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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 95 out of 154

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VAERS ID: 1189305 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385962

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Public Health assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189306 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385965

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1189311 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP 2166 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac failure, Heart rate
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   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: FURADANTIN; OMEPRAZOL SANDOZ [OMEPRAZOLE]; NITROLINGUAL; ALVEDON; UREA; IMPUGAN [FUROSEMIDE]; ENALAPRIL SANDOZ; BISOPROLOL SANDOZ; OXASCAND; ISONOVA; ALLOPURINOL SANDOZ; WARAN; ZOPICLONE ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: blood pressure; Result Unstructured Data: Test Result:without remark; Test Date: 20210312; Test Name: pulse; Result Unstructured Data: Test Result:without remark
CDC Split Type: SEPFIZER INC2021371022

Write-up: death/Cause of death: cardiac failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority SE-MPA-2021-020843, Safety Report Unique Identifier SE-MPA-1615988685350. A 92-year-old female patient received bnt162b2 (COMIRNATY, lot number EP 2166 and expiration date not provided), intramuscular, administered in Arm Right second dose on 12Mar2021 at 0.3 mL, single for covid-19 immunisation. The patient''s medical history included atrial fibrillation and cardiac failure. The patient''s concomitant medications included nitrofurantoin (FURADANTIN) from 13Aug2020 at 150 mg, 1x/day; omeprazole (OMEPRAZOL SANDOZ [OMEPRAZOLE]) from 22Jun2020 at 20 mg, 1x/day; glyceryl trinitrate (NITROLINGUAL) from 22Jun2020 at 0.4 mg, as needed; paracetamol (ALVEDON) at 1000 mg, as needed; urea from 16Jul2020 at Lubricate as needed; furosemide (IMPUGAN [FUROSEMIDE]) from 16Jul2020 at 80 mg, 1x/day; enalapril maleate (ENALAPRIL SANDOZ) from 22Jun2020 at 10 mg, 1x/day; bisoprolol fumarate (BISOPROLOL SANDOZ) from 22Jun2020 at 5 mg, 1x/day; oxazepam (OXASCAND) from 22Jun2020 at 5 mg, 1x/day; isosorbide mononitrate (ISONOVA) from 22Jun2020 at 30 mg, 1x/day; allopurinol (ALLOPURINOL SANDOZ) from 07May2020 at 300 mg, 1x/day; warfarin sodium (WARAN) from 07May2020 at according to special prescription; and zopiclone (ZOPICLONE ACTAVIS) from 22Jun2020 at 5 mg, 1x/day. The patient historical vaccine includes bnt162b2 (COMIRNATY) first dose on Jan2021 for COVID-19 immunization. It was reported that patient received the second dose on 12Mar2021, the patient appeared to be as usual. No fever. Pulse and blood pressure without remark. The next day on 13Mar2021, the patient was found dead in her bed. The cause of death was cardiac failure. The patient died on 13Mar2021. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: death/Cause of death: cardiac failure


VAERS ID: 1189370 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-22
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: AUPFIZER INC2021377625

Write-up: Dyspnoea; Respiratory rate increased; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority (Regulatory authority number 529039). A 94 years male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 22Mar2021 the patient experienced dyspnoea and respiratory rate increased.The outcome of both events was reported as fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Dyspnoea; Respiratory rate increased


VAERS ID: 1189371 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-11
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EMO477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Diagnostic procedure, Laboratory test, Multimorbidity, Pulmonary embolism, Respiratory failure, SARS-CoV-2 test
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 17
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: TOILAX; IMOVANE; FURIX; KALIUMKLORID; ASCORBIC ACID; QUETIAPIN ACCORD; LACTULOSE ORIFARM; BETOLVEX; APOVIT B COMBIN; AMITRIPTYLIN "DAK"; OXYNORM; MOVICOL; SIMVASTATIN KRKA; MIRTAZAPIN "ACTAVIS"; TRADOLAN; CALCIUM + VIT D; TOUJEO; FOLIMET; B
Current Illness: Bipolar disorder; Cardiac disorder; Constipation; COVID-19 (A few days before vaccination, routinely testet. One day after vaccination, test result positive.); Depression; Edema; Kidney failure; Living in nursing home; Multimorbidity (Severe co-morbidity); Pain; Skin infection (Exit site); Sleeplessness; Type 2 diabetes mellitus; Vitamin B12 deficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Diagnostic procedure; Result Unstructured Data: Test Result:Unspecified diagnostic imaging, unknown results; Comments: Unspecified diagnostic imaging, unknown results; Test Date: 202101; Test Name: Laboratory test; Result Unstructured Data: Test Result:Unspecified, unknown results; Test Date: 20210108; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: DKPFIZER INC2021370082

Write-up: Developed lung embolisms and respiratory failure, and died of the complications.; Lung embolisms; COVID-19; multimorbidity; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0059241. This is a spontaneous case, received on 23Mar2021 from a physician (Internal ID: XMO-A09DA4056C6C4C3A8199155E969CD535) and a requested follow-up received on 26Mar2021 from the same physician, which describes the occurrence of Embolism lung (Lung embolisms) and Respiratory failure (Developed lung embolisms and respiratory failure, and died of the complications) in a 57 years old female patient vaccinated with COMIRNATY (tozinameran). A 57-year-old female patient received BNT162b2 (COMIRNATY, Lot #EMO477) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included severe multimorbidity/co-morbidity and living in nursing home, both ongoing. Patient concurrent conditions included: depression, skin infection (exit site), vitamin B12 deficiency, cardiac disorder, edema caused by kidney failure, sleeplessness, constipation, pain, bipolar disorder and type 2 diabetes mellitus. Concomitant medications included oral bisacodyl (TOILAX) taken for constipation from 23Jul2020 at 10mg 1x/day; oral zopiclone (IMOVANE) taken for insomnia from 26Jun2020 at 7.5mg 1x/day; oral cefuroxime (FURIX) taken for oedema from 05Jan2021 at 250mg 1x/day; oral kaliumklorid taken for potassium supplementation from 05Jan2021 at 2 tablets morning and 1 tablet evening; oral ascorbic acid taken for vitamin supplementation from 01Sep2020 at 80 mg, 1x/day; oral quetiapine fumarate (QUETIAPIN ACCORD) taken for bipolar disorder from 25Jun2020 400 mg, 1x/day; oral lactulose (LACTULOSE ORIFARM) taken for constipation from 14Jun2018 15 mL, 1x/day; oral cyanocobalamin zinc tannate (BETOLVEX) taken for vitamin B12 deficiency at 1 mg, 1x/day; oral calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (APOVIT B COMBIN) taken for vitamin supplementation from 01Sep2020 at 1 DF, 1x/day; oral amitriptyline hydrochloride (AMITRIPTYLIN "DAK") taken for depression from 02Aug2018 at 100 mg, 1x/day; oral oxycodone hydrochloride (OXYNORM) taken for pain from 30Dec2020 to 13Jan2021 at 10 mg, 1x/day; oral macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation from 07Oct2020; oral simvastatin (SIMVASTATIN KRKA) taken for cardiovascular disorder from 06Jun2019 at 10 mg, 1x/day; oral mirtazapine (MIRTAZAPIN "ACTAVIS") taken for depression from 26Jun2020 at 30 mg, 1x/day; oral tramadol hydrochloride (TRADOLAN) taken for pain from 26Jun2018 at 50 mg, as needed; oral calcium carbonate, vitamin D NOS (CALCIUM + VIT D) taken for calcium supplementation from 07Dec2020 at 2 DF, 1x/day; subcutaneous insulin glargine (TOUJEO) taken for diabetes mellitus from 28Aug2018 at 20 DF, 1x/day; oral folic acid (FOLIMET) taken for vitamin supplementation from 02Sep2020 at 15 mg, weekly; cutaneous mupirocin calcium (BACTROBAN) taken for skin infection from 11Nov2020 at 2 DF, 1x/day; oral carvedilol (CARVEDILOL HEXAL) taken for cardiac disorder from 26Mar2013 at 25 mg, 1x/day; oral paracetamol (PANODIL) taken for pain from 07Dec2020 at 4000 mg, 1x/day; oral linagliptin (TRAJENTA) taken for type 2 diabetes mellitus from 07Jun2015 at 5 mg, 1x/day. The patient was routinely tested for COVID-19 a few days before vaccination and one day after vaccination, on 08Jan2021, test result was positive. On 11Jan2021 the patient developed embolism lung (onset first dose day 4). On 28Jan2021 the patient developed respiratory failure (onset first dose day 21). The ADRs were reported as being life threatening, resulting in hospitalisation, and being fatal (28Jan2021). No treatment or medical procedure due to the ADRs were reported. No autopsy was performed. Reported cause of death was respiratory failure, lung embolism, COVID-19, multimorbidity (severe co-morbidity). Only normal confirmation of death was performed post-mortem, findings unknown. Test results included SARS-CoV-2 test, 08Jan2021, positive; laboratory test, Jan2021, unspecified, unknown results; diagnostic procedure, Jan2021, unspecified diagnostic imaging, unknown results. It was unknown if the death was reported to the police since the reporting physician has not conducted the confirmation of death. The physician does not wish to report the death to the police. Causality: The physician comments that she originally hadn''t reported the ADRs on her own initiative and believed the COVID-19 infection compared with severe co-morbidity is cause of the patient''s death. The reason for the late report is that the patient''s daughter has contacted her after the cases regarding thrombosis and AstraZeneca (ChAdOx1 nCoV-19) was announced in the media, and requested of having the case reported - despite the patient was vaccinated with Comirnaty. The physician comments furthermore that she despite of her not believing the vaccine is the cause of death, she cannot rule it out due to the timeframe from given vaccination to the lung embolisms and the death occurs. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; Respiratory failure; Lung embolism; Multimorbidity


VAERS ID: 1189375 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dysarthria, Lethargy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFOX; CLAVIX [CLOPIDOGREL BISULFATE]; POLPRIL; PRADAXA; NONPRES; TRIMEDUCTAN; IPP [OMEPRAZOLE]; TORSEMED; ATORIS; METFORMAX; BISOCARD; GENSULIN
Current Illness: Arterial hypertension; Atherosclerosis; Atrial fibrillation; Diabetes; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Drug-eluting stent placement (anti-proliferative drug-eluting stents;); Heart attack (3 x myocardial infarction)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021370939

Write-up: Sudden death - SCA - on the 5th day after vaccination with the 2nd dose of Pfizer vaccine/asystole; Slurred speech; fainted/swoon; depressed/mopey/lethargic; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is PL-URPL-3-469-2021. A contactable physician reported that an 89-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: ET3674; Expiration Date: 31Jul2021), intramuscular, administered in the left arm on 18Mar2021 19:18 as 0.3 mL, single for COVID-19 immunization. Medical history included arterial hypertension, diabetes, ischemic heart disease, atherosclerosis, atrial fibrillation all from an unknown date and ongoing. The patient had stents implanted with antiproliferative drugs in 01Nov2020. The patient also had three heart attacks on unspecified dates. No allergies were found. Concomitant medications included isosorbide mononitrate (EFFOX); clopidogrel bisulfate (CLAVIX [CLOPIDOGREL BISULFATE]); ramipril (POLPRIL); dabigatran etexilate mesilate (PRADAXA); eplerenone (NONPRES); trimetazidine hydrochloride (TRIMEDUCTAN); omeprazole (IPP [OMEPRAZOLE]); torasemide (TORSEMED); atorvastatin calcium (ATORIS); metformin hydrochloride (METFORMAX); bisoprolol fumarate (BISOCARD); insulin human (GENSULIN), all taken for an unspecified indication, start and stop date were not reported. On 23Mar2021, on the fifth day after the second vaccination, at 2.30 PM, the patient experienced sudden death/sudden cardiac arrest. There was no hospitalization due to a post-vaccination reaction. Before cardiac arrest, which was the cause of death, the patient was depressed/mopey/lethargic and had slurred speech, and also fainted/swoon. The emergency medical team recognized asystole and started CPR. The wife who lived with the patient, was also vaccinated on the same days with many chronic diseases, feels well now. The patient had no symptoms after receiving the first dose of bnt162b2. The doctor diagnosed an adverse vaccine reaction due to the time frame after vaccination. All the events were reported as fatal. The patient died on 23Mar2021. An autopsy will not be performed. Reporter comment: Sudden cardiac arrest, asystole, lethargy, slurred speech, and fainting are unexpected symptoms following the administration of COMIRNATY. Until 30Mar2021, the Agency Regulatory Authority database reported cases of cardiac arrest, speech disorder, depressed mood, syncope. An autopsy was not performed. In the assessment, URPL took into account information about the patient''s health, chronic diseases and the opinion of a doctor who linked death with vaccination due to the existing time relationship. Taking into account the patient''s medical history and the doctor''s opinion, it cannot be stated whether the vaccine had an impact on the patient''s death. There is a time relationship between the administration of the vaccine and the occurrence of side effects. The person reporting Adverse event following immunization (AEFI) qualified it as serious. Due to the qualification of the reporting person and the health result of the death, Regulatory Authority assessed the AEFI as serious. Relatedness of drug to all events assessed by Agency Regulatory Authority as Possible (WHO scale-assessment method). No follow-up attempts possible. No further information expected.; Reporter''s Comments: Sudden cardiac arrest, asystole, lethargy, slurred speech, and fainting are unexpected symptoms following the administration of COMIRNATY. Until 30Mar2021, the Agency Regulatory Authority database reported cases of cardiac arrest, speech disorder, depressed mood, syncope. An autopsy was not performed. In the assessment, Regulatory Authority took into account information about the patient''s health, chronic diseases and the opinion of a doctor who linked death with vaccination due to the existing time relationship. Taking into account the patient''s medical history and the doctor''s opinion, it cannot be stated whether the vaccine had an impact on the patient''s death. There is a time relationship between the administration of the vaccine and the occurrence of side effects. The person reporting Adverse event following immunization (AEFI) qualified it as serious. Due to the qualification of the reporting person and the health result of the death, Regulatory Authority assessed the AEFI as serious.; Reported Cause(s) of Death: Slurred speech; depressed/mopey/lethargic; fainted/swoon; Sudden death - SCA - on the 5th day after vaccination with the 2nd dose of Pfizer vaccine/asystole


VAERS ID: 1189630 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-30
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377622

Write-up: Cardiac arrest; Vomiting; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number 529382. An 89 female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiac arrest and vomiting on 30Mar2021. The events were fatal. 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: Cardiac arrest; Vomiting


VAERS ID: 1189631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-30
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Cardiac arrest, Hyperhidrosis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377629

Write-up: Anxiety; Cardiac arrest; Hyperhidrosis; Vomiting; This is a spontaneous report received from a contactable other health professional via the Regulatory Authority. Regulatory authority number is 529947. A 89-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 30Mar2021 the patient experienced anxiety on 30Mar2021, cardiac arrest, hyperhidrosis and vomiting The outcome for all events was reported as fatal. It was not reported if an autopsy was performed No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Anxiety; Cardiac arrest; Hyperhidrosis; Vomiting


VAERS ID: 1189633 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-14
Onset:2021-02-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Carotid artery occlusion, Cerebrovascular accident, Embolism, Hemiparesis, Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Itching (occasionally slight itching on the skin, not definable); Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021370526

Write-up: Ischemic stroke; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; Occlusion d. Internal carotid due to embolism, stroke, left medial syndrome with aphasia, right hemiparesis.; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021040265]. Other case identifier number DE-PEI-202100027957. A 91-year-old female patient received bnt162b2 (COMIRNATY), first dose intramuscular on 14Feb2021 (Batch/Lot Number: EL8723) as single dose for covid-19 immunisation. Medical history included Idiopathic Parkinson''s Syndrome, arterial hypertension, occasionally slight itching on the skin, not definable from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced ischemic stroke, occlusion d. internal carotid due to embolism, stroke (apoplectic fit; Plaque build-up in the intra- and extracranial vessels), left medial syndrome with aphasia, right hemiparesis on 19Feb2021. The patient was hospitalized due to the events from 19Feb2021 to 01Mar2021. The patient died on 05Mar2021 due to ischemic stroke. An autopsy was not performed. The outcome of ischemic stroke was fatal while the patient did not recover from the remaining events. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1190688 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377624

Write-up: Unresponsive to stimuli; This is a spontaneous report from a contactable other health professional received from the Regulatory Authority. Regulatory authority report number 529022. A 97-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was unresponsive to stimuli on an unspecified date with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unresponsive to stimuli


VAERS ID: 1190689 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-27
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021377628

Write-up: Malaise; This is a spontaneous report received from the Regulatory Authority (RA) (Regulatory authority number 529418). The reporter type to the RA was reported as a HCP. This is a line listing report. A 91 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 27Mar2021 the patient experienced malaise which led to patient death on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained; Reported Cause(s) of Death: Malaise


