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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine is COVID19 and Patient Died

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Case Details

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VAERS ID: 1679872 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-08-04
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Suspected COVID-19
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: 2021-08-04
   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: Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101131327

Write-up: COVID-19 respiratory infection; Drug ineffective; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20216790. A 78-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EK9788) dose 2 via an intramuscular route of administration, on 08Feb2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing parkinson''s disease from unknown start date. The patient''s concomitant medications were not reported. On 04Aug2021 the patient experienced covid-19 respiratory infection, drug ineffective and on an unspecified date, vaccination failure. Patient was hospitalized on an unspecified date. The patient was died on 04Aug2021. The outcome of the event covid-19 respiratory infection and drug ineffective was fatal. The outcome of the event vaccination failure was unknown. Autopsy performed was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: infection covid


VAERS ID: 1679909 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004233 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Dementia Alzheimer''s type; Hypertensive heart disease, unspecified; Infarct myocardial; Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: SARS-CoV-2 test Positive
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death unexplained; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-PV20212455) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death unexplained) in a 90-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004233) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 25-Jan-2021 and Stroke. Concurrent medical conditions included Infarct myocardial, Dementia Alzheimer''s type, Hypertensive heart disease, unspecified, Cardiac failure and Smoker. On 05-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. Death occurred on 06-Aug-2021 The patient died on 06-Aug-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided. Company comment: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. However elderly age and patient?s medical history of cardiac failure, myocardial infraction , hypertensive heart disease and stroke could be a confounder. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Translation received on 02-sep-2021 includes information on medical condition (Smoker).; Sender''s Comments: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. However elderly age and patient?s medical history of cardiac failure, myocardial infraction , hypertensive heart disease and stroke could be a confounder.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1680558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), 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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:no heart beat; Comments: Went to the scan and told there was no heart beat. Vaccine taken at 11+1 baby died at 11+3
CDC Split Type: GBPFIZER INC202101133106

Write-up: Miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108301639126920-YL2YN, Safety Report Unique Identifier GB-MHRA-ADR 25869929. This consumer or other non hcp reported information for both mother and fetus/baby. This is a maternal report. A 35-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FC9001, Expiry date was not reported), via an unspecified route of administration on 21Aug2021 as single dose for COVID-19 immunization. The patient''s medical history included abortion spontaneous from an unknown date and unknown if ongoing, suppressed lactation from an unknown date and unknown if ongoing, pregnancy from an unknown date and unknown if ongoing (patient no longer pregnant at the time of reporting), Folic acid supplementation from an unknown date and unknown if ongoing. The patient''s concomitant medication(s) included folic acid was taken for Folic acid supplementation, start and stop date were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number, Expiry date was not reported) via an unspecified route of administration on unknown date for COVID-19 immunization. The patient experienced maternal exposure during pregnancy on 21Aug2021, miscarriage on 23Aug2021. The mother reported she became pregnant while taking bnt162b2. The vaccine was taken at 11+1 weeks and baby died at 11+3 week. An autopsy was not performed. The patient went for a routine 12 weeks scan and told the baby died around the time of having the 2nd vaccine. Patient was not tested COVID-19 positive since having the vaccine. One previous miscarriage caused by detached placenta at 20 weeks. Patient was exposed to the medicine first-trimester. The event caused death, medically significant. The patient had 3 healthy pregnancies. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 20Aug2021 No - Negative COVID-19 test, scan was no heartbeat (Went to the scan and told there was no heartbeat. Vaccine taken at 11+1 baby died at 11+3). The outcome of the event was maternal exposure during pregnancy was unknown, miscarriage was Fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1680604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Death, Loss of consciousness, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   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: PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; SEROQUEL
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20210910877

Write-up: DEATH; LOSS OF CONSCIOUSNESS; SHOCK CIRCULATORY; BLOOD PRESSURE DECREASED; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, GR-GREOF-20217207) on 06-SEP-2021 concerned a 73 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on 23-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included Plaquenil (hydroxychloroquine phosphate), and Seroquel (quetiapine fumarate) drugs used for unknown indication. On 24-AUG-2021, the patient experienced loss of consciousness, had shock circulatory and her blood pressure decreased. On 25-AUG-2021, the patient died from shock circulatory and an autopsy was not performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood pressure decreased, death and loss of consciousness on 25-AUG-2021. This report was serious (Death, and Other Medically Important Condition).; Reported Cause(s) of Death: SHOCK CIRCULATORY


