on both sides), ongoing sigmoid diverticulitis, deep vein thrombosis (Z.N. extensive arm vein thrombosis on the right), ongoing emphysema pulmonary (highly chronic obstructive pulmonary emphysema) and pain in the musculoskeletal system. It was also reported that in the days before the vaccination, the patient had refused to eat and drink, she had nausea and nausea also on particular days (e.g. on December 14th, 2020, December 23rd, 2020). Concomitant medications included bisoprolol fumarate (BISOPROLOL SANDOZ) on 28Oct2020, calcium chloride dihydrate, potassium chloride, sodium chloride, sodium lactate (RINGERLACTAT NACH HARTMANN BAXTER VIAFLO) on 17Dec2020, risperidone (RISPERIDON SANDOZ) on 24Dec2020, mirtazapine (MIRTAZAPIN SANDOZ) on 24Dec2020, lactulose (LAEVOLAC-LAKTULOZ) on 01Dec2020, metamizole sodium (NOVALGINE) from 04Nov2020 for pain in the musculoskeletal system, pantoprazole (PANTOLOC [PANTOPRAZOLE]) from 19Oct2020 and apixaban (ELIQUIS) on 28Oct2020. There were no signs of another infection, fever. Daily health check (cough, sore throat, shortness of breath, vomiting, diarrhea, loss of smell) were OK in the days after vaccination. On 28Dec2020 at 20:22, the patient experienced nausea with vomiting. The outcome of the event nausea with vomiting was recovered on 29Dec2020. On 01Jan2021, the patient experienced nausea with vomiting again with an unknown outcome. On 03Jan2021, the patient experienced posterior myocardial infarction. The patient died on 03Jan2021 due to posterior myocardial infarction. Autopsy was performed. Autopsy findings from 05Jan2021 showed cause of death of posteroseptal myocardial infarction. Sender''s comments: BASGAGES comment from 07Jan2020: Data capture aid form of Pfizer taken into consideration for further request of FU. Cause of death and Autopsy findings requested. Confounding factors: elderly age and underlying type II diabetes mellitus, nausea, Nausea, chronic heart failure, atrial fibrillation, generalized arteriosclerosis, etc. The causal relationship between the product Comirnaty and myocardial infarction is assessed as unlikely. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Posterior myocardial infarction; Autopsy-determined Cause(s) of Death: posteroseptal myocardial infarction


VAERS ID: 978323 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EMO477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid increased, Cardiovascular disorder, Coagulopathy, Haemoglobin decreased, Hypovolaemic shock, Rectal haemorrhage
SMQs:, Haematopoietic erythropenia (broad), Lactic acidosis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Hypovolaemic shock conditions (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; BICALUTAMIDE; STEOVIT FORTE; SYSTANE COMPLETE; ASAFLOW; IRON; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm; Prostate carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: Lactate blood increased; Result Unstructured Data: Test Result:increased; Test Date: 20210108; Test Name: Hemoglobin decreased; Result Unstructured Data: Test Result:decreased
CDC Split Type: BEPFIZER INC2021060786

Write-up: Coagulation disorder; Cardiovascular disorder; Vaccine was administered after 1h of relapse RBPA; 3x abundant with secondary hypovolaemic shock and death as a result; further decreasing hemoglobin; Arterial blood gas showed substantial lactate; This is a spontaneous report from physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB BE-FAMHP-DHH-N2021-75441 and received via Regulatory Authority. A 94-year-old male patient received BNT162B2 (COMIRNATY Solution for injection, lot no: EMO477, expiry date not reported), via an unspecified route of administration on 08Jan2021 at a single dose for covid-19 immunization. Medical history included Aorta neurysm CNI stage IV and prostate carcinoma. Concomitant medication included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), bicalutamide (BICALUTAMIDE), calcium carbonate, colecalciferol (STEOVIT FORTE), propylene glycol (SYSTANE COMPLETE), acetylsalicylic acid (ASAFLOW) , iron, pantoprazole; all on unspecified dates for unspecified indications. Patient had nutritional supplement: Fortimel creme vanilla. On 08Jan2021, male patient suffered from cardiovascular disorder, coagulation disorder, rectal blood loss (vaccine was administered after 1h of relapse rbpa),hypovolaemic shock (3x abundant with secondary hypovolaemic shock and death as a result) ,lactate blood increase (Arterial blood gas showed substantial lactate) and hemoglobin decreased (further decreasing hemoglobin) during treatment with COMIRNATY. The patient died on 14Jan2021. An autopsy was not performed. Clinic comment: Patient was admitted to the emergency department on 8/1/2021 at 8am with a one-time large haemorrhage per anum. On PPA examination in the emergency department, no more blood was seen. The patient was stable in the ER (hemoglobin 8.5, previously 9.5) and it was decided to vaccinate the patient (vaccine administered around 12.30 pm in the ER). 1 hour later, haemorrhage per anum detected again. 3 episodes of extensive blood loss leading to secondary hypovolemic shock and death (around 16:30-17:00) despite transfusion. In consultation with the family no further endoscopy was done. Asaflow, listed in the concomitant medication alongside other drugs, had been used for years and taken until the day before. Aortic aneurysm was still present. The reporter does not rule out rupture of this aneurysm as a possible cause of death, but this is not consistent with the location of the haemorrhage, according to the reporter. No autopsy is planned and no further information is expected. According to the reporter and the head doctor of the hospital, the vaccine probably did not contribute to the evolution (the bleeding was already present before vaccination). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 978324 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Basophil count, Blood creatinine, Blood urea, Cardiovascular disorder, Dyspnoea, Glomerular filtration rate, Haematocrit, Haemoglobin, Hypotension, Lymphocyte count, Malaise, Monocyte count, Neutropenia, Neutrophil count, Oxygen saturation decreased, Platelet count, Pyrexia, Red blood cell sedimentation rate, Respiratory disorder, Tachycardia, White blood cell count
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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: RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]; COVERSYL AM; PROLOPA; CIRCADIN; DECA-DURABOLIN; DOVOBET; RANOMAX; NEXIAM [ESOMEPRAZOLE MAGNESIUM]; VITAMINE B12; CORUNO; ASAFLOW
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris aggravated (Coronarography test due to increased angina pectoris); Bilateral bronchopneumonia; Bile acid diarrhea; Bowen''s disease (Head skin lesion: hypertrophic Bowen''s disease.Removed in total); Churg Strauss syndrome; Coronary disease (requiring placement of a stent on the left marginal artery branch); Coronary disease; Parkinson''s disease; Pulmonary embolism (Bilateral pulmonary embolism, since then oral anticoagulation); Right middle lobe pneumonia (Temporarily involved with shock and hypovolaemia and secondary ischemic hepatitis); Syncope (Withdrawal due to syncope.)
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: Basophil count; Result Unstructured Data: Test Result:10 /uL; Test Date: 20210114; Test Name: Creatinine; Test Result: 1.74 mg/dl; Test Date: 20210114; Test Name: Urea; Test Result: 90.1 mg/dl; Test Date: 20210114; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:36 mL/min/1.73m2; Comments: eGFR (MDRD): 36 mL/min/1.73m2; Test Date: 20210114; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:32 mL/min/1.73m2; Comments: eGFR (CKD-EPI): 32 mL/min/1.73m2; Test Date: 20210114; Test Name: Hematocrit; Test Result: 36.3 %; Test Date: 20210114; Test Name: Hemoglobin; Result Unstructured Data: Test Result:11.7 g/dl; Test Date: 20210114; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:431 uL; Test Date: 20210114; Test Name: Monocyte count; Result Unstructured Data: Test Result:21 uL; Test Date: 20210114; Test Name: Monocyte count; Result Unstructured Data: Test Result:1%; Test Date: 20210114; Test Name: Segmented neutrophil count; Result Unstructured Data: Test Result:1548 uL; Test Date: 20210114; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:0.115 10*6/uL; Test Date: 20210114; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:4.05 milj/uL; Test Date: 20210114; Test Name: Leukocyte count; Result Unstructured Data: Test Result:2080 cells/uL
CDC Split Type: BEPFIZER INC2021060958

Write-up: Malaise; Fever; saturation 82%; Cardiovascular problem; Problem with breathing; Neutropenia; Hypotension; Tachycardia; Dyspnea; This is a serious spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is BE-FAMHP-DHH-N2021-75444. A 98-year-old male patient received bnt162b2 (COMIRNATY, lot: EM0477), via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunisation. The patient''s medical history included Bile acid diarrhea in Oct1998, Coronary two-stroke disease (coronarography October ''98 which showed proximal LAD stenosis of 70% for which balloon dilation and a distal stenosis on art. circumflex that was non-significant. At li. ventricular angiography, mild apical hypokinesia); Churg and Strauss disease, Bilateral pulmonary embolism in 1999, since then was on oral anticoagulation; in pneumonia right side Sep2001: temporarily involved with shock and hypovolaemia and secondary ischemic hepatitis; withdrawal due to syncope in Feb2003 which was negative investigation (including tilt testing and electrophysiological investigation; bilateral Bronchopneumonia in Feb2004; Angina pectoris increased in Apr2005 in which the patient had coronarography test (Coronary 3-branch disease with PTCA and stent grafting of the culprit lesion on the midLAD); two-stroke coronary disease in Dec2007 requiring placement of a stent on the left marginal artery branch (Medtronic Driver 2.5 x 12 mm) and a stent in the center of the right coronary artery (Medtronic Driver 3.0 x 12 mm) in two times; Bowen''s disease hypertrophic on 04Jan2016 (Head skin lesion and removed in totalit), all were unknown if ongoing and Parkinson''s disease on an unknown date. Concomitant medication included fluticasone furoate, vilanterol trifenatate (RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]), amlodipine besilate, perindopril erbumine (COVERSYL AM), benserazide hydrochloride, levodopa (PROLOPA), melatonin (CIRCADIN), nandrolone decanoate (DECA-DURABOLIN) , betamethasone dipropionate, calcipotriol (DOVOBET), tamsulosin hydrochloride (RANOMAX), esomeprazole magnesium (NEXIAM [ESOMEPRAZOLE MAGNESIUM]), cyanocobalamin (VITAMINE B12), molsidomine (CORUNO), and acetylsalicylic acid (ASAFLOW). On 14Jan2021, the patient experienced malaise, fever, saturation 82%, cardiovascular problem, problem with breathing, neutropenia, hypotension, tachycardia, and dyspnea. The patient underwent lab tests and procedures which included basophil count: 10 /ul , blood creatinine: 1.74 mg/dl, blood urea: 90.1 mg/dl, glomerular filtration rate: 36 ml/min/1.73m2 and 32 ml/min/1.73m2, eGFR (MDRD): 36 mL/min/1.73m2, eGFR (CKD-EPI): 32 mL/min/1.73m2 , haematocrit: 36.3 %, haemoglobin: 11.7 g/dl, lymphocyte count: 431 /ul, monocyte count: 21/, monocyte count: 1% , neutrophil count: 1548 /ul, platelet count: 0.115 10x6/ul, red blood cell sedimentation rate: 4.05 milj./ul, and white blood cell count: 2080 cells/ul. The patient died on 14Jan2021 due to the events malaise, fever, saturation 82%, cardiovascular problem, problem with breathing, neutropenia, hypotension, tachycardia, and dyspnea. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CARDIOVASCULAR PROBLEM; NEUTROPENIA; Problem with breathing; MALAISE; FEVER; DYSPNEA; saturation 82%; HYPOTENSION; TACHYCARDIA


VAERS ID: 978325 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORMETAZEPAM; OXYCONTIN; PARACETAMOL; GLUCOPHAGE [METFORMIN HYDROCHLORIDE]; RAMIPRIL; METOPROLOL; UNI DIAMICRON; INDAPAMIDE; ASAFLOW; BETASERC; TERAZOSAB; CRESTOR; CORUNO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Arterial hypertension; Diabetes mellitus; Obesity; Percutaneous transluminal coronary angioplasty; Smoker; Surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021060967

Write-up: Cardiovascular disorder; This is a spontaneous report from a contactable physician from the Medicines Agency (MA) Regulatory Authority -WEB BE-FAMHP-DHH-N2021-75491. A 76-year-old male patient received their first dose of BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included obesity, AHT (arterial hypertension), diabetes mellitus type 2, PTCA from RAC with stenting; all from an unknown date, spinal surgery in 2007, smoking and alcohol use from an unknown date and unknown if ongoing. Concomitant medication included lormetazepam, oxycodone hydrochloride (OXYCONTIN), paracetamol, metformin hydrochloride (GLUCOPHAGE), metoprolol, gliclazide (UNI DIAMICRON), betahistine hydrochloride (BETASERC), rosuvastatin calcium (CRESTOR), all for unspecified indications; ramipril, indapamide, acetylsalicylic acid (ASAFLOW), terazosin hydrochloride (TERAZOSAB), molsidomine (CORUNO) in the morning before the administration of the vaccine all for unspecified indications. The patient experienced cardiovascular disorder on an unspecified date. The patient died on 15Jan2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Reporter''s comments: In the early morning sudden death in bed in absence of suspicion of medical detoriation, patient helped partner during the night to go to toilet a few hours before he himself died, stable known cardiac suffering since 2001 with PTCA of RAC with stenting and a complete right bundle-branch block with recent cardiology check-up complete; besides the normal medication no other medication administered besides the vaccine. No follow-up attempts possible. No further information expected. Information about lot/batch cannot be obtained.; Reporter''s Comments: In the early morning sudden death in bed in absence of suspicion of medical detoriation, patient helped partner during the night to go to toilet a few hours before he himself died, stable known cardiac suffering since 2001 with PTCA of RAC with stenting and a complete right bundle-branch block with recent cardiology check-up complete; besides the normal medication no other medication administered besides the vaccine.; Reported Cause(s) of Death: Cardiovascular disorder


VAERS ID: 978326 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: Medical History/Concurrent Conditions: Hip surgery; Venous occlusion
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021060777

Write-up: Cardiovascular disorder; Sudden death/massive pulmonary embolism; This is a spontaneous report from a contactable physician, downloaded from the Medicines Agency (MA) Regulatory authority-WEB, Regulatory authority report number: BE-FAMHP-DHH-N2021-75499. A 77-years-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477, expiration date: unknown), via an unknown route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history included hip surgery and venous occlusion. The patient''s concomitant medications were not reported. The patient experienced cardiovascular disorder on an unspecified date, and sudden death from massive pulmonary embolism, two days after vaccination (15Jan2021). It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Sudden death two days after vaccination. No side effects previously reported. According to the general practitioner who diagnosed death, massive pulmonary embolism as a complication of venous occlusion after hip surgery. So probably not related to vaccination.; Reported Cause(s) of Death: Cardiovascular disorder; sudden death/massive pulmonary embolism


VAERS ID: 978333 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021060592

Write-up: Patient died in temporal association; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB. Regulatory authority report number is DE-PEI-PEI2021000817. An 85-year-old female patient received first dose of BNT162B2 (COMIRNATY; Solution for injection, Lot number: EJ6796, unknown expiration), intramuscular on 11Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication included OA li. Three hours after vaccination, the patient died in temporal association on 11Jan2021. The patient died due to unknown cause of death. It was unknown if autopsy was performed. The event unknown cause of death was assessed as unclassifiable to COMIRNATY by Regulatory Authority. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Patient died in temporal association


VAERS ID: 978334 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2021-01-07
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hypertension; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021060633

Write-up: the patient is dead; the patient tested positive for covid-19 test; the patient tested positive for covid-19 test; This is a spontaneous report from physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB DE-PEI-PEI2021000821 received via Regulatory authority. A 62-year-old female patient started to receive bnt162b2 (COMIRNATY, lot number: unknown), via an unspecified route of administration from 28Dec2020 to 28Dec2020 at SINGLE DOSE for covid-19 immunisation. Medical history included depression, type 2 diabetes mellitus and hypertension. The patient''s concomitant medications were not reported. On an unspecified date, the reporter stataed that the patient is dead. Also, the patient tested positive for covid-19 test on 07Jan2021. Outcome of the events drug ineffective and COVID-19 virus test positive was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: patient is dead


VAERS ID: 978335 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Dementia; Hypertension; Myocardial infarction; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021060620

Write-up: The patient is dead; This is a spontaneous report downloaded from the Regulatory Authority-WEB. Regulatory authority report number is DE-PEI-PEI2021000829. A non-contactable physician reported that a 97-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection; lot number: EJ6797; expiry date: not known), intramuscular on 31Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension, dementia, renal insufficiency, and myocardial infarction. The patient''s concomitant medications were not reported. The patient was dead on 01Jan2021. It was reported that the patient had no adverse reaction. An autopsy was performed but autopsy results was not available. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: The patient is dead


VAERS ID: 978336 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Multiple organ dysfunction syndrome, Pulmonary sepsis
SMQs:, Lack of efficacy/effect (narrow), 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021060589

Write-up: COVID-19 pneumonia; COVID-19 pneumonia; Pneumogenic sepsis; Consecutive multiple organ failure; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021000830. A 74-year-old male patient received first dose of BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 30Dec2020, the same day after vaccination, the patient developed COVID-19 pneumonia, pulmonary sepsis also reported as pneumogenic sepsis, and consecutive multiorgan failure. The patient died on 06Jan2021. An autopsy was performed that revealed COVID-19 pneumonia. Information on the batch number has been requested.; Reported Cause(s) of Death: COVID-19 pneumonia; Pneumogenic sepsis; multiple organ failure; Autopsy-determined Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 978337 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19 pneumonia, Cardiac failure, Chronic kidney disease, Drug ineffective, Heart rate, Oxygen saturation, Polymerase chain reaction, SARS-CoV-2 test, Tachyarrhythmia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Lack of efficacy/effect (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Chronic kidney disease (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2020-12-31
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; Bladder carcinoma; Cardiac insufficiency; Dementia; Heart failure; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Test Date: 20201231; Test Name: body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Test Date: 20201231; Test Name: pulse; Result Unstructured Data: Test Result:140; Test Date: 20201231; Test Name: SaturationOxygen saturation; Test Result: 87 %; Test Name: PCR; Result Unstructured Data: Test Result:positive Covid-19; Test Name: rapid test for Sars-CoV 2; Result Unstructured Data: Test Result:negative
CDC Split Type: DEPFIZER INC2021060324

Write-up: Covid-19 Pneumonie/PCR test was now positive; Covid-19 Pneumonie/PCR test was now positive; Decompensation cardiac; acute chronic kidney disease; Tachyarrhythmia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB regulatory authority number DE-PEI-PEI2021000834. An 89-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6796), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. Medical history included arterial hypertension, atrial fibrillation, dementia, bladder carcinoma, cardiac insufficiency and heart failure; all unknown if ongoing, and bladder carcinoma surgery (not ongoing). The patient''s concomitant medications were not reported. It was reported that the patient was vaccinated by the health department on 29Dec2020, a rapid test for Sars-CoV 2 was negative, but there have been cases of Covid 19 in the house. The next day (30Dec2020) he developed feeling cold and temperature up to 37.4, a PCR test was now positive (unspecified date). On 31Dec2020 he had a fever of 39.2 and a pulse of 140. The patient was admitted to the hospital and the oxygen saturation was 87%. Despite treatment with antibiotics, oxygen, remdesivir and dexamethasone the patient died due to the events decompensation cardiac, COVID-19 pneumonie/PCR test was now positive, acute chronic kidney disease and tachyarrhythmia. The patient died on 31Dec2020. 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: Decompensation cardiac; Covid-19 Pneumonie/PCR test was now positive; Covid-19 Pneumonie/PCR test was now positive; acute chronic kidney disease; Tachyarrhythmia


VAERS ID: 978338 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, COVID-19, Diet refusal, Drug ineffective, Food refusal, Heart rate, Oxygen saturation, Pneumonia, SARS-CoV-2 test, Tachycardia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Dementia; Renal insufficiency; Stroke
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Test Name: Heart rate; Result Unstructured Data: Test Result:123 BpM; Test Date: 20210107; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:74-78 %; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: ct value 31
CDC Split Type: DEPFIZER INC2021060326

Write-up: COVID-19 virus test (result: positiv/positive); COVID-19 virus test (result: positiv/positive); Temperature increase; Vd. a. pneumonia; Tachycardia; Food refusal/Diet refusal; Food refusal/Diet refusal; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB. The regulatory authority report number is DE-PEI-PEI2021000840. An 83-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: EJ6796), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. Medical history included dementia, cardiac insufficiency, renal insufficiency, all from unknown dates and unknown if ongoing; and stroke from Apr2019 to an unknown date. The patient''s concomitant medications were not reported. On 30Dec2020, after vaccination, the patient developed diet refusal/food refusal; and on 06Jan2021, the patient experienced tachycardia, body temperature increased and pneumonia, lasting for unknown. The patient was dead and condition was life threatening. The reporter assessed the events diet refusal/food refusal, tachycardia, body temperature increased and pneumonia as serious (death and life threatening). It was also reported that the patient experienced COVID-19 virus test (result: positiv/positive) on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 37.9 centigrade, heart rate: 123 bpm and COVID-19 virus test: positive (ct value 31), all on unspecified dates; and oxygen saturation: 74-78 % on 07Jan2021. The outcome of the events diet refusal/food refusal, tachycardia, body temperature increased and pneumonia was fatal while the outcome of the event COVID-19 virus test (result: positiv/positive) was unknown. The patient died on 07Jan2021. Causes of death were diet refusal/food refusal, tachycardia, body temperature increased and pneumonia. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number was already obtained.; Reported Cause(s) of Death: Tachycardia; Temperature increase; Vd. a. pneumonia; Food refusal/Diet refusal; Food refusal/Diet refusal


VAERS ID: 978339 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: DEPFIZER INC2021060330

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the Agency-WEB Regulatory Authority number DE-PEI-PEI2021000859. An 80-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13Jan2021, it was reported that after vaccination, the patient developed sudden cardiac death, lasting for unknown. The patient is dead and was not hospitalized and condition was life threatening. Death cause was reported as sudden cardiac death. The patient died on 13Jan2021. The outcome of the event was fatal. 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: Sudden cardiac death


VAERS ID: 978341 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Death, 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: 2021-01-20
   Days after onset: 13
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: body temperature; Result Unstructured Data: Test Result:$g 38.0 Centigrade; Test Date: 20210107; Test Name: Covid-19 test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021061132

Write-up: The patient passed away on 20Jan2021. Cause of death was not reported.; Corona positive; Corona positive; This is a spontaneous report from a contactable physician and a consumer received via Regional Authority and Biontech. An 80-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced infection of respiratory tract and Corona (COVID-19 test) positive from 07Jan2021, infection with worsening of general condition and fever $g 38.0 centigrade. The patient passed away on 20Jan2021. Cause of death was not reported (pending for clarification). No vaccination complications after previous vaccinations and vaccine had not been re-administered. Outpatient treatment was necessary. It was not reported if an autopsy was performed. Outcome of the event Corona positive was unknown. Causal relation to Covid vaccination questionable. Information on the lot/batch number has been requested.; Sender''s Comments: A causal association between BNT162B2 and the reported events Drug ineffective and COVID-19 cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and assessed as unrelated. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: The patient passed away on 20Jan2021. Cause of death was not reported.