VAERS ID: 1190714 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021372976

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; The first report downloaded from the Regulatory Authority GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. This is the seventh of eight reports. A contactable physician reported for a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on an unspecified date. The clinical course was reported as follows: This lady''s cause of death was Covid-19. This lady was one of 8 patients in the nursing home who died of Covid-19 within a month of receiving the same vaccine. I did not complete a yellow card for all of them. The events were assessed as results in death and medically significant. 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. Amendment: This follow-up report is being submitted to amend previously reported information: Updated the labelling for the events SARS-CoV-2 infection (COVID-19 and Drug ineffective) from listed to unlisted.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1193825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: AUPFIZER INC2021377623

Write-up: Pneumonia; This is a spontaneous report from a contactable Healthcare Professional received from the Agency Regulatory Authority (Regulatory authority number 528392). This is a line listing report. A 92-year-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia, which was fatal. 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: Pneumonia


VAERS ID: 1193830 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-12
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Cardiogenic shock, Confusional state, Dyspnoea, Electrocardiogram, Hypotension, Sinus tachycardia, Syncope, Troponin
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; CONCOR; JANUVIA [SITAGLIPTIN PHOSPHATE]; EUTHYROX; NITRODERM; CITALOPRAM MEPHA; PANTOZOL CONTROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hashimoto''s thyroiditis; Ischaemic cardiomyopathy; Metabolic syndrome; Terminal renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: blood pressure; Result Unstructured Data: 80/60 mmHg, hypovolemic shock; Test Date: 20210313; Test Name: ECG; Result Unstructured Data: revealed sinus tachycardia, ST elevation to limits, non-specific T-wave alterations and baseline instability on leads I,III,aVL,V1,V2; Test Date: 20210313; Test Name: troponin; Result Unstructured Data: ng/L; Test Date: 20210314; Test Name: troponin; Result Unstructured Data: ng/L
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: cardiogenic shock; dyspnoeic; confused; syncope; sinus tachycardia; low blood pressure (80/60); Asthenia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIOGENIC SHOCK (cardiogenic shock), HYPOTENSION (low blood pressure (80/60)), ASTHENIA (Asthenia), SYNCOPE (syncope), SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (dyspnoeic) and CONFUSIONAL STATE (confused) in a 93-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Ischaemic cardiomyopathy in 2017, Terminal renal insufficiency and Metabolic syndrome. Concurrent medical conditions included Diabetes mellitus in 1981 and Hashimoto''s thyroiditis. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), BISOPROLOL FUMARATE (CONCOR), SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), LEVOTHYROXINE SODIUM (EUTHYROX), GLYCERYL TRINITRATE (NITRODERM), CITALOPRAM HYDROBROMIDE (CITALOPRAM MEPHA) and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOZOL CONTROL) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPOTENSION (low blood pressure (80/60)) (seriousness criteria hospitalization and medically significant) and ASTHENIA (Asthenia) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced SYNCOPE (syncope) (seriousness criteria hospitalization and medically significant) and SINUS TACHYCARDIA (sinus tachycardia) (seriousness criterion hospitalization). On 14-Mar-2021, the patient experienced CARDIOGENIC SHOCK (cardiogenic shock) (seriousness criteria death, hospitalization and medically significant), DYSPNOEA (dyspnoeic) (seriousness criterion hospitalization) and CONFUSIONAL STATE (confused) (seriousness criterion hospitalization). The patient was hospitalized on 12-Mar-2021 due to ASTHENIA, CARDIOGENIC SHOCK, CONFUSIONAL STATE, DYSPNOEA, HYPOTENSION, SINUS TACHYCARDIA and SYNCOPE. The patient died on 14-Mar-2021. The reported cause of death was Cardiogenic shock. An autopsy was not performed. At the time of death, HYPOTENSION (low blood pressure (80/60)), ASTHENIA (Asthenia), SYNCOPE (syncope), SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (dyspnoeic) and CONFUSIONAL STATE (confused) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood pressure measurement: 80/60 mmhg 80/60 mmHg, hypovolemic shock. On 12-Mar-2021, Electrocardiogram: Inconclusive. On 13-Mar-2021, Electrocardiogram: abnormal revealed sinus tachycardia, ST elevation to limits, non-specific T-wave alterations and baseline instability on leads I,III,aVL,V1,V2. On 13-Mar-2021, Troponin increased: 1889 ng/L. On 14-Mar-2021, Troponin increased: 8175 ng/L. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIOGENIC SHOCK (cardiogenic shock) to be unlikely related. No further causality assessments were provided for HYPOTENSION (low blood pressure (80/60)), ASTHENIA (Asthenia), SYNCOPE (syncope), SINUS TACHYCARDIA (sinus tachycardia), DYSPNOEA (dyspnoeic) and CONFUSIONAL STATE (confused). On 13/03/2021, during her usual hemodialysis session, after approx. 1 h 30 min from the start of dialysis, presented with marked low blood pressure with an episode of syncope lasting approximately 10-15 minutes, fluctuate with unstable haemodynamic Treatment medication include "Noradrenaline and Dobutamine support" and also gradually reduce the catecholamine therapy in progress and to accompany this with palliative care. The patient died on 14/03/2021 at 12:48 with her family present. Reason for death: cardiogenic shock following acute STEMI-type coronary syndrome in a context of ischemic-hypertensive heart disease. Company comment:Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1193833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Apr-2021 and was forwarded to Moderna on 03-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (death) in an 88-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history.). On 03-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 05-Mar-2021 The patient died on 05-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (death) to be unlikely related. Reporter did not allow further contact; Sender''s Comments: This case refers to an 88 year-old elderly female patient who died 48 hours after receiving the mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1193836 (history)  
Form: Version 2.0  
Age: 101.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 722 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Immobilization prolonged; Weakness
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA and PYREXIA (Fever) in a 101-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 722) for COVID-19 vaccination. The patient''s past medical history included Immobilization prolonged, Cardiac failure and Weakness. On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced DYSPNOEA (seriousness criterion death) and PYREXIA (Fever) (seriousness criterion death). The patient died on 08-Mar-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was provided. This is a case of death in a 101-year-old male subject with unknown medical history of cardiac failure and prolonged immobilization, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow-up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 101-year-old male subject with unknown medical history of cardiac failure and prolonged immobilization, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow-up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1193970 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021370947

Write-up: Vomiting; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number PL-URPL-3-467-2021. An 83-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 25Mar2021 09:57 (Batch/Lot Number: ET3674; Expiration Date: 28Mar2021) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Mar2021 04:15, the patient experienced vomiting. The patient died on 26Mar2021. An autopsy was performed and results were not provided. Sender comment: Comirnaty- vaccine against COVID-19 (mRNA). Nausea is mentioned as an expected effect in the SmPC, therefore it cannot be excluded that vomiting was caused by the vaccination. The direct cause of death is unknown, an autopsy will be performed, URPL has requested additional information. There is a time relationship between vaccination and death. The reporting person qualified AEFI as severe. URPL assessed the AEFI as severe. Vomiting: Source of assessment NCA, Method of assessment WHO scale, Result of Assessment Possible. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1193971 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-03-03
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, COVID-19, Dizziness, Feeling hot, Myalgia, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Spinal disorder (Degeneration of the spine)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Respiratory failure; Dizziness; Feeling hot; Weakness generalized; Muscle pain; COVID-19; This regulatory authority case was reported by a non-health professional and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure) and COVID-19 (COVID-19) in a 74-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spinal disorder (Degeneration of the spine). On 20-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness), FEELING HOT (Feeling hot), ASTHENIA (Weakness generalized) and MYALGIA (Muscle pain). On 05-Mar-2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criterion death) and COVID-19 (COVID-19) (seriousness criterion death). The patient died on 05-Mar-2021. The reported cause of death was Respiratory failure and covid-19, virus identified. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), FEELING HOT (Feeling hot), ASTHENIA (Weakness generalized) and MYALGIA (Muscle pain) outcome was unknown. Concomitant product use was not provided. Treatment information was not provided. The reporter''s contact information was not provided. Reporter did not allow further contact; Reported Cause(s) of Death: Respiratory failure; COVID-19, virus identified


VAERS ID: 1193975 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385843

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193976 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385895

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193977 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385896

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193978 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385898

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193979 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385899

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193980 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385901

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193981 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385902

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193982 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385909

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193983 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385911

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193984 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385917

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193985 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385919

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193986 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385920

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193987 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385921

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193988 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385924

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193989 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385925

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193990 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385927

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193991 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385930

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193992 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385933

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193993 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385938

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193994 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385939

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193995 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385940

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193996 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385941

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193997 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385942

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193998 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385943

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1193999 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385944

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194000 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385946

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194001 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385947

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194002 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385949

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194003 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385953

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194004 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385955

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194005 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385956

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194006 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385958

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194007 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385959

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194008 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385961

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194009 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385963

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194010 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385964

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1194011 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Ill-defined disorder NOS (unspecified comorbidities)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021385966

Write-up: COVID-19 an average of 12 days after first dose; This is a spontaneous report from three contactable physicians reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of an unspecified age and gender received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included unspecified comorbidities. Concomitant medications were not reported. In 2021 (between 01Jan2021-14Mar2021), the patient died after receiving the first dose and a diagnosis of COVID-19 was established. The patient died on an unknown date in 2021 with the cause of death reported as COVID-19. It was unknown if an autopsy was performed. Among the 76 reported cases, the average date of onset of COVID-19 was 12 days after the administration of the first dose with the average days to death of 23 days. Agency Regulatory Authority assessed that there was no causal mechanism between the vaccine administration and the cause of death. Data analysis showed that there was no direct link between vaccination and death. Taking into consideration the time past from the vaccination date to the date of confirmation with SARS CoV-2 infection, vaccination of this person did not assure the optimal protection in the face of the infection. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, no full protection from BNT162b2 could be reasonably expected considering the less than minimal 14 days intervals may not elicit adequate amount of antibodies in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.;RO-PFIZER INC-2021376163 Same reporter, same suspect product, same event, different patient.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1197417 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-18
Submitted: 0000-00-00
Entered: 2021-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker user; Fibrosis lung; Oxygen therapy (O2 therapy at home)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: dyspnea for one week with worsening; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST in an 86-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fibrosis lung, Oxygen therapy (O2 therapy at home) and Artificial cardiac pacemaker user. On 19-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form in total. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (dyspnea for one week with worsening). On 19-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (seriousness criterion death). The patient died on 19-Mar-2021. The reported cause of death was Standstill cardiac. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (dyspnea for one week with worsening) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided. Reporter did not allow further contact; Reporter''s Comments: Cardiac arrest in patient with multiple conditions (severe pulmonary fibrosis on O2 therapy at home + implanted PM) that occurred this morning after the second dose of the Moderna vaccine. Relatives reported dyspnea for one week with worsening since yesterday evening.; Reported Cause(s) of Death: Standstill cardiac


VAERS ID: 1199796 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-03-01
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Air embolism, Anti-aquaporin-4 antibody, Anti-cyclic citrullinated peptide antibody, Anti-saccharomyces cerevisiae antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Antiphospholipid antibodies, Beta-2 glycoprotein antibody, Blood electrolytes, Cardiolipin antibody, Chest X-ray, DNA antibody, Immunoelectrophoresis, Investigation, Liver function test, Magnetic resonance imaging, Optic neuritis, Oxygen saturation, Respiratory distress, Rheumatoid factor, Serology test, Visual acuity tests
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SYMBICORT; CETIRIZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Allergy ((to grasses and horse)); Anaphylaxis (his mother''s serious anaphylaxis); Blepharoplasty (Bilateral blepharoplasty); Carcinoma basal cell (his mothers- Basal cell carcinoma of nose)
Allergies:
Diagnostic Lab Data: Test Name: anti-AQP4 antibodies; Test Result: Negative ; Test Name: Anti-cyclic citrullinated peptide antibody; Test Result: Negative ; Test Name: ANCA; Test Result: Negative ; Test Name: Fluorescent antinuclear antibodies; Result Unstructured Data: Test Result:+1/640? homogenous; Test Date: 20210312; Test Name: Fluorescent antinuclear antibodies; Result Unstructured Data: Test Result:+1/640? homogenous; Test Name: anti-phospholipid; Test Result: Negative ; Test Name: ASCA; Test Result: Negative ; Test Name: anti-Beta2GP1; Test Result: Negative ; Test Name: Electrolytes; Result Unstructured Data: Test Result:normal; Test Name: anti-cardiolipin; Test Result: Negative ; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:normal; Test Date: 20210312; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:did not reveal pneumothorax; Comments: did not reveal pneumothorax; Test Name: anti-deoxyribonucleic acid; Result Unstructured Data: Test Result:negatve; Test Name: Immunoelectrophoresis-Serum; Result Unstructured Data: Test Result:normal; Test Name: Anti-MOG antibodies; Test Result: Positive ; Test Name: EPP; Result Unstructured Data: Test Result:normal; Test Name: liver function test; Result Unstructured Data: Test Result:normal; Test Name: MRI; Result Unstructured Data: Test Result:papillitis with bilateral retrobulbar optic neurit; Comments: papillitis with bilateral retrobulbar optic neuritis; Test Name: Spinal cord MRI; Result Unstructured Data: Test Result:MRI of the spinal cord: normal.; Comments: MRI of the spinal cord: normal; Test Date: 20210312; Test Name: o2 saturation; Test Result: 83 %; Test Name: Rheumatoid factors; Test Result: Negative ; Test Name: blood counts; Result Unstructured Data: Test Result:normal; Test Name: Visual acuity; Result Unstructured Data: Test Result:3/10 right eye; Comments: First examination; Test Date: 20210304; Test Name: Visual acuity; Result Unstructured Data: Test Result:8/10; Test Date: 20210308; Test Name: Visual acuity; Result Unstructured Data: Test Result:8/10; Test Date: 20210312; Test Name: Visual acuity; Result Unstructured Data: Test Result:8/10
CDC Split Type: FRPFIZER INC2021342553

Write-up: bilateral retrobulbar optic neuritis; air embolism; respiratory distress; This is a spontaneous report downloaded from the regulatory authority number FR-AFSSAPS-RN20210913. A contactable physician reported that a 60-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: EJ6789), dose 2 intramuscular, administered in (left upper limb)Arm Left on 05Feb2021 as single dose for covid-19 immunization. Medical history included mentioned his mother''s serious anaphylaxis, basal cell carcinoma from 2017 to an unknown date, Basal cell carcinoma of nose, On 12Feb2021 Bilateral blepharoplasty under local anesthesia and described onset of pain triggered by moving both eyeballs in the week of 22Feb202. In view of a very significant increase in pain around 27Feb2021 associated with a decrease in right monocular visual acuity and frontal headaches causing insomnia, he had a consultation on 01Mar2021. There was right monocular inferior visual field reduction associated with a decrease in visual acuity to 3/10, as well as a more moderate impairment of the visual field on the left, with retained visual acuity in this eye. Fundus examination revealed bilateral papilledema. Administration of SOLUMEDROL bolus, 1 g daily for 3 days. Ophthalmic check-up on 04Mar2021 showed an improvement in visual acuity to 8/10 and a reduction in scotoma, as well as a total disappearance of pain, but as the improvement was not sufficiently significant, it was decided to perform plasmaphereses, organized 1 day/2 according to the usual management pursued by the ward. Corticosteroid boluses were continued for additional 2 days (5 days in total). On 08Mar2021, after the first 2 plasmaphereses, visual acuity was still measured at 8/10 with a slight improvement in scotoma. A decision was made to continue the therapy for a total of 5 plasma exchanges (discussed with the patient). In view of a positive result of anti-MOG antibodies assay, giving rise to suspicion of a myelin oligodendrocyte glycoprotein (MOG) spectrum disease, treatment was switched to oral corticosteroid therapy at a dose of 1 mg/kg, i.e. 80 mg per day, which was started on 05Mar2021. On 12Mar2021, after 5 plasmaphereses, visual acuity was still measured at 8/10 on the right with a decrease in the lower scotoma of the right visual field. Asthma, hypersensitivity (to grasses and horse) from on an unspecified date. On an unspecified date concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT), cetirizine (CETIRIZINE) taken for an unspecified indication. The patient experienced air embolism (death and medically significant) on an unspecified date, respiratory distress (death and medically significant) on 12Mar2021 17:40, bilateral retrobulbar optic neuritis (optic neuritis) (hospitalization and medically significant) on 01Mar2021. Patient vaccinated on 08Jan2021 with Comirnaty - dose 1. The patient underwent lab tests and procedures which included anti-aquaporin-4 antibody: negative, anti-cyclic citrullinated peptide antibody: negative, antineutrophil cytoplasmic antibody: negative, antinuclear antibody: +1/640 degree homogenous, DNA antibody: negative, immunoelectrophoresis: normal, investigation: positive, antiphospholipid antibodies: negative, anti-saccharomyces cerevisiae antibody: negative, beta-2 glycoprotein antibody: negative, blood electrolytes: normal, cardiolipin antibody: negative, chest x-ray: normal on an unspecified date, antinuclear antibody: +1/640 degree homogenous on 12Mar2021, chest x-ray: did not reveal pneumothorax on 12Mar2021. Therapeutic measures were taken as a result of respiratory distress (respiratory distress). The patient died on 13Mar2021. Cause of death was air embolism and respiratory distress. It was not reported if an autopsy was performed. The outcome of the events air embolism and respiratory distress was fatal and outcome of event optic neuritis was not recovered. No follow-up attempts are possible.; Reported Cause(s) of Death: air embolism; Respiratory distress