VAERS ID: 1680841 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-07-20
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute abdomen, Angiogram, Blood creatine phosphokinase MB, Blood lactate dehydrogenase, Blood lactate dehydrogenase increased, Body temperature, Computerised tomogram head, Computerised tomogram thorax, Disorientation, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Myocardial necrosis, Pulmonary embolism, Pyrexia, Sopor, Troponin, Unresponsive to stimuli, Urine output, Urine output decreased
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), 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), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 16
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: CARDIOASPIRIN; TORVAST
Current Illness: Cerebrovascular disorder (Current Condition); Diabetic polyneuropathy (Current Condition); Ischemic heart disease (Current Condition; previous lower necrosis); Type II diabetes mellitus with neurological manifestations (Current Condition; Type II diabetes mellitus with neurological manifestations)
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic neuropathy; Unspecified cerebrovascular disease
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: Angiogram; Result Unstructured Data: Test Result:evidenced pulmonary embolism; Test Date: 20210727; Test Name: Blood creatine phosphokinase MB; Test Result: 12.5 ng; Test Date: 20210727; Test Name: Blood lactate dehydrogenase; Result Unstructured Data: Test Result:922; Comments: (UNDER 1000) increased IU; Test Date: 20210720; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Test Date: 20210727; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:unknown results; Test Date: 20210726; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:unknown results; Test Date: 20210726; Test Name: Fibrin D dimer; Test Result: 56.6 mg; Comments: increased; Test Date: 20210727; Test Name: Troponin; Test Result: 161.8 ng; Comments: increased; Test Date: 20210720; Test Name: Urine output; Result Unstructured Data: Test Result:decreased
CDC Split Type: ITPFIZER INC202101089258