VAERS ID: 978342 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-08
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Body temperature, Oxygen saturation, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Name: O2 saturation; Result Unstructured Data: Test Result:dropped
CDC Split Type: DEPFIZER INC2021061151

Write-up: Acute infectional exacerbation of chronic respiratory insufficiency with oxygen requirement; Acute infectional exacerbation of chronic respiratory insufficiency with oxygen requirement; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: UNKNOWN), via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 08Jan2021, the patient experienced acute infectious exacerbation of chronic respiratory insufficiency with oxygen requirement. The symptoms included cough. On an unknown date, the patient''s body temperature was 37.7 degrees Centigrade and oxygen saturation had dropped. Treatment in the hospital was necessary; however, the patient refused treatment. The clinical outcome of acute infectious exacerbation of chronic respiratory insufficiency with oxygen requirement was fatal and the patient died on 13Jan2021. The cause of death was acute respiratory insufficiency. It was not reported if an autopsy was performed. The reporter commented that the causal relationship between the events and COVID-19 vaccination was questionable.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the "acute infectious exacerbation of chronic respiratory insufficiency with oxygen requirement" and suspect vaccine BNT162B2. Additional information regarding relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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: acute respiratory insufficiency


VAERS ID: 978343 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Condition aggravated, Drug ineffective, General physical health deterioration, Respiratory tract infection
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021061212

Write-up: Corona Infection; Respiratory infection with cough; reduced general condition; condition worsened; Corona Infection; This is a spontaneous report from a non-contactable physician received via Regional Authority and Biontech. An 87-year old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration on 05Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient had no vaccination complications after previous vaccinations. On 07Jan2021, the patients diagnoses/ suspected diagnosis was Corona infection. On the same day of 07Jan2021, the patient experienced respiratory infection with cough and reduced general condition, rapid general health deterioration, and condition worsened. The patient died 19Jan2021. Course and therapy of the vaccination reaction: outpatient treatment was necessary, inpatient treatment at the hospital was necessary but was refused. The vaccination reaction was life- threatening. Outcome of events was fatal. The patient died on 19Jan2021. The reported causes of death were corona infection, respiratory infection with cough and reduced general condition, rapid general health deterioration. It was unknown if an autopsy was performed. Causal relation to Covid vaccination was reported as questionable. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Corona infection; Corona infection; respiratory infection with cough; reduced general condition; condition worsened


VAERS ID: 978344 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Nausea, Personality change, Renal failure, Unresponsive to stimuli, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic renal insufficiency (grade II); Hip surgery; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Blood pressure; Result Unstructured Data: Test Result:not measurable
CDC Split Type: DEPFIZER INC2021073491

Write-up: not responsive; nausea; vomiting; personality change; kidney failure; This is a spontaneous report from a contactable other health professional. An 88-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EM0477), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history included chronic renal insufficiency (grade II) from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing, osteoporosis from an unknown date and unknown if ongoing, femur neck surgery from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 20Jan2021 at 17:00, the patient experienced: not responsive (hospitalization, medically significant), nausea (hospitalization), vomiting (hospitalization), and personality change (hospitalization). On 21Jan2021, the patient experienced kidney failure (death, medically significant). The patient underwent lab tests and procedures which included blood pressure: not measurable on 20Jan2021. The clinical outcome of the events: not responsive, nausea, vomiting, and personality change, was unknown. The clinical outcome of the event, kidney failure, was fatal. The patient died in Jan2021 due to kidney failure. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Kidney failure


VAERS ID: 978345 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
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: Dementia; General physical health deterioration (old age impairment); Living in nursing home; Multimorbidity; Parkinsonism; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021060114

Write-up: The reporter cannot exclude that the vaccine may have a minor role in further worsening of the patients general condition; This is a spontaneous report downloaded from regulatory authority WEB DK-DKMA-WBS-0028817. The case was received from a contactable physician .A 78-year-old male patient received bnt162b2 the first dose of (COMIRNATY, lot number: EJ6797), via an unspecified route of administration on 02Jan2021 at a single dose for covid-19 immunization. Medical history included parkonsonism, dementia, pneumonia, general physical health deterioration (old age impairment) and the patient was living in nursing home. The patient''s concomitant medications were not reported. The reporter described the occurrence of death due to General physical health deterioration/Age weakening/deterioration (The reporter cannot exclude that the vaccine may have a minor role in further worsening of the patients general condition) . On 11Jan2021, 9 days after vaccination, the patient died. The patient did not experience any visible side effects. Reported causes of death was Pneumonia and General physical health deterioration. There is no information regarding test results. Reporter reports that coherence with Corminaty is of temporal character and causality is uncertain. The reporter does not believe that the vaccine is the direct cause of the patient''s death, but that he cannot exclude that the vaccine may have a minor role in the patient''s death at this time. He refers to the immune response that the vaccination gives in the elderly patients; Reported Cause(s) of Death: General physical health deterioration; Pneumonia


VAERS ID: 978346 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia normocytic; Dementia; General physical health deterioration (old age impairment/Age weakening/deterioration); Living in nursing home; Multimorbidity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021060054

Write-up: The reporter cannot exclude that the vaccine may have a minor role in further worsening of the patients general condition; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB regulatory authority DK-DKMA-WBS-0028818, Safety Report Unique Identifier DK-DKMA-ADR 24582375. This is a spontaneous case, received on 12Jan2021 from a physician, which describes the occurrence of death due to General physical health deterioration (The reporter cannot exclude that the vaccine may have a minor role in further worsening of the patients general condition) of a 98 year old multimorbid female patient, vaccinated with Comirnaty (Tozinameran). There is no information regarding concomitant medication. There is no information regarding past medication. Patient concurrent conditions included dementia, anemia normocutic and general physical health deterioration (old age impairment/Age weakening/deterioration). The patient was living in a nursing home. On 02Jan202, the patient was vaccinated with the first dose of Comirnaty (Batch number: EJ6797) for COVID-19 immunisation. On 10Jan2021(8 days after vaccination) the patient died. The patient did not experience any visible side effects. The ADRs were by the reporter reported as Fatal. Reported cause(es) of death: General physical health deterioration (old age impairment). There is no information regarding test results. Causality: Reporter reports that coherence with Corminaty is of temporal character and causality is uncertain. The reporter does not believe that the vaccine is the direct cause of the patient''s death, but he cannot exclude that the vaccine may have a minor role in the patient''s death at this time. He refers to the immune response that the vaccination gives in the elderly patients. If the Danish Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: The reporter cannot exclude that the vaccine may have a minor role in further worsening of the patients general condition


VAERS ID: 978348 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia with Lewy bodies (moderate-severe); Ferropenic anemia (Hb = 9.9 g/dl on 28Nov2019, no usual treatment); Uterovaginal prolapse
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021061785

Write-up: Sudden death; FEVER; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB ES-AEMPS-717741. A 95-year-old institutionalized female patient received BNT162B2 (COMIRNATY, solution for injection, lot number EJ6796/expiration date) dose number 1, intramuscularly on 07Jan2021 at 0.3 mL, single dose for COVID-19 vaccination. Medical history included moderate-severe dementia with lewy bodies, uterovaginal prolapse, and ferropenic anemia (Hb = 9.9 g/dl on 28Nov2019, no usual treatment). Concomitant medications were not reported. On 14Jan2021 at dawn, she presented with fever. A few hours later she died (sudden death). Autopsy was not performed. The causality was reported as follows: the chronology, the age of the patient, and the clinical manifestation (fever) do not allow to establish a causal relationship with the vaccine. No follow-up attempts are possible; no information is expected.; Reported Cause(s) of Death: Sudden death; Fever


VAERS ID: 978407 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Drug ineffective, Dyspnoea, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021057396

Write-up: Death unexplained; breathing difficulty; suspected COVID-19; suspected COVID-19; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number was GB-MHRA-ADR 24576180 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-20210110084322. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 09Jan2021 as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was not enrolled in the clinical trial. On 09Jan2021, the patient received the first dose of the vaccine. On 10Jan2021 at 02:00, the patient had breathing difficulty. On 10Jan2021, the patient had suspected COVID-19. It was reported that the patient had not been tested or had an inconclusive test for COVID-19. On 10Jan2021 at 07:00, the patient experienced death unexplained. It was not reported if an autopsy was performed. The clinical outcome of breathing difficulty was unknown; while the outcome of suspected COVID-19 was not recovered at the time of death. No follow-up attempts are possible; information about lot number cannot be obtained.; Reported Cause(s) of Death: Unexplained death


VAERS ID: 978410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Fall (sustained head wound; elderly gentleman, recently registered but had co-morbidities and was frail); Frailty; Wound
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021057381

Write-up: Unknown cause of death; cardiac arrest; might have choked on vomit; This is a spontaneous report from a contactable healthcare professional received products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210110125656 and GB-MHRA-ADR 24578105. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1688), via an unspecified route of administration, on 31Dec2020 at a single dose for COVID-19 immunization. Medical history included non-ongoing fall (sustained head wound; elderly gentleman, recently registered but had co-morbidities and was frail) on 18Dec2020 and head wound on 18Dec2020 and frail. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient had not been tested/or has had an inconclusive test for COVID-19. The patient''s concomitant medications were not reported. The patient had an unknown cause of death on 06Jan2021, which was reported as fatal. The patient also experienced cardiac arrest and might have choked on vomit on 06Jan2021. It was reported that an ambulance was called, and resuscitation was attempted; however, the patient passed away. The clinical outcome of cardiac arrest and might have choked on vomit was unknown. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 06Jan2021. The cause of death was reported as unknown. 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: Unknown cause of death


VAERS ID: 978472 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Comments: Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021062529

Write-up: Died in sleep; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202101211533503430, Safety Report Unique Identifier GB-MHRA-ADR 24626442. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4243), via an unspecified route of administration on unspecified date in Jan2021 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. The patient did not have a COVID-19 test. Unsure if patient is enrolled in clinical trial. It was reported that the patient died in sleep on an unspecified date in Jan2021. It was unknown whether an autopsy was performed or not. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: died in sleep


VAERS ID: 978475 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Coronary artery disease
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM CARBONATE; CLENIL MODULITE; FERROUS SULFATE; LOSEC [OMEPRAZOLE MAGNESIUM]; PARACETAMOL; QUININE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Dyspepsia; Muscle spasms; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: Post-mortem; Result Unstructured Data: Test Result:coronary artery disease as cause of death
CDC Split Type: GBPFIZER INC2021066873

Write-up: coronary artery disease; This is a spontaneous report received from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202101212159072100, and Safety Report Unique Identifier: GB-MHRA-ADR 24629305. A 93-year-old female patient received single dose of BNT162B2 (Solution for injection, lot number: EL0141, exp date not reported), via an unspecified route of administration on 09Jan2021 for COVID-19 immunization. Medical history included asthma, dyspepsia, and muscle spasms. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included calcium carbonate from 07Apr2003 for osteoporosis prophylaxis, beclometasone dipropionate (CLENIL MODULITE) from 07Apr2003 for asthma, ferrous sulfate from 07Apr2003 for blood iron, omeprazole magnesium, (LOSEC) from 06Feb2003 for dyspepsia, paracetamol from 11Jul2005 for analgesic therapy, quinine for muscle spasms, and salbutamol from 24Nov2008 for asthma. Patient has not tested positive for COVID-19 since having the vaccine. Patient attended vaccination centre on 09Jan2021. Patient was found unresponsive in chair on 12Jan2021 and pronounced dead by paramedics on 13Jan2021 (as reported). Post-mortem give coronary artery disease (onset date not reported) as cause of death. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: coronary artery disease; Autopsy-determined Cause(s) of Death: coronary artery disease


VAERS ID: 978488 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 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: IEPFIZER INC2021073695

Write-up: SUDDEN DEATH UNEXPECTED; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is IE-HPRA-2021-063468. A 78-year-old male patient received BNT162B2 (COMIRNATY; Lot number unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient''s medical history was not reported. There were no concomitant medications. The patient experienced sudden death unexpected on an unspecified date, following vaccination. The death occurred 24 hours post vaccination; the patient died. It was reported that the death was sudden and unexpected. 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 cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 978490 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Malaise, Pyrexia, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: 2021-01-23
   Days after onset: 22
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 (treated with medications)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021067523

Write-up: a suspicion that he had corona; a suspicion that he had corona; he raised fever; he did not feel well; This is a spontaneous report from a contactable consumer reported for his/her father. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date in Jan2021 (reported as 3 weeks ago) at single dose for covid-19 immunisation. Medical history included hypertension treated with medications. The patient''s concomitant medications were not reported. The patient who was generally healthy was vaccinated 3 weeks ago on an unspecified date in Jan2021 and he was supposed to receive the 2nd vaccine dose today on 23Jan2021. This morning on 23Jan2021, he passed away after he did not feel well from Jan2021 for 3 days and yesterday on 22Jan2021 he raised fever. The cause of death is unknown but there is a suspicion that he had corona. The patient died on 23Jan2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. Information about lot/batch number has been requested.; Reported Cause(s) of Death: a suspicion that he had corona


VAERS ID: 978500 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2020-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-06
   Days after onset: 8
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMOVANE; HALDOL; PARACETAMOL; AFIPRAN; ROBINUL; ALBYL-E; PURSENNID [SENNOSIDE A+B CALCIUM]; LAXOBERAL; MIDAZOLAM PANPHARMA; REMERON; BETULAC; SELO-ZOK; SOMAC; MORFIN [MORPHINE]; AMLODIPIN SANDOZ [AMLODIPINE BESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (Vascular); Behavioural disorder; Bypass surgery; Cardiac arrest; Cardiovascular disorder; Cerebral infarct; Dementia (Severe degree. High incidence of behavioural disorder and psychiatric disorder related to dementia.); Depression; Hypercholesterolemia; Hypertension; Living in nursing home (Resident of nursing home last 5 years, sheltered unit for the past 3 years.); Mental disorder; Nausea; Obstipation; Palliative care; Sleep disorder; Stomach ulcer; Terminal state; Unrest
Allergies:
Diagnostic Lab Data: Test Date: 20200129; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Date: 20210105; Test Name: Body temperature; Result Unstructured Data: Test Result:38.7 Centigrade
CDC Split Type: NOPFIZER INC2021027038

Write-up: Patient died 8 days after vaccination; VOMITING; FEVER; The initial case was missing the following minimum criteria: no first-hand knowledge of the incidents. Upon receipt of follow-up information on 22Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician and healthcare professional downloaded from the Regulatory Authority-WEB. Regulatory authority report number is NO-NOMAADVRE-FHI-2021-U1n7e with Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013746. A 83-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number; EJ6796), intramuscularly in the left arm on 29Dec2020 12:15 at a single dose for COVID-19 immunization. The patient''s medical history included Terminal state, Cerebral infarct from 2006, Depression, Dementia (Severe degree. High incidence of behavioural disorder and psychiatric disorder related to dementia), Living in nursing home (Resident of nursing home last 5 years, sheltered unit for the past 3 years), Hypercholesterolemia, Cardiac arrest in 1999, Hypertension, Bypass surgery in 2004, Alzheimer''s disease (Vascular), Palliative care, sleep disorder, unrest, nausea, cardiovascular disorder, obstipation and stomach ulcer. Concomitant medications included zopiclone (IMOVANE) from 08Oct2018 to 30Dec2020 for sleep disorder, haloperidol (HALDOL) from 18Dec2019 to 29Dec2020, then from 27Dec2020 for unrest, nausea and palliative care, paracetamol from 27Nov2019 to 29Dec2020, metoclopramide hydrochloride (AFIPRAN) from 04Sep2019 to 29Dec2020 for nausea, glycopyrronium bromide (ROBINUL) from 27Dec2020, acetylsalicylic acid, magnesium oxide (ALBYL-E) from an unspecified date to 29Dec2020 for cardiovascular disorder, sennoside A + B calcium (PURSENNID) from 19Feb2018 to 29Dec2020 for obstipation, sodium picosulfate (LAXOBERAL) from 13Mar2019 to 29Dec2020 for obstipation, midazolam hydrochloride (MIDAZOLAM PANPHARMA) from 27Dec2020 for palliative care, mirtazapine (REMERON) from 27May2020 to 29Dec2020 for sleep disorder, lactulose (BETULAC) from 29Jan2020 to 29Dec2020, metoprolol succinate (SELO-ZOK) from 06Nov2017 to 29Dec2020 for hypertension, pantoprazole sodium sesquihydrate (SOMAC) from 14Aug2019 to 29Dec2020 for stomach ulcer, morphine (MORFIN) from 27Dec2020 for palliative care, amlodipine besilate (AMLODIPIN SANDOZ) from 13Mar2019 to 29Dec2020 for hypertension. In the press release by the Agency, it was stated that the Agency and the Institute were carefully examining seven reported deaths to assess whether there was a connection with the corona vaccine. During the pandemic vaccination, the Agency and the Institute monitor side effects that were reported on an ongoing basis, and respond quickly to suspected unexpected, new or serious side effects. As of January 8th, seven reports of deaths that occurred a few days after vaccination was received. Currently, residents of selected nursing homes have received the corona vaccine Comirnaty (BioNTech/Pfizer). The very weakest and most vulnerable, who have serious diseases, were now being vaccinated. Then there will probably be deaths close to the time of vaccination. We must then consider whether it was the vaccine that was the cause of the death, or whether it was a coincidence that it happens so soon after vaccination, said the medical director. In nursing homes, about 400 people die per week. The Institute monitors mortality in certain population. The Agency and the Institute follow-up all reports of suspected side effects, including death, to assess the causality. Comirnaty and side effects: The studies on which the temporary approval of the vaccine was based do not include persons over 85 years of age. Therefore, we know little about how any side effects will affect the very elderly. We assume that any side effects will be the same in the elderly as in younger age groups. This was something we follow closely. The most common side effect of the vaccine was pain at the injection site, which more than 80 percent of those vaccinated will experience. Other common side effects are fatigue, headache, muscle aches, joint pain, chills and fever. The reactions can be unpleasant but go away after a few days. Following the use of the vaccine in certain countries, some cases of severe allergic reactions have been reported. Most side effects occur shortly after vaccination and disappear after a few days. Even if the new vaccines have been tested in large studies with many participants, it will never be possible to completely insure against unknown side effects. It was reported that the patient experienced Vomiting and Fever which were both Disabling/Incapacitating on 29Dec2020, after vaccination with COVID-19 Vaccine, Comirnaty. The patient was already in palliative care and in terminal phase prior to the vaccination. The palliative care plan was made two days before the vaccination. The patient often needs palliative treatment and is in a terminal phase. She was not to be given cardiopulmonary resuscitation (DNR order) for the past 3 years. She had complex somatic and cognitive challenges and a gradual deterioration of health/function level in the last two years, with significant worsening last (approximately) 4 months. In consultation with a doctor, it was considered that the patient could receive the vaccine against covid-19. On the day of vaccination, the patient was afebrile and had no acute infection. Her temperature was 37.6 shortly after the vaccination on 29Jan2020. After that, the temperature has varied from normal values to a maximum of 38.7 on 05Jan2021 and Albyl-E was given to the patient immediately after vaccination. The patient had been in bed a lot in the last days before the vaccination. It was reported that the patient died 8 days after vaccination on 06Jan2021. The death was expected since the patient was seriously ill. The outcome of the event vomiting was unknown while the outcome of the event pyrexia was not recovered. It was unknown if an autopsy was performed and cause of death was not reported. Reporter comment: 08Jan2021 NIPH: Received additional information fatal outcome. This is a preliminary report 13Jan2021 NIPH: Requested additional information about fatal outcome. This is a preliminary report 14Jan2021 NIPH: Received additional information fatal outcome. This is a final report. Frail nursing home resident with severe dementia, psychiatric disorders, other somatic underlying conditions, and with a significant deteriorating of health for the past months, experienced symptoms as described the day after vaccination. Terminal care has been initiated. Sender comment: An 83-year-old female patient with vomiting, fever and decreased general condition after vaccination (same day) with covid-19 vaccine (Comirnaty). The patient was already in palliative care and in terminal phase before vaccination. This vaccine is marked with a black triangle because it is a new vaccine. This means that the vaccine is subject to special treatment monitoring to detect new safety information as fast as possible. Healthcare professionals are encouraged to report suspected side effects. It is especially important that serious and / or unusual side effects are reported. The most common side effects with study participants was injection site pain ($g 80%), fatigue ($g 60) %), headache ($g 50%), myalgia and chills ($g 30%), arthralgia ($g 20%), fever and swelling at the injection site ($g 10%). They occurred within 1-2 days after vaccination, was usually of mild or moderate intensity and went over after a few days. Nausea is reported after this vaccine. In conjunction with fever and malaise that may occur in the first 1-2 days. After vaccination, vomiting and vomiting may occur occur as an accompanying symptom. It is stated in the message that the patient has underlying diseases. When vaccinating marginal patients who are ill with many underlying diseases some serious incidents, including deaths, may occur occur shortly after vaccination. In each case it is difficult to know if the incident is due the vaccine, the patient''s underlying disease or other random, at the same time cause that has nothing to do with it current vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Patient died 8 days after vaccination