VAERS ID: 1199888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-30
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Dyspnoea, Headache, Myocarditis, Neck pain, Pericardial effusion, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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 INC2021370485

Write-up: Pericardial effusion; Myocarditis; Dyspnoea; Thorax pain; Tachycardia; Cervical pain; Headache; patient died; This is a spontaneous report from a non-contactable pharmacist downloaded from the regulatory authority. Regulatory authority number DE-PEI-202100029368. A 35-year-old female patient received bnt162b2 (COMIRNATY, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericardial effusion, myocarditis, dyspnoea, thorax pain, tachycardia, cervical pain, and headache; all on an unspecified date. The events pericardial effusion, myocarditis, dyspnoea was reported as life-threatening. The patient died on 30Jan2021. Autopsy was not performed. The patient had not recovered from the event pericardial effusion, myocarditis, dyspnoea, thorax pain, tachycardia, cervical pain, and headache. No follow-up attempts possible, batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: patient died


VAERS ID: 1199890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021370489

Write-up: Blood clots in the head, resulting in death; Blood clots in the head, resulting in death; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority. The regulatory authority report number is DE-PEI-CADR2021040861, Safety report unique identifier DE-PEI-202100028706. A 91-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 30Jan2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 09Jan2021 and experienced blood clot on 25Jan2021, dizziness on 10Jan2021 and exhaustion on unknown date. The patient experience blood clots in the head, resulting in death in 2021. The patient died on 11Feb2021. An autopsy was not performed. It was reported that the patient passed away on 11Feb2021 in the nursing home administration of a second Covid-19 vaccination with a blood clot in her head. She had received the first vaccination on 09Jan2021 and the second on 30Jan2021. A few days after the first vaccination, she developed weakness and dizziness and was found sitting on the floor in the bathroom at night, according to the nursing home. She was admitted to the district hospital (here the blood clot was diagnosed but not treated), discharged after a few days on 30Jan2021 and despite her weakened condition still received the 2nd Covid vaccination on the day of discharge in the nursing home. Information on lot and batch numbers cannot be obtained. No further information expected.; Reported Cause(s) of Death: disease progression; Blood clot


VAERS ID: 1199894 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Brain oedema, Cerebrovascular accident, Dysphagia, Malaise, Paralysis, Vascular occlusion
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 52
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: DEPFIZER INC2021389808

Write-up: had another severe stroke and was left paralyzed; Swelling / edema in the head; couldn''t swallow anymore; had another severe stroke and was left paralyzed; was able to express 2-3 words at the beginning, but the coming days became more and more difficult and; Vascular occlusion; she whined a bit that she was not doing well; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 32336], license party for Comirnaty. A female patient of unknown age received second dose of BNT162B2 (COMIRNATY) on 19Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccination included first dose of COMIRNATY for Covid-19 immunisation on unknow date. The patient had the 2nd vaccination with suspect vaccine on 19Feb2021. The following week, on Tuesday, she was still doing her own shopping by car (she lived alone and was still able to take care of herself completely). On Thursday / Friday of the following week she was already moaning that she was not doing well (Feb2021). On Sunday 28Feb2021 in the afternoon she was admitted to the hospital with the emergency physician with a vascular occlusion. She was operated on Sunday, had to be intubated with local anesthesia after 30 minutes during the operation and was in the intensive care unit until Wednesday. She was transferred to the ward on Thursday afternoon, and on Friday it turned out that she had a severe stroke and was paralyzed on her left side on 05Mar2021. There was also swelling / edema in the head on 05Mar2021. She was immediately transferred to the stroke unit on Friday. In addition, she could no longer swallow on 05Mar2021 and was initially able to say 2-3 words coherently, which became more and more difficult in the coming days (in Mar2021) and in the end not possible anymore and she only reacted by moving her head (when she was not sleeping). We switched to palliative care after talking to a physician and on 22March, in this worse condition, she was then transferred to the nursing home for short-term care. The patient did not recover from aphasia, the outcome of other events was unknown. At home, the patient died on 26March due to stroke. It was unknown if an autopsy was performed. Lot/batch number has been requested.; Reported Cause(s) of Death: had another severe stroke


VAERS ID: 1199895 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021390077

Write-up: stroke after the second vaccination; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 32336], license party for Comirnaty. The consumer reported similar events for two patients. This is the second of two reports. A female patient of an unknown age received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: unknown) on an unknown date at single dose for COVID-19 immunization. Medical history and concomitant drugs were not reported. The patient received the first dose of vaccine on an unknown date. It was reported that after the 2nd vaccination the patient suffered a stroke an unknown date in 2021 and died. Lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021389808 same drug, same source, different patient; Reported Cause(s) of Death: stroke


VAERS ID: 1199896 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-03-04
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; SIMVASTATIN; VIBEDEN; LOSARTAN; FURIX [CEFUROXIME]; METFORMIN; LANSOPRAZOLE
Current Illness: Anaemia pernicious; Diabetes; Gastroesophageal reflux; Hypercholesterolaemia; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Myocardial infarct; Unspecified vitamin B deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021370067

Write-up: Died 10 days after vaccination; This is a spontaneous report downloaded from the Regulatory Authority (regulatory authority number: DK-DKMA-ADR 25005752) received from a lawyer and a physician from the Association via the Agency. An 84-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection lot number: EP9598, expiration date: 30Jun2021), via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunisation. Medical history included hypertension, diabetes, anaemia pernicious, hypercholesterolaemia, gastroesophageal reflux, all were from an unspecified date and ongoing; b-vitamin deficiency; myocardial infarct and apoplexy from 2017 to an unspecified date. Concomitant medication(s) included clopidogrel (CLOPIDOGREL) taken for thrombosis prophylaxis from 2016 to an unspecified stop date; simvastatin (SIMVASTATIN) taken for hypercholesterolaemia from 2016 to an unspecified stop date; hydroxocobalamin (VIBEDEN) taken for pernicious anaemia from 2016 to an unspecified stop date; losartan (LOSARTAN) taken for hypertension from Feb2019 to an unspecified stop date; cefuroxime (FURIX [CEFUROXIME]) taken for diuretic therapy from 20May2020 to an unspecified stop date; metformin (METFORMIN) taken for diabetes mellitus from Mar2019 to an unspecified stop date; lansoprazole (LANSOPRAZOLE) taken for gastrooesophageal reflux disease from 2019 to an unspecified stop date. The patient died 10 days after vaccination on 04Mar2021. An autopsy was performed and results were not provided. Causality: The physician does not suspect that the death is due to the vaccine, as the patient is co-morbid. Therefore, he has not reported it as an ADR of the vaccine. The patient is known to have hypertension, Hypercholesterolaemia, diabetes and B-vitamin deficiency. The patient has previously had Myocardial infarct and Apoplexy in 2017. The physician is not aware that the patient should have reacted to vaccines in the past. The physician states that he has been in contact with the Police at the beginning of March, and that he therefore is aware that an inquest and autopsy of the patient should be performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on available information it is unlikely that the patient''s death was related to bnt162b2 (COMIRNATY). The patient''s hypertension, diabetes, anaemia pernicious, hypercholesterolaemia may have all contributed to the patient''s death: however, based on current convention, the case of death is assessed as related to bnt162b2 (COMIRNATY). until sufficient information is available to confirm an unrelated cause of death. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Died 10 days after vaccination


VAERS ID: 1199917 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Computerised tomogram head, Haemoglobin, Haemorrhagic stroke, Heart rate, Laboratory test, Oxygen saturation, Physical examination, Platelet count, SARS-CoV-2 test, Ventilation/perfusion scan, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Embolism pulmonary (Treated with PRADAXA.); Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210322; Test Name: Blood pressure; Result Unstructured Data: Test Result:131/120 mmHg; Comments: in the left arm; Test Date: 20210322; Test Name: Blood pressure; Result Unstructured Data: Test Result:147/133 mmHg; Comments: in the right arm; Test Date: 20210322; Test Name: cerebral CT; Result Unstructured Data: Test Result:left parieto-occipital intraparenchymal hemorrhage; Comments: with active arterial bleeding in it. Pontomeencephalic intraparenchymal hematoma. Left temporal subarachnoid hemorrhage. Acute left subdural hematoma, with chronic component. Sign of commitment under falcoriel and bitemporal; Test Date: 20210322; Test Name: hemoglobin; Result Unstructured Data: Test Result:13.2 g/dl; Test Date: 20210322; Test Name: Heart rate; Result Unstructured Data: Test Result:53; Test Date: 20210322; Test Name: biological assessment; Result Unstructured Data: Test Result:leukocytes 8 g/l, hemoglobin 13.2 g/dL; Comments: platelets 232 g/l; Test Date: 20210322; Test Name: saturation; Test Result: 93 %; Test Date: 20210322; Test Name: physical examination; Result Unstructured Data: Test Result:dextro 1.58 g/l, G 6/15, bilateral mydriasis; Comments: probable inhalation; Test Date: 20210322; Test Name: Plateletes; Result Unstructured Data: Test Result:232 g/l; Test Date: 20210322; Test Name: COVID-19 test: PCR/serology; Result Unstructured Data: Test Result:Unknown results; Comments: in progress; Test Date: 20210322; Test Name: Ventilation rate; Result Unstructured Data: Test Result:22; Comments: full, regular breaths per minute; Test Date: 20210322; Test Name: Leucocytes; Result Unstructured Data: Test Result:8 g/l
CDC Split Type: FRPFIZER INC2021369657

Write-up: haemorrhagic stroke; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-AN20211114. An 87-year-old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 1 intramuscular on 17Mar2021 (batch/lot number and expiry date not reported) as single dose for covid-19 immunization; dabigatran etexilate mesilate (PRADAXA), oral from an unspecified date (batch/lot number and expiry date not reported) to 22Mar2021, at 2 DF, once a day for embolism pulmonary; levothyroxine sodium (LEVOTHYROX), oral from an unspecified date (batch/lot number and expiry date not reported) to 22Mar2021, at unspecified dose for an unspecified indication. Medical history included embolism pulmonary unknown if ongoing and treated with pradaxa, migraine unknown if ongoing. The patient at risk of developing a severe form of COVID-19 disease was no, previous Covid-19 was unknown. The patient''s concomitant medications were not reported. The patient experienced haemorrhagic stroke on 22Mar2021. The reporter informed that on 22Mar2021 (5 days after vaccination), the patient has severe headaches with pain in the eye then vomiting, inconsistent speech, stammers, did not respond to simple commands. The patient moved an arm to painful stimulation, symmetrical pupils. The reporter informed that when the firefighters arrive, the patient reacted very little to the stimulation, at 4 p.m., eye pain, vomiting a lot and loss of urine. The patient''s heart rate was 53, blood pressure in the left arm was 131/120 mmHg, in the right arm 147/133 mmHg. The patient''s ventilation rate was at 22 full, regular breaths per minute, and has a 93 % saturation. The reporter informed that the patient''s usual treatment was pradaxa, levothyrox. The patient has a COVID-19 test: PCR/serology was in progress and was taken on 22Mar2021. The reporter informed physical examination upon arrival at the emergency room on 22Mar2021 was dextro 1.58 g/l, G 6/15, bilateral mydriasis, probable inhalation. The patient had additional test of cerebral CT on 22Mar2021 and the result was left parieto-occipital intraparenchymal hemorrhage, with active arterial bleeding in it. Pontomeencephalic intraparenchymal hematoma. Left temporal subarachnoid hemorrhage. Acute left subdural hematoma, with chronic component. Sign of commitment under falcoriel and bitemporal. The patient''s biological assessment on 22Mar2021 was leukocytes 8 g/l, hemoglobin 13.2 g/dL, platelets 232 g/l. The patient''s treatment and evolution was decision of palliative care. The reporter informed that the patient''s death was on 23Mar2021 at 12:30 a.m. The reporter informed that the conclusion was that the patient under pradaxa who presented a hemorrhagic stroke 6 days after a first dose of COMIRNATY vaccine resulting in death overnight. The summary was that patient on dabigatran who presented with a haemorrhagic stroke 6 days after a first dose of COMIRNATY vaccine resulting in death overnight. A drug was coded as an active principle when the specialty name was unknown to "us". The action taken in response to the events for the suspect drugs was not applicable. Therapeutic measures were taken as a result of haemorrhagic stroke (haemorrhagic stroke). The patient died on 23Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: haemorrhagic stroke


VAERS ID: 1199922 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARDEGIC; SECTRAL; ZYMAD; PARIET; FLECTOR [DICLOFENAC SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Constipation; Diverticulosis; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210318; Test Name: CT brain scan; Result Unstructured Data: Test Result:hematoma; Comments: intracranial hematoma, with ventricular flooding, mass effect with sub-falcorial and left temporal involvement. Beginning of hydrocephalus.
CDC Split Type: FRPFIZER INC2021380058

Write-up: Haemorrhagic stroke; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number is FR-AFSSAPS-BR20211057. An 87-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 1 intramuscular, administered on left arm on 16Mar2021 (Batch/Lot Number: ET3620) at single dose (at the age of 87 years old) for COVID-19 immunisation. Medical history included diverticulum, atrial fibrillation paroxysmal, constipation and hypertension arterial. Concomitant medications included acetylsalicylate lysine (KARDEGIC), acebutolol hydrochloride (SECTRAL), colecalciferol (ZYMAD), rabeprazole sodium (PARIET) and diclofenac sodium (FLECTOR [DICLOFENAC SODIUM]), all taken for an unspecified indication, start and stop date were not reported. On 18Mar2021 around 8:30 am, she was found on the ground, unconscious, by her husband who heard her go to the bathroom and called the Medical Service). The cerebral CT scan in the ER found an intracranial hematoma, with ventricular flooding, mass effect with sub-falcorial and left temporal involvement (Haemorrhagic stroke). Beginning of hydrocephalus. Palliative care recommended after advice from the neurologist. The patient died on 18Mar2021 at 7:35 p.m. It was not reported if autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1199923 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram thorax, Investigation, Recalled product administered, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (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: ELIQUIS; BISOCE; PANTOPRAZOLE; RAMIPRIL; AMIODARONE; LEVEMIR; HUMALOG; UVEDOSE; LAMALINE; DOLIPRANE
Current Illness: AFib; Aortic stenosis; Bladder cancer stage IV; Chronic renal failure; Cognitive disorder; COPD; Hypertension arterial; Tachyarrhythmia; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic alcoholism; Hip fracture; Metastatic carcinoma of the bladder; Urinary bladder polyp
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: CT chest; Result Unstructured Data: Test Result:shows a 5 cm long axis, right lower lobar mass and; Comments: shows a 5 cm long axis, right lower lobar mass and a 24 mm long axis pleural mass in the posterior segment of the right upper lobe. Possible metastasis of the bladder tumour lesion. No pathological opinion requested; Test Date: 20201203; Test Name: investigation; Result Unstructured Data: Test Result:discovery of a suspicious looking lung tissue; Comments: lesion in the right lower lobe; Test Date: 20210226; Test Name: investigation; Result Unstructured Data: Test Result:discovery of a complex fracture of the thoracic; Comments: vertebra 10 in patty; Test Date: 20210305; Test Name: investigation; Result Unstructured Data: Test Result:presence of metastatic osteosis of the T10, L2; Comments: S2 and S3 vertebrae with grade 3 malignant compression in T10; Test Date: 20201109; Test Name: Covid RT-PCR test; Test Result: Negative ; Test Date: 20201130; Test Name: Covid RT-PCR test; Test Result: Negative ; Test Date: 20210227; Test Name: Covid RT-PCR test; Test Result: Negative ; Test Date: 20210302; Test Name: Covid RT-PCR test; Test Result: Negative ; Test Date: 20210322; Test Name: Covid RT-PCR test; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC2021380254