VAERS ID: 978503 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: Alzheimer''s disease (resident of the dementia ward since Feb2019); Anxiety (gradually stayed more in bed and reduction of food intake); Atrial fibrillation; Cheyne-Stokes respiration; Heart failure; Living in nursing home; Reduced general condition; Terminal state (all medications were discontinued); Tiredness
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: 02 Saturation; Result Unstructured Data: Test Result:93-94
CDC Split Type: NOPFIZER INC2021061096

Write-up: died peacefully; vomiting; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB regulatory authority number NO-NOMAADVRE-FHI-2021-U33zn, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013958. An 84-year-old male patient received the first dose of bnt162b2 (COMIRNATY, batch number: PAA156571, lot number: EJ6795), intramuscular on right arm on 05Jan2021 12:00 at a single dose for covid-19 immunisation. Medical history included advanced Alzheimer''s disease diagnosed in 2015 (resident of the dementia ward since Feb2019); atrial fibrillation, living in nursing home, heart failure; terminal state in Nov2020 (all medications were discontinued. He recovered, and has throughout Christmas been awake and participating for long periods, but also very tired); reduced general condition in Nov2020, periods of anxiety. Then, gradually stayed more in bed and reduction of food intake over the last couple of weeks, but no noticeable deterioration. It was reported that pro''s and con''s of the Covid19 vaccine was considered. The patient obviously had a short life expectancy, in the sense of couple of weeks or months. The benefit of the vaccine was thus marginal, but if he continued in a stable condition, the family would be able to visit him more, something they had a strong desire for. The patient had no difficulty breathing (except Cheyne stokes respiration). The patient''s concomitant medications were not reported. Oxygen (O2) saturation 93-94 (11Jan2021), no pain, afebrile, well circulated. The patient was examined by doctor 11Jan2021 and was considered as preterminal. "Last days of Life" was introduced in understanding with the family. The patient experienced vomiting on 08Jan2021. It was reported that the patient died peacefully on 13Jan2021 and the case was considered to be serious. Outcome of the event vomiting was unknown. Outcome of the event died peacefully was fatal. It was unknown whether an autopsy was performed. Sender''s Comments: Patient in his 80s with advanced Alzheimer''s dementia, atrial fibrillation, heart failure, with expected short life received vaccine 05Jan2021. Unchanged condition the first few days, but gradually less food and drink intake, and less contactable for long periods. An episode with vomiting 08Jan2021. Rated as preterminal 11Jan2021. Died 13Jan2021. Comment: The information is registered in the national adverse reaction register ( Medicines Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. Based on the information in the report, it is likely that known underlying diseases are the cause of death. However, there is a temporal connection, and it cannot be completely ruled out that the vaccine may have contributed to the aggravation of the patient''s underlying disease. Based on WHO criteria, we consider the causal link between Comirnaty and death to be possible. That is, 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. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: died peacefully


VAERS ID: 978504 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: NOPFIZER INC2021027033

Write-up: seven reports of deaths which occurred some days after vaccination/found dead on the floor six days after vaccination; The initial case was missing the following minimum criteria: no first-hand knowledge of the incidents. Upon receipt of follow-up information on 22Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician and healthcare professional downloaded from the regulatory authority -WEB. Regulatory authority report number is NO-NOMAADVRE-FHI-2021-U4ed1, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013970. A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number; EJ6795), intramuscularly at the left arm on 07Jan2021 13:41 at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. In the press release by the Agency, it was stated that the Agency and the Public Health were carefully examining seven reported deaths to assess whether there was a connection with the corona vaccine. During the pandemic vaccination, the Agency and the Public Health monitor side effects that were reported on an ongoing basis, and respond quickly to suspected unexpected, new or serious side effects. As of January 8th, seven reports of deaths that occurred a few days after vaccination was received. Currently, residents of selected nursing homes have received the corona vaccine Comirnaty (BioNTech/Pfizer). The very weakest and most vulnerable, who have serious diseases, were now being vaccinated. Then there will probably be deaths close to the time of vaccination. We must then consider whether it was the vaccine that was the cause of the death, or whether it was a coincidence that it happens so soon after vaccination, said the medical director. In nursing homes, about 400 people die per week. The Public Health monitors mortality in the population. The Agency and the Public Health follow-up all reports of suspected side effects, including death, to assess the causality. Comirnaty and side effects: The studies on which the temporary approval of the vaccine was based do not include persons over 85 years of age. Therefore, we know little about how any side effects will affect the very elderly. We assume that any side effects will be the same in the elderly as in younger age groups. This was something we follow closely. The most common side effect of the vaccine was pain at the injection site, which more than 80 percent of those vaccinated will experience. Other common side effects are fatigue, headache, muscle aches, joint pain, chills and fever. The reactions can be unpleasant but go away after a few days. Following the use of the vaccine in the county and another county, some cases of severe allergic reactions have been reported. Most side effects occur shortly after vaccination and disappear after a few days. Even if the new vaccines have been tested in large studies with many participants, it will never be possible to completely insure against unknown side effects. It was reported that a woman in her 90s (reported as 93 years old), a nursing home resident, received the covid-19 vaccine Comirnaty. Allegedly no side effects reported after vaccination. She was found dead on the floor on 13Jan2021, six days after vaccination. There was no information in the report on the woman''s state of health in the time just before vaccination or on the day of vaccination, nor information on previous illnesses or medications. The patient died on 13Jan2021. Cause of death was not reported. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Sender''s comments: "A woman in her 90s, a nursing home resident, received the covid-19 vaccine Comirnaty. Allegedly no side effects reported after vaccination. She was found dead on the floor six days after vaccination. There is no information in the report on the woman''s state of health in the time just before vaccination or on the day of vaccination, nor information on previous illnesses or medications. When vaccinating marginal patients who are ill with underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It can not be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease, but based on the information in the report, we have no basis for assessing this. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else accidentally occurring at the same time, a cause that has nothing to do with the vaccination in question. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established."; Reported Cause(s) of Death: seven reports of deaths which occurred some days after vaccination/found dead on the floor six days after vaccination


VAERS ID: 978507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder; Dementia; Dyslipidaemia; Hospitalization (long-term); Hypertension; Non-insulin-dependent diabetes mellitus; Recurrent respiratory tract infections
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021060849

Write-up: Death; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority -WEB PT-INFARMED-J202101-711. A contactable other health care professional reported that an 81-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EL1491), intramuscular on 14Jan2021 at a single dose for COVID19 immunisation. The patient''s medical history included non-insulin diabetes mellitus, recurrent respiratory tract infections, hypertension, dyslipidaemia, cardiovascular disorder, and dementia all from an unknown date and unknown if ongoing; and long-term hospitalization from 07Nov2019. Concomitant medications were not reported. The patient experienced death on 14Jan2021. The adverse reaction (ADR) occurred a few minutes after administration of the first dose of the suspected vaccine (more than 60 minutes, less than 180 minutes). The patient was observed for 30 minutes after administration of the vaccine without complications. The patient had been hospitalized since 07Nov2019 and was awaiting transfer to a home. He had a history of recurrent respiratory infections, dyslipidemia, hypertension, non-insulin-treated diabetes mellitus, uncharacterized but advanced dementia and terminal cardiovascular disease. The decision was made not to resuscitate due to the general fragile state of health presented by the patient. A history of adverse reaction to any drug is unknown. Given the patient''s clinical history, it was decided not to perform an autopsy. Evolution of ADR was fatal. Reporter Comment indicated causality was possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 978516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac disorder, Crepitations, Oxygen saturation, Oxygen saturation decreased, Pulmonary oedema, Sepsis
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Infective pneumonia (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: LEVAXIN; LACTULOSE; MIRTAZAPINE; ELIQUIS; OMEPRAZOLE; BETOLVIDON; OXASCAND; ALVEDON; ZOPICLONE; JANUVIA [SITAGLIPTIN PHOSPHATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Cardiac failure; Chronic pain; Depression; Diabetes; DVT; Fall (She had some pain after the trauma); Heart disease, unspecified; Hypothyroidism; Memory disturbance; Myocardial infarct
Allergies:
Diagnostic Lab Data: Test Name: bloodpressure; Result Unstructured Data: Test Result:without any comments for the next 24 hours; Test Name: temperature; Result Unstructured Data: Test Result:38,1 Centigrade; Test Name: saturation; Test Result: 89 %; Test Name: saturation; Test Result: 70 %
CDC Split Type: SEPFIZER INC2021060260

Write-up: Acute sepsis-like infection; Acute heart disease, aggravated; coughing/possible pulmonary edema; saturation 70%; crackles; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority WEB, Regulatory Authority number SE-MPA-2021-000177, other case identifier number SE-MPA-1610094420362. A 97-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date to an unspecified date at a single dose for covid-19 immunisation. The patient''s medical history included myocardial infarct, memory disturbance, hypothyroidism, heart disease, unspecified, cardiac failure, anxiety, depression, chronic pain, diabetes all from an unknown date and unknown if ongoing; deep vein thrombosis (DVT) in 2018 and unknown in ongoing, and Fall in 30Dec2020. Concomitant medications included levothyroxine sodium (LEVAXIN), lactulose, mirtazapine (MIRTAZAPINE), apixaban (ELIQUIS), omeprazole, cyanocobalamin (BETOLVIDON), oxazepam (OXASCAND), paracetamol (ALVEDON), zopiclone, and sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]. The patient experienced acute heart disease aggravated and acute sepsis-like infection on an unspecified date. It further reported that the same day the patient received Comirnaty, the patient had a fall, a medical examination was done by a physician, she showed no signs of serious injury. She had some pain after the trauma. The blood pressure was without any comments for the next 24 hours. In the morning day 2 after the vaccination she started coughing and crackles, the temperature was 38.1 degrees Celsius and saturation was 89%. A physician decided together with the relatives, that she should stay and be given palliative medicines. The patient''s condition was detoriated, saturation 70%. Furix was given for possible pulmonary edema and Robinul for crackles was given. Two days after vaccination the patient died due to sepsis and acute heart disease agrravated. It was unknown if an autopsy was performed. Outcome for all the other events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Sepsis; acute heart disease aggravated


VAERS ID: 978519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2020-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-01
   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: FUROSEMID ACCORD; RESONIUM; SOBRIL; ALLOPURINOL NORDIC DRUGS; ARANESP; MINIDERM [GLYCEROL]; GLYCERYLNITRAT I ESSEX; ACETYLCYSTEINE; MIDAZOLAM HAMELN; LATANOPROST STADA; AERIUS [DESLORATADINE]; ROBINUL; MORFIN MEDA; ALVEDON; VISCOTEARS; FINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Chronic renal failure; Fall; Hospitalization; Infection; Ischemic heart disease; Necrosis (due to vascular disease); Peripheral swelling; Peripheral vascular disease; Pulmonary edema; Somnolence (after Imovane intake); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021060002

Write-up: DEATH; breath shortness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, report number SE-MPA-2021-000419, other case identifier SE-MPA-1610636715016. An 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot/batch number: EJ6796) solution for injection, intramuscular in Dec2020 at a single dose for Covid-19 vaccination. Medical history included somnolence in 2016 after Imovane intake, atrial fibrillation, Peripheral vascular disease, chronic renal failure, cardiac failure, type II diabetes mellitus, ischemic heart disease, Peripheral swelling and some fluid in lung; all unknown if ongoing; admitted to hospital after fall, unknown infection, and necrotic toes. Concomitant medications included furosemide sodium (FUROSEMID ACCORD) from 18Dec2020 as needed, 2-4 ml, sodium polystyrene sulfonate (RESONIUM) from 14Dec2020 at 0.5 DF, as needed, oxazepam (SOBRIL, 5mg) from 23Dec2020 as needed, 1-2 tablets, allopurinol (ALLOPURINOL NORDIC DRUGS, 100mg) from 22Aug2020 to Dec2020 at 100 mg, daily, darbepoetin alfa (ARANESP, 30ug) from 07Dec2020 at 1 DF, every 2 weeks, glycerol (MINIDERM [GLYCEROL], 20%) from 28Nov2020 to Dec2020 at 1 DF, as needed, glyceryl trinitrate (GLYCERYLNITRAT I ESSEX, 1%) from 28Nov2020 to Dec2020 at 1 DF, as needed, max 2 DF/daily, acetylcysteine 200mg from 28Nov2020 to Dec2020, midazolam hydrochloride (MIDAZOLAM HAMELN) from Dec2020 at as needed, 0.2-0.5 ml, latanoprost (LATANOPROST STADA, 50ug/ml) from 25May2018 to Dec2020 at 1 DF, daily, 1 drop at night, desloratadine (AERIUS [DESLORATADINE, 5mg]) from 20Dec2020 at 5 mg, daily, glycopyrronium bromide (ROBINUL) from 23Dec2020 at 1 mL, as needed, morphine hydrochloride (MORFIN MEDA) from Dec2020 at as needed, 0.25-1 ml, paracetamol (ALVEDON, 500mg) from 08Dec2020 at 3000 mg, daily, carbomer (VISCOTEARS, 2mg/g) from 25May2018 to Dec2020 at 1 DF, as needed, 1 dropp, finasteride (FINASTERID SANDOZ, 5mg) from 21Nov2017 to Dec2020 at 5 mg, daily, sodium picosulfate (CILAXORAL, 7.5mg/ml) from 18Dec2020 at daily, 10-20 drops per night, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) from 19Dec2020 at 1-2 sachets per day, omeprazole 10mg from 28Nov2020 to Dec2020 at 10 mg, daily, furosemide (FURIX [FUROSEMIDE, 500mg]) from Dec2020 at 250 mg, daily, haloperidol (HALDOL, 5mg/ml) from Dec2020 at as needed, 0.1-0.2 ml, morphine hydrochloride (MORFIN ABCUR, 10mg/ml) from 23Dec2020 at as needed, 0.25-0.5 ml, budesonide, formoterol fumarate (SYMBICORT FORTE TURBUHALER) from 09Dec2020 at 2 DF, daily, dalteparin sodium (FRAGMIN, 5000 IU) from 10Dec2020 at 1 DF, daily, hypromellose (HYPROSAN, 3.2mg/ml) from 15Jan2019 to Dec2020 at 1 DF, as needed, 1 dropp. The patient previously took zopiclone (IMOVANE) in 2016 and experienced somnolence. Patient was admitted to hospital after fall with unknown infection and necrotic toes due to vascular disease. Treated with antibiotics. During the hospital visit, patient had worsened renal and heart failure despite treatment. Transferred to palliative care. Awake, eating and drinking but bedridden. Peripheral swelling and some fluid in lung. Patient was then vaccinated with Comirnaty. After an hour, patient received palliative injection with morphine for breath shortness. Patient died the same evening. According to the reporter, since the patient was in the palliative care phase, it was not sure that death was caused by the vaccine. The patient died in Dec2020. The action taken in response to the event for bnt162b2 was not applicable. It was unknown if an autopsy was performed. No follow-up activities are needed. No further information is expected.; Reported Cause(s) of Death: Uknown cause of death


VAERS ID: 978520 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Auscultation, Blood creatinine, Blood pressure measurement, Heart rate, Infection, Oxygen saturation, Pulmonary oedema, Respiratory rate, SARS-CoV-2 test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), 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), Haemodynamic oedema, effusions and fluid overload (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Basal ganglion degeneration; Essential hypertension; Progressive supranuclear palsy (PSP/Parkinson +); Prostate cancer; Prostatectomy
Allergies:
Diagnostic Lab Data: Test Name: Lung Auscultation; Result Unstructured Data: Test Result:with rattle but no stridor or rhonchi; Test Name: creatinine; Result Unstructured Data: Test Result:250; Test Name: bloodpressure; Result Unstructured Data: Test Result:around 80 systolic; Comments: low blood pressure; Test Name: bloodpressure; Result Unstructured Data: Test Result:elevated; Test Name: pulse; Result Unstructured Data: Test Result:palpable; Comments: in radials and groins but not on feet; Test Name: saturation; Test Result: 80 %; Test Name: respiratory rate; Result Unstructured Data: Test Result:around 40; Test Name: respiratory rate; Result Unstructured Data: Test Result:reduced to 25; Test Name: Covid-19 test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021060174

Write-up: Pulmonary oedema; Acute renal failure; suspect infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, Regulatory Authority number SE-MPA-2021-000424. Other case identifier number SE-MPA-1610692019196. A 76-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on Jan2021 at a single dose for Covid-19 immunisation. Medical history included essential hypertension, basal ganglion degeneration, prostate cancer with prostatectomy from 2011, and progressive supranuclear palsy (PSP/Parkinson+); all unknown if ongoing. The patient''s concomitant medications were not reported. On Jan2021, the patient experienced pulmonary oedema and acute renal failure. It was reported that the day after vaccination with Comirnaty the patient was found with dyspnea and reduced general condition. The patient was sent to hospital and pre-hospital he received furosemide (FURIX) 40 mg and Combivent with no effect, he arrived in the hospital with 15 liters of Oxygen on a breathing mask. According to the rapporteur the patient has fulminant pulmonary oedema and acute renal failure (creatinine 250). According to the rapporteur, the lungs were auscultated with rattle but no stridor or rhonchi, respiratory rate around 40. The patient has a low blood pressure around 80 systolic but the pulse is palpable in radials and groins but not on feet. The patient gets CPAP-treatment and Nitroglycerine, then the blood pressure elevated, and respiratory rate reduced to 25 and saturation 80 %. The patient was also getting antibiotics described in the report as "Pip/Taz 4g" and 300 mg of Nebcina because of suspect infection. The patient was Covid-19 negative. According to the rapporteur the patient gets palliative treatment and dies one week later. The patient died on an unspecified date due to pulmonary oedema and acute renal failure. The outcome of the event suspect infection was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Acute renal failure; Pulmonary oedema


VAERS ID: 980257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood lactic acid increased, Intestinal dilatation, Intestinal ischaemia, Leukocytosis, SARS-CoV-2 test, Sepsis
SMQs:, Acute pancreatitis (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific dysfunction (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: 2021-01-13
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 PCR; Result Unstructured Data: Test Result:no result yet
CDC Split Type: BEPFIZER INC2021073957

Write-up: Clinical signs of intestinal ischemia; since this morning 13/01/21 severe stomach pain; Sepsis; high lactate; Leukocytosis; Intestinal loops plotted on abdominal overview; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency. The regulatory authority report number is BE-FAMHP-DHH-N2021-75412. An 82-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 08Jan2021 as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced the following events on 13Jan2021, which were serious as they involved hospitalization, and lead to death: clinical signs of intestinal ischemia; since this morning 13/01/21 severe stomach pain; sepsis; high lactate; leukocytosis; intestinal loops plotted on abdominal overview. Details were ad follows: the reporter noted that on entry, still fairly good blood count and ionogram, normal kidney function; high lactate and leukocytosis were noted. The patient''s condition rapidly deteriorated, she fell into sepsis and died. A CT was not performed. A Covid-19 PCR was performed on an unspecified date, but no results yet. The patient was on an unspecified anticoagulation therapy. The patient had included in her last will, that her life should not be prolonged in certain cases. The patient died on 13Jan2021. It was not reported if an autopsy was performed, but an autopsy has been requested. No follow-up ttempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: On entry, still fairly good blood count and ionogram, normal kidney function; ; high lactate and leucocytosis The patient''s condition rapidly deteriorated, she fell into sepsis and died. A CT is not performed. Covid-19 PCR performed but no result yet. General practitioner does not mention Covid-19 cases in the residential care centre. An autopsy has been requested. The patient was on anticoagulation therapy. The patient had included in her last will that her life should not be prolonged in certain cases.; Reported Cause(s) of Death: Intestinal loops plotted on abdominal overview