Write-up: COVID-19/develops symptomatic COVID, variant; Vaccine failure confirmed; On 12Feb2021 there was a recall of bnt162b2 vaccine with lot EJ6789; This is a spontaneous report downloaded from the regulatory authority manufacturer report number FR-AFSSAPS-BS20210522. A contactable pharmacist reported that an 86-year-old male patient received bnt162b2 (COMIRNATY), the second dose on 12Feb2021 (Lot Number: EJ6789) and the first dose on 15Jan2021 (Lot Number: EM0477) both via intramuscular route, as a single dose for COVID-19 immunization. Medical history included bladder cancer stage IV, possible metastasis of the bladder tumour lesion, chronic renal failure, type 2 diabetes mellitus, ongoing aortic stenosis, cognitive disorder, hypertension arterial, atrial fibrillation (AFib) and chronic obstructive pulmonary disease (COPD) all from an unknown date and ongoing and chronic alcoholism from an unknown date and unknown if ongoing. The patient had a fracture of the right iliopubic branch and fortuitous discovery of bladder polyps suspected of being tumour lesions on 30Nov2020. On 03Dec2020, there was a discovery of a suspicious looking lung tissue lesion in the right lower lobe. The patient had no history of COVID-19. The patient had negative RT-PCR tests on 09Nov2020, 30Nov2020, 27Feb2021 and 02Mar2021. Concomitant medications included apixaban (ELIQUIS); bisoprolol fumarate (BISOCE); pantoprazole (manufacturer unknown); ramipril (manufacturer unknown); amiodarone (manufacturer unknown); insulin detemir (LEVEMIR); insulin lispro (HUMALOG); colecalciferol (UVEDOSE); caffeine, papaver somniferum tincture, paracetamol (LAMALINE) and paracetamol (DOLIPRANE) all taken for an unspecified indication, start and stop date were not reported. On 10Feb2021, the patient had a chest CT scan shows a 5 cm long axis, right lower lobar mass and a 24 mm long axis pleural mass in the posterior segment of the right upper lobe. Possible metastasis of the bladder tumour lesion. No pathological opinion requested. On 12Feb2021 there was a recall of bnt162b2 vaccine with lot EJ6789. On 26Feb2021, there was a discovery of a complex fracture of the thoracic vertebra 10 in patty. On 05Mar2021, presence of metastatic osteosis of the T10, L2, S2 and S3 vertebrae with grade 3 malignant compression in T10. On 18Mar2021 (day 34), the patient presents with a hacking cough on his chronic obstructive pulmonary disease, fatigue, pallor and loss of appetite. On 19Mar2021, palliative and comfort treatment is decided. The patient was given morphine, Valium, scopolamine, mirtazapine, amoxicillin/clavulanic acid. The patient has a fever. On 21Mar2021 (day 37), the patient is very poorly oxygenated with the need for morphine and Valium. On 22Mar2021 (day 38), an RT-PCR test comes back positive for COVID (ct 17/16), variant. The patient had COVID-19 on 19Mar2021. The patient is agitated and de-saturated. On 23Mar2021 (day 39), the patient dies. The patient develops symptomatic COVID, variant, at day 34, 18Mar2021 of bnt162b2 vaccine booster knowing that he was in palliative care for bladder cancer metastasized to the lung and bone. Vaccine failure confirmed. The patient died on 23Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: COVID-19/develops symptomatic COVID, variant; Vaccine failure confirmed


VAERS ID: 1199926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain, Bradycardia, Cardiac arrest, Cardio-respiratory arrest, Computerised tomogram, Computerised tomogram thorax, Condition aggravated, Disease recurrence, Gastrointestinal haemorrhage, Hyperkalaemia, Hypotension, Intestinal ischaemia, Loss of consciousness, Malaise, Muscular weakness, Shock haemorrhagic
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUOPLAVIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute coronary syndrome; Anginal pain; Angioplasty; Atrioventricular block third degree; Coronary artery sclerosis; Diabetic neuropathy; Diabetic retinopathy; Discomfort; Dyslipidaemia; End stage renal failure; Gastrointestinal pain; Gastroparesis; Haemorrhagic stroke; Hemodialysis; Hyperkalaemia; Hypertension; Implantable defibrillator user; Ischaemic heart disease; Mesenteric ischemia; Neuropathy; Pain; Recovered smoker; Type 1 diabetes mellitus (on an insulin pump)
Allergies:
Diagnostic Lab Data: Test Name: Angio computer tomography; Result Unstructured Data: Test Result:probable thrombosis; Comments: probable thrombosis of the inferior mesenteric artery stent; Test Date: 202010; Test Name: CT scan; Result Unstructured Data: Test Result:mesenteric angina pain related to atheromatous; Comments: mesenteric angina pain related to atheromatous coelic and mesenteric stenosis; Test Date: 202101; Test Name: pulmonary artery CT scan; Result Unstructured Data: Test Result:permeable stent, no digestive ischemia
CDC Split Type: FRPFIZER INC2021369849

Write-up: Mesenteric ischemia; Mesenteric ischemia; loss of consciousness; malaise; muscle weakness; abdominal pain; hypotension; digestive distress; bradycardia; hyperkalaemia; hyperkalaemia; Persistent asystole; cardiopulmonary arrest; hemorrhagic shock; digestive hemorrhage; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-BX20212589. A 72-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 22Mar2021 (Lot Number: ET3620) as SINGLE DOSE for COVID-19 immunization. Medical history included smoking stopped since 2014 at 40, type 1 diabetes on an insulin pump, with diabetic retinopathy, diabetic neuropathy, vegetative neuropathy with gastroparesis, diabetic nephropathy dialysis 3x / week, tritronascular stented ischemic heart disease. In August 2014: tight stenosis of the proximal coronary artery; In October 2014, acute coronary syndrome ST, in January 2015: installation: automatic implantable defibrillator, in march 2020: mesenteric angina pain related to atheromatous coelic and mesenteric stenosis seen on CT scan of October 2020, in October 2020, revascularized acute mesenteric ischemia, in December 2020: atrioventricular block 3 secondary to hyperkalaemia, on 19Jan2021, new angioplasty of the superior and inferior mesenteric arteries and since then, regular recurrence of digestive pain, numerous visits to the emergency room for discomfort during paroxysmal pain attacks; since end of January 2021, pulmonary artery CT scan: permeable stent, no digestive ischemia. Concomitant medications included acetylsalicylic acid, clopidogrel bisulfate (DUOPLAVIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced recurrence of mesenteric ischemia, on day 2 of vaccination, with death on day 3. On day 2 of the vaccination (dose 1), the patient experienced malaise at home with loss of consciousness, muscle weakness and painful abdominal pain. Hospitalization with bradycardia on atrioventricular block 3, hyperkalaemia and hypotension. Angio computer tomography: probable thrombosis of the inferior mesenteric artery stent. Transfer to radiology for angioplasty: absence of significant proximal stenosis. Decision: No revascularization procedure because the stent is permeable. Probable digestive distress due to non-revascularisable stenosis of the mesenteric vascular network. No curative anticoagulation in a context of limitation and discontinuation of active therapies, maintenance of DUOPLAVIN(aspirin, clopidogrel). Dialysis transfer during the night from day 2 to day 3 pain relieved by morphine titration. The morning of day 3, patient found in cardiopulmonary arrest. Beginning of resuscitation in the room. Persistent asystole after 30 minutes of cardiac massage, orotracheal intubation and 12 mg of adrenaline. Death noted at 5:50 a.m. Possible cause: hemorrhagic shock / digestive hemorrhage on mesenteric ischemia (clinical upper digestive hemorrhage during resuscitation). N.B.: Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. The patient died on 25Mar2021. An autopsy was not performed. The outcome of the rest of the events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: hemorrhagic shock; digestive hemorrhage; Mesenteric ischemia; Mesenteric ischemia


VAERS ID: 1199927 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-03-13
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood albumin, Blood creatinine, Blood pressure measurement, C-reactive protein, COVID-19, COVID-19 pneumonia, Computerised tomogram, Fibrin D dimer, Heart rate, Investigation, Liver function test, Multiple organ dysfunction syndrome, Oxygen saturation, PCO2, Prealbumin, SARS-CoV-2 test, Scan, Vaccination failure, White blood cell count, pH body fluid
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 (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Anal carcinoma (squamous cell carcinoma of the anal canal); Apathy; Dysuria (with chronic urinary retention); Encephalopathy; Morbid obesity (obesity BMI 35); Oedema of lower extremities; Venous insufficiency (with lymphedema of the lower limbs)
Allergies:
Diagnostic Lab Data: Test Date: 20210318; Test Name: albumin; Result Unstructured Data: Test Result:26 g/l; Comments: Undernutrition; Test Date: 20210318; Test Name: creatinine; Result Unstructured Data: Test Result:113 umol/l; Comments: Mild renal failure; Test Date: 20210318; Test Name: blood pressure; Result Unstructured Data: Test Result:110; Comments: normal; Test Date: 20210324; Test Name: Blood pressure; Result Unstructured Data: Test Result:122/72; Test Date: 20210318; Test Name: Thoracic CT; Result Unstructured Data: Test Result:COVID-type pneumonia with frosted glass areas with; Comments: COVID-type pneumonia with frosted glass areas with an impairment estimated at 25%, condensation in bilateral subpleural bands, no image in favor of pulmonary superinfection. Ectatic aspect of the ascending aorta at 6 cm.; Test Date: 20210318; Test Name: CRP; Result Unstructured Data: Test Result:29 mg/l; Test Date: 20210318; Test Name: D-dimer; Result Unstructured Data: Test Result:750 ng/ml; Test Date: 20210318; Test Name: heart rate; Result Unstructured Data: Test Result:89; Test Date: 20210324; Test Name: Heart rate; Result Unstructured Data: Test Result:115; Test Date: 20210318; Test Name: Investigation; Result Unstructured Data: Test Result:Glasgow 15, no deficit sign, no headache, no focus; Comments: Glasgow 15, no deficit sign, no headache, no focusing sign. Lungs free. Heart noise regular, no congestive signs, no signs of heart feilure. Mild edema of the lower limbs (known lymphedema). Diagnosis of COVID-19 type pneumonia, English variant Patient stabilized under 3L of O2 with glasses; Test Date: 20210324; Test Name: Investigation; Result Unstructured Data: Test Result:Marked asthenia. On auscultation, diffuse cracklin; Comments: Marked asthenia. On auscultation, diffuse crackling, indrawing, polypnea.; Test Date: 20210324; Test Name: Investigation; Result Unstructured Data: Test Result:Very hypoxic patient, polypneic at 45 / min, setti; Comments: Very hypoxic patient, polypneic at 45 / min, setting up FiO2 at 90% under Optiflow 60 L / min. Glasgow 15. Correct hemodynamics.; Test Date: 20210328; Test Name: Investigation; Result Unstructured Data: Test Result:marked worsening with multiple organ failure. Pati; Comments: marked worsening with multiple organ failure. Patient less and less reactive and communicating. On the respiratory level, congestion, polypnea, episodes of desaturation, clear tendency to hypercapnia with respiratory acidosis. OptiFlow shutdown and permanently switched on non-invasive ventilation. Also hemodynamic degradation with hypotension, mottling. Renal function degradation. Hypernatremia and increased lactates.; Test Date: 20210318; Test Name: liver test; Result Unstructured Data: Test Result:normal; Test Date: 20210318; Test Name: 02 saturation; Test Result: 93 %; Comments: under 2L of O2; Test Date: 20210318; Test Name: O2 level; Result Unstructured Data: Test Result:60 mmHg; Comments: hypoxia; Test Date: 20210324; Test Name: O2 saturation; Test Result: 84 %; Comments: under 6L; Test Date: 20210324; Test Name: O2 saturation; Test Result: 93 %; Comments: under 15L; Test Date: 20210318; Test Name: PCO2; Result Unstructured Data: Test Result:normal capnia; Test Date: 20210318; Test Name: ph; Result Unstructured Data: Test Result:normal; Test Date: 20210318; Test Name: pre-albumin; Result Unstructured Data: Test Result:0.165 g/l; Test Date: 20210314; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: English variant; Test Date: 202103; Test Name: chest scanner; Result Unstructured Data: Test Result:Covid pneumonia; Test Date: 20210318; Test Name: leukocytes; Result Unstructured Data: Test Result:0.32 x10 9/l; Comments: lymphopenia
CDC Split Type: FRPFIZER INC2021380315

Write-up: COVID-19/Covid infection, 1 month after the 2nd dose (complete vaccination schedule); Vaccination failure/Covid infection, 1 month after the 2nd dose (complete vaccination schedule); COVID-19 pneumonitis; Multiple organ dysfunction syndrome; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-BX20212622. A 70-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EM0477), administered in arm left on 13Jan2021 as a single dose, then the second dose (Batch/Lot Number: EJ6789), administered in arm right on 13Feb2021; both intramuscular as a single dose for COVID-19 immunisation. Medical history included morbid obesity (BMI 35), oedema of lower extremities, encephalopathy, anal carcinoma (squamous cell carcinoma of the anal canal), weaned alcoholism, apathy, venous insufficiency (with lymphedema of the lower limbs) and dysuria (with chronic urinary retention) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced Covid infection, 1 month after the 2nd dose (complete vaccination schedule)/vaccination failure, with diagnosis confirmed by PCR (English variant) and images of Covid pneumonia on chest scanner, rapidly progressing with respiratory deterioration 3 days after the first signs and death from multiple organ failure 2 weeks after diagnosis. Description of the effect: 1 month after dose 2, 13Mar: high fever, 14Mar: PCR positive, 16Mar: desaturation leading to hospitalization in medical service then transfer to continuing care. Evolution: 29Mar: death of the patient. Update V1: 18Mar: referred to emergency for deterioration of general condition, mottling and dyspnea. Normal constants arterial pressure at 110, heart frequency at 89, afebrile, 93% saturation under 2L of O2, Glasgow 15, no deficit sign, no headache, no focusing sign. Lungs free. Heart noise regular, no congestive signs, no signs of heart failure. Mild edema of the lower limbs (known lymphedema). Diagnosis of COVID-19 type pneumonia, English variant. Patient stabilized under 3L of O2 with glasses. Thoracic CT: COVID-type pneumonia with frosted glass areas with an impairment estimated at 25%, condensation in bilateral subpleural bands, no image in favor of pulmonary superinfection. Ectatic aspect of the ascending aorta at 6 cm. Biology: CRP at 29 mg/L, fibrinogen at 7 g/L, D-dimer at 750 ng/mL and lymphopenia at 0.32 G/L. Mild renal failure with creatinine at 113 umol/L. No ionic problem. Undernutrition with albumin at 26 g/L and pre-albumin at 0.165 g/L. Normal liver test. Blood gases: hypoxia at 60 mm Hg, normal capnia and pH. Put on dexamethasone 6 mg / day and enoxaparin. Hospitalization in medical service. 21Mar: initiation of treatment with amoxicillin/clavulanic acid. 24Mar morning: respiratory degradation with 84% saturation under 6L,$g 93% under 15L. Marked asthenia. On auscultation, diffuse crackling, indrawing, polypnea. Arterial pressure at 122/72 and heart rate at 115. Apyretic. Transfer to continuing care service. Very hypoxic patient, polypneic at 45/min, setting up FiO2 at 90% under Optiflow 60 L/min. Glasgow 15. Correct hemodynamics. 28Mar: marked worsening with multiple organ failure. Patient less and less reactive and communicating. On the respiratory level, congestion, polypnea, episodes of desaturation, clear tendency to hypercapnia with respiratory acidosis. OptiFlow shutdown and permanently switched on non-invasive ventilation. Also, hemodynamic degradation with hypotension, mottling. Renal function degradation. Hypernatremia and increased lactates. 29Mar: death at 10:40 a.m. of a COVID + patient with multiple organ failure. Change in cause of death (multiple organ failure and Covid-19 pneumonia). The patient was hospitalized for vaccination failure, covid-19, COVID-19 pneumonitis and multiple organ dysfunction syndrome from 16Mar2021 to an unknown date. The causes of death were reported as COVID-19 pneumonitis and multiple organ dysfunction syndrome. Therapeutic measures were taken as a result of all events. The outcome of the events was fatal. The patient died on 29Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonitis; Multiple organ dysfunction syndrome


VAERS ID: 1199928 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Intracranial hematoma; Smoking
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021380159

Write-up: Death NOS; Stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority Report Number : FR-AFSSAPS-BX20212666. This is a spontaneous report from a contactable physician reporting for a patient downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-BX20212666. A 66-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 19Mar2021 (Batch/Lot Number: EM0477) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. Medical history included intracranial hematoma following unspecified falls, smoking and excessive alcohol consumption from unspecified dates and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death nos and stroke on 25Mar2021. Clinical course was reported as follows: On 25Mar2021, he ate his meal and then died suddenly. Emergency service doctor concluded it was a stroke, no autopsy. Notabene: Accountability made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. The patient died on 25Mar2021. Autopsy was not performed. No follow-up attempts are possible. No further information is expected. Lot number was received.; Reported Cause(s) of Death: Death NOS; Stroke


VAERS ID: 1199946 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Infarction
SMQs:, Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Drug hypersensitivity (Hypersensitivity to aspirin); Dyslipidaemia; Hypertension; Obesity; Sleep apnea; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021380220

Write-up: massive infarction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-LY20212472. An 85-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EM6950), intramuscular, administered in the left arm on 16Feb2021 as a single dose for covid-19 immunization. The patient''s medical history included hypertension, chronic obstructive pulmonary disease (COPD), dyslipidaemia, type 2 diabetes mellitus, sleep apnoea, drug hypersensitivity (hypersensitivity to aspirin) and obsesity. The patient''s concomitant medications were not reported. The patient received the first dose of COMIRNATY on an unspecified date as prophylactic vaccination an experienced no adverse effect. On 11Mar2021, the patient experienced massive infarction. The patient died on 11Mar2021. 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: massive infarction