VAERS ID: 985901 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Glycosylated haemoglobin, 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: 2021-01-01
   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: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; LISINOPRIL; METFORMIN; NITRAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus inadequate control (Poorly controlled); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Mental disorder; Neglect of personal appearance; Comments: Known poorly controlled diabetic. Poor attender at surgery. Routine bloods in April 2020 HbA1c 80. Very unkempt individual with concerns re self-neglect. Attendance for vaccination was first attendance at surgery in 10 months. Known mental illness, on long-term benzodiazepines Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 202004; Test Name: hba1c; Result Unstructured Data: Test Result:80
CDC Split Type: GBPFIZER INC2021056670

Write-up: Sudden death unexplained; This is a spontaneous report from a contactable physician. This is a report received from Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory authority report number was GB-MHRA-ADR 24619825 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-202101201100194950. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK1768), via an unspecified route of administration on 16Jan2021 as a single dose for COVID-19 immunization. Medical history included immunodeficiency (an illness or condition which reduces the immune response), poorly controlled diabetic (HbA1c in Apr2020 was 80), mental illness, and unkempt individual with concerns of self-neglect. The patient had not had symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications included acetylsalicylic acid (ASPIRIN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), and nitrazepam (MANUFACTURER UNKNOWN). On an unknown date in Jan2021, the patient experienced sudden death unexplained. The clinical course was as follows: The patient came in for the vaccination and was not overtly unwell. He was observed for 15 minutes following the vaccination. On 20Jan2021, the patient was found dead by police and had been transferred to the coroner. It was not confirmed if an autopsy was going to be performed. At the time of reporting, there was no clear evidence as of yet to link the vaccination and death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 985913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 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: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified; Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021069130

Write-up: SUDDEN DEATH (FIVE DAYS AFTER VACCINATION); This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB (NO-NOMAADVRE-FHI-2021-U33rm & NO-NOMAADVRE-E2B_00013923). A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscularly in the left arm on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, unspecified and living in nursing home. The patient''s concomitant medications were not reported. The patient experienced sudden death (five days after vaccination) on 12Jan2021. There were no acute adverse reactions after the vaccination. The patient died on 12Jan2021. It was unknown if an autopsy was performed. The reporter had no strong suspicion that the death is related to the vaccine. Severe dementia (and age) are considered the most likely cause of death. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or some else accidental, concurrent cause that has nothing to do with the vaccination in question. Based on the information in the report, only the reporter''s causality assessment is registered. The reporter has stated that there is no suspicion of a connection with vaccination, and therefore a causal connection with vaccination is considered unlikely. Since the patient died, the report is classified as serious. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reporter''s Comments: 14Jan2021: batch no. missing, have sent request to reporter (in Sender''s Com.) 15Jan2021 NIPH: Received additional information (phone) about most likely cause of death. This is a final report.; Sender''s Comments: The Company cannot completely exclude the possible causality between the reported sudden death and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. However, the pre-existing medical condition of heart disease for this 95-year-old female patient might have provided alternative explanations. 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: SUDDEN DEATH (FIVE DAYS AFTER VACCINATION)


VAERS ID: 985915 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Fatigue, General physical health deterioration, Pyrexia, Red blood cell sedimentation rate
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   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: Atrial fibrillation; Cardiac failure
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden (Last couple of years. Able to be seated in a chair some of the time during the day.); Living in nursing home; Oral candidiasis; Rheumatic disorder; Urosepsis
Allergies:
Diagnostic Lab Data: Test Date: 20210103; Test Name: Body temperature; Result Unstructured Data: Test Result:$g38 Centigrade; Test Date: 20201223; Test Name: C-reactive protein; Result Unstructured Data: Test Result:82 mg/l; Test Date: 20201228; Test Name: C-reactive protein; Result Unstructured Data: Test Result:50 mg/l; Test Date: 20210103; Test Name: C-reactive protein; Result Unstructured Data: Test Result:52 mg/l; Test Date: 20201228; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:78; Comments: Units: mm/h
CDC Split Type: NOPFIZER INC2021069111

Write-up: FEVER; REDUCED GENERAL CONDITION; TIREDNESS; This is a spontaneous report downloaded from the regulatory authority-WEB NO-NOMAADVRE-FHI-2021-Upj5z, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013906. A contactable physician reported that a 96-year-old female patient had received bnt162b2 (COMIRNATY, batch/lot number EJ6796), via intramuscular route on 29Dec2020, at single dose (first dose, administered into left arm) for covid-19 immunisation. Medical history included being bedridden from an unknown date and unknown if ongoing (last couple of years, able to be seated in a chair some of the time during the day), living in residential institution from 11Dec2020 to an unknown date, urosepsis from an unspecified date in Dec2020 to an unspecified date in Dec2020, ongoing cardiac failure, oral candidiasis from an unspecified date in Dec2020 to an unspecified date in Dec2020, ongoing atrial fibrillation, and rheumatic disorder from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took cefotaxime for urosepsis from an unspecified date to 23Dec2020. The patient experienced tiredness (fatigue) (death) on 01Jan2021, fever (pyrexia) (death) on 03Jan2021, and reduced general condition (general physical health deterioration) (death) on 01Jan2021. The patient underwent lab tests and procedures which included body temperature: $g38 centigrade on 03Jan2021, c-reactive protein: 82 mg/l on 23Dec2020, 50 mg/l on 28Dec2020, 52 mg/l on 03Jan2021, and red blood cell sedimentation rate: 78 mm/h on 28Dec2020. The patient died on 03Jan2021. It was not reported if an autopsy was performed. The Regional Pharmacovigilance Center has assessed the causal relationship between the suspect product and the reported event(s) as Possible. Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: A 96 Years old Female patient received Comirnaty on 29Dec2020 for VACCINATION. The patient was admitted to NURSING HOME (11Dec2020), after being treated for CARDIAC FAILURE, UROSEPSIS (Dec2020 - Dec2020), ORAL CANDIDIASIS (Dec2020 - Dec2020), for which the patient was treated with Cefotaxime until 23Dec2020. The medical history also included ATRIAL FIBRILLATION, RHEUMATIC DISORDER, and the patient has been BEDRIDDEN the last couple of years, but able to be seated in a chair some of time during the day. On 01Jan2021, the patient developed increasing TIREDNESS, REDUCED GENERAL CONDITION with reduced fluid and food intake. On 03Jan2021, the patient also developed FEVER. Relevant laboratory findings and investigations included in the report ( C-REACTIVE PROTEIN, 23Dec2020, 82 mg/L (Upon discontinuation of cefotaxime.) )( C-REACTIVE PROTEIN, 28Dec2020, 50 mg/L, Stable value since discontinuing cefotaxime.)( ERYTHROCYTE SEDIMENTATION RATE, 28Dec2020, 78 mm/h )( BODY TEMPERATURE, 03Jan2021, $g38 deg C )( C-REACTIVE PROTEIN, 03Jan2021, 52 mg/L ). The reporting physician stated that despite an increased value of C-reactive protein before vaccination, no new infection focus was found, and the patient was clinically stable and in no pain. The physician had also contacted an infectious diseases specialist for advice regarding another geriatric patient with ongoing long-term antibiotic treatment and increased C-reactive treatment, and had received a green light for vaccination with Comirnaty. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. This case was received from a Physician. Sender''s Comments (Health Authority comments): "The report concerns a patient in her 90s, who experienced fatigue, reduced general condition and fever a few days after the first dose of the Covid-19 vaccine Comirnaty, and the patient died. Reporter states that the patient was admitted to the institution after treatment for urosepsis, heart failure and oral candidiasis. The patient had also experienced atrial fibrillation and had been Bedridden for the past couple of years. The patient had been on long-term treatment with cefotaxime, which was discontinued approximately one week before the vaccine was given. The patient had stably elevated CRP (50 mg/L) after discontinuation of cefotaxime, but was clinically stable with no increase in pain and no new focus of infection was found. Another geriatric patient with ongoing long-term antibiotic treatment and elevated CRP had received a clear signal for vaccination from drugs for infection. The most common adverse reactions with Comirnaty in study participants were injection site pain ($g 80%), fatigue ($g 60%), headache ($g 50%), myalgia and chills ($g 30%), arthralgia ($g 20%), fever and swelling at the injection site ($g 10%). They occurred within 1-2 days after vaccination, were usually of mild or moderate intensity and passed after a few days. Adverse reactions occurred less frequently in the elderly ($g 55 years) than in younger adults. Data from use in frail patients with co-morbidity (eg cardiovascular disease) are nevertheless limited, and such lack of information will be obtained in post-marketing studies, among other things. It is stated in the report that the patient had underlying diseases before vaccination. As the incident is described, it is more likely that these diseases are behind the incident. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or other accidental, concurrent 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. Since the patient died afterwards, the report is also classified as serious, even though no causal link between the vaccine and the death has been established". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: TIREDNESS; FEVER; REDUCED GENERAL CONDITION


VAERS ID: 985918 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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: 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: SEPFIZER INC2021066543

Write-up: Mors subita; This is a spontaneous report from a contactable consumer. An 88-years-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced mors subita on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Mors subita


VAERS ID: 990129 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-29
Onset:2021-01-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

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: 2021-01-17
   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: Cholecystolithiasis; Dementia due to Parkinson''s disease; Hydronephrosis (Hydronephrosis II on both sides); Hypospadias (Urethral hypospadias in indwelling catheters); Kidney stones; Reduced general condition; Ulcer duodenal (Ulcera Bulbus duodeni); Urethral catheterization
Preexisting Conditions: Medical History/Concurrent Conditions: Acute kidney injury (status post-acute kidney failure in July 2019); Basal ganglia infarction; Brain stem infarction (basal ganglia infarction)
Allergies:
Diagnostic Lab Data: Test Date: 20201228; Test Name: COVID-19 antigen test; Test Result: Negative ; Comments: Roche SD Biosensor Antigen Test
CDC Split Type: ATPFIZER INC2021068091

Write-up: Death; This is a spontaneous report from a contactable other health professional downloaded from the Medicines Agency (MA) Regulatory authority-WEB. This is a report received from the regulatory authority (BASGAGES). The regulatory authority report number is AT-BASGAGES-2021-00406. An 81-year-old male patient received the bnt162b2 (COMIRNATY; Lot Number: EJ6796), via an unspecified route of administration on 29Dec2020 at 11:00 at a single dose for COVID-19 immunization. The patient''s medical history included brain stem infarction (basal ganglia infarction) from an unknown date and unknown if ongoing, ongoing kidney stones from an unknown date, acute kidney injury from Jul2019 to an unknown date (status post-acute kidney failure in July 2019), ongoing reduced general condition from an unknown date, ongoing hydronephrosis (Hydronephrosis II on both sides) from an unknown date, ongoing hypospadias (Urethral hypospadias in indwelling catheters) from an unknown date, ongoing dementia due to Parkinson''s disease from an unknown date, ongoing Ulcer duodenal (Ulcera Bulbus duodeni) from an unknown date, ongoing cholelithiasis from an unknown date, ongoing indwelling catheters from an unknown date. Concomitant medications were not reported. The patient experienced death on 17Jan2021. The clinical course was reported as follows: At the time of the vaccination, there were no signs of infection. The day before, on 28Dec2020, a rapid antigen test was carried out-by Roche SD biosensor results-negative. The patient underwent lab tests and procedures which included COVID-19 antigen test: negative on 28Dec2020 (Roche SD Biosensor Antigen Test). The patient died on 17Jan2021 due to unknown cause of death. It was unknown if an autopsy was performed. Sender Comment: BASGAGES comment from 21Jan2021: "No symptoms after vaccination on 29Dec2020. Missing information on cause of death - autopsy findings pending and requested." No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 990133 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-01
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: 2021-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Coronary artery disease; Hypertension; Insufficiency cerebrovascular; Myocardial infarction; Polyneuropathy
Preexisting Conditions: Medical History/Concurrent Conditions: Drop seizures; Fall; Laceration of head
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021074222

Write-up: died at the day of vaccination; This is a spontaneous report from consumer via regulatory authority downloaded from the regulatory authority-WEB DE-PEI-CADRPEI-2021012730 A 89-year-old male patient received the first dose of bnt162b2 (COMIRNATY) on 18Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing myocardial infarction, ongoing atrial fibrillation, ongoing insufficiency cerebrovascular, ongoing hypertension , drop seizures, ongoing coronary artery disease and ongoing polyneuropathy. Patient had a fall with a head laceration in Jan2021 (reported as 1 - 2 days before), no further symptoms. The patient''s concomitant medications were not reported. The patient died at the day of vaccination (18Jan2021) in the evening. Event was reported as serious as fatal and due to hospitalization on 18Jan2021. An autopsy was not performed. The family doctor wanted to perform a routine visit on 19Jan2021 and found out about dying on vaccination day. As far as the doctor known, natural death was recorded at the inquest with no further consequences. Sender Comment: coronary heart disease, old myocardial infarction, polyneuropathy, hypertension, atrial fibrillation, cerebrovascular insufficiency, tendency to fall. Regulatory authority assessment for Comirnaty and death was unclassifiable.No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: died at the day of vaccination


VAERS ID: 990137 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   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:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:not available
CDC Split Type: DEPFIZER INC2021067235

Write-up: Ventricular fibrillation of unknown origin; This is a spontaneous report from non-contactable physician downloaded from the regulatory authority-WEB. Regulatory authority report number DE-PEI-PEI2021001023. A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Jan2021 as first single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced ventricular fibrillation of unknown origin on 18Jan2021, which was serious as it lead to death. The patient underwent lab tests and procedures which included electrocardiogram on an unspecified date, the results were not available. The patient died on 18Jan2021. An autopsy was not performed. Death cause was reported as ventricular fibrillation. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Ventricular fibrillation


VAERS ID: 990138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-03
   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: Apoplexy; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Comments: continuously
CDC Split Type: DEPFIZER INC2021067276

Write-up: Temperatures of 39.5 ? C continuously; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (DE-PEI-PEI2021001079). A 100-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing hypertension arterial and ongoing apoplexy; both from an unspecified date. The patient''s concomitant medications were not reported. The patient experienced temperatures of 39.5 ? C continuously on 01Jan2021. The event was reported as being fatal. The patient underwent lab tests and procedures on 01Jan2021 which included: body temperature: 39.5 ? C continuously. The patient died on 03Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Temperatures of 39.5 ? C continuously


VAERS ID: 990139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-01-18
   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: Apoplexy; Coronary heart disease; COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210118; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade
CDC Split Type: DEPFIZER INC2021067286

Write-up: Temperatures of 40 Centigrade; This is a spontaneous report from a non-contactable physician downloaded from the Agency-WEB (DE-PEI-PEI2021001083). An 85-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Jan2021 at a single dose for COVID-19 immunization. Medical history included non-ongoing covid-19 from Jul2020 to an unknown date, coronary heart disease and apoplexy. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 immunization. The patient experienced temperatures of 40 centigrade on 18Jan2021, which was reported as being fatal. The patient underwent lab tests and procedures which included body temperature: 40 centigrade on 18Jan2021. The outcome of temperatures of 40 Centigrade was fatal. The patient died on 18Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Temperatures of 40 Centigrade


VAERS ID: 990143 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Decreased appetite, Diet refusal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes mellitus; Fracture rib; Hypertension; Hypothyroidism; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021073638

Write-up: Unknown cause of death (authopsy results pending); Appetite lost; Food refusal; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory authority-WEB. Regulatory Authority DE-PEI-PEI2021001281. This 83-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot number EM0477), via intramuscular, at single dose on 09Jan2021 for COVID-19 immunization. Relevant medical history included hypertension, diabetes mellitus, fracture rib from 2020, Parkinson''s disease with dementia, and hypothyroidism, all unknown if ongoing at the time of death (as reported). No relevant concomitant medications were provided. According to the facility management and care documentation, at the time of the vaccination (09Jan2021) and in the 3 following days there were no special health conditions / complaints. The resident complained of loss of appetite at lunchtime on 12Jan2021, he refused to eat in the evening and then died in the evening. The care documentation did not reveal any abnormalities in the context of the medical investigation. No abnormalities or vaccination complications in connection with previous vaccinations were documented. The patient died on 12Jan2021 due to appetite lost and diet refusal. However, the final cause of death was unknown (autopsy results pending). Senders comment: The report from the nursing home: the death of a resident who received a COVID vaccination as part of the local vaccination campaign occurred 3 days ago. From the point of view of the caring staff, the resident died "unexpectedly". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Appetite lost; Food refusal; Unknown cause of death


VAERS ID: 990144 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Malaise, Sudden death, Vital signs measurement
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: 2021-01-13
   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: SPIRONOLACTON; FOLSAN; LANTUS; LEVETIRACETAM; OXAZEPAM; RUPATADINE [RUPATADINE FUMARATE]; ACTRAPID; NEUROTRAT [CYANOCOBALAMIN;LIDOCAINE HYDROCHLORIDE;PYRIDOXINE HYDROCHLORIDE;THIAMINE HYDROCHLORIDE]; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute allergic urticaria; Allergic contact dermatitis; Cerebral artery stenosis; Cerebral infarction; Consciousness clouding; Diabetes mellitus; Epilepsy; Hip prosthesis user; Korsakov''s syndrome; Psoriasis; Stroke; Traumatic brain injury
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: blood glucose; Test Result: 128 mg/dl; Test Date: 20210113; Test Name: vital signs; Result Unstructured Data: Test Result:normal
CDC Split Type: DEPFIZER INC2021067333

Write-up: Death of unknown cause; Malaise; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority -WEB. This is a report received from the German Regulatory Authority. Regulatory authority report number was DE-DCGMA-21187498. A 79-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EJ6796), via an unspecified route of administration on 13Jan2021 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included traumatic brain injury from an unknown date and unknown if ongoing, cerebral artery stenosis from an unknown date and unknown if ongoing, diabetes mellitus from 05Nov2012 and unknown if ongoing, stroke on an unknown date, epilepsy from 04Mar2014 and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, cerebral infarction on 04Mar2014, allergic contact dermatitis from an unknown date and unknown if ongoing, hip prosthesis user from an unknown date and unknown if ongoing, Korsakoff''s syndrome from 05Nov2012 to an unknown date, consciousness clouding from 04Mar2014 and unknown if ongoing, and acute allergic urticaria from 04Nov2019 and unknown if ongoing. Concomitant medications included spironolactone (SPIRONOLACTON), folic acid (FOLSAN), insulin glargine (LANTUS), levetiracetam (MANUFACTURER UNKNOWN), oxazepam (MANUFACTURER UNKNOWN), rupatadine fumarate (MANUFACTURER UNKNOWN), insulin (ACTRAPID), cyanocobalamin/lidocaine hydrochloride/pyridoxine hydrochloride/thiamine hydrochloride (NEUROTRAT), and bisoprolol (MANUFACTURER UNKNOWN). On 13Jan2021, the patient experienced malaise and sudden death of unknown cause. The clinical course was as follows: After getting the vaccine, the patient apparently did not feel well. Vital signs were normal. Blood glucose in the evening was 128mg / dl and 6 units of insulin glargine was taken as always. The patient was not given regular insulin. The patient died on 13Jan2021. It was not reported if an autopsy was performed. The clinical outcome of the malaise was reported as fatal. According to the physician, the patient was not expected to die and the cause of death was unclear and was stated as such on the death certificate. The physician stated that there was a temporal connection with the vaccination, but it could also be a coincidence. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 990146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-02
Onset:2021-01-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Fluid intake reduced, General physical health deterioration, Hypophagia
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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: CALCIUM OG D-VITAMIN; SERTRALINE; CENTYL MED KALIUMKLORID; PANODIL
Current Illness: Dementia (Severe dementia for many years); General physical health deterioration; Markedly reduced food intake (In the christmas days the patient becomes quietly and food intake reduces)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021067921

Write-up: The reporter cannot exclude that the vaccine may have a minor role in further worsening of the patients general condition; The reporter cannot exclude that the vaccine may have a minor role in further worsening of the patients general condition; Fluid intake reduced; Markedly reduced food intake; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB (DK-DKMA-WBS-0029044 and DK-DKMA-ADR 24598215). A 91-year-old female patient received BNT162B2 (COMIRNATY; Lot number: EJ6797), via an unspecified route of administration, on 02Jan2021 at a single dose for COVID-19 immunisation. Medical history included ongoing dementia (severe dementia for many years), ongoing markedly reduced food intake (in the Christmas days the patient becomes quietly and food intake reduces), and ongoing general physical health deterioration. Concomitant medications included calcium, vitamin D substances (CALCIUM OG D-VITAMIN) taken for calcium supplementation from 12Sep2018, sertraline (MANUFACTURED BY: HEXAL) taken for sedative therapy from 07Jun2017, bendroflumethiazide, potassium chloride (CENTYL MED KALIUMKLORID) taken for diuretic therapy from 27Jun2016, and paracetamol (reported as: PANODIL BRUS) taken for pain from 04Apr2019. On 05Jan2021, the reporter cannot exclude that the vaccine may have a minor role in further worsening of the patient''s general condition; which was reported as fatal. The patient also experienced fluid intake reduced and markedly reduced food intake on 05Jan2021. It was reported that the patient did not experience any visible side effects. The clinical outcome of fluid intake reduced and markedly reduced food intake was unknown. The patient died on 07Jan2021. The cause of death was reported as general physical health deterioration. An autopsy was not performed. The causality assessment of the physician was reported as: the increasing general weakening had already begun in the Christmas days and that the coincidence with the vaccination is random. The reporter does not believe that the vaccine is the direct cause of the patient''s death, but that he cannot exclude the vaccine. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General physical health deterioration; General physical health deterioration