VAERS ID: 1199949 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood urea, Brain natriuretic peptide, Electrocardiogram, Interstitial lung disease, Leukocytosis, Oxygen saturation, Respiratory distress, SARS-CoV-2 test, Troponin
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TEMERIT; LOXEN L P; FLUDEX PE; KARDEGIC; PRAVASTATIN; MESOPRAL; DAFALGAN; CORDARONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis (unconstricted); Diabetes; Endarterectomy; Hemiparesis; Hypertension; Ischemic stroke (with sequelae hemiparesis)
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: Creatinine; Test Result: 120 umol; Test Date: 20210315; Test Name: Urea; Test Result: 12 mmol; Test Date: 20210315; Test Name: BNP; Result Unstructured Data: Test Result:1000; Test Date: 20210315; Test Name: ECG; Result Unstructured Data: Test Result:no frank ischaemic signs; Test Date: 20210315; Test Name: Polymorphonuclear neutrophils; Result Unstructured Data: Test Result:17G; Test Date: 20210318; Test Name: Oxygen saturation; Test Result: 91 %; Test Date: 20210315; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210315; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210315; Test Name: Troponin; Result Unstructured Data: Test Result:6700; Comments: without chest pain
CDC Split Type: FRPFIZER INC2021380235

Write-up: Distress respiratory; Interstitial pneumonitis; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority (RA), regulatory authority number FR-AFSSAPS-MA20211067. An 86-years-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), intramuscular on 10Mar2021 as single dose for covid-19 vaccination; and macrogol (TRANSIPEG), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypertension, diabetes, loose (unconstricted) aortic stenosis, ischaemic stroke with sequential haemiparesis, endarterectomy. The patient had no reported COVID history. Concomitant medications included nebivolol hydrochloride (TEMERIT), nicardipine hydrochloride (LOXEN L P), chlorphenamine maleate, paracetamol, phenylephrine hydrochloride (FLUDEX PE), acetylsalicylate lysine (KARDEGIC), pravastatin, esomeprazole magnesium (MESOPRAL), paracetamol (DAFALGAN), and amiodarone hydrochloride (CORDARONE); all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient was hospitalised on unspecified dates in 2021 with distress respiratory (also reported as acute hypoxaemic respiratory distress) and interstitial pneumonitis experienced on 15Mar2021 within days of a first vaccination with Comirnaty. The patient had the vaccine on 10Mar2021. No information between 10 and 15Mar2021, but no infectious contagion because the patient does not leave home. The events distress respiratory and interstitial pneumonitis were also reported as life-threatening. Clinical course was reported as follows: On 15Mar2021, the patient was admitted to hospital with haemoptysis, chest pain, vomiting and diarrhoea, plus oxygen dependence at 4 litres. He had a dry cough with dyspnoea for several days. The angioscanner did not find any pulmonary embolism or active bleeding. The examination was compatible with COVID pneumonia, but also with other pathologies, infectious or not. The 2 PCRs performed were negative (15Mar2021). Other lab tests on 15Mar2021 included: Creatinine 120 umol, urea 12 mmol, no ionic disorder, troponin 6700 without chest pain, Brain natriuretic peptide (BNP) 1000, polynuclear neutrophils (PNN) 17G. Electrocardiography (ECG): no frank ischaemic signs. Left Ventricular Ejection Fraction (LVEF) preserved on transthoracic echocardiogram (TEE). Antibiotic treatment was started with a bolus of corticosteroids. Rapidly unfavourable evolution, need for 15l of O2 for a 91% saturation (18Mar2021), then deterioration of the respiratory function and death on 18Mar2021. The action taken in response to the events for bnt162b2 and macrogol was not applicable. The patient died on 18Mar2021. The causes of death were distress respiratory and interstitial pneumonitis. It was unknown if an autopsy was performed. No follow-up attempts possible; information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: distress respiratory; interstitial pneumonitis


VAERS ID: 1199950 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-02-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Heart rate, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (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? No
Previous Vaccinations:
Other Medications: MEMANTINE ALMUS; ESCITALOPRAM ALMUS; ABASAGLAR; PIRACETAM ARROW; NOVORAPID; JANUVIA [SITAGLIPTIN PHOSPHATE]; BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]; COUMADINE; ROSUVASTATIN; SERETIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Diabetes mellitus insulin-dependent; Pneumonia; Pneumopathy
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: body temperature; Result Unstructured Data: Test Result:38/38.5 Centigrade; Test Date: 20210202; Test Name: heart rate; Result Unstructured Data: Test Result:tachycardia; Test Date: 20210202; Test Name: oxygen saturation; Result Unstructured Data: Test Result:desaturation; Test Date: 20210202; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021380068

Write-up: fever/fever at 38 deg/38.5 deg C; diarrhea; desaturation; vomiting; tachycardia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority FR-AFSSAPS-MP20210174. An 85-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 25Jan2021 (Batch/Lot Number: EJ6788) as single dose for covid-19 immunisation. Medical history included Alzheimer''s disease, diabetes mellitus insulin-dependent, pneumopathy from 2019 and pneumonia from 2019. The patient has no history of COVID-19 and was considered to be at risk of developing a severe form of COVID-19 disease due to patient''s age. Concomitant medications included memantine hydrochloride (MEMANTINE ALMUS), escitalopram oxalate (ESCITALOPRAM ALMUS), insulin glargine (ABASAGLAR), piracetam (PIRACETAM ARROW), insulin aspart (NOVORAPID), sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), indapamide, perindopril arginine (BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]), warfarin sodium (COUMADINE), rosuvastatin and fluticasone propionate, salmeterol xinafoate (SERETIDE). The patient experienced fever, diarrhea, desaturation, vomiting, and tachycardia, all on 02Feb2021. On 02Feb2021, onset of diarrhea, vomiting, and fever at 38 deg/38.5 deg C. The patient subsequently presented with a desaturation associated with tachycardia. The patient had an aggravation leading to taking charge by Urgent Medical Assistance Service/firefighters. Unfavorable development leading to death (date not communicated). The patient underwent lab tests and procedures which included body temperature: 38/38.5 centigrade, heart rate: tachycardia, oxygen saturation: desaturation and COVID-19 virus test: negative, all on 02Feb2021. The patient died on an unspecified date. It was unknown if an autopsy was performed. NB: Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry of Health No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: fever; diarrhea; desaturation; vomiting; tachycardia


VAERS ID: 1199964 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Dyspnoea, Specialist consultation, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic disorder; Arterial insufficiency coronary; Deafness; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210104; Test Name: Cardiological check; Result Unstructured Data: Test Result:stable underlying pathology
CDC Split Type: FRPFIZER INC2021380223

Write-up: Death unexplained; difficult breathing; asthenic; wheezing; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority Report Number : FR-AFSSAPS-NT20210856. An 80-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EP9598), first dose (pending clarification if first or second dose) intramuscular, administered in Arm Left on 24Feb2021, single dose for covid-19 immunisation. Medical history included deafness, aortic disorder, Arterial insufficiency coronary, hypertension arterial, all from an unknown date. The patient''s concomitant medications were not reported. Autonomous patient living with his wife, found dead on 10Mar2021 at D+14 of a second dose (pending clarification if first or second dose) of COMIRNATY against COVID-19. The patient was asthenic on the day of his death and it is stated that he presented with wheezing and difficult breathing. The two injections (pending clarification) were not associated with symptoms of reactogenicity. A cardiological check performed on 04Jan2021 found a stable underlying pathology. No autopsy performed. The outcome of the event death unexplained was fatal, other events was unknown. Notabene: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1199965 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Fall, Fatigue, Haematoma, Head injury, Malaise, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIDOSE VITAMINE D; CLOPIDOGREL; DULOXETINE [DULOXETINE HYDROCHLORIDE]; FUROSEMIDE; LANSOPRAZOLE; MIANSERIN; PRAVASTATIN; RAMIPRIL; UVEDOSE; ALPRAZOLAM; DOLIPRANE; MACROGOL; SMECTA [MONTMORILLONITE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Aortic stenosis (Tight aortic stenosis,); Artificial cardiac pacemaker user; Atheroma coronary artery (Moderate atheroma of the supra-aortic trunks); Bilateral cataracts; Chronic renal failure (Severe chronic renal failure, approximately 30 mL/min); Congestive heart failure (Chronic congestive heart failure without Pulmonary hypertension); COVID-19 (tested on 30Oct2020); Left ventricular ejection fraction (Left ventricular ejection fraction at 35% in Oct2019); Osteoarthritis; Peripheral arterial occlusive disease (Peripheral artery disease (PAD) with left iliac lesion); Permanent cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data: Test Date: 20201030; Test Name: COVID-19; Test Result: Positive
CDC Split Type: FRPFIZER INC2021380257

Write-up: Falling down; Wound to the skull with hematoma; Wound to the skull with hematoma; tired; Malaise; This is as spontaneous report received from a contactable pharmacist downloaded from the Regulatory Agency (RA). The regulatory authority report number is FR-AFSSAPS-NT20210888. A 92-year-old female patient received the second dose of BNT162B2 (COMIRNATY Solution for injection, lot number: EP9605, expiry date: unknown), intramuscular administered in the right arm, on 19Mar2021 16:00, as single dose, for COVID-19 immunisation. Medical history included chronic renal failure (severe chronic renal failure, approximately 30 mL/min); AFib; peripheral arterial occlusive disease (peripheral artery disease (pad) with left iliac lesion); congestive heart failure (chronic congestive heart failure without pulmonary hypertension); aortic disorder (tight aortic stenosis); permanent cardiac pacemaker insertion; bilateral cataract in 2013; atheroma coronary artery (moderate atheroma of the supra-aortic trunks); diffuse osteoarthritis; left ventricular ejection fraction (left ventricular ejection fraction at 35%) in Oct2019; and COVID-19 (tested) on 30Oct2020. Concomitant medications included calcium carbonate, colecalciferol (CALCIDOSE VITAMINE D); clopidogrel; duloxetine hydrochloride (DULOXETINE 30 mg); furosemide 500 mg; lansoprazole 15 mg; mianserin 10 mg; pravastatin 20 mg; ramipril 1. 25 mg; colecalciferol (UVEDOSE); alprazolam 0.25 mg; paracetamol (DOLIPRANE 500 mg); macrogol; and montmorillonite (SMECTA), all taken for unspecified indications, start and stop dates were not reported. On 20Mar2021 at 07:30, the patient fell down (reported as "falling down"). Wound to the skull with hematoma was noticed. The patient was still conscious but was tired; she was then picked up and installed in bed. Within 15 minutes, the patient experienced malaise and then died. The outcome of the event "falling down" was fatal; and the outcome of the remaining events was unknown. The patient died on 20Mar2021. It was not reported if an autopsy was performed. Health Authority Comment: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. No follow-up attempts possible. No further information expected. Information on lot number was obtained.; Reported Cause(s) of Death: falling down


VAERS ID: 1199966 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-28
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: IPRATROPIUM; NOVORAPID; DOLIPRANE; TERBUTALINE ARROW; AMLOR; IMOVANE; BUDESONIDE ARROW; VALSARTAN ARROW
Current Illness: COPD; Heart failure; Hypertension arterial; Insulin-requiring type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210228; Test Name: sars-cov 2 test; Result Unstructured Data: Test Result:variant
CDC Split Type: FRPFIZER INC2021380275

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-NY20210628. An 88-year-old female patient received first dose of bnt162b2 (COMIRNATY; lot number not reported) on 15Jan2021 and second dose of bnt162b2 (COMIRNATY; Lot Number: EK9788) on 04Feb2021 both given intramuscular as single dose for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease, ongoing insulin-requiring type 2 diabetes mellitus, ongoing hypertension, ongoing cardiac failure, and living in residential institution. Concomitant medications included ipratropium; insulin aspart (NOVORAPID); paracetamol (DOLIPRANE); terbutaline sulfate (TERBUTALINE ARROW); amlodipine besilate (AMLOR); zopiclone (IMOVANE); budesonide (BUDESONIDE ARROW); valsartan (VALSARTAN ARROW). On 28Feb2021, the patient was diagnosed with COVID infection (variant) in the context of cluster COVID cases in nursing homes. The patient was hospitalized in 2021 in response to the event. The patient died on 03Mar2021. Cause of death was reported as COVID-19 infection. It was unknown if an autopsy was performed. Imputability (according to the method): I1 dubious. NB: Accountability without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Therapy 1985; 40: 111-8. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1199967 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-23
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

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: APIXABAN; BISOCE; LANSOPRAZOLE; LEVOTHYROXINE; LACTULOSE; LANSOYL; MIANSERINE [MIANSERIN HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Chronic respiratory failure (Chronic non-smoking respiratory failure); COVID-19 (last in April 2020: probable COVID: negative PCR in May2020, positive serology in Jun2020); Decompensation cardiac; Depressive disorder; Heart failure (Heart failure with LVEF preserved but several decompensations.); Infection; Major depressive disorder aggravated; Malnutrition; Renal failure, unspecified (Minimal renal failure at baseline (creatinine 53 uM / l).); Unable to eat (Partial food refusal for months, variable from day to day.); Urinary infection (last one in Dec2020, cured)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021380292

Write-up: Fatigue; dehydration; Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-PA20210408. A 94-year-old female patient received first dose of bnt162b2 (COMIRNATY; lot EM0477) intramuscular on 11Jan2021 as 0.3 mL, single for COVID-19 immunisation; and mirtazapine oral from 18Jan2021 to 22Jan2021, at 15 mg, once a day for an unspecified indication. Medical history included Factors that may have favored the onset of the adverse reaction: chronic non-smoking respiratory failure, heart failure with LVEF preserved but several decompensations, former depressive syndrome treated (substitution of mianserin by mirtazapine), minimal renal failure at baseline (creatinine 53uM / l); last years of life enameled with infections, especially respiratory (last in Apr2020: probable COVID: negative PCR in May2020, positive serology in Jun2020) and urinary infection (last in Dec2020, cured) and / or passing through ACFA, events which all led to more or less significant cardiac decompensation, partial food refusal for months, variable from day to day, undernutrition and atrial fibrillation (Afib) and Major depressive disorder aggravated. Concomitant medications included apixaban, bisoprolol fumarate (BISOCE), lansoprazole, levothyroxine, lactulose, paraffin, liquid (LANSOYL) and mianserin hydrochloride (MIANSERINE) taken for Major depressive disorder aggravated from 03Apr2018 to 22Jan2021. On an unspecified date, the patient had fatigue and dehydration since vaccination but no acute noisy events or signs of infection. On 23Jan2021, the patient experienced sudden death. The death was not especially expected by the healthcare team. In total, unexpected death of a female patient with a long medical history after dose 1 of Comirnaty and introduction of Mirtazapine, 5 days before. The action taken in response to the event for mirtazapine was not applicable. Outcome of events fatigue and dehydration was unknown. The patient died on 23Jan2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1199975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-03-17
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021380305

Write-up: Oxygen saturation decreased/desaturation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The regulatory authority number is FR-AFSSAPS-RN20210993. An 85-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: EJ6795), intramuscularly, administered in the right arm on 19Jan2021 as a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced oxygen saturation decreased/desaturation which required hospitalization on 17Mar2021. The outcome of the event was fatal. The patient died on 17Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-RN20210705; Reported Cause(s) of Death: Oxygen saturation decreased/desaturation


VAERS ID: 1200021 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke, Magnetic resonance imaging
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021380245

Write-up: hemorrhagic stroke; This is a spontaneous report from a contactable physician (patient''s wife) via a Pfizer sales representative. A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation and rivaroxaban (XARELTO), route of administration, start and stop date, batch/lot number and dose were not reported for atrial fibrillation. The patient''s medical history included atrial fibrillation and concomitant medications were not reported. The patient experienced hemorrhagic stroke on an unspecified date. The patient consulted the physician (his wife) due to slight malaises and dizziness and the physician thought that it was due to rivaroxaban. She prescribed him an MRI (results not yet available). The patient then died of a hemorrhagic stroke. As the patient was also vaccinated, the physician did not know if the event was due to bnt162b2 or rivaroxaban. The action taken in response to the event for rivaroxaban is not applicable. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Considering the patient was administrated with rivaroxaban for atrial fibrillation, the reported event hemorrhagic stroke is likely due to rivaroxaban, based on the bleeding risk of the suspected drug. The latency of the event to administration of BNT162B2 is unknown, the event is unrelated to BNT162B2 based on the very limited information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: hemorrhagic stroke


VAERS ID: 1200022 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: AMLODIPINE; BISOPROLOL; PARACETAMOL; TAMOXIFEN; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Hip replacement (3 Hip replacement, left hip twice); Metastasis in lung (Secondary breast cancer in lungs since 2005); Metastatic breast cancer; Pain; Scoliosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021382527

Write-up: catastrophic stroke; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-202104061341221100. Safety Report Unique Identifier GB-MHRA-ADR 25086691. An 86-year-old female patient (mother) received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 16Jan2021 (Lot Number: EL0739) as single dose for covid-19 immunisation. Medical history included pain, scoliosis, High blood pressure, hip arthroplasty and 3 Hip replacement, left hip twice, Additionally breast cancer metastasis, secondary breast cancer in lungs since 2005. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication(s) included amlodipine taken for blood pressure, bisoprolol taken for blood pressure, unspecified diuretic, influenza vaccine (INFLUENZA VIRUS) taken for immunization on 23Oct2020; paracetamol taken for pain, tamoxifen taken for breast cancer metastatic from 16Sep2020; tramadol taken for pain. The patient suffered a catastrophic stroke on 18Jan2021, approx. 48 hours after receiving this vaccination on 16Jan2021, which subsequently sadly led to her death on 21Jan2021. Patient has not tested positive for COVID-19 since having the vaccine Suspect Reactions. Follow-up attempts are completed. No further information is expected. ; Reported Cause(s) of Death: Stroke


VAERS ID: 1200084 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-07
Onset:2021-01-31
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Loss of consciousness, Pulmonary embolism, Pulmonary hypertension, Syncope, Thrombosis, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Pulmonary hypertension (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pleuropneumonia (already been described about 20 years ago); Postphlebitic syndrome (already been described about 20 years ago)
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis (from time to time)
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: echo; Result Unstructured Data: Test Result:pulmonary hypertension; Test Date: 20210131; Test Name: Sonography; Result Unstructured Data: Test Result:in the assessment tab; Comments: lower leg thromboses on both legs, found pulmonary hypertension
CDC Split Type: DEPFIZER INC2021380842

Write-up: Lung embolism/severe pulmonary embolism; syncopated; unconscious for a short time; lower leg thromboses on both legs; Pulmonary hypertension; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority report number is DE-PEI-CADR2021040401. Safety report unique identifier DE-PEI-202100027932. A 100-year-old female patient received BNT162B2 (COMIRNATY), intramuscular , dose 1 on 17Jan2021 (Batch/Lot number was not reported) and dose 2 on 07Feb2021 (Batch/Lot number was not reported) at 0.3 mL (standard dose), single dose, for COVID-19 immunisation. Ongoing medical history included pleuropneumonia and postphlebitic syndrome already been described about 20 years ago, and bronchitis from time to time. The patient had no known allergies. The patient''s concomitant medications were not reported. On 31Jan2021 the patient experienced lung embolism. Further reported that on 31Jan2021, 2 weeks after first vaccination, the patient syncopated, was unconscious for a short time. The hospital found lower leg thromboses on both legs by sonography, found pulmonary hypertension in the echo. From GP''s point of view, this was wrongly seen as a hypertension problem with "primary pulmonary hypertension". The patient died on 16Feb2021, one week after second vaccination on 07Feb2021, under the picture of oppression and shortness of breath and chest pain in 2021 without coagulation-specific medication. The thromboses with pulmonary hypertension are mentioned in the discharge letter, but no one seems to have thought of the actually typical symptoms of a severe pulmonary embolism. The outcome was fatal for lung embolism, recovered for unconscious and unknown for the other events. It was not reported if an autopsy was performed. This report is serious for death. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? : no No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lung embolism/severe pulmonary embolism


VAERS ID: 1200085 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / 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? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021370494

Write-up: Severe stroke; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority report number: DE-PEI-CADR2021041088). A non-contactable consumer (contactable through Regulatory Authority only) reported that a 99-year-old female patient received BNT162B2 (COMIRNATY, Lot number and expiration date were not reported), intramuscular on 04Mar2021 as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 04Mar2021, the patient was diagnosed with severe stroke (described as "sudden paralysis and speech disorder"). The patient had died on 04Mar2021 due to stroke. It was unknown if an autopsy was performed. No follow-up attempts are possible. Batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1200404 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-24
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment; Hypertension arterial; Prostate cancer
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:unknown result
CDC Split Type: FRPFIZER INC2021380307

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority -WEB, regulatory authority number FR-AFSSAPS-RN20210986. A 93-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: EP2166), intramuscular, administered in left arm on 03Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, mild cognitive impairment and, prostate cancer from an unknown date. Long-term treatment not reported. No history of allergy was reported. No history of COVID-19 was reported. Concomitant medications were not reported. On 24Mar2021 during the night, unexpected sudden death without prodrome, nocturnal, suggestive of embolism or cardiac accident without further information. Given the time of death and the uncertainty of the diagnosis and age, no examination was carried out and no autopsy was requested. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown results on an unknow date. The patient died on 24Mar2021. An autopsy was not performed. No follow-up attempts is possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1200422 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-13
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC2021382426

Write-up: Death; This is a spontaneous report from a contactable consumer or other non healthcare professional received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104061126301180. Safety Report Unique Identifier GB-MHRA-ADR 25085543. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: not known) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19 . Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient died o an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test: inconclusive test. An autopsy was not performed. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Follow-up attempts are completed. No further information is expected Information about lot/batch number cannot be obtained; Reported Cause(s) of Death: Death


VAERS ID: 1200438 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cardiac arrest, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Body mass index increased; Dyslipidaemia; Upper respiratory tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade
CDC Split Type: GRPFIZER INC2021384546

Write-up: cardiac arrest; COVID-19 infection; fever (39 degrees Celsius); This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number GR-GREOF-20211826. A 75-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on 09Mar2021 (Batch/Lot Number: EP2166) at 75-years-old as 0.3 mL, single for COVID-19 immunization. Medical history included chronic dyslipidaemia from an unknown date and unknown if ongoing, unregulated arterial hypertension from an unknown date and unknown if ongoing, very high Body Mass Index (BMI) increased from an unknown date and unknown if ongoing, mild symptoms of infection of the upper respiratory tract from 05Mar2021 to an unknown date. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) taken for dyslipidaemia, start and stop date were not reported. On 09Mar2021, the patient experienced: fever (39 degrees Celsius) (non-serious), cardiac arrest (death, medically significant), COVID-19 infection (death, medically significant), death (as reported) (death, medically significant). The clinical course was reported as follows: According to the reporter, the patient on the day of the vaccination did not report any acute symptoms while he was providing his medical history, neither any allergies. The patient just reported the chronic dyslipidaemia treatment. It was the first dose of the vaccine COMIRNATY and the patient remained in the vaccination center for 15 minutes according to the guidelines; without presenting any symptoms. On 16Mar2021, the patient''s son, called the reporter to declare the death of his father. The patient''s son stated that the patient had a fever the same day of the vaccination and passed away approximately six hours later. A close relative was found positive with SARS-CoV-2 on 13Mar2021; and on the day of the report was still hospitalized. The patient was "buried after the death certificate from a private physician." On 18Mar2021, the patient''s son was contacted, who was also a physician. According to the patient''s son, his father had unregulated arterial hypertension, dyslipidaemia and very high Body Mass Index (BMI) (weighed 110 kilograms for over 40 years with 170 cm height). The patient, four days before his vaccination, had mild symptoms of infection of the upper respiratory tract (mild cough, sniffle and sore throat). On 09Mar2021, the patient was vaccinated and three hours later presented high fever (39 degrees Celsius). The patient three hours later died. The patient''s son stated that the physician who examined his father told him that he found representative data of cardiac arrest and the cause of death was cardiac arrest. Three days later, the patient''s wife was found positive with COVID-19 infection and was hospitalized. According to the patient''s son''s opinion, his father died from COVID-19 infection, even though the patient had not tested positive. The patient underwent lab tests and procedures which included body temperature: 39 Centigrade on 09Mar2021. The clinical outcome of the events: cardiac arrest, COVID-19 infection, death, was fatal. The clinical outcome of the event fever (39 degrees Celsius), was unknown. The patient died on 09Mar2021 due to cardiac arrest, death, COVID-19 infection (according to the patient''s son). It was unknown if an autopsy was performed. The causality assessment from the a regulatory authority for vaccines was unlikely; Method of assessment: a regulatory authority causality criteria. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: COVID-19 infection; Cardiac arrest


VAERS ID: 1200557 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatinine, Blood lactic acid, Body temperature, C-reactive protein, International normalised ratio, PCO2, PO2, Platelet count, Procalcitonin, Purpura, Sepsis, Thrombocytopenia, pH body fluid
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EUTIROX; BACTRIM; NOVORAPID; DIBASE; TOUJEO; IMBRUVICA; ACICLOVIR; PANTORC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autologous bone marrow transplantation therapy; GVHD (chronic cutaneous and intestinal vHD Graft reaction); Hip prosthesis user; Hodgkin''s lymphoma (scleronodular variant); Steroid therapy (Iiatrogenic metabolic decompensation under cortisone therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: PTYT; Result Unstructured Data: Test Result: 79; Test Date: 20210325; Test Name: AST; Result Unstructured Data: Test Result:407; Test Date: 20210325; Test Name: CPK; Result Unstructured Data: Test Result:5159; Test Date: 20210325; Test Name: creat; Result Unstructured Data: Test Result:2.15; Test Date: 20210325; Test Name: Lac; Result Unstructured Data: Test Result:8.5; Test Date: 20210324; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: at around 1 pm fever 39 C which drops to 37 C in the afternoon after taking paracetamol 1000 mg; Test Date: 20210324; Test Name: Body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210324; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: At 9 pm T 38 C.; Test Date: 20210325; Test Name: PCR; Result Unstructured Data: Test Result:30.33; Test Date: 20210325; Test Name: INR; Result Unstructured Data: Test Result:2.88; Test Date: 20210325; Test Name: PaCO2; Result Unstructured Data: Test Result:20; Test Date: 20210325; Test Name: pH; Result Unstructured Data: Test Result:7.26; Test Date: 20210325; Test Name: PTLS; Result Unstructured Data: Test Result:41.000; Test Date: 20210325; Test Name: PaO2; Result Unstructured Data: Test Result:236; Test Date: 20210325; Test Name: PCT; Result Unstructured Data: Test Result:62.91
CDC Split Type: ITPFIZER INC2021370951

Write-up: Fever, pain in the upper and lower limbs, swelling, diffuse bluish spots. Diffuse purpura, hypotension, tachycardia, tachypnea; Fever, pain in the upper and lower limbs, swelling, diffuse bluish spots. Diffuse purpura, hypotension, tachycardia, tachypnea; Fever, pain in the upper and lower limbs, swelling, diffuse bluish spots. Diffuse purpura, hypotension, tachycardia, tachypnea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA), regulatory authority number IT-MINISAL02-706690. A 45-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 23Mar2021 12:32 am (Batch/Lot Number: ET1831) as single dose for Covid-19 immunization. Medical history included Hodgkin''s disease from 01Jan2012 to an unknown date (scleronodular variant), hip prosthesis user from 01Jan2019 to an unknown date, autologous bone marrow transplantation therapy from 01Jan2015 to an unknown date, GVHD (graft versus host disease) chronic cutaneous and intestinal vHD Graft reaction from 01Jan2018 to an unknown date, and corticosteroid therapy (Iiatrogenic metabolic decompensation under cortisone therapy) from an unspecified date. Concomitant medications included levothyroxine sodium (EUTIROX), sulfamethoxazole, trimethoprim (BACTRIM), insulin aspart (NOVORAPID), colecalciferol (DIBASE), insulin glargine (TOUJEO), ibrutinib (IMBRUVICA), aciclovir (ACICLOVIR), and pantoprazole sodium sesquihydrate (PANTORC); all taken for an unspecified indication, start and stop date were not reported. The patient previously had the following vaccines: Vaxigrip Tetra flu vaccine (Oct2020), Boostrix (2019), Imovax polio (2019), Engerix B (2019), ACTHIB (2019), Prevenar 13 (2019), Nimenrix (2019), and Influvac S Tetra (2019); no adverse reactions to vaccines administered. On 23Mar2021 at 12.32 am the 1 dose of vaccine is administered. On 24Mar2021 at around 1 pm, the patient experienced fever 39 C which drops to 37 C in the afternoon after taking paracetamol 1000 mg. At 9 pm, T (temperature) 38 C, taken 1 tablet of Brufen 400 mg. During the night, the patient had pain in the upper and lower limbs, swelling and the appearance of numerous diffuse bluish spots. On 25Mar2021 at 8.21 he arrives at the Emergency Department with presence of diffuse purpura, hypotension, tachycardia, tachypnea. Tests performed on 25Mar2021: EGA, pH (pH body fluid) 7.26, PaO2 236, PaCO2 20, BE-15.4, Lac (Blood lactic acid) 8.5, PTLS (platelet) 41.000; creat (Blood creatinine) 2.15; CPK (Blood creatine phosphokinase) 5159, AST (Aspartate aminotransferase) 407, PCR (C-reactive protein) 30.33, PCT (Procalcitonin) 62.91, INR (International normalised ratio) 2.88, PTYT (partial thromboplastin time) 79. On ultrasound guide positioned cvc in right jugular. On the advice of an infectious specialist, therapy with meropenem 1g, Tigeciclina 100 mg, Ecalta 200 mg. Diagnosis: Sepsis, Thrombocytopenia. At 3.27 pm, she was transferred to the intensive care of Hospital. The patient arrived in the ICU already in cardiorespiratory arrest. The body inspection showed a diffuse and very severe purpura, while the pre-admission course showed the signs and symptoms of an apparent septic shock with an important and irreversible vasoplegic component. Performed cardiopulmonary resuscitation maneuvers found to be in vain. There were no elements of suspicion about serious vaccine reactions. Waiting for information from autopsy results. The clinical picture of rapid onset, its precipitous progression, diffuse skin symptoms, the circulatory structure of progressive and permanent collapse and the Absolute non-responsiveness to drugs are generally suggestive of evolutionary and fatal septic shock, with an irreversible vasoplegic component. Autopsy report is requested again. The patient died on 25Mar2021. An autopsy was performed, and results were not provided. Sender''s comments: 25Mar2021 Local Center of Health Authority: further information and documentation are requested from the reporter and the vaccination service. 26Mar2021 Local Center of Health Authority: Documentation attached to the form is retrieved: Discharge report, photographic documentation, certification of vaccinations performed. 26Mar2021 Local Center of Health Authority: requests for information on follow up and outcome to another health facility. Waiting for an answer 29Mar2021 Local Center of Health Authority: prompt request for information to the Hospital PRIVACY. Waiting for an answer No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Sender''s Comments: Based on the available clinical data and in agreement with reporter, event sepsis, purpura and thrombocytopenia with fatal outcome were intercurrent medical conditions not related to vaccine administration. Patient underlying Hodgkin''s disease is considered contributory to the occurrence of events.; Reported Cause(s) of Death: fatal septic shock


VAERS ID: 1200579 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIOASPIRIN; ZYLORIC; FOLIC ACID; CARVEDILOL; LANSOPRAZOLE; LASIX [FUROSEMIDE]; SIDERAL FORTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user (The woman had recovered well from the surgery.); Demented (Her medications for the initial form of dementia had been stopped.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021370975

Write-up: Sudden death within 24 hours of Comirnaty - Pfizer vaccine booster/cardiac arrest in heart failure in a patient already vasculopathic with dementia and outcome of cerebral stroke; Sudden death within 24 hours of Comirnaty - Pfizer vaccine booster/cardiac arrest in heart failure in a patient already vasculopathic with dementia and outcome of cerebral stroke; Sudden death within 24 hours of Comirnaty - Pfizer vaccine booster/cardiac arrest in heart failure in a patient already vasculopathic with dementia and outcome of cerebral stroke; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from a regulatory authority- IT-MINISAL02-708552. An 85-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, at age 85 years, on 27Mar2021 09:30 (Batch/Lot Number: ET7205) as 0.3mL, SINGLE DOSE for covid-19 immunisation. Patient''s medical history includes artificial cardiac pacemaker user in 2019 and patient had recovered well from the surgery, and being demented from an unspecified date but her medications for the initial form of dementia had been stopped. Concomitant medications included acetylsalicylic acid (CARDIOASPIRIN), allopurinol (ZYLORIC), folic acid (FOLIC ACID), carvedilol, lansoprazole, furosemide (LASIX) and ascorbic acid, ferric pyrophosphate (SIDERAL FORTE); all taken for an unspecified indication, start and stop date were not reported. Patient historically received first dose of COMIRNATY [BIONTECH MANUFACTURING GMBH (J07BX03) (Batch number: EP9598)] on 06Mar2021 at 09:10 AM for COVID-19 immunisation. On 28Mar2021 09:30, patient had a sudden death within 24 hours of COMIRNATY- Pfizer vaccine booster/cardiac arrest in heart failure in a patient already vasculopathic with dementia and outcome of cerebral stroke. Patient attended a day center. Having heard the attending physician, who claims to have taken note of the statement made by the daughter for the compilation of the Istat certificate as of 31Mar2021 that specified that cause of death cardiac arrest in heart failure in a patient already vasculopathic with dementia and outcome of cerebral stroke. Patient''s daughter stated that death occurred at 09:30 (summer time), about 24 hours after the administration of the 2nd dose of the Pfizer vaccine. The patient died on 28Mar2021. It was not reported if an autopsy was performed. Event assessment: primary source/Comirnaty/ Certain. Sender Comment: Patients with dementia. He attended day center. Having heard the attending physician, who claims to have taken note of the statement made by the daughter for the compilation of the certificate. UPDATE of 31Mar2021: it is specified that on the certificate it was reported as a cause of death cardiac arrest in heart failure in a patient already vasculopathic with dementia and outcome of cerebral stroke Reporter Comment: The report is the daughter - Death occurred at 9.30 (summer time). It should be noted that the death of my mother occurred about 24 hours after the administration of the 2nd dose of the Pfizer vaccine (which took place at about 9.10 on 27Mar2021), as indicated in the same sheet. $g$g Daughter claims that two years ago a pacemaker implant was installed on her mother. The woman had recovered well from the surgery. Her medications for the initial form of dementia had been stopped. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The report is the daughter - Death occurred at 9.30 (summer time). It should be noted that the death of my mother occurred about 24 hours after the administration of the 2nd dose of the Pfizer vaccine (which took place at about 9.10 on 27Mar2021), as indicated in the same sheet. $g$g Daughter claims that two years ago a pacemaker implant was installed on her mother. The woman had recovered well from the surgery. Her medications for the initial form of dementia had been stopped. ; Reported Cause(s) of Death: Sudden death within 24 hours of Comirnaty - Pfizer vaccine booster/cardiac arrest in heart failure in a patient already vasculopathic with dementia and outcome of cerebral stroke; Sudden death within 24 hours of Comirnaty - Pfizer vaccine booster/car