VAERS ID: 990148 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Hypotension, PO2
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Dehydration (broad), Hypokalaemia (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (HTA); Arthrosis; Dyslipidaemia; Gait disturbance
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: Arterial oxygen partial pressure; Test Result: 85 %; Comments: decreased
CDC Split Type: ESPFIZER INC2021068117

Write-up: Acute respiratory failure; Acute hypotension; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority Agency (EMA) Regulatory Authority -WEB ES-AEMPS-713830. A 91-year-old female patient received bnt162b2 (COMIRNATY) Batch/lot number EJ6796, via an unspecified route of administration on 07Jan2021 at single dose for covid-19 vaccination. Medical history included arthrosis, dyslipidaemia, gait disturbance, arterial hypertension. The patient''s concomitant medications were not reported. The patient previously took lorazepam (ORFIDAL), calcium carbonate colecalciferol (CALCIUM CARBONATE/VITAMIN D3, 2.500 mg (1.000 mg Ca)/880 UI solution/oral suspension oral effervescent), omeprazole (OMEPRAZOL), hydrochlorothiazide ramipril (RAMIPRIL/HYDROCHLOROTHIAZIDE 5 mg/25 mg tablet). The patient experienced acute respiratory failure and acute hypotension on 07Jan2021. The stop date for event acute respiratory failure was reported as 10Jan2021, stop date for event acute hypotension was reported as 08Jan2021, however both events were reported as serious per life threatening and death. The patient underwent lab tests and procedures which included arterial oxygen partial pressure: 85 % (decreased) on 07Jan2021. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute respiratory failure; Acute hypotension


VAERS ID: 990149 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: Medical History/Concurrent Conditions: Dilated cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021067903

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Spanish regulatory authority (AEMPS). The regulatory authority report number is ES-AEMPS-721042. A 46-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EJ6796), intramuscularly on 11Jan2021 at a single dose for covid-19 immunization. The patient''s medical history included uncontrolled idiopathic dilated cardiomyopathy from an unknown date and unknown if ongoing. Concomitant medications were not reported. The clinical course was reported as follows: 46-year-old woman who died two days after the vaccine administration. The patient was a worker of a residence for the elderly. The patient''s background included: uncontrolled idiopathic dilated cardiomyopathy. The family did not associate the vaccine with the death, since her risk of sudden death was very high due to her disease. No more information in digital health history. The clinical outcome of the event was fatal. The patient experienced death on 13Jan2021. The patient died on 13Jan2021 due to an unknown cause of death. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 990150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Peripheral ischaemia
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: ADIRO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular risk; Chronic kidney disease; Dyslipidemia; Hypertension; Type 2 diabetes mellitus; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021067953

Write-up: Leg ischemia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (ES-AEMPS-721677). A 95-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly, on 08Jan2021 at 0.3 mL, single (reported as: 0.3 mL, every 3 months) for COVID-19 vaccination. Medical history included cardiovascular risk factors, hypertension (HT), type 2 diabetes, vascular dementia, chronic kidney disease, and dyslipidemia. Concomitant medications included acetylsalicylic acid (ADIRO). The patient experienced leg ischemia on 11Jan2021, which was reported as fatal. The patient died on 13Jan2021. The cause of death was reported as leg ischemia. 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: Leg ischemia


VAERS ID: 990151 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   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: Arteritis; Hypertension; Non-insulin-dependent diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021073665

Write-up: Cardiac arrest; This is a spontaneous report from a contactable other Healthcare Professional (HCP) from the Medicines Agency (MA) Regulatory Authority -WEB FR-AFSSAPS-CN20210070. An 89-year-old female patient living in a nursing house received the first dose of BNT162B2 (COMIRNATY, Lot # EM0477), intramuscular, on 18Jan2021 at single dose for COVID-19 immunisation. Medical history included arteritis, hypertension, non-insulin-dependent type 2 diabetes. The patient had not presented covid-19 (but not tested). Seven hours after administration of the vaccine, the patient suffered cardiac arrest. Death occurs 58 minutes later despite attempts at resuscitation on 18Jan2021. According to the declarer this effect was completely unexpected. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 990154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Anxiety, Arrhythmia supraventricular, Atrial fibrillation, Blood creatinine, Blood potassium, Blood sodium, Body mass index, C-reactive protein, Cardio-respiratory arrest, Cognitive disorder, Confusional state, Depressed level of consciousness, Dysarthria, Fall, Full blood count, Haemoglobin, Heart rate, Investigation, Malaise, Oxygen saturation, Platelet count, Procalcitonin, Renal failure, SARS-CoV-2 test, Thrombocytopenia, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: VITAMIN D 3; GABAPENTIN; LEVOTHYROX; ZOPICLONE
Current Illness: Tetraparesis (on narrow cervical canal)
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization; Hypothyroidism; Junctional tachycardia (one episode in 2010, no rhythm disturbance since); Kyphoscoliosis (Severe); Malnutrition (BMI 16.5); Osteoporosis; Shingles
Allergies:
Diagnostic Lab Data: Test Date: 20210115; Test Name: creatinine; Result Unstructured Data: Test Result:187 umol/l; Test Date: 20210115; Test Name: potassium; Result Unstructured Data: Test Result:5.4 mmol/L; Comments: hyperkalaemia; Test Date: 20210115; Test Name: sodium; Result Unstructured Data: Test Result:133 mmol/L; Comments: hyponatremia; Test Name: BMI; Result Unstructured Data: Test Result:16.5; Test Date: 20210112; Test Name: CRP; Result Unstructured Data: Test Result:100 mg/l; Test Date: 20210115; Test Name: CRP; Result Unstructured Data: Test Result:186 mg/l; Test Date: 20210112; Test Name: CBC; Result Unstructured Data: Test Result:normal; Test Date: 20210115; Test Name: Hb; Result Unstructured Data: Test Result:13 g/dl; Test Date: 20210112; Test Name: Heart rate; Result Unstructured Data: Test Result:tachycardia 150 beats per minute; Test Date: 20210115; Test Name: Heart rate; Result Unstructured Data: Test Result:alternating episode of 150 bpm tachycardia and sin; Comments: alternating episode of 150 bpm tachycardia and sinus bradycardia; Test Date: 20210104; Test Name: biological assessment; Result Unstructured Data: Test Result:normal; Test Date: 20210112; Test Name: saturation; Test Result: 60 %; Test Date: 20210115; Test Name: saturation; Test Result: 92 %; Comments: O2 requested at 5 L; Test Date: 20210115; Test Name: thrombocytes; Result Unstructured Data: Test Result:96000; Comments: thrombocytopenia 96,000 / mm3; Test Date: 20210115; Test Name: PCT; Result Unstructured Data: Test Result:1 ug/L; Test Date: 20210115; Test Name: Covid CRP test; Test Result: Negative ; Test Date: 20210115; Test Name: leukocytes; Result Unstructured Data: Test Result:10000; Comments: PNN at 10,000 / mm3
CDC Split Type: FRPFIZER INC2021067661

Write-up: Cardio-respiratory arrest; renal failure; thrombocytopenia; cardiorespiratory decompensation; CHUTE; supraventricular arrhytmia; malaise with acute cardiorespiratory decompensation; atrial fibrillation; anxiety progressively worsening; Obnubilation; dysarthria; cognitive disturbances; CONFUSION; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB. This is a report received from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-MP20210050. A 96-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EJ6795), intramuscularly on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included osteoporosis from an unknown date and unknown if ongoing, ongoing tetraparesis (on narrow cervical canal) from an unknown date, kyphoscoliosis from an unknown date and unknown if ongoing (severe), hypothyroidism from an unknown date and unknown if ongoing, junctional tachycardia from 2010 to an unknown date (one episode in 2010, no rhythm disturbance since), shingles from 2018 to an unknown date, hospitalized in a cure center for the elderly from an unknown date and unknown if ongoing, stable undernourished state from an unknown date and unknown if ongoing (BMI 16.5). Concomitant medications included colecalciferol (VITAMIN D 3) taken for an unspecified indication from an unspecified date to an unspecified date (3 months), gabapentin (MANUFACTURER UNKNOWN) taken for neuropathic pain in the narrow cervical canal from an unspecified date to an unspecified date, levothyroxine sodium (LEVOTHYROX) taken for an unspecified indication from an unspecified date to an unspecified date, zopiclone (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to an unspecified date; no recent change in treatment. The patient experienced the following events and outcomes: cardio-respiratory arrest (death, medically significant) on 17Jan2021, obnubilation (death, medically significant) on 08Jan2021, atrial fibrillation (death, medically significant) on 12Jan2021, renal failure (death, medically significant) on 15Jan2021, confusion (death) on 08Jan2021, chute (death) on 12Jan2021, supraventricular arrhythmia (death) on 12Jan2021, dysarthria (death) on 08Jan2021, cognitive disturbances (death) on 08Jan2021, cardiorespiratory decompensation (death, medically significant) on 12Jan2021, malaise with acute cardiorespiratory decompensation (death) on 12Jan2021, anxiety progressively worsening (death) on 08Jan2021, thrombocytopenia (death, medically significant) on 15Jan2021; all reported as fatal. The clinical course was reported as follows: 04Jan2021: normal biological assessment. 08Jan2021: appearance of cognitive disorders with confusion, speech disorder, anxiety progressively worsening. Constants were normal. From the night from 11Jan2021 to 12Jan2021: the patient experienced a fall out of the bed, obnubilation. 12Jan2021: malaise with acute cardiorespiratory decompensation, on AFib (cardiac arrhythmia due to atrial fibrillation) with tachycardia at 150 bpm (AFib was not previously known, cardiologist opinion confirmed AFib and distinguished it from an attack of junctional tachycardia), saturation 60%, absence of fever. The patient''s biological assessment: isolated CRP at 100 (normal CBC); antibioprophylaxis and oxygen therapy. 14Jan2021: very altered clinical state, patient not very reactive, O2 needed. Despite correct figures, the doctor considered the prognosis to be vital and do not find any obvious somatic cause explaining this clinical situation. 15Jan2021: At the clinical level: no improvement, O2 requested at 5 L, saturation at 92%, no fever. Alternating episode of 150 bpm tachycardia and sinus bradycardia. 16Jan2021: dyspneic, the patient received 5 mg of morphine subcutaneously. 17Jan2021: patient deceased The patient underwent lab tests and procedures which included creatinine: 187 umol/l on 15Jan2021, potassium: 5.4 mmol/l on 15Jan2021 (hyperkalaemia), sodium: 133 mmol/l on 15Jan2021 (hyponatremia), body mass index (BMI): 16.5 on an unspecified date, c-reactive protein (CRP): 100 mg/l on 12Jan2021, c-reactive protein: 186 mg/l on 15Jan2021, full blood count (CBC): normal on 12Jan2021, haemoglobin (Hb): 13 g/dl on 15Jan2021, heart rate: tachycardia 150 beats per minute (bpm) on 12Jan2021, heart rate: alternating episode of 150 bpm tachycardia and sinus bradycardia on 15Jan2021, biological assessment: normal on 04Jan2021, saturation: 60 % on 12Jan2021, oxygen saturation: 92 % on 15Jan2021 (O2 requested at 5 L), thrombocytes: 96000 on 15Jan2021 (thrombocytopenia 96,000 / mm3), procalcitonin (PCT): 1 ug/l on 15Jan2021, COVID CRP test: negative on 15Jan2021, leukocytes: 10000 on 15Jan2021 (PNN at 10,000 / mm3). Therapeutic measures were taken as a result of atrial fibrillation, cardiorespiratory decompensation. The patient died on 17Jan2021 due to cardio-respiratory arrest. An autopsy was not performed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 990155 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood pressure measurement, Creatinine renal clearance, Glomerular filtration rate, Productive cough, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: AMLOR; EUPRESSYL [URAPIDIL HYDROCHLORIDE]; KARDEGIC; IRBESARTAN; JANUVIA [SITAGLIPTIN PHOSPHATE]; PARACETAMOL; SEROPLEX; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; ZOPICLONE; METFORMIN; TAHOR
Current Illness: Anxiodepressive syndrome; Chronic renal failure (followed by a nephrologist); Hypertension arterial; Non-insulin-dependent diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Face injury; Fall; Hospitalization (for a fall and facial trauma); Living in residential institution (with a daily nurse); Stools watery
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:12.6 mg/l; Test Date: 20210116; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:normal; Test Date: 202009; Test Name: creatinine clearance; Result Unstructured Data: Test Result:40 ml/min; Test Name: assessment of kidney function (DFG); Result Unstructured Data: Test Result:44 ml/min
CDC Split Type: FRPFIZER INC2021067272

Write-up: Sudden death unexplained; scanty whitish sputum; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority- report received from regulatory authority (AFSSAPS). The regulatory authority report number is FR-AFSSAPS-NY20210069. An 82-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EM0477), intramuscularly on 12Jan2021 at 0.3 mL, single for COVID-19 immunization. Medical history included ongoing Chronic renal failure (followed by a nephrologist) from an unknown date, ongoing anxiodepressive syndrome from an unknown date, ongoing non-insulin-dependent type 2 diabetes from an unknown date, ongoing hypertension arterial from an unknown date, living in a retirement home (with a daily nurse) from an unknown date and unknown if ongoing, hospitalized (for a fall and facial trauma) from Sep2020 to an unknown date, fall and facial trauma from Sep2020 to an unknown date, watery stools from an unknown date and unknown if ongoing. Concomitant medications included amlodipine besilate (AMLOR) taken for an unspecified indication from an unspecified date to an unspecified date, urapidil hydrochloride (EUPRESSYL [URAPIDIL HYDROCHLORIDE]) taken for an unspecified indication from an unspecified date to an unspecified date, acetylsalicylate lysine (KARDEGIC) taken for an unspecified indication from an unspecified date to an unspecified date, irbesartan (MANUFACTURER UNKNOWN) taken for hypertension arterial from an unspecified date to an unspecified date, sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]) taken for type 2 diabetes mellitus from an unspecified date to an unspecified date, paracetamol (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to an unspecified date, escitalopram oxalate (SEROPLEX) taken for anxiodepressive syndrome from an unspecified date to an unspecified date, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) taken for an unspecified indication from an unspecified date to an unspecified date, zopiclone (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to an unspecified date, metformin (MANUFACTURER UNKNOWN) taken for type 2 diabetes mellitus from an unspecified date to an unspecified date, atorvastatin calcium (TAHOR) taken for an unspecified indication from an unspecified date to an unspecified date. The patient experienced: sudden death unexplained (death, medically significant), and scanty whitish sputum (medically significant) on 17Jan2021. The clinical course was reported as follows: On 12Jan2021, the patient was vaccinated with BNT162B2 in the vaccination center. There was nothing noted on the immediate tolerance of the vaccine in the following days. The nurse would visit every day. The patient had been seen on 16Jan2021 as usual. The only complaint, per the nurse: mention of diarrhea but the patient occasionally had watery stools. There was no mention of abdominal pain. There was a normal blood pressure measurement. On 17Jan2021 in the morning, the patient was found in her chair. The patient had eaten the night before (plate on her side) but had not gone to bed. The doctor on duty noted the presence of scanty whitish sputum when the death was ascertained. The death certificate mentioned sudden death. The family did not object to an autopsy. As of 18Jan2021, the attending physician reported: no clearance control since Sep2020. Creatinine 12.6 mg/l, assessment of kidney function (DFG) 44 ml/min. The patient had been hospitalized in Sep2020 for a fall and facial trauma; nothing significant since. Conclusion as reported: Sudden death in an 82-year-old woman with a history of arterial hypertension, non-insulin-dependent type 2 diabetes, chronic renal failure followed by a nephrologist, anxiety-depressive syndrome, five days after the vaccination with BNT162B2. The patient underwent lab tests and procedures which included creatinine: 12.6 mg/l on an unspecified date, creatinine clearance: 40 ml/min in Sep2020, assessment of kidney function (DFG): 44 ml/min on an unspecified date, blood pressure measurement: normal on 16Jan2021. The clinical outcome of the event, scanty whitish sputum, was unknown. The patient died on 17Jan2021 due to sudden death unexplained. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 990192 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EE8493 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Death, Malaise
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   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: Obesity; Comments: Staff member received the vaccine as part of the vaccination programme. Health questionnaire highlighted 1 risk factor - obesity No other health contraindications noted in the assessment Unsure if patient has had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021029248

Write-up: death unexplained; Chest tightness; Chest pain; Generally unwell; This is a spontaneous report received from the Regulatory Agency. Regulatory Authority Report Number: GB-MHRA-WEBCOVID-20210113081829, Safety Report Unique Identifier: GB-MHRA-ADR 24587106. A contactable other healthcare professional reported that a 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EE8493, expiration date: unknown), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included obesity; health questionnaire highlighted 1 risk factor as obesity. No other health contraindications noted in the assessment. The patient''s concomitant medications were not reported. It was unsure if the patient has had symptoms associated with COVID-19. The patient has not been tested/or has had an inconclusive test for COVID-19. The patient is not enrolled in clinical trial. The staff member received the vaccine on Tuesday (05Jan2021) as part of the vaccination programme, felt generally unwell, returned to work and worked for the rest of the week. On Friday (08Jan2021), the patient reported to the line manager, feeling generally unwell with some mild chest tightness. The patient was advised to attend meeting but refused and was sent home with the guidance to seek medical help if not better. According to a family member, the chest pain increased during the evening, 999 was called but the patient died prior to arrival. Paramedics attempted resuscitation for approximately 45 minutes but were unsuccessful. The patient has not tested positive for COVID-19 since having the vaccine. The patient died on 08Jan2021. The outcome of the rest of the events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 990293 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021078981

Write-up: POSSIBLE DEATH; This is a spontaneous report from a contactable Physician downloaded from the Medicines Agency (MA) WEB, IE-HPRA-2021-063510. A 93-years-old female receive first dose of bnt162b2 (COMIRNATY) Lot #EM0477 on 16Jan2021 at 0.3 mL single dose for covid-19 immunisation . Medical history included dementia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced possible death on 21Jan2021.Clincal course was as follows: The action taken in response to the event(s) for bnt162b2 was not applicable. On 20Jan2021, the patient went to bed as usual. On 21Jan2021, at 8.40 am, the patient was observed breathing comfortably in her sleep. At 8.50 am, the patient had stopped breathing. It was reported that the patient appeared to have died peacefully in her sleep. It was outlined that while she had dementia, the reporter had no clear proximate cause of death and having discussed this with the Coroner, she was sent for a post mortem. The patient was physically well at the time of death.it was not reported if an autopsy was performed.Outcome of the event was fatal. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: POSSIBLE DEATH


VAERS ID: 990297 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysuria, Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: LASIX [FUROSEMIDE]; TRIATEC [RAMIPRIL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Hypertension arterial; Vascular encephalopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021074309

Write-up: from the afternoon of the day of vaccination fever, absent the next day and reappearing the day after accompanied by dysuria, sudden death in the night; from the afternoon of the day of vaccination fever, absent the next day and reappearing the day after accompanied by dysuria, sudden death in the night; from the afternoon of the day of vaccination fever, absent the next day and reappearing the day after accompanied by dysuria, sudden death in the night; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-655250. A 92-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1484, expiration date 30Apr2021), intramuscular at at 0.3 mL on 12Jan2021 for COVID-19 immunization. Medical history included hypertension, vascular encephalopathy and aortic stenosis. Concomitant medication included furosemide (LASIX ) and ramipril (TRIATEC). It was reported that from the afternoon of the day of vaccination on 12Jan2021 the patient had fever, absent the next day and reappearing the day after accompanied by dysuria, sudden death. The patient died on 15Jan2021. 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: 990298 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021068116

Write-up: Dyspnea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is IT-MINISAL02-656016. A 91-year-old female patient received BNT162B2 (COMIRNATY; Lot number EL1484, expiration date 30Apr2021), intramuscular into the left arm on 15Jan2021, at 18:00 as single dose covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced dyspnea on 16Jan2021, which was serious as it lead to death. The patient died on 18Jan2021. It was not reported if an autopsy was performed. Sender''s comment: additional information requested from reporter including discharge report.; Reported Cause(s) of Death: Dyspnea


VAERS ID: 990300 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Fall, Restlessness
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: AFib; Bleeding intracranial; Cardiac failure; Ejection fraction; Infarct myocardial; Pacemaker insertion (cardiac); Renal failure; Trifascicular block
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021074273