VAERS ID: 1200600 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Diarrhoea, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   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: NORVASC; PRITORPLUS; LOPRESOR [METOPROLOL TARTRATE]; DIAMICRON; OMNIC; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Hyperuricemia; Ischemic cardiomyopathy; Prostatic hypertrophy (benign)
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021380428

Write-up: drug ineffective/ positive COVID-19 PCR test; drug ineffective/ positive COVID-19 PCR test; asthenia and diarrhea; asthenia and diarrhea; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority report number is IT-MINISAL02-709108. An 84-year-old male patient received BNT162B2 (COMIRNATY), on 23Mar2021 at 08:50 (lot number: ET3620; second dose) at 0.3 mL, single in the left arm and on 02Mar2021 (lot number: EP2166; first dose), single dose (as reported); both intramuscularly, for COVID-19 immunization. The patient medical history included hypertension, ischemic cardiomyopathy, diabetes mellitus, prostatic hypertrophy (benign), and hyperuricemia. Concomitant medications included amlodipine besilate (NORVASC, strength: 5 mg) taken for hypertension; hydrochlorothiazide (strength: 80 mg), telmisartan (strength: 12.5 mg) (PRITORPLUS) taken for hypertension; metoprolol tartrate (LOPRESOR [METOPROLOL TARTRATE], strength: 100 mg) taken for ischemic cardiomyopathy; gliclazide (DIAMICRON, strength: 30 mg) taken for diabetes mellitus; tamsulosin hydrochloride (OMNIC, strength: 0.4 mg) taken for prostatic hypertrophy (benign); and allopurinol (ZYLORIC, strength: 300 mg) taken for hyperuricemia. On 23Mar2021, the patient experienced asthenia and diarrhea. On 26Mar2021, the patient experienced drug ineffective/ positive COVID-19 PCR test. The patient died on 28Mar2021 due to the events. It was not reported if an autopsy was performed. Reporter comments: first dose vaccine lot EP2166 administered on 02Mar2021: no adverse reactions. Symptoms appeared a few hours after second vaccination therefore I prescribed the COVID-19 PCR test with a positive outcome on 26Mar2021. From my point of view it is not clinical vaccination failure due to lack of adequate distance from the administration of the second dose or the result. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: first dose vaccine lot EP2166 administered on 02Mar2021: no adverse reactions. Symptoms appeared a few hours after second vaccination therefore I prescribed the COVID-19 PCR test with a positive outcome on 26Mar2021. From my point of view it is not clinical vaccination failure due to lack of adequate distance from the administration of the second dose or the result.; Reported Cause(s) of Death: asthenia and diarrhea; asthenia and diarrhea; drug ineffective/ positive COVID-19 PCR test; drug ineffective/ positive COVID-19 PCR test


VAERS ID: 1200627 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dysuria, Incorrect route of product administration, Pyrexia, Renal pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: Body temperature; Result Unstructured Data: Test Result:high fever of over 39
CDC Split Type: ITPFIZER INC2021380085

Write-up: Severe pain in the kidneys with increasing difficulty in urinating.On 30Mar2021 a high fever of over 39 occurred, which did not go down with antipyretics.On 31Mar2021 he died.Vaccinated with Cominarty; Severe pain in the kidneys with increasing difficulty in urinating.On 30Mar2021 a high fever of over 39 occurred, which did not go down with antipyretics.On 31Mar2021 he died.Vaccinated with Cominarty; Severe pain in the kidneys with increasing difficulty in urinating.On 30Mar2021 a high fever of over 39 occurred, which did not go down with antipyretics.On 31Mar2021 he died.Vaccinated with Cominarty; COMIRNATY cutaneous; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number: IT-MINISAL02-709680. A 90-year-old male patient received second dose of bnt162b2 (COMIRNATY), cutaneous, administered in Arm Right (right shoulder) on 17Mar2021 (Lot Number: ET1831) as a single dose (1 DF) for covid-19 immunisation. Medical history was not reported. Other products used (treatments based on supplements, medicinal plants or homeopathic substances): none. Patient received first dose of bnt162b2 (COMIRNATY) on 21Feb2021 for covid-19 immunisation. On 28Mar2021 patient experienced severe pain in the kidneys with increasing difficulty in urinating, on 30Mar2021 a high fever of over 39 occurred, which did not go down with antipyretics. On 31Mar2021 patient died due to severe pain in the kidneys with increasing difficulty in urinating and high fever. Vaccinated with Comirnaty. It was not reported if an autopsy was performed. It was reported that on 01Apr2021 was contacted the reporter to ask him to specify the batch of vaccine administered and other documentation useful for the evaluation of the case. Unfortunately it was not possible to do anything other than declare the death. Impact on quality of life (10/10). Reporter''s comment: cancer. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Kidney pain; Urination difficulty; Fever


VAERS ID: 1200635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620-12-041 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome
SMQs:, Myocardial infarction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021380042

Write-up: Acute coronary syndrome; This is a spontaneous report downloaded from the regulatory authority (Regulatory Authority report number: IT-MINISAL02-709770). A contactable physician (contactable through Regulatory Authority only) reported that a 97-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot number: ET3620-12-041; Expiration date was not reported), intramuscularly on the right arm on 20Mar2021 (14:23) as a single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On 25Mar2021, the patient had acute coronary syndrome. The patient was not a heart patient and had no major medical conditions. The patient had died on 25Mar2021 due to acute coronary syndrome. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Lot number was already provided.; Reporter''s Comments: The patient was given the second dose of Comirnaty Vaccine on 20Mar2021. On 25Mar2021 she died of acute coronary syndrome. the patient was not a heart patient and had no major medical conditions.; Reported Cause(s) of Death: acute coronary syndrome


VAERS ID: 1200655 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-03-11
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine increased, COVID-19, Drug ineffective, Hyperbilirubinaemia, Respiratory failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: Creatinine; Result Unstructured Data: Test Result:increased; Test Date: 20210325; Test Name: Hyperbilirubinaemia; Result Unstructured Data: Test Result:aggravated; Test Date: 20210311; Test Name: TNF SARS-CoV 2; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC2021380160

Write-up: 23Feb I vaccine dose; 11Mar TNF SARS-CoV 2 for pos contact tracking; 20Mar insuff. acute respiratory tract with the need for hospitalization The Patient resides in a country; hyperbilirubinaemia aggravated; creatinine: increased; 23Feb I vaccine dose; 11Mar TNF SARS-CoV 2 for pos contact tracking; 20Mar insuff. acute respiratory tract with the need for hospitalization The Patient resides in a country; 23Feb I vaccine dose; 11Mar TNF SARS-CoV 2 for pos contact tracking; 20Mar insuff. acute respiratory tract with the need for hospitalization The Patient resides in a country; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB [IT-MINISAL02-710342]. A 99-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot Number: EP9598; Expiration Date: 30Jun2021), intramuscular, administered in left deltoid (reported as left shoulder) on 23Feb2021 13:12 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 23Feb2021 the patient had the first vaccine dose of bnt162b2. On 11Mar2021, TNF SARS-COV 2 for positive contact tracing. On 20Mar2021, the patient had insuff. acute respiratory tract (Failure respiratory) with the need for hospitalization as the patient resides in certain area. Actions taken for the events insuff. acute respiratory tract and TNF SARS-COV 2 for positive included oxygen therapy, hydration, steroids. The patient underwent lab tests and procedures which included TNF SARS-CoV 2: positive on 11Mar2021, creatinine: increased on 20Mar2021, and hyperbilirubinaemia aggravated on 25Mar2021. The patient died on 26Mar2021. Cause of death was insuff. acute respiratory tract and TNF SARS-COV 2 for positive. It was unknown if an autopsy was performed. The outcome of the events insuff. acute respiratory tract and TNF SARS-COV 2 for positive was fatal. The outcome of the remaining events was unknown.; Reported Cause(s) of Death: insuff. acute respiratory tract; TNF SARS-COV 2 for positive; TNF SARS-COV 2 for positive


VAERS ID: 1200779 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:37 to 37.9 Centigrade; Comments: after the vaccination
CDC Split Type: JPPFIZER INC2021385050

Write-up: persistent fever in the range of 37 to 37.9 degrees centigrade; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21101088. A 37-year-old male patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly, on 05Apr2021 at 18:00 (Lot Number: ER9480; Expiration Date: 31Jul2021) (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included arrhythmia. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot number: EP9605; Expiration date: 30Jun2021), intramuscularly, on 18Mar2021 at 18:00 (at the age of 37-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced cardio-respiratory arrest on 08Apr2021 at 08:00, which was reported as fatal. The patient also experienced persistent fever in the range of 37 to 37.9 degrees centigrade on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 37 to 37.9 centigrade on an unspecified date (after the vaccination). The patient did not receive any treatment as a result of the events. The patient died on 08Apr2021. The cause of death was under investigation and not reported. It was not reported if an autopsy was performed (reported as: scheduled for 09Apr2021). It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: Under investigation


VAERS ID: 1202820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021380051

Write-up: Myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-20935. A 94-year-old female patient received BNT162B2 (COMIRNATY; lot number: EP2163), intramuscular on 03Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Mar2021, the patient died due to myocardial infarction. It was not reported if an autopsy was performed. Sender Comment: BASGAGES-comment: Follow-up information requested. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1202833 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-03
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0004246 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bronchoalveolar lavage, Computerised tomogram, Death, Decreased appetite, Dyspnoea, Fatigue, Headache, Oxygen saturation, 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Ex-tobacco user; Hepatic cirrhosis; Hypothyroidism; Idiopathic pulmonary fibrosis; Osteoporosis; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Bronchoalveolar lavage; Result Unstructured Data: Severely contaminated with bronchial secretion and blood; Test Date: 2021; Test Name: CT; Result Unstructured Data: CT shows ground glass changes; Test Date: 2021; Test Name: SpO2; Test Result: 85 %; Result Unstructured Data: low; Test Date: 2021; Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: COVID swab 2 x negative
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: dyspnea exacerbated; headache; inappetence; fatigue; death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death), DYSPNOEA (dyspnea exacerbated), HEADACHE (headache), DECREASED APPETITE (inappetence) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 0004246) for COVID-19 vaccination. The patient''s past medical history included Ex-tobacco user, Hepatic cirrhosis, Rheumatoid arthritis, Idiopathic pulmonary fibrosis, Diabetes mellitus, Hypothyroidism and Osteoporosis. On 21-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DEATH (death) (seriousness criterion death), DYSPNOEA (dyspnea exacerbated) (seriousness criterion hospitalization), HEADACHE (headache) (seriousness criterion hospitalization), DECREASED APPETITE (inappetence) (seriousness criterion hospitalization) and FATIGUE (fatigue) (seriousness criterion hospitalization). The patient died on an unknown date. At the time of death, DYSPNOEA (dyspnea exacerbated), HEADACHE (headache), DECREASED APPETITE (inappetence) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Bronchoalveolar lavage: abnormal (abnormal) Severely contaminated with bronchial secretion and blood. In 2021, Computerised tomogram: abnormal (abnormal) CT shows ground glass changes. In 2021, Oxygen saturation: 85 percent (Low) low. In 2021, SARS-CoV-2 test: negative (Negative) COVID swab 2 x negative. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered HEADACHE (headache), DECREASED APPETITE (inappetence) and FATIGUE (fatigue) to be possibly related and DYSPNOEA (dyspnea exacerbated) to be unlikely related. No further causality assessment was provided for DEATH (death). No concomitant medication were reported. No treatment medications were provided. This is a case of death in a 79-year-old female subject with a medical history of Ex-tobacco user, Hepatic cirrhosis, Rheumatoid arthritis, Idiopathic pulmonary fibrosis, Diabetes mellitus, Hypothyroidism and Osteoporosis, who died 18 days after receiving the first dose of vaccine. Based on reporter''s causality of attributing to pulmonary fibrosis exacerbation, the death is assessed as unlikely related to mRNA-1273. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 79-year-old female subject with a medical history of Ex-tobacco user, Hepatic cirrhosis, Rheumatoid arthritis, Idiopathic pulmonary fibrosis, Diabetes mellitus, Hypothyroidism and Osteoporosis, who died 18 days after receiving the first dose of vaccine. Based on reporter''s causality of attributing to pulmonary fibrosis exacerbation, the death is assessed as unlikely related to mRNA-1273. No follow up is possible.


VAERS ID: 1202846 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   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: IMOVANE 3.75 mg; LEVOTHYROXINE SODIUM; LASILIX 40 mg; BISOPROLOL FUMARATE; MONOPROST 50 mg/ml; SIMBRINZA 10 mg/ml + 2 mg/ml; PRAVASTATIN SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrillation atrial; Ischaemic heart disease; Subdural haematoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Ischemic stroke; This case was received via Company (Reference number: QTS-210409-125) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (Ischemic stroke) in a 92-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042722) for COVID-19 vaccination. The patient''s past medical history included Subdural haematoma, Ischaemic heart disease and Fibrillation atrial. Concomitant products included PRAVASTATIN SODIUM [PRAVASTATIN SODIUM] from an unknown date to 10-Mar-2021 for Dyslipidaemia, LEVOTHYROXINE SODIUM from an unknown date to 10-Mar-2021 for Hypothyroidism, LASILIX 40 mg from an unknown date to 10-Mar-2021 and BISOPROLOL FUMARATE from an unknown date to 10-Mar-2021 for Ischaemic heart disease, IMOVANE 3,75 mg from an unknown date to 10-Mar-2021, MONOPROST 50 mg/ml from an unknown date to 10-Mar-2021 and SIMBRINZA 10 mg/ml and 2 mg/ml from an unknown date to 10-Mar-2021 for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ISCHAEMIC STROKE (Ischemic stroke) (seriousness criteria death and medically significant). The patient died on 12-Mar-2021. The reported cause of death was Ischemic stroke. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products included PRAVASTATIN SODIUM from an unknown date to 10-Mar-2021 for Dyslipidaemia, LEVOTHYROXINE SODIUM from an unknown date to 10-Mar-2021 for Hypothyroidism, LASILIX 40 mg from an unknown date to 10-Mar-2021 and BISOPROLOL FUMARATE from an unknown date to 10-Mar-2021 for Ischaemic heart disease, IMOVANE 3,75 mg from an unknown date to 10-Mar-2021, MONOPROST 50 mg/ml from an unknown date to 10-Mar-2021 and SIMBRINZA 10 mg/ml + 2 mg/ml from an unknown date to 10-Mar-2021 for an unknown indication. This is a case of death in a 92-year-old male subject with unknown medical history of Subdural hematoma, Ischemic heart disease and Fibrillation atrial, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 92-year-old male subject with unknown medical history of Subdural hematoma, Ischemic heart disease and Fibrillation atrial, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1202850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-02-21
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Atrial fibrillation, Blood creatinine, Blood pressure measurement, Body temperature, COVID-19, Cardiomyopathy, Coma scale, Computerised tomogram, Drug ineffective, Echocardiogram, Electrocardiogram, Heart rate, Hypotension, Livedo reticularis, Multiple organ dysfunction syndrome, Oxygen saturation, Renal failure, Respiratory rate, SARS-CoV-2 test, Sepsis, Ventricular hypokinesia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOCE; CORTANCYL; DESLORATADINE; ELIQUIS; KARDEGIC; LASILIX [FUROSEMIDE]; METOCLOPRAMIDE; NIVOLUMAB; PERINDOPRIL; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic renal failure (basic creatinine = 130 umol / L); Hypertension arterial; Hyperthyroidism (thyroid overload); Ischaemic heart disease (ischemic heart disease with myocardial infarction (MI) in 2018); Lung cancer metastatic (treated by left nephrectomy in 2013 and radiotherapy on pulmonary recurrence); Malignant melanoma excision (operated on in 2016); Mediastinal metastases (treated by left nephrectomy in 2013 and radiotherapy on pulmonary recurrence); Melanoma (operated on in 2016); Metastases to bone (treated by left nephrectomy in 2013 and radiotherapy on pulmonary recurrence); Metastatic renal carcinoma (treated by left nephrectomy in 2013 and radiotherapy on pulmonary recurrence); Myocardial infarction (ischemic heart disease with myocardial infarction (MI) in 2018); Nephrectomy (treated by left nephrectomy in 2013 and radiotherapy on pulmonary recurrence); Pneumocystosis (Pneumocystosis in 2019 treated with BACTRIM, now on pentamidine for prophylaxis); Radiotherapy (treated by left nephrectomy in 2013 and radiotherapy on pulmonary recurrence); Renal carcinoma (with pleural involvement treated with pazobanib then nivolumab since Jun2018)
Allergies:
Diagnostic Lab Data: Test Date: 20210225; Test Name: Creatinine; Result Unstructured Data: Test Result:137 umol/l; Test Date: 20210222; Test Name: blood pressure; Result Unstructured Data: Test Result:80/40 mmHg; Test Date: 20210222; Test Name: body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Test Date: 20210225; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Date: 20210222; Test Name: Thoraco-abdominal CT scan; Result Unstructured Data: Test Result:COVID19 infection extended to 25% of the lung pare; Comments: COVID19 infection extended to 25% of the lung parenchyma.; Test Date: 20210301; Test Name: Echocardiography; Result Unstructured Data: Test Result:myocardial astonishment with global hypokinesia wi; Comments: myocardial astonishment with global hypokinesia without recovery on the iterative ultrasounds performed.; Test Date: 20210225; Test Name: ECG; Result Unstructured Data: Test Result:: atrial fibrillation with appearance of right bun; Comments: atrial fibrillation with appearance of right bundle branch block.; Test Date: 20210222; Test Name: Heart rate; Result Unstructured Data: Test Result:83 bpm; Test Date: 20210222; Test Name: Heart rate; Result Unstructured Data: Test Result:76 bpm; Test Date: 20210225; Test Name: Heart rate; Result Unstructured Data: Test Result:150 bpm; Test Date: 20210225; Test Name: Heart rate; Result Unstructured Data: Test Result:104 bpm; Test Date: 20210225; Test Name: saturation; Test Result: 87 %; Comments: under non-invasive ventilation (NIV); Test Date: 20210225; Test Name: respiratory; Result Unstructured Data: Test Result:polypneic at 45 / min; Test Date: 20210221; Test Name: PCR COVID19; Test Result: Positive
CDC Split Type: FRPFIZER INC2021380214