Write-up: found dead; Restlessness; night fall; generalised weakness; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-657068, Safety report unique identifier IT-MINISAL02-657068. A 98-years-old male patient received bnt162b2 (COMIRNATY), Lot number : EJ6797, Expiration date 30Apr2021 on 15Jan2021 17:00 at single dose for covid-19 immunisation . Medical history included Cardiac failure from an unknown date and unknown if ongoing , atrial fibrillation, haemorrhage intracranial from 01Oct2018, trifascicular block, renal failure , myocardial infarction from 01Jan2014,all unknown if ongoing. The patient''s concomitant medications were not reported. The day after the vaccination ,on 16Jan2021;the patient experienced generalized weakness and night fall.On 18Jan2021 he developed restlesness, no local reaction and was found dead in the bed on 19Jan2021.The outcome of the event "found dead" was fatal while the outcome of the other events was unknown Reporter''s comment: This is a 98-year-old patient in a highly compromised general state, with severe heart failure, a VVI-rr pacemaker since 2012, incomplete trifascicular block, myocardial infarction in 2014, ejection fraction 27%, permanent atrial fibrillation, chronic renal failure, haemorrhage right fronto-temporal subarachnoid (October 2018). Last cardiological visit 23Sep2020, pacemaker change scheduled. Sender''s comment: After follow-up with the reporter added additional information (date and hour of the vaccination). No follow-up attempts possible. No further information expected ; Reporter''s Comments: This is a 98-year-old patient in a highly compromised general state, with severe heart failure, a VVI-rr pacemaker since 2012, incomplete trifascicular block, myocardial infarction in 2014, ejection fraction 27%, permanent atrial fibrillation, chronic renal failure, haemorrhage right fronto-temporal subarachnoid (October 2018). Last cardiological visit 23Sep2020, pacemaker change scheduled.; Reported Cause(s) of Death: foun dead


VAERS ID: 990306 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: LAXOBERAL; SEROQUEL; LEVOLAC; PARACETAMOL; NORSPAN [BUPRENORPHINE]; VISCOTEARS; VITAMIN D [VITAMIN D NOS]
Current Illness: Dementia vascular; Hypertension; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021073731

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the Agency and received via Regulatory Authority NO-NOMAADVRE-FHI-2021-U5ed4 . Safety Report Unique Identifier (NO-NOMAADVRE-E2B_00014025). A 92-year-old female patient started to receive bnt162b2 (COMIRNATY), Lot# EJ6795, intramuscular on 12Jan2021 single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included stroke, ongoing hypertension, ongoing vascular dementia from 2016, ongoing living in residential institution. Patient has declined gradually over time but no recent acute changes. Concomitant medications included sodium picosulfate (LAXOBERAL) for obstipation from 29Jul2020, quetiapine fumarate (SEROQUEL) for restlessness from 04Nov2020, lactulose (LEVOLAC) for obstipation from 20Jun2020, paracetamol for pain from 21Aug2019, buprenorphine (NORSPAN) for pain from 13May2020, carbomer (VISCOTEARS) for dry eyes from 08Jan2020, vitamin D from 06Jan2021. It was reported patient was in completely normal shape after the vaccination on 12Jan2021, no reported changes in shape or general condition. The night watch spoke to the patient at midnight and the patient then appeared to be in a habitual state. The patient was found dead in bed at 02.30 on 15Jan2021. In all probability this is a natural death but recently administered covid-19 vaccine. It was not reported if an autopsy was performed. The reporter and supervising doctor thinks in their assessment that this is a natural death, probably independent of the vaccine, but it is reported since the vaccine was given less than 3 days ago. Sender Comment: The information is registered in the national adverse reaction register (the Medicines Agency), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. Your message is important to increase knowledge about any side effects that have not been discovered in the studies. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. 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. The report states that this is a natural death, probably independent of the vaccine, but that this is reported as a suspected side effect due to the temporal connection with the vaccine. Due to the temporal relationship, we can not completely rule out that the vaccine may have contributed to the worsening of the patient''s underlying disease. Based on WHO criteria, we consider the causal link between COMIRNATY and death to be possible. That is, 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. Based on given criteria, the report is considered serious. Relatedness of suspect drug to AE assessed by Regulatory Authority as Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 990307 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Oxygen saturation decreased, Urinary tract infection
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   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: Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210113; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased/sharp drop
CDC Split Type: NOPFIZER INC2021069188

Write-up: OXYGEN SATURATION DECREASED; urinary tract infection; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB (NO-NOMAADVRE-FHI-2021-U5ep4). An 84-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly in the left arm, on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history included nursing home resident. The patient''s concomitant medications were not reported. The patient experienced oxygen saturation decreased on 13Jan2021, which was reported as fatal. The patient also experienced a urinary tract infection on 08Jan2021. The clinical course was reported as follows: The patient was vaccinated on 07Jan2021 and urinary tract infection was detected the day after vaccination. The infection was treated with oral pivmecillinam (SELEXID). Six days after vaccination, she experienced a sharp drop in oxygen saturation on 13Jan2021. Oxygen treatment was tried without effect, and she died a few hours later on the same day. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of oxygen saturation decreased was fatal and of urinary tract infection was unknown. The patient died on 13Jan2021. The cause of death was reported as oxygen saturation decreased. It was not reported if an autopsy was performed. The causality assessment of the relatedness of the vaccine to the event was reported as unlikely by the Agency. Sender''s Comments: The current event of sudden drop in oxygen saturation without other symptoms is not a known side effect of this vaccine. Based on the knowledge we currently have about the vaccine and its side effects, it is difficult to explain how the vaccine could cause this six days after vaccination. Another cause other than the vaccine is more likely, and a causal link between the vaccine and the death has not been established. When vaccinating marginal patients, some serious events may occur shortly after vaccination, without a direct connection to the vaccination. However, it cannot be completely ruled out that the vaccine may have contributed to a worsening of any underlying disease / condition in the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: oxygen saturation decreased


VAERS ID: 990309 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dysphagia, Fatigue, General physical health deterioration
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   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: PARACET [PARACETAMOL]; DIVISUN; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multi-infarct dementia; Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021074099

Write-up: REDUCED GENERAL CONDITION; Fatigue; DECREASED APPETITE; Dysphagia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB and received via Regulatory Authority NO-NOMAADVRE-FHI-2021-Upy3p. Safety Report Unique Identifier (NO-NOMAADVRE-E2B_00014006). A male patient in his 90''s, a nursing home resident, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (COMIRNATY), Lo t# EJ6795, via intramuscular route in left arm on 06Jan2021 at 11:04, at single dose for COVID-19 immunization. Medical history included Vitamin D deficiency and multi-infarct dementia, both from an unknown date. Concomitant medications included oral paracetamol (PARACET) from 15Jan2018 for pain, oral colecalciferol (DIVISUN) from 26May2020 to 08Jan2021 for Vitamin D deficiency and oral apixaban (ELIQUIS) from 05Feb2010 to 09Jan2016 (as reported) for multi-infarct dementia. The patient was described as stable prior to vaccination (he was examined by a doctor on the day of vaccination), but at the same time frail and considered not to have very much time left to live. On 07Jan2021, the day after he received the vaccine, he got worse with reduced general condition, felt tired, had reduced food intake and difficulty swallowing. The man died on 12Jan2021, six days after being vaccinated. The doctor stated that it is very possible that he would have died even if he had not received the vaccine, but also that he might have been too fragile to get a vaccine. All the reported events were reported as fatal. It was not reported if an autopsy was performed. Sender''s comments: Non-specific symptoms such as general feeling of sickness / reduced general condition, fatigue, feeling unwell, nausea may occur in the first days after vaccination. Swallowing difficulty is not in itself described as a known side effect of the vaccine. It is difficult to know for sure whether the symptom picture, with subsequent death, is due to the vaccine, the patient''s underlying disease / condition or other incidental, concurrent cause that has nothing to do with the vaccination in question. The report states that the patient was frail and had an underlying disease before vaccination. The described symptoms may represent side effects of the vaccine, which in turn may have contributed to a deterioration of the patient''s general condition. There is a coincidence in time between the described symptoms and the time of vaccination (one day). The patient died six days after vaccination. Since the patient died, the report is classified as serious, even though a direct causal link between the vaccine and the death has not been established. Relatedness of suspect drug to adverse events was assessed by Regional Pharmacovigilance Center as Possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: General physical health deterioration; Fatigue; Decreased appetite; Dysphagia


VAERS ID: 990314 (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: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, 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: 2021-01-01
   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: ATORVASTATIN; FURIX [CEFUROXIME]; SOBRIL; METOPROLOL; LEVAXIN; WARAN; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Celiac disease; COVID-19; Ejection fraction low (35%); Heart failure; Hypothyroidism; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021067491

Write-up: Death; positive Covid-19 virus test after vaccination; positive Covid-19 virus test after vaccination; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (SE-MPA-2021-000325 & SE-MPA-1610531706795). An 84-year-old female patient received bnt162b2 (COMIRNATY; Lot number: EL 1484), intramuscularly in Jan2021 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation, Celiac disease, ejection fraction low (35%), type II diabetes mellitus, hypothyroidism, heart failure, COVID-19. Concomitant medication included atorvastatin (MANUFACTURER UNKNOWN), taken from 01Jan2017 to Jan2021, cefuroxime (FURIX), taken from 01Jan2017 to Jan2021, oxazepam (SOBRIL), taken from 01Jan2017 to Jan2021, metoprolol (MANUFACTURER UNKNOWN), taken from 01Jan2017 to Jan2021, levothyroxine sodium (LEVAXIN), taken from 01Jan2013 to Jan2021, warfarin sodium (WARAN), taken from 01Jan2011 to Jan2021 and ramipril (MANUFACTURER UNKNOWN) taken from 01Jan2013 to Jan2021. The patient had a positive Covid-19 virus test after vaccination and experienced death in Jan2021. The patient had no infection symptoms but tiredness days before vaccination. The patient was found dead, the day after vaccination with a suspected cerebro/cardiovascular event. The patient underwent lab tests and procedures which included COVID-19 virus test: positive in Jan2021. The outcome of positive Covid-19 virus test after vaccination was unknown. The patient died in Jan2021. It was not reported if an autopsy was performed. According to rapporteur, patient is not autopsied. Cerebro/cardiovascular event is only a suspicion based on patients medical history. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 990316 (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: 2021-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 2 - / 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: 2021-01-01
   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: METOPROLOL; FURIX [FUROSEMIDE]; BETMIGA; KALCIPOS; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic atrial fibrillation; Diastolic heart failure; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021067849

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (SE-MPA-2021-000743 and SE-MPA-1611135901631). A 94-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot number: EJ6796), intramuscularly, in Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included diastolic heart failure, hypothyroidism, and chronic atrial fibrillation. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), furosemide (FURIX), mirabegron (BETMIGA), calcium carbonate (KALCIPOS), and apixaban (ELIQUIS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced sudden death in Jan2021, which was reported as fatal. The patient was at habitual state and alert and was found dead same evening of vaccination. The patient died in Jan2021. The cause of death was unknown. It was reported that the death was unexpected. It was reported that an autopsy will be performed (but has not yet). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 993166 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   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: ZOLPIDEM; OLEOVIT-D3; FOLSAN; LIXIANA; FUROHEXAL [FUROSEMIDE]; SERTRALINE
Current Illness: Atrial fibrillation; Cardiac insufficiency; Dementia; Renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction (condition after cerebral insult)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021074016

Write-up: Exitus letalis; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority -WEB [Regulatory Authority number AT-BASGAGES-2021-00424] from a contactable physician. An 85-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) (Lot# EJ6797), via an unspecified route of administration, on 14Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing cardiac failure, ongoing dementia, ongoing atrial fibrillation, ongoing renal failure, cerebral infarction (not ongoing, condition after cerebral insult). Concomitant medications included zolpidem (unknown manufacturer) from 01Dec2020 and ongoing at 10 mg 1x/day (Long-term therapy), colecalciferol (OLEOVIT-D3) (Long-term therapy), folic acid (FOLSAN) (Long-term therapy), edoxaban tosilate (LIXIANA) 30 mg from 01Dec2020 to an unknown date, at 30 mg 1x/day (Long-term therapy), furosemide (FUROHEXAL) from 01Dec2020 to an unknown date at 20 mg 1x/day (Long-term therapy), sertraline (unknown manufacturer) from 01Dec2020 to an unknown date at 50 mg 1x/day (Long-term therapy). The patient experienced exitus letalis on 17Jan2021 at 04:20. The event was considered serious as life threatening and as per fatal outcome. It was not reported if an autopsy was performed. Relatedness of drug to reaction/event: Source of assessment: Primary Source Reporter, Result of Assessment: D. Unclassifiable. Regulatory Authority comment: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts are possible. No further information is expected. .; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 993167 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: TRITTICO; TEMESTA [LORAZEPAM]; CLOPIDOGREL
Current Illness: Coronary heart disease; Dementia (severe); Diabetes mellitus; Ovarian neoplasm (7 cm mass ovary right)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021073991

Write-up: Lethal outcome; Tiredness; Sleepiness; This is a spontaneous report downloaded from the Medicines Agency (EMA) EudraVigilance-WEB [Regulatory Authority number AT-BASGAGES-2021-00427] from a contactable physician. An 89-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) (lot# EJ6797), intramuscular, on 14Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing coronary heart disease, ongoing dementia (severe), ongoing ovarian neoplasm (7 cm mass ovary right), ongoing diabetes mellitus. Concomitant medications included trazodone hydrochloride (TRITTICO) at 50 mg daily (50 mg retard, Long-term therapy years), lorazepam (TEMESTA) at 2.5 mg daily (Long-term therapy years), clopidogrel (unknown manufacturer) at 75 mg daily (Long-term therapy years). The patient experienced tiredness on 15Jan2021, sleepiness on 15Jan2021 and lethal outcome on 16Jan2021 at 05:50 AM. The events were considered serious as life threatening and as per fatal outcome on 16Jan2021. It was not reported if an autopsy was performed. Causality assessment: Comirnaty/ Death, Somnolence, Fatigue/ Primary Source Reporter/ Unassessable/Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lethal outcome; Sleepiness; Tiredness


VAERS ID: 993168 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Fatigue, Influenza like illness, Multiple organ dysfunction syndrome
SMQs:, 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), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021081827

Write-up: lost her appetite; flu like symptoms; extreme fatigue; weak; multiple organ failure; This is a spontaneous report from a contactable consumer, who reported for her mother. This nearly 90-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. Relevant medical history was not reported. Although the patient was nearly 90 years old, she was not frail, she was very well, agile, active and happy. She still lived independently and took one low dose blood pressure tablet daily, which had been her only regular medication for many decades. She had no underlying health issues. Concomitant medications included an unspecified blood pressure medication. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 for COVID-19 immunisation and she lost her appetite for a couple of days, but then returned to full health. Following her second dose of vaccination, in Jan2021, she felt well initially, but then once again lost her appetite, felt flu like symptoms and extreme fatigue. This continued for nearly 2 weeks and she became very weak. The outcome of all these events was unknown. She was finally admitted to hospital on 20Jan2021, where she died on 24Jan2021 from multiple organ failure. The reporter felt almost certain that her mother''s demise was due to her Pfizer Covid-19 mRNA vaccinations. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: multiple organ failure


VAERS ID: 993169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: MIRTAZAPINE; FUROSEMIDE; MOBISTIX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021074415

Write-up: Hemorrhage intracranial; This is a spontaneous report received from a contactable other hcp via the Federal agency for medicines and health products (FAMHP) downloaded from the Medicines Agency (MA) Regulatory Authority-WEB BE-FAMHP-DHH-N2021-75634 A 93-years-old female patient received the first dose of bnt162b2 (COMIRNATY, lot EM0477), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunisation. The patient received also rivaroxaban (XARELTO, 15 mg), via an unspecified route of administration from an unspecified date at 1 DF, 1x/day in the morning for an unspecified indication. The patient medical history was not reported. Concomitant medication included mirtazapine (unknown manufacturer), furosemide (unknown manufacturer), paracetamol (MOBISTIX) and food supplement Vista D3 1000. The patient experienced hemorrhage intracranial on 19Jan2021. The action taken for rivaroxaban was unknown. The patient died on 19Jan2021 due to the event. It was not reported if an autopsy was performed. Reporter comment: Description of adverse reactions. 93-year-old patient - 50kg. Vaccinated on 15-01. Died 19-01, following a spontaneous intracranial hemorrhage objectified by a brain scan. No trauma but taking anticoagulants: Xarelto 15mg 1co 1x / d in the morning. ADR treatment: NO No follow-up attempts possible. No further information expected.; Reporter''s Comments: Description of adverse reactions 93-year-old patient - 50kg. Vaccinated on 15-01. Died 19-01, following a spontaneous intracranial hemorrhage objectified by a brain scan. No trauma but taking anticoagulants: Xarelto 15mg 1co 1x / d in the morning ADR treatment: NO; Reported Cause(s) of Death: Hemorrhage intracranial


VAERS ID: 993170 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021079898

Write-up: Death; This is a spontaneous report from a contactable physician. This is a report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. Regulatory authority report number BE-FAMHP-DHH-N2021-75644. A 77-year-old female patient received bnt162b2 (COMIRNATY) (lot number unknown), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient died on 19Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 993177 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2020-12-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / 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: 2020-12-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021067239

Write-up: Sudden death, cause unknown; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB regulatory authority number DE-DCGMA-21187481. A 99-year-old female patient received BNT162B2 (COMIRNATY Solution for injection, lot no. and expiry date not reported) , intramuscular on 27Dec2020 at a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. 4 days after vaccination, (30Dec2020), the patient developed sudden death, cause unknown. The patient died on 30Dec2020. 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: sudden death, cause unknown


VAERS ID: 993182 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: Medical History/Concurrent Conditions: Bronchial carcinoma; Cerebral infarction; Middle cerebral artery stenosis (unsuccessful lysis therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021068325

Write-up: patient died on 15Jan2021 due to recurrent stroke; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADRPEI-2021012488 and received via Regulatory Authority. A 76-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 15Jan2021 at a single dose for covid-19 immunization. Medical history included bronchial carcinoma, cerebral infarction and middle cerebral artery stenosis on 25Dec2020 with unsuccessful lysis therapy. The patient''s concomitant medications were not reported. On 15Jan2021, same day after vaccination, the patient died. The action taken in response to the event for bnt162b2 was not applicable. The patient died on 15Jan2021 due to recurrent stroke. An autopsy was not performed. Reporter''s comments: Vaccination on January 15th, 21 according to care around noon. Patient essentially normal during the rest of the day, no fever, normal vital signs, no evidence of an allergic reaction in the area of skin / mucous membranes / respiratory tract / circulation. No indication of relevant pain (but with the patient''s ability to communicate significantly reduced due to aphasia). Sender Comment: I do not have any information about allergies to drugs/vaccines. Condition after cerebral infarction Artery cerebri media left with ACI stenosis December 25, 2020, unsuccessful lysis therapy. CHD, especially bronchial carcinoma. Note: on the death certificate, a relapse apoplexy was given as the presumed cause of death, as the connection with the vaccination could not or is not sufficiently assessed for me. An autopsy was not initially sought. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Vaccination on January 15th, 21 according to care around noon. Patient essentially normal during the rest of the day, no fever, normal vital signs, no evidence of an allergic reaction in the area of skin / mucous membranes / respiratory tract / circulation. No indication of relevant pain (but with the patient''s ability to communicate significantly reduced due to aphasia).; Reported Cause(s) of Death: Recurrent stroke


VAERS ID: 993183 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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:
Current Illness: Cardiac failure; Coronary artery disease; Dementia (advanced); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021074195

Write-up: passed away; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) Regulatory authority -WEB DE-PEI-CADRPEI-2021012754. A 91-year-old female patient received first dose of BNT162B2 (COMIRNATY), Intramuscularly on 19Jan2021 as a single dose for COVID-19 immunisation, lot number: unknown. Medical history included dementia (advanced), cardiac failure, hypertension, coronary artery disease, all ongoing. Concomitant medications were not reported. It was reported that 50 minutes after vaccination, on 19Jan2021, the patient underwent reanimation and passed away due to unknown cause. The patient is dead and was hospitalized. No autopsy was performed. Patient underwent cardiopulmonary resuscitation. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 993184 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-01-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Lipid metabolism disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021074224

Write-up: Death; Fever; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority number DE-PEI-CADRPEI-2021012861. An 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY) (lot no.: was not reported), intramuscular at single dose on 15Jan2021 for Covid-19 immunisation. Medical history included apoplexy, ongoing arterial hypertension, lipid metabolism disorder NOS. Concomitant medications were not reported. On 18Jan2021, the patient developed fever and unknown cause of death The patient is dead and was hospitalized. An autopsy was not performed. Death cause was reported as unknown cause of death. Comirnaty/ Fever, Unknown cause of death/PEI/ D. Unclassifiable. Sender Comment: apoplexy 2010, arterial hypertension, lipometabolic disorder. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 993196 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory distress, Coma scale, Dyspnoea, Investigation, Malaise, Neurological examination, Oxygen saturation, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: Pulmonary fibrosis
Allergies:
Diagnostic Lab Data: Test Name: Glasgow; Result Unstructured Data: Test Result:10; Comments: 10/15 (eye:3/verbal:3/motor:3); Test Name: Cardiopulmonary; Result Unstructured Data: Test Result:hypophonetic heart noise, rhonchi and; Comments: hypophonetic heart noise, rhonchi and scattered crackles in both lung fields at auscultation, use of accessory muscles; Test Name: Neurologically; Result Unstructured Data: Test Result:conscious, disoriented, responding to the calling; Comments: conscious, disoriented, responding to the calling and external stimuli, pupils isochoric normoreactive to light; Test Name: oxygen saturation; Test Result: 94 %; Test Date: 20210105; Test Name: fever; Result Unstructured Data: Test Result:38.5 Centigrade
CDC Split Type: ESPFIZER INC2021068046

Write-up: Cardio-respiratory distress; Breathing difficult; General malaise; 38,5?C; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB ES-AEMPS-715166. An 89-year-old female patient received first dose of bnt162b2 (COMIRNATY) lot number: EJ6796, intramuscular on 04Jan2021 at 0.3 mL, single dose for COVID-19 immunization. Medical history included pulmonary fibrosis. The patient''s concomitant medications were not reported. The patient received the bnt162b2 vaccine. The next day (05Jan2021), she had fever (38.5?C), malaise and difficulty breathing. On 08Jan2021, the temperature dropped, dyspnea persists. The patient experienced cardio-respiratory distress on 12Jan2021. She presented significant respiratory distress despite saturation 94% with oxygen through nasal glasses. Neurologically: conscious, disoriented, responding to the calling and external stimuli, pupils isochoric normoreactive to light Glasgow 10/15 (eye:3/verbal:3/motor:3). Cardiopulmonary: hypophonetic heart noise, rhonchi and scattered crackles in both lung fields at auscultation, use of accessory muscles. Diagnosis was lower respiratory infection coinciding with COVID vaccine. The patient died on 16Jan2021 due to complications from lower respiratory infection and history of pulmonary fibrosis. It was not reported if an autopsy was performed. All the events were assessed as serious-medically significant and fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: complications from lower respiratory infection; pulmonary fibrosis; fever (38.5?C); malaise; difficulty breathing


VAERS ID: 993199 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: QUETIAPINE; HALOPERIDOL; DIAZEPAM; LANTUS; OMEPRAZOLE; GLICLAZIDE; PYRIDOXINE; ZOLPIDEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asymptomatic COVID-19; Diabetes; Hypertension; Schizophrenia
Allergies:
Diagnostic Lab Data: Test Name: COVID Antigen Test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021079004

Write-up: Death sudden; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the regulatory authority-WEB (ES-AEMPS-724464). A 59-year-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot number EM0477) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included hypertension, schizophrenia, asymptomatic COVID-19 from 02Sep2020 to unknown date and diabetes mellitus. The patient received the first dose of BNT162B2 (COMIRNATY; Lot number EJ6796) on 29Dec2020. Concomitant medications included quetiapine, haloperidol, diazepam, insulin glargine (LANTUS), omeprazole, gliclazide, pyridoxine and zolpidem. On 21Jan2021, the patient experienced death sudden. On 21Jan2021, they notify the emergency department from the residence. The caregivers reported that the patient ate the first course normally in the dining room, and when they went to offer him a second dessert, they observed that he was leaning forward, badly colored, very pale. They did not observe that he was coughing or difficulty breathing. They took him to the infirmary; they found no pulse and he was not breathing. They did CPR for 20 minutes, with no response. The patient underwent a COVID Antigen Test on an unspecified date with negative results. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 993202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm, 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: 2021-01-16
   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: KLOTRIPTYL [AMITRIPTYLINE HYDROCHLORIDE;CHLORDIAZEPOXIDE]; DESOGESTREL RATIOPHARM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021082918

Write-up: Aneurysm; Subarachnoid haemorrhage; This is a spontaneous report downloaded from the Regulatory Authority-WEB [Regulatory Authority number FI-FIMEA-20210183] from a non contactable physician. A 50-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, on 14Jan2021, at single dose, for COVID-19 immunisation. Medical history included headache. Concomitant medication included amitriptyline hydrochloride, chlordiazepoxide (KLOTRIPTYL) for headache, desogestrel (DESOGESTREL RATIOPHARM) for contraception. The patient experienced aneurysm and subarachnoid haemorrhage both on 15Jan2020 with fatal outcome on 16Jan2021. It was not reported if an autopsy was performed. It was likely that the vaccine was not related with the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Aneurysm; Subarachnoid haemorrhage


VAERS ID: 993203 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Culture urine, Death, Fatigue, SARS-CoV-2 test, White blood cell count
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: OPAMOX; CALCICHEW D3 FORTE; MEMANTIN ORION
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (diagnosed in 2013); Fever (17Dec2020, she had a one day fever of 38; health station emergency room antibiotic was prescribed with idea of urinary tract infection which was stopped after 3 days because urine culture was negative); Muscle weakness (could no longer stand on her own)
Allergies:
Diagnostic Lab Data: Test Name: urine culture; Result Unstructured Data: Test Result:negative; Test Name: COVID sample; Result Unstructured Data: Test Result:negative; Test Date: 20210120; Test Name: leuk; Result Unstructured Data: Test Result:leuk 11.3, no more abnormal results, no symptoms o
CDC Split Type: FIPFIZER INC2021082943

Write-up: Found dead; Fatigue; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FI-FIMEA-20210185. An 87-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 20Jan2021 as single dose for covid-19 immunization. Medical history included advanced Alzheimer''s disease, diagnosed in 2013, 17Dec2020, patient had a one day fever of 38 (units not provided); health station emergency room antibiotic was prescribed with idea of urinary tract infection which was stopped after 3 days because urine culture was negative; On an unknown date reported as (5.1) home care doctor''s home visit, progressing muscle weakness was noted in the patient and could no longer stand on her own. Concomitant medication included oxazepam (OPAMOX) for relaxation therapy and sleep disorder from 29SEP2020, calcium carbonate, colecalciferol (CALCICHEW D3 FORTE) for supplementation therapy form 12May2017, memantine hydrochloride (MEMANTIN ORION) for Alzheimer''s disease from 06Feb2018. The patient experienced fatigue on 21Jan2021, that lead to death; the patient was found dead on 20Jan2021. Details were as follows: Welfare of the patient had been in sharp decline since the end of last year, tilting while sitting. 17Dec2020, she had a one day fever of 38, health station emergency room antibiotic was prescribed with idea of urinary tract infection which was stopped after 3 days because urine culture was negative, COVID sample was also negative. The last visit to the emergency room was on 31Dec2020, then there was nothing to treat in laboratory tests or ECG. On an unknown date reported as (5.1) home care doctor''s home visit, progressing muscle weakness was noted in the patient and could no longer stand on her own. Latest lab tests on 20Jan2021 with leucocytes ( leuk) 11.3, no more abnormal results, no symptoms of infection. According to the treatment records, the patient was already very tired the day before the vaccination and COVID-vaccine administered on 20Jan2021, without any problems, no abnormalities in the follow-up. 21Jan2021, in the morning, the patient was tired, but otherwise no other abnormalities. She ate breakfast. Found dead at the table at 1 p.m. THL chief physician was consulted, and a causal link to vaccination was unlikely because of the strong progression of the underlying disease. Death certificate was dated 22Jan2021. The patient died on 21Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 993204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Body temperature, Bronchial obstruction, Constipation, Death, Increased bronchial secretion, Investigation, Pyrexia, SARS-CoV-2 test
SMQs:, Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-18
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORMACOL BISMUTH; ALPRAZOLAM; UVEDOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Absence attacks (episode of absence treated with anti-epileptic (stopped since because normal EEG).); Anorexia; Atrial fibrillation (cardiac decompensation on AF); Idiopathic thrombocytopenic purpura (Patient entered nursing home EHPAD in July 2019 after falling and thrombocytopenia)
Allergies:
Diagnostic Lab Data: Test Name: Body mass index; Result Unstructured Data: Test Result:18; Test Date: 20210118; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Name: examination of the body; Result Unstructured Data: Test Result:no apparent wound/trauma "Very withdrawn patient"; Test Date: 20210108; Test Name: PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021074145

Write-up: Death unexplained; Fever; Increased bronchial secretion; bronchial obstruction; constipation; This is a spontaneous report from a contactable physician via Regulatory Authority (AFSSAPS), downloaded from the Medicines Agency (MA) Regulatory Authority (regulatory authority report number FR-AFSSAPS-BX20210109). A 78-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6788) intramuscular on 15Jan2021 at 0.3 mL single for COVID-19 immunisation and she started to receive fentanyl (DUROGESIC) transdermal from 12Jan2021 and ongoing at 0.01 mg (frequency reporter as 1 hour) for an unspecified indication. Relevant medical history included atrial fibrillation from an unknown date and unknown if ongoing (cardiac decompensation on AF), anorexia from an unknown date and unknown if ongoing, Idiopathic thrombocytopenic purpura from an unknown date and unknown if ongoing (patient entered nursing home EHPAD in Jul2019 after falling and thrombocytopenia), absence from an unknown date (episode of absence treated with anti-epileptic [stopped since because normal EEG]). The patient had a Body Mass Index at 18. Concomitant medications included bismuth subnitrate/sterculia urens (NORMACOL BISMUTH), alprazolam and colecalciferol (UVEDOSE). The patient experienced constipation in Jan2021 with outcome unknown and on 18Jan2021 she experienced bronchial obstruction with outcome unknown and increased bronchial secretion, fever at 38.2 and death unexplained, all with fatal outcome. The patient entered nursing home EHPAD in Jul2019 after falling and thrombocytopenia. In May2020: cardiac decompensation on AF. No other events since then. The patient received vaccination with BNT162B2 on 15Jan2021. On 16-17Jan2021: no events reported except constipation. Undesirable effect: 18Jan2021 morning: fever at 38.2 C and bronchial obstruction. Decision to treat with paracetamol. While looking for paracetamol, the patient was found dead. The patient had no known allergy. Last PCR test on 08Jan2021: negative. On examination of the body, no apparent wound or trauma "Very withdrawn patient". Request made to perform a medical-scientific autopsy. To be noted: imputation made without prejudice to the elements of investigations that it could have been carried out within the framework of legal or amicable compensation procedures. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 993205 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adjusted calcium, Blood albumin, Blood creatinine, Blood potassium, Blood sodium, Blood triglycerides, Blood urea, Blood uric acid, Blood uric acid increased, Body temperature, C-reactive protein increased, Glomerular filtration rate, Glycosylated haemoglobin, Glycosylated haemoglobin increased, Haemoglobin, Headache, High density lipoprotein, Platelet count, Protein C, Pyrexia, Sudden death, Total cholesterol/HDL ratio, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: FORLAX; GAVISCON [ALGINIC ACID;ALUMINIUM HYDROXIDE;SODIUM BICARBONATE]; KARDEGIC; LANSOYL; METEOSPASMYL [ALVERINE CITRATE;DL-METHIONINE]; NASONEX; PARKINANE; VENTOLINE [SALBUTAMOL SULFATE]; XATRAL; XALACOM; AMLODIPINE; BROMAZEPAM; GLICLAZID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol withdrawal syndrome; Anxiety; Anxiodepressive syndrome; Behavior disorder; Benign prostatic hypertrophy; Bronchial disorder; Colon adenomatous polyp; Constipation; Delusion of persecution; Diabetes; Disorder gastrointestinal; Dolichocolon; Fractured nose; Glaucoma both eyes; Hypertension; Hypoactive bladder; Lumbar spinal stenosis; Mixed anxiety and depressive disorder; Non-insulin-dependent diabetes mellitus; Overweight; Parkinson''s syndrome; Renal disorder; Sleep apnea
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: Corrected calcium; Result Unstructured Data: Test Result:2.32 mmol/L; Test Date: 20210112; Test Name: Albumin; Result Unstructured Data: Test Result:40.5 g/l; Test Date: 20210112; Test Name: Creatinine; Result Unstructured Data: Test Result:73 mmol/L; Test Date: 20210112; Test Name: Potassium; Result Unstructured Data: Test Result:4.2 mmol/L; Test Date: 20210112; Test Name: Sodium; Result Unstructured Data: Test Result:142 mmol/L; Test Date: 20210112; Test Name: Triglycerides; Result Unstructured Data: Test Result:1.36 mmol/L; Test Date: 20210112; Test Name: Urea; Result Unstructured Data: Test Result:4.6 mmol/L; Test Date: 20210112; Test Name: Uric acid; Result Unstructured Data: Test Result:422 umol/l; Test Date: 20210110; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 degrees Centigrade; Comments: in the morning; Test Date: 20210110; Test Name: Body temperature; Result Unstructured Data: Test Result:39 degrees Centigrade; Comments: at 9.20 am; Test Date: 20210111; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 degrees Centigrade; Test Date: 20210112; Test Name: DFG; Result Unstructured Data: Test Result:86 ml/min; Comments: /1.73m2; Test Date: 20210112; Test Name: Glycated hemoglobin; Test Result: 6.4 %; Comments: 46mmol / molHb; Test Date: 20210112; Test Name: Hemoglobin; Result Unstructured Data: Test Result:13.7 g/dl; Test Date: 20210112; Test Name: HDL Cholesterol; Result Unstructured Data: Test Result:1.34 mmol/L; Test Date: 20210112; Test Name: Platelets; Result Unstructured Data: Test Result:280 x10 9/l; Test Date: 20210112; Test Name: Reactive C protein; Result Unstructured Data: Test Result:37.5 mg/l; Test Date: 20210112; Test Name: Total Cholesterol; Result Unstructured Data: Test Result:3.76 mmol/L; Test Date: 20210112; Test Name: white blood cells; Result Unstructured Data: Test Result:9.29 x10 9/l
CDC Split Type: FRPFIZER INC2021067310

Write-up: MORT SUBITE; Glycated hemoglobin 6.4percent (N less than 6); Reactive C protein 37.5mg/L (N less than 5); Uric acid 422umol /L (N202-417); patient''s temperature recorded 38.8 degrees C in the morning and 39 degrees C at 9.20 am; headache; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB, FR-AFSSAPS-CN20210066. A 75-year-old male patient received BNT162B2 (COMIRNATY; lot number: EM0477, expiry date unknown), intramuscular on 07Jan2021 at 0.3mL, single for COVID-19 vaccination. The patient''s medical history included DNID (Diabete Non Insulino-Dependant / Non-Insulin-Dependent Diabetes) with renal complications, hypertension, overweight, paired sleep apnea, hypoactive bladder, narrow lumbar canal, chronic bilateral glaucoma, anxiety-depressive syndrome, episodes of delusions of persecution, withdrawal alcoholism, megadolichocolon, tubular adenoma of the sigmoid, fractured bones of the nose, constipation, disorder gastrointestinal, Parkinson''s syndrome, Bronchial disorder, Benign prostatic hypertrophy, anxiety, diabetes, Behaviour disorder, and Anxiodepressive syndrome. The patient had no history of Covid-19 disease. Concomitant medications included macrogol 4000 (FORLAX) for constipation; alginic acid, aluminium hydroxide, sodium bicarbonate (GAVISCON) for Disorder gastrointestinal; acetylsalicylate lysine (KARDEGIC) for an unknown indication; paraffin, liquid (LANSOYL) for constipation; alverine citrate, dl-methionine (METEOSPASMYL) for Disorder gastrointestinal; mometasone furoate (NASONEX) for an unknown indication; trihexyphenidyl hydrochloride (PARKINANE) for Parkinson''s syndrome; salbutamol sulfate (VENTOLINE) for Bronchial disorder; alfuzosin hydrochloride (XATRAL) for Benign prostatic hypertrophy; latanoprost, timolol maleate (XALACOM) for Glaucoma; amlodipine for hypertension; bromazepam for anxiety; gliclazide for diabetes; metformin for diabetes; olanzapine for Behaviour disorder; pantoprazole for an unknown indication; propranolol for hypertension; and venlafaxine for Anxiodepressive syndrome. On 10Jan2021, patient''s temperature recorded 38.8 degrees C in the morning and 39 degrees C at 9.20 am. Patient was "constant correct" and complained of headache. On 11Jan2021, patient''s temperature recorded 36.6 degrees C, was under paracetamol systematically, had normal auscultation, had no complaints, no call point (no voiding burn). On 12Jan2021, a biological assessment was carried out and results showed: Hemoglobin 13.7g /dL (N 12.9-16.7), Platelets 280G/L (N140-385), White blood cells 9.29G /L (N3.8-10), Glycated hemoglobin 6.4percent (N less than 6) or 46mmol/molHb (N less than 42), Total Cholesterol 3.76mmol /L (N less than 5.2), HDL Cholesterol 1.34mmol/L (N greater than1), Triglycerides 1.36mmol/L (N less than 1.7), and Reactive C protein 37.5mg/L (N less than 5). Biochemistry results showed: Sodium 142mmol/L (N136-145), Potassium 4.2mmol/L (N3.4-4.5), Albumin 40.5g /L (N 35-52), Corrected calcium 2.32mmol/L (N 2.2-2.55), Uric acid 422umol /L (N202-417), Urea 4.6mmol /L (N2.8-8.1), Creatinine 73mmol/L (N59-104), and DFG CKDepi 86ml/min/1.73m2. The patient recovered from "patient''s temperature recorded 38.8 degrees C in the morning and 39 degrees C at 9.20 am" and "headache" on 11Jan2021. Outcome of the events "Glycated hemoglobin 6.4percent (N less than 6)," "Reactive C protein 37.5mg/L (N less than 5)," and "Uric acid 422umol /L (N202-417)" was unknown. It was reported that at 2 a.m. when the IDE passed, patient was asleep. The patient MORT SUBITE (sudden death unexplained); he was found deceased on 19Jan2021 at 5:30 a.m., lying at the foot of his bed, face and extremities cyanotic, on his back. His sleep apnea device was in place on his face, securely fastened. The cause of death was unknown. No autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: MORT SUBITE


VAERS ID: 993206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: XARELTO; SERESTA; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; LYRICA; EUPANTOL; DOLIPRANE; CARDENSIEL; AMLOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Hiatus hernia; Hypertension; Ischemic stroke (with sequelae left hemiplegia,); Left hemiplegia; Mitral stenosis (in Barlows disease operated on in 1984); Rib fracture (hospitalized on 30Dec2020); Von Willebrand''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021067253

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB regulatory authority FR-AFSSAPS-NC20210057. A 90-year-old female patient received bnt162b2 (COMIRNATY, lot number: EM0477) intramuscular on 14Jan2021 at a single dose for COVID-19 vaccination. Medical history included ischemic stroke in 2004 with sequelae left hemiplegia, hypertension, mitral stenosis in Barlows disease operated on in 1984, AF, hiatus hernia, von Willebrands disease, no cognitive disorders, normal renal function (40um/L), was hospitalized on 30Dec20 for a rib fracture with usual BP 120/70 mmHg and usual HR at 70 bpm. Concomitant medication included rivaroxaban (XARELTO), oxazepam (SERESTA), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), pregabalin (LYRICA), pantoprazole sodium sesquihydrate (EUPANTOL) , paracetamol (DOLIPRANE), bisoprolol fumarate (CARDENSIEL), and amlodipine besilate (AMLOR). It was reported that on 14Jan2021, the patient was vaccinated with bnt162b2 with good local tolerance and no undesirable effects reported. Occurrence in the night of 15Jan2021 to 16Jan2021, was of a confusing episode. Normal view by Hospital Services Officer around 10:15 a.m. On 16Jan2021, the patient was a little irritated when waking up because she usually gets up around 10:30 am and was awakened that day around 9:30 am. The patient was placed in the chair, felt good, no complaints and no intercurrent pathology. Found deceased (death unexplained) at 11 a.m. in her chair, no obvious cause of death, not cyanotic. No autopsy planned. No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: Death unexplained


VAERS ID: 993207 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / 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: 2021-01-16
   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: STRESAM; FUROSEMIDE; THERALENE; L THYROXINE SERB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Fall; Fracture multiple; Hip prosthesis insertion; Hip replacement (before Christmas); Hypertension arterial; Hypothyroidism; Osteoporosis; Shoulder fracture (around Sept to Oct2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021067241

Write-up: Sudden death unexplained; This is a spontaneous report from contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NY20210068. A 96-year-old female patient received bnt162b2 (COMIRNATY) (lot number: EJ6795), intramuscular on 14Jan2021 08:50 at 0.3 mL, single for COVID-19 immunisation. Medical history included osteoporosis, Hypertension arterial, Hypothyroidism, Anxiodepressive syndrome, all from an unknown date and unknown if ongoing; Hip prosthesis insertion in Dec2020 and multiple fractures following repeated falls (left shoulder fracture around Sept to Oct2020 and hip replacement before Christmas). Concomitant medication included etifoxine hydrochloride (STRESAM) for Anxiodepressive syndrome, furosemide for Hypertension arterial, alimemazine tartrate (THERALENE) for Dementia and levothyroxine sodium (L THYROXINE SERB) for Hypothyroidism. No anticoagulation in progress at the time of vaccination. The vaccination was carried out on 14Jan2021 around 8:50 am and not in the afternoon. She had good immediate tolerance and no adverse effects on 15Jan2021 (while other facility patients had fever). On 16Jan2021, normal lunch at noon. The patient was seen at 4 p.m. having a snack. She was found dead at 5 p.m. in her chair. Death certificate mentioning sudden death unexplained. The patient died on 16Jan2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 993209 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory distress, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: AMLODIPINE ARROW; ALPRAZOLAM MYLAN; FOSAMAX; PRAVASTATIN ARROW; XATRAL; LANSOPRAZOLE MYLAN; AMISULPRIDE MYLAN; FUMAFER; ZOPICLONE ARROW; MIRTAZAPINE ARROW; VESICARE; LANSOYL; LEPTICUR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Effusion pleural; Fall; Parkinsonism; Psychosis; Respiratory disorder; Rib fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: COVID test; Result Unstructured Data: Test Result:unknown result
CDC Split Type: FRPFIZER INC2021078884