Write-up: multiple organ failure with acute respiratory distress syndrome (ARDS) severe; multiple organ failure with acute respiratory distress syndrome (ARDS) severe; myocardial astonishment and renal failure on dialysis; myocardial astonishment with global hypokinesia/myocardial astonishment and renal failure on dialysis; myocardial astonishment with global hypokinesia; AFib; arterial hypotension (blood pressure 80/40 mmHg); mottling/Diffuse mottling of the lower limbs and trunk.; sepsis with fever at 38.9C; PCR COVID19 positive; PCR COVID19 positive; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority FR-AFSSAPS-LY20211640. This is a report received from the Regulatory Authority. A 77-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 18Jan2021 as single dose (lot EM0477); and dose 2 intramuscular on 15Feb2021 as single dose (lot EK9788), for COVID-19 vaccination. Medical history included metastatic renal carcinoma in the lung, mediastinum and bone treated by left nephrectomy in 2013 and radiotherapy on pulmonary recurrence, new recurrence of renal carcinoma in 2017 with pleural involvement initially treated with pazobanib then nivolumab since Jun2018, pneumocystosis in 2019 treated with bactrim, now on pentamidine for prophylaxis, chronic renal failure (basic creatinine was 130umol / L), melanoma (operated on in 2016), ischemic heart disease with myocardial infarction (MI) in 2018, hypertension arterial, complete arrhythmia by atrial fibrillation, Hyperthyroidism (thyroid overload), and long-term corticosteroid therapy in a context of colitis under immunotherapy - corticosteroids a priori suddenly stopped suddenly recently. History of COVID19 was not specified. Concomitant medications included bisoprolol fumarate (BISOCE), prednisone (CORTANCYL), desloratadine (DESLORATADINE), apixaban (ELIQUIS), acetylsalicylate lysine (KARDEGIC), furosemide (LASILIX), metoclopramide, nivolumab, perindopril and pantoprazole. On 19Feb2021, the patient experienced fever, body aches, chills, headache, digestive disorders. On 21Feb2021, the patient had a PCR COVID-19 positive. On 22Feb2021, the patient presented to the emergency room with the persistence of fever and the appearance of rapidly progressive dyspnea. In the emergency room, a picture of sepsis with fever at 38.9C, mottling, arterial hypotension (blood pressure 80/40 mmHg) which rises after vascular filling. Oxygen request was at 3 L / min with no sign of respiratory distress. Thoraco-abdominal CT scan showed COVID19 infection extended to 25% of the lung parenchyma. Start ceftriaxone and rovamycin + an injection of amikacin. Hydrocortisone EPS in the face of suspected acute adrenal insufficiency (sudden stop of chronic corticosteroid therapy). On 22Feb2021: heart rate was 83 bpm, and 76 bpm. On 24Feb2021, heart rate was at 83 bpm. On 25Feb2021, sudden respiratory degradation and was resuscitation. Respiratory: polypneic at 45 / min, 87% saturation under non-invasive ventilation (NIV). Hemodynamically: stable except amine. Patient had diffuse mottling of the lower limbs and trunk and cold ends. Cardiovascular: tachycardia at 150 bpm and ECG: atrial fibrillation with appearance of right bundle branch block. Neurologically: Glasgow 15 On the digestive level: supple and painless abdomen. On the renal level: no urinary functional signs. Creatinine 137umol / L. Before the sudden onset of distress and the surge of complete arrhythmia by atrial fibrillation, a cardiac origin to the respiratory distress was suspected. Treatment of challenge with furosemide, maintenance of NIV, slowing of complete arrhythmia by atrial fibrillation with amiodarone and magnesium. There was no improvement after one hour, patient was intubated + noradrenaline. Reduced atrial fibrillation on 27Feb2021 with amiodarone ESP. Curative anticoagulation by Calciparin. Probable acute coronary syndrome (ACS) type 2. On 25Feb2021, heart rate was at 104bpm. On 01Mar2021, echocardiography showed myocardial astonishment with global hypokinesia without recovery on the iterative ultrasounds performed. On 02Mar2021, there was multiple organ failure with acute respiratory distress syndrome (ARDS) severe, myocardial astonishment and renal failure on dialysis which led to discontinuation of active therapies. Outcome of event AFib was not recovered; and outcome of the rest of the events was unknown. The patient died on 02Mar2021 due to PCR COVID19 positive. It was unknown if autopsy was performed.; Reported Cause(s) of Death: PCR COVID19 positive; PCR COVID19 positive


VAERS ID: 1202857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardio-respiratory arrest, Cough, Dyspnoea, Haemoptysis, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: MODOPAR; AMLOR; HYTACAND; MELATONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021380267

Write-up: Cardio-respiratory arrest; faintness; massive hemoptysis; asthenia; Fever; Cough; Dyspnoea; This is a spontaneous report from contactable physician downloaded from a regulatory authority-WEB FR-AFSSAPS-PS20210705. A 75-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Batch/Lot Number: ET1831), intramuscular, administered in arm left on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included Parkinson''s disease and hypertension from an unknown date and unknown if ongoing. Concomitant medications included benserazide hydrochloride, levodopa (MODOPAR), amlodipine besilate (AMLOR), candesartan cilexetil, hydrochlorothiazide (HYTACAND) and melatonin taken for an unspecified indication, start and stop date were not reported. Clinical course was as follows: The day of the injection: no fever, no vaccine contraindication for vaccination with the Pfizer vaccine. The immediate end of the vaccination took place without any particular event, as well the night following the injection. On 18Mar2021, the day after the vaccination: onset of a cough that was initially dry then worsening and becoming "oily and taking on the lungs" (as reported) associated with difficulty of breathing. Taking oxomemazine (TOPLEXIL) cough syrup and paracetamol in the presence of an associated fever (not measured): "the patient was suffocating with heat" (as reported). Faced with the worsening of the cough, associated with asthenia, the subject call from doctor on Saturday, 20Mar2021. Thirty (30) minutes after the call: no doctor came. Call from the emergent medical services on the night of 20 to 21Mar2021: worsening of the patient''s state of health, he was no longer breathing and appeared to be dead. By telephone, the medical regulator requested the implementation of an emergency maneuver (cardiac massage by the patient''s friend for about ten minutes before the arrival of the EMS) which would have triggered massive hemoptysis ("he spat a lot of blood while coughing"). The patient''s friend is then relayed by the EMS team (8 people), for about 2 hours (resuscitation procedures, cardiac massage). The patient''s death after massive hemoptysis was observed on 21Mar2021 at 6:15 am at home, 4 days after the first injection of COMIRNATY. The death certificate mentioned "the absence of medico-legal obstacles (as reported). The causes of death mentioned are cardiopulmonary arrest, following a faintness and a fatty cough evolving for 48 hours. Apparent circumstances of death: natural death. Additional information: No PCR was performed at the time of the onset of the fatty cough. Note that the patient''s friend performed a PCR one week after death, which came back negative (as reported). Absolutely independent patient, living at home. Seen by his neurologist and his occupational doctor a week before the death: everything was fine. No history of arrhythmias. No recent change in treatment except the increase in melatonin for sleep disorders. No other specific complaints. No decompensation of a chronic pathology. No possible signs of anaphylactic manifestation shortly before death. Death from cardio-respiratory arrest occurring 4 days after vaccination, following difficulty in breathing associated with a fatty cough and fever. 1) From a chronological point of view, the data do not allow to exclude the role of the anti-Covid19 vaccine in the occurrence of this death, the cause of which remains however unidentified to this day and which occurs four days after the vaccination. 2) On the semiological level, in the absence of an autopsy, the cause of this death is not identified. The hypothesis of a pulmonary infection (COVID?) can be raised (as reported). The outcome of the events was fatal. The patient died on 21Mar2021. Cause of death was also reported as fever, cough, dyspnoea, asthenia, massive hemoptysis, cardiopulmonary arrest, following a faintness and a fatty cough. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: In absence of autopsy report, due to a positive drug-event temporal association, the company cannot completely exclude a causal association between Comirnaty administration and the reported events, at the present time, all qualified as fatal. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: cardiopulmonary arrest; faintness; fatty cough; asthenia; massive hemoptysis; fever; Dyspnoea


VAERS ID: 1202862 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Mouth haemorrhage, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASITONE; DUOPLAVIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Mild febrile episode the day after vaccination, death overnight, blood stains found at labial commisure; blood stains found at labial commisure; Mild febrile episode the day after vaccination; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Apr-2021 and was forwarded to Moderna on 01-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Mild febrile episode the day after vaccination, death overnight, blood stains found at labial commisure) in an 87-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included No adverse event. Previously administered products included for Product used for unknown indication: GASTROLOC - "20 MG COMPRESSE GASTRORESISTENTI" 14 COMPRESSE IN BLISTER AL/OPA/AL/PVC (GLAX and FOSTER (CHIESI FARMACEUTICI S.P.A.) (R03AK08). Past adverse reactions to the above products included No adverse reaction with FOSTER (CHIESI FARMACEUTICI S.P.A.) (R03AK08) and GASTROLOC - "20 MG COMPRESSE GASTRORESISTENTI" 14 COMPRESSE IN BLISTER AL/OPA/AL/PVC (GLAX. Concomitant products included ACETYLSALICYLIC ACID, CLOPIDOGREL BISULFATE (DUOPLAVIN) from 06-Jul-2016 to 19-Mar-2021 for Atherothrombosis prophylaxis, FUROSEMIDE, SPIRONOLACTONE (LASITONE) from 01-Aug-2012 to 19-Mar-2021 for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 18-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Mild febrile episode the day after vaccination). On 19-Mar-2021, the patient experienced MOUTH HAEMORRHAGE (blood stains found at labial commisure). The patient died on 19-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MOUTH HAEMORRHAGE (blood stains found at labial commisure) and PYREXIA (Mild febrile episode the day after vaccination) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Per the patient''s family, the patient was in a state of well-being at the time of vaccination. Treatment information was not provided. Company comment: Very limited information regarding these events has been provided at this time. Patient''s age along with unknown underlying conditions may have been contributory for the occurrence of the death. No further follow-up information is expected. Reporter did not allow further contact; Reported Cause(s) of Death: Death


VAERS ID: 1202866 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021380148

Write-up: In the late afternoon, abdominal pain; In the late afternoon, retrosternal pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority with regulatory authority number IT-MINISAL02-710033. An 85-year-old female patient received bnt162b2 (COMIRNATY reported as COVID 19 COMIRNATY VACCINE (PFIZER) * 195FL 0,45ML), dose 1 via an unspecified route of administration on 31Mar2021 13:52 (Lot Number: ET7205) as single dose for covid-19 immunisation. Medical history included CVA (cerebrovascular accident) from 01Jan2017 to an unknown date. The patient''s concomitant medications were not reported. It was reported that in the late afternoon (31Mar2021), the patient abdominal and retrosternal pain. It was reported that the patient was intubated, massaged and received drug treatment. The patient was transported to Emergency Room (ER). The outcome of the events was fatal. The patient died on 31Mar2021. It was not reported if an autopsy was performed. Sender Comment: 02Apr2021 Regional Pharmacovigilance Center: requests for follow-up information from the reporter regarding clinical report and case management. Waiting. Reporter comment: Sent by specific profile No follow-up attempts possible. No information expected.; Reporter''s Comments: Sent by specific profile; Reported Cause(s) of Death: abdominal pain; Retrosternal pain


VAERS ID: 1202869 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6775 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021386375

Write-up: Loses consciousness; Find him out of breath; This is a spontaneous report received from a regulatory authority. The regulatory authority report number is 5813-4. A non-contactable healthcare professional reported that a 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6775, Expiration Date: 01Jun2021), intramuscular in left arm, on 14Mar2021 at 08:15 AM, at a single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was healthy before vaccination. The patient received a dose of BNT162B2 at 8:15 AM without incident during his waiting time. The patient retires to his home where he takes a meal and sits in a garden chair where his relatives observe that he loses consciousness and when they approach to check they find him out of breath at 09:00 AM (45 minutes after the first dose on 14Mar2021). A neighbor approaches to give him CPR maneuvers without change after the intervention. The relatives go again to the healthcare professional to report what happened. The outcome of the events was fatal. The patient died on 14Mar2021. 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: Find him out of breath; Loses consciousness


VAERS ID: 1202870 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6775 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disseminated Bacillus Calmette-Guerin infection, Insomnia, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (of 5 years of evolution); Epilepsy (of 86 years of evolution)
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021386389

Write-up: BCG infection; Difficulty to sleep; vomiting several times; This is a spontaneous report from a non-contactable healthcare professional. This is a report received from a regulatory authority via email. The regulatory authority report number is 9112-4. An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly administered in the left arm on 09Mar2021 (Batch/Lot Number: EP6775; Expiration Date: 30Jun2021) at the age of 87-years-old as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history included chronic obstructive pulmonary disease (COPD) from 2016, and epilepsy from 1935. It was reported that the patient was not healthy before vaccination (COPD of 5 years of evolution and epilepsy of 86 years of evolution). The patient''s concomitant medications were not reported. On 09Mar2021, the patient experienced BCG infection, difficulty to sleep, and vomiting several times. It was reported that the timeframe between the vaccination and and the start of symptoms was 3 hours. It was reported that the patient presented vomiting several times, 3 hours after the vaccination. Therapeutic measures were taken as a result of the events which included omeprazole and metoclopramide. The patient died on an unspecified date due to the events. It was not reported if an autopsy was performed. The case was reported as serious. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: BCG infection; Difficulty to sleep; vomiting several times


VAERS ID: 1202871 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ3002 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Discomfort, Dyspnoea, Fatigue, General symptom, Headache, Hypertension, Irritability, Malaise, Myalgia, Oropharyngeal pain, Pyrexia, Respiratory distress, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:Fever equal to or greater than 38 grades Celsius Centigrade
CDC Split Type: MXPFIZER INC2021386390

Write-up: respiratory distress; Fever equal to or greater than 38 grades Celsius; headache; asthenia; fatigue; irritability; rhinorrhea; oropharyngeal pain; dyspnea; myalgia; arthralgia; discomfort; malaise; general symptoms; hypertension; This is a spontaneous report from a non-contactable other health professional. This is a report received from the Regulatory Authority via email. Regulatory authority report number is 11575-4. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EJ3002; Expiration Date: 01Apr2021), intramuscular, administered in arm left on 13Jan2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fever equal to or greater than 38 grades celsius, headache, asthenia/fatigue, irritability, rhinorrhea, oropharyngeal pain, dyspnea, respiratory distress, myalgia, arthralgia. Clinical course was as follows: Start the discomfort three days after the vaccination, with fever, malaise and headache, self-medicated with paracetamol, after that, general symptoms were added, presented hypertension at the evaluation. All events occurred on 16Jan2021. Timeframe between vaccination and starting of symptoms: 2 days, 20 hours, 60 minutes. Therapeutic measures were taken as a result of fever equal to or greater than 38 grades Celsius, malaise, headache and discomfort. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. The events were assessed as serious, hospitalization required and caused death by the regulatory authority. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fatigue; respiratory distress; Fever equal to or greater than 38 grades Celsius; headache; asthenia; irritability; rhinorrhea; oropharyngeal pain; dyspnea; myalgia; arthralgia; discomfort; malaise; general symptoms; hypertension


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