Write-up: Respiratory distress; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Medicines Agency (MA) FR-AFSSAPS-PS20210104 and received via Regulatory Authority (AFSSAPS). A 76-years-old female patient received bnt162b2 (COMIRNATY, LOT#number EM0477), intramuscular on 13Jan2021 at single dose for covid-19 immunization. Medical history included chronic psychosis, recently diagnosed breast cancer (end of 2020), Parkinsonian sd, ''allergy to iodine'' and ''to aspirin'' not documented but without anaphylaxis mentioned, rib fractures and pleural effusion with intermittent oxygen dependence since Aug2020, fall, respiratory discomfort from Aug2020. The patient did not have COVID. Concomitant medication included amlodipine besilate (AMLODIPINE ARROW), alprazolam (ALPRAZOLAM MYLAN), alendronate sodium (FOSAMAX), pravastatin sodium (PRAVASTATIN ARROW), alfuzosin hydrochloride (XATRAL) , lansoprazole (LANSOPRAZOLE MYLAN), amisulpride (AMISULPRIDE MYLAN), ferrous fumarate (FUMAFER), zopiclone (ZOPICLONE ARROW), mirtazapine (MIRTAZAPINE ARROW) , solifenacin succinate (VESICARE), paraffin, liquid (LANSOYL), tropatepine hydrochloride (LEPTICUR). The patient experienced respiratory distress on 14Jan2021. First episode of respiratory distress on 14Jan2021 (around 7:00 p.m. after vaccination), regressive. Recurrence of respiratory distress on 19Jan2021, patient put on oxygen, sudden death. No urticarial skin lesions, no pruritus, no fever. The rib fractures and pleural effusion had no connection with breast cancer as she was hospitalized in Aug2020 and the effusion analyzed was reassuring (nonspecific and no signs of malignancy although on the same side as breast cancer unknown at the time and rib fractures). The fractures are related to a fall (the patient had not yet had a scintigraphy as part of the cancer extension workup). Since the August episode, the patient has had this intermittent respiratory discomfort with the need for oxygen therapy. Breast cancer was probably not very progressive because a suspicious image already existed in 2018 and the care plan was to be exposed to her on the day of her death. The respiratory distress which led to the death is probably not related to a pleural effusion which would have increased because the last auscultation carried out on 14Jan2021 did not suspect it. The effusion would have settled in 4 days while the patient was seen almost daily following recurrent falls until the day before her death. The hypothesis of pulmonary embolism in a cancerous state remains. The patient was tested COVID on 16Jan2021 (PCR or antigen test). Outcome of the event was fatal. The patient died on 19Jan2021. It was not reported if an autopsy was performed. In view of the antecedents and the context, the link with vaccination is doubtful. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Respiratory distress


VAERS ID: 993210 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Fainting; Gout; Hypertension arterial; Infection staphylococcal (Bone staphylococcus infection); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: Test; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: FRPFIZER INC2021078898

Write-up: Death unexplained; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Medicines Agency (EMA) (regulatory authority report number FR-AFSSAPS-RE20210068). A 97-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number EM0477) intramuscular in the left arm on 14Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included hypertension arterial, gout, bone staphylococcus infection, cardiac pacemaker insertion, type 2 diabetes mellitus, all from an unknown date and unknown if ongoing, and fainting. Concomitant medication included an unspecified anticoagulant. The patient did not contract COVID-19. 08Jan2021, he performed a test (unspecified) with unknown results. On 15Jan2021, the patient died in the morning. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 993214 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / 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: 2021-01-13
   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: ABILIFY; ATENOLOL; DAFALGAN; FLUANXOL [FLUPENTIXOL DIHYDROCHLORIDE]; IMOVANE; BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]; KETODERM [KETOCONAZOLE]; LANSOYL; MACROGOL; PARKINANE LP; SULFARLEM S 25; UVEDOSE
Current Illness: Arterial hypertension; Schizophrenia
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Cognitive disorders; Gait disturbance; Malnutrition; Type II diabetes mellitus; Urinary incontinence; Urinary tract infection; Wheelchair user
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021067340

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) FR-AFSSAPS-TS20210016 and received via Regulatory Authority (AFSSAPS). A 73-year-old male patient received BNT162B2 (COMIRNATY solution for injection, lot number: EM0477, expiration date not reported), intramuscular on 13Jan2021 14:38 at 1 DF, single dose, for COVID-19 immunization. Medical history included ongoing Arterial hypertension and schizophrenia, and cognitive disorders, type II diabetes mellitus, benign prostatic hyperplasia, repeated urinary tract infections due to urinary incontinence, walking disorders (patient is in a wheelchair), and undernutrition, all from unknown dates. Concomitant medication included aripiprazole (ABILIFY), atenolol, paracetamol (DAFALGAN), flupentixol dihydrochloride (FLUANXOL), zopiclone (IMOVANE), indapamide, perindopril arginine (BIPRETERAX), ketoconazole (KETODERM), paraffin, liquid (LANSOYL), macrogol, trihexyphenidyl hydrochloride (PARKINANE LP), anethole trithione (SULFARLEM S 25), and colecalciferol (UVEDOSE). It was reported that the patient was vaccinated on 13Jan2021 at 2:38 PM in the establishment. Monitoring for 15 minutes had nothing to report, no clinical signs, no complaints, no discomfort, and no rash. The patient went up to the first floor of the establishment. Around 3:30 PM, the patient took a snack with the other residents: he was fine, he was not complaining about anything, no cough reported. He was seen in a wheelchair in the corridors around 4:00 PM. At 4:40 PM (Hour 2 of the vaccination) he was found in his room, fallen in front of his chair, in knee-chest position, purple face, immediate care with call from nurse and doctor on site stated impregnable blood pressure, no pulse; rapid treatment with cardiac massage, introduction of oxygen at 15 l/min; the defibrillator does not trigger (flat card of cardiac arrest) call from the Emergency medical aid service (no team travel given the flat line, comorbidities and GIR at 2). The patient''s sudden death was announced at 5.10 PM. The doctor noted no sign in favor of an anaphylactic manifestation: no rash, no edema of the face, no edema of the lips, nor of the tongue; no diarrhea at the time of death; no wound, no apparent head trauma; No cough after the snack that could suggest a wrong path. Scientific autopsy was refused by the family. In total, sudden death between 1:30 and 2 hours after vaccination in a patient treated with neuroleptics and carrying comorbidities. In view of the circumstances of the event, the clinical data, the medical history and the heavy treatment with neuroleptic, the imputability of the vaccine is low insofar as there is no objective argument allowing to conclude that the death could be related to vaccination. The patient died on 13Jan2021 at 17:01.; Reported Cause(s) of Death: Sudden death


VAERS ID: 993418 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2021-01-05
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   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:
Current Illness:
Preexisting Conditions: Comments: Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021077026

Write-up: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report received from a contactable other health professional via the Regulatory Authority. The Regulatory Authority report number is GB-MHRA-WEBCOVID-202101221706160690. Safety Report Unique Identifier GB-MHRA-ADR 24634077. An 87-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EJ0553), via an unspecified route of administration, on 17Dec2020, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient experienced COVID-19 virus test positive on 05Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 05Jan2021. The infection was suspected from 03Jan2021. The patient died on 07Jan2021 due to COVID-19 virus test positive. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 virus test positive; COVID-19 virus test positive


VAERS ID: 993419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Lower respiratory tract infection, 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: 2021-01-05
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021079551

Write-up: Lower respiratory tract infection; COVID-19; COVID-19; This is a spontaneous report from a contactable healthcare professional received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202101221716105980, Safety Report Unique Identifier GB-MHRA-ADR 24634163. An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ0553) via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included ongoing Parkinson''s disease and ongoing dementia. Concomitant medications were not reported. The patient was not enrolled in clinical trial. On 26Dec2020, a COVID-19 virus test showed positive result and, on an unspecified date, he developed a lower respiratory tract infection (chest infection). The outcome of the lower respiratory tract infection (chest infection) was unknown; the patient died due to COVID-19 on 05Jan2021. It was not reported if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: covid 19


VAERS ID: 993420 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-17
Onset:2020-12-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021077287

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report received from a contactable other health professional received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202101221748287090, Safety Report Unique Identifier GB-MHRA-ADR 24634241. An 89-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EJ0553), via an unspecified route of administration, on 17Dec2020, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient experienced SARS-CoV-2 infection on 30Dec2020. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 30Dec2020. The patient died on 20Jan2021 due to SARS-CoV-2 infection. 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: SARS-CoV-2 infection


VAERS ID: 993422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, COVID-19, Chest X-ray, Culture, Drug ineffective, Dyspnoea, Immune system disorder, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Endometrial cancer (Figo stage 3c1); Type II diabetes mellitus (Longstanding)
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis; Cataracts; Chronic kidney disease; Kidney cancer (treated 2006); Kidney stones (Recurrent); Obesity; Uterine cancer; Comments: Unsure if patient has had symptoms associated with COVID-19. Inconclusive test. Patient is not enrolled in clinical trial.
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown result; Test Name: Chest X-ray; Result Unstructured Data: Test Result:unknown result; Test Name: Culture; Result Unstructured Data: Test Result:unknown result; Test Date: 20210106; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC2021077178

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; Immune imbalance; Shortness of breath; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101241753594380, Safety Report Unique Identifier GB-MHRA-ADR 24639286. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ688), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. Medical history included ongoing endometrial cancer (Figo stage 3c1), uterine cancer (not ongoing), renal cancer (not ongoing) treated 2006, ongoing type 2 diabetes mellitus (longstanding), obesity (unknown if ongoing), chronic kidney (unknown if ongoing), cataract (unknown if ongoing), nephrolithiasis (recurrent, unknown if ongoing) and ankylosing spondylitis (unknown if ongoing). Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient previously received influenza vaccine (split virion, inactivated) on 01Oct2020 and pneumococcal vaccine polysacch on 03Dec2020 bot for immunization. The patient experienced sars-cov-2 infection, immune imbalance and shortness of breath on 06Jan2021. The patient was admitted to hospital on 06Jan2021 and died on 07Jan2021 due to SARS-CoV-2 infection. It was unsure if patient has had symptoms associated with COVID-19. The patient underwent lab tests and procedures which included blood test, culture and chest x-ray on unknown date with unknown results. The patient ad and inconclusive COVID-19 virus test on 06Jan2021. It was not reported if an autopsy was performed. All the events were considered serious as important medical events and hospitalization. Only sars-cov-2 infection had a fatal outcome. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 993423 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   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: ASPIRIN [ACETYLSALICYLIC ACID]; FOLPIK; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (Well managed); Comments: Well managed hypertension Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021077599

Write-up: Cardiac arrest; This is a spontaneous report received from a contactable consumer. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-ADR 24642631, Safety Report Unique Identifier GB-MHRA-WEBCOVID-202101251304343790. A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EL0739), via an unspecified route of administration at single dose on 19Jan2021 08:30 for Covid-19 immunisation. Medical history included hypertension from (well managed). Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), felodipine (FOLPIK) for hypertension, simvastatin. The patient experienced cardiac arrest on 19Jan2021 before 9:25am. Downtime 29 minutes before circulation was restored by the paramedic on the scene. Transferred to ED where a stent was fitted. The patient died on 22Jan2021. It was not reported if an autopsy was performed. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 993424 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 0739 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: ALENDRONIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder; Hypertension; Comments: cerebrovascular disease hypertension Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021079555

Write-up: Death sudden; This is a spontaneous report received from a contactable physician by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202101251345290740 and WWID is GB-MHRA-ADR 24642992. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL 0739), via an unspecified route of administration on 20Jan2021at single dose for covid-19 immunization. Medical history included cerebrovascular disease, hypertension from an unknown date and unknown if ongoing. Concomitant medication included alendronic acid from 22Jun2018. The patient experienced death sudden on 23Jan2021. It was not reported if an autopsy was performed. Unsure if patient had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. Patient was found dead in her chair ambulance called resus unsuccessful. Referred to coroner. 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: Death sudden


VAERS ID: 993425 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   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: ACETYLSALICYLIC ACID; ATORVASTATIN; BISACODYL; CLOMIPRAMINE; FLUDROCORTISONE; LANSOPRAZOLE; LAXIDO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder (on CT brain scan); Sleepy (in the week running up to the vaccine); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); TIA (has an event 4 days before the vaccine where she possibly had a TIA); Transient ischaemic attack (history of TIAs); Vascular dementia; Comments: Vascular dementia and history of TIAs and known cerebrovascular disease on CT brain scan . She was getting more sleepy in the week running up to the vaccine and has an event 4 days before the vaccine where she possibly had a TIA . Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: CT brain scan; Result Unstructured Data: Test Result:cerebrovascular disease
CDC Split Type: GBPFIZER INC2021080283

Write-up: CVA; approximately 3 hours after receiving the vaccine when she was being fed she jolted; lost consciousness; This is a spontaneous report from a contactable physician received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101261402076050, Safety Report Unique Identifier GB-MHRA-ADR 24649264. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: not known) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. Medical history included vascular dementia; history of (transient ischaemic attack) TIAs; known cerebrovascular disease on CT brain scan; steroid therapy, taking regular steroid treatment (e.g. orally or rectally); she was getting more sleepy in the week running up to the vaccine and had an event 4 days before the vaccine (21Jan2021) where she possibly had a TIA. Concomitant medication included acetylsalicylic acid, atorvastatin, bisacodyl, clomipramine, fludrocortisone, influenza vaccine (INFLUENZA VIRUS) on 12Nov2020, lansoprazole, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO). Approximately 3 hours after receiving the vaccine on 25Jan2021, when she was being fed she jolted, eyes stared corner of her mouth dropped. Then she lost consciousness. She did not choke. Coroner attended the scene. Coroner investigated at the scene. CPR unsuccessful. The physician believed that was a CVA. Patient has not had symptoms associated with COVID-19. 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. The patient died on 25Jan2021. It was not reported if an autopsy was performed. The outcome of CVA was fatal, the outcome of other events were unknown. No follow-up attempts are possible; information about batch/lot cannot be obtained.; Reported Cause(s) of Death: CVA


VAERS ID: 993426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

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: 2021-01-23
   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:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021080432

Write-up: Death; This is a spontaneous report received from a contactable consumer by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The Sender''s (Case) Safety Report Unique Identifier is: GB-MHRA-ADR 24648933, and the Regulatory authority''s case report number is: GB-MHRA-WEBCOVID-202101261505264870. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient died on 23Jan2021. Patient has not tested positive for COVID-19 since having the vaccine The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test. 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.; Reported Cause(s) of Death: Death


VAERS ID: 993461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Q fever
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: TALOFEN; METFORMINA ALMUS; CLEXANE; LOSFERRON; PARACETAMOL; TIMOPTOL
Current Illness: Vascular encephalopathy (Chronic)
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment; Dehydration; Glaucoma (Left eye); Ideomotor apraxia; Type II diabetes mellitus; Urosepsis (Recently); Vision decreased (Bilateral); Visual acuity decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021079668

Write-up: Dyspnoea; Q-fever; This is a spontaneous report downloaded from the Medicines Agency (EMA) EudraVigilance-WEB [Ministero Della Salute (MINISAL02) number IT-MINISAL02-657731] from a contactable physician. An 85-year-old female patient received bnt162b2 (COMIRNATY) (lot# EL1484), intramuscular in right deltoid, on 19Jan2021 morning, at single dose, for COVID-19 immunisation. Medical history included urosepsis (recently), ideomotor apraxia, dehydration, type II diabetes mellitus, ongoing vascular encephalopathy (chronic), cognitive impairment, hypovisus for glaucoma left eye, decrease in bilateral vision. Concomitant medications included promazine hydrochloride (TALOFEN) from 21Sep2020 to 20Jan2021, metformin hydrochloride (METFORMINA ALMUS) from 26Oct2020 to 20Jan2021, enoxaparin sodium (CLEXANE) from 21Sep2020 to 20Jan2021, ferrous gluconate (LOSFERRON) from 06Oct2020 to 20Jan2021, paracetamol (unknown manufacturer) 10 mg/ml from 21Sep2020 to 20Jan2021, timolol maleate (TIMOPTOL) from 23Sep2020 to 20Jan2021. The patient experienced dyspnoea and Q-fever both on 19Jan2021 at 23:00. For this reason she was transported to the emergency room and subsequently to the internal medicine ward. The patient died on 20Jan2021 at 16:42 due to dyspnoea and Q-fever. It was unknown if an autopsy was performed. Reporter comment: the clinical report of the death is attached on 22Jan2021.; Reporter''s Comments: The clinical report of the death is attached on 22Jan2021.; Reported Cause(s) of Death: Dyspnoea; Q fever


VAERS ID: 993476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-20
   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: CANDESARTAN CILEXETIL;HYDROCHLOROTHIAZIDE; DIAZEPAM; AMLODIPINE; BROMAZEPAM; PROPRANOLOL; BETAHISTINE; PREGABALIN
Current Illness: Dementia due to Parkinson''s disease; Osteoarthrosis (Severe, with cemented fracture from D8 to D12 and L2, L3 and L5)
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Asthma; Dyslipidemia; Ear operation (Otologic surgery on the right); Epileptic seizure (at age 34, of unknown etiology); Hypertension arterial; Hypoacusis; Hypothyroidism (in the past); Osteoporosis with fracture; Psoriasis; Venous insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021074491

Write-up: This is a spontaneous report downloaded from [Regulatory Authority number PT-INFARMED-T202101-959] a contactable other health professional. A 78-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY) (lot# EL1491) 0.3 ml, intramuscular, on 19Jan2021 at 15:36, at 0.3 mL single, for COVID-19 immunisation. Vaccination was uneventful, within the recommended surveillance time of 30 minutes. Conservation, preparation and administration were carried out in accordance with the recommendations. Medical history included epileptic seizure (at age 34, of unknown etiology), anxiodepressive syndrome (unknown if ongoing), ear operation (not ongoing, otologic surgery on the right), ongoing dementia due to Parkinson''s disease, dyslipidemia (unknown if ongoing), venous insufficiency (unknown if ongoing), asthma (unknown if ongoing), hypothyroidism (not ongoing, in the past), hypertension arterial (unknown if ongoing), psoriasis (unknown if ongoing), hypoacusis (unknown if ongoing), ongoing osteoarthrosis (severe, with cemented fracture from D8 to D12 and L2, L3 and L5). As per reporter''s knowledge, the patient was never infected with the SARS-Cov-2 virus. As far as known, the patient had no history of allergies or previous reactions to drugs. Concomitant medication included candesartan cilexetil; hydrochlorothiazide (unknown manufacturer) (32 mg + 25 mg) at 1 DF 1x/day oral, diazepam (unknown manufacturer) at 5 mg 1x/day oral, amlodipine (unknown manufacturer) at 5 mg 1x/day oral, bromazepam (unknown manufacturer) at 1.5 mg 1x/day oral, propranolol (unknown manufacturer) at 20 mg 1x/day oral, betahistine (unknown manufacturer) at 48 mg 1x/day oral, pregabalin (unknown manufacturer) at 50 mg 1x/day oral and unspecified multivitamin. Previously the patient received 1st dose of Comirnaty (lot# EL1491), in 2020 (interval of at least 21 days between each dose), for COVID-19 immunisation. The patient experienced cardio-respiratory arrest on 20Jan2021 approximately 16 hours after the vaccination, with fatal outcome the same day. INEM and GNR services were requested. No therapeutic measures were taken as a result of the event. The patient was transported to the hospital where the death certificate was prepared. It was not reported if an autopsy was performed. There was no suspicion of interaction between drugs. The reporter was not sure if the death was related to the vaccine, but considered it important to notify. Reporter''s comment: Did a Medication Error occur? -No Other information-We have the bottle from which the dose of vaccine administered to the patient was taken, hours of preparation and administration - 15.36 h. We have digital record of the refrigerator temperature and manual of the Glacier thermometer. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Did a Medication Error occur? -No Other information-We have the bottle from which the dose of vaccine administered to the patient was taken, hours of preparation and administration - 15.36 h. We have digital record of the refrigerator temperature and manual of the Glacier thermometer.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 993480 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, Polymerase chain reaction, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: Alzheimer''s disease; Artificial cardiac pacemaker user; Cardiac failure; Dementia; Lung cancer; Lung lobectomy; Pulmonary fibrosis; Sick sinus syndrome
Allergies:
Diagnostic Lab Data: Test Name: PCR; Test Result: Negative ; Test Name: quick test (Ag); Test Result: Negative
CDC Split Type: SEPFIZER INC2021067677

Write-up: decreased general health condition; Acute dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB, Regulatory Authority number SE-MPA-2021-000450. Other case identifier number SE-MPA-1610703950759. An 86-year-old female patient received bnt162b2 (COMIRNATY) (Lot/Batch number and expiration date unknown), intramuscular on Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included dementia of Alzheimer''s type, lung cancer with a lung lobectomy 20 years previously, pulmonary fibrosis, cardiac failure, sick sinus syndrome with pacemaker and Artificial cardiac pacemaker user. The patient''s concomitant medications were not reported. On 14Jan2021, the woman desaturated in the nursing home and was transferred to hospital. After arrival at the hospital, the woman''s care became palliative and she passed away. According to relatives, the woman had been vaccinated with Comirnaty 7 days previously and after that she had developed decreased general health condition. The patient experienced acute dyspnoea (fatal outcome) on Jan2021. It was not reported if an autopsy was performed. The patient was tested for COVID-19 with a quick test (Ag) and PCR, both negative. The outcome of the event "decreased general health condition" was unknown. The following information on the lot/batch number has been requested.; Reported Cause(s) of Death: Acute dyspnoea


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