Write-up: ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB, company number IT-SA-SAC20210817000841. This is a spontaneous serious case received by PRIVACY (license partner of other company regarding levofloxacin). (Reference Number: IT2021166199) on 04Aug2021 and received by PRIVACY on 10Aug2021. This case was reported by a physician via regulatory authority and described the occurrence of pulmonary embolism in an 83-year-old male patient who received levofloxacin (LEVOXACIN) tablet for dyspnea, oral started from an unknown date at 500 mg once daily (500 mg daily). Co-suspect products included bnt162b2 (COMIRNATY) dose 2 intramuscular on 22Apr2021 (Lot number EX0893 expiry date 31Jul2021) as 0.3 ML single for covid-19 vaccination. Concurrent medical conditions included ongoing diabetic polyneuropathy; ongoing ischemic heart disease (previous lower necrosis); ongoing cerebrovascular disorder; ongoing type II diabetes mellitus with neurological manifestations; Diabetic neuropathy; and Unspecified cerebrovascular disease. Concomitant products included acetylsalicylic acid (CARDIOASPIRIN) and atorvastatin calcium (TORVAST). Historical vaccine included bnt162b2 (COMIRNATY, formulation "0.45 ml concentrate for injectable dispersion, intramuscular route, vial (ve)") 1st dose on 01Apr2021 for covid-19 vaccination with no adverse event. On 20Jul2021 (as reported), unknown after starting levofloxacin, the patient experienced pulmonary embolism (serious criteria hospitalization, death, and PRIVACY company medically significant), unresponsive to verbal stimuli (serious criteria hospitalization, death, and PRIVACY company medically significant), acute abdomen (serious criteria hospitalization, death, and PRIVACY company medically significant), myocardial necrosis (serious criteria hospitalization, death, and PRIVACY company medically significant), lactate dehydrogenase increased (serious criteria hospitalization, death), temporal disorientation (serious criteria hospitalization, death), fibrin d dimer high (serious criteria hospitalization, death), dyspnea (serious criteria hospitalization, death), sopor (Abnormally deep sleep) (serious criteria hospitalization, death), fever (serious criteria hospitalization, death) and urine output decreased (serious criteria hospitalization, death), with description of "ever, diff. respiratory and temporal disorientation, high DDimer value, e.g. chest CT angiography evidenced pulmonary embolism on 26/06 / acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06.". On 05Aug2021, the outcome of the embolism pulmonary, unresponsive to verbal stimuli, acute abdomen, myocardial necrosis, LDH (Blood lactate dehydrogenase) increased, temporal disorientation, fibrin d dimer high, dyspnea, sopor (Abnormally deep sleep), fever and urinary output diminished were fatal. The patient died on 05Aug2021. The reported cause of death was urinary output diminished, dyspnea, fever, temporal disorientation, fibrin d dimer high, acute abdomen, sopor (Abnormally deep sleep), unresponsive to verbal stimuli, ldh increased, myocardial necrosis and embolism pulmonary. It was not reported if an autopsy was performed. It was unknown if the reporter considered the embolism pulmonary, unresponsive to verbal stimuli, acute abdomen, myocardial necrosis, LDH (Blood lactate dehydrogenase) increased, temporal disorientation, fibrin d dimer high, dyspnea, sopor (Abnormally deep sleep), fever and urinary output diminished to be related to Levofloxacin. The patient underwent lab tests and procedures which included angiogram: evidenced pulmonary embolism on 26Jun2021 (as reported); Blood creatine phosphokinase MB: 12.5 ng on 27Jul2021; Blood lactate dehydrogenase: 922 (UNDER 1000) increased IU on 27Jul2021; body temperature: fever on 20Jul2021; computerised tomogram head: unknown results on 27Jul2021; computerised tomogram thorax: unknown results on 26Jul2021; Fibrin D dimer: 56.6 mg increased on 26Jul2021; Troponin: 161.8 ng increased on 27Jul2021; urine output: decreased on 20Jul2021. The action taken in response to the events for levofloxacin was provided as not applicable. PRIVACY Reference number: 764592. Also reported that the Health Care professional considered the events Urine output decreased, Fibrin D dimer increased, Pyrexia, Disorientation, Acute abdomen, Sopor, Pulmonary embolism, Blood lactate dehydrogenase increased, Myocardial necrosis, Unresponsive to stimuli, Dyspnoea were as Related/Reasonable possibility with levofloxacin. PRIVACY (license partner of other company) Company Comment: Initial 10Aug2021 levofloxacin [levofloxacin]. Pulmonary embolism (Hospitalized) (IME), Unresponsive to stimuli (Hospitalized) (IME), Acute abdomen (Hospitalized) (IME) , Myocardial necrosis (Hospitalized) (IME) , Blood lactate dehydrogenase increased (Hospitalized) , Disorientation (Hospitalized) , Fibrin d dimer increased (Hospitalized) , Dyspnoea (Hospitalized) , SOPOR (Hospitalized) , Pyrexia (Hospitalized) , Urine output decreased (Hospitalized) , In summary, this case report does not change the known safety profile of levofloxacin[levofloxacin]: Reporter causality: Unknown, Company causality: Related. Initial information from Italy regarding an unsolicited valid serious case received from Physician via PRIVACY under reference: IT2021166199 on 10Aug2021 and transmitted to PRIVACY on 17Aug2021. Initial information was received from a physician via regulatory authority on 04Aug2021: fever, diff. respiratory and temporal disorientation, high D Dimer value, e.g. (exempli gratia) chest CT angiography evidenced pulmonary embolism on 26Jun2021 acute abdomen picture with greater than of LDH (Blood lactate dehydrogenase) and IND (Investigational New Drug) of myocardial necrosis 27Jun2021. Follow-up information was received from a physician via regulatory authority: Upon follow-up, Seriousness upgraded to Fatal for all events. Patient death details updated and cause of death was added. Follow-up 18Aug2021 levofloxacin [levofloxacin]. Pulmonary embolism (Death) (IME), Unresponsive to stimuli (Death) (IME), Acute abdomen (Death) (IME), Myocardial necrosis (Death) (IME), Blood lactate dehydrogenase increased (Death), Disorientation (Death), Fibrin d dimer increased (Death), Dyspnoea (Death), SOPOR (Death), Pyrexia (Death), Urine output decreased (Death): Reporter causality: Unknown, Company causality: Related. In summary, this case report does not change the known safety profile of levofloxacin [levofloxacin]. Initial information from Italy regarding an unsolicited valid serious case received from Physician via PRIVACY under reference: IT2021166199 on 18Aug2021 and transmitted to PRIVACY on 23Aug2021: Patient death details were added, Outcome was updated from not recovered/not resolved to Fatal for all events. Seriousness criteria was updated to Fatal. Sender (other company) assessed the events Urine output decreased, Fibrin D dimer increased, Pyrexia, Disorientation, Acute abdomen, Sopor, Pulmonary embolism, Blood lactate dehydrogenase increased, Myocardial necrosis, Unresponsive to stimuli, Dyspnoea were as Reportable with levofloxacin. Sender (other company) comments: PRIVACY company comment dated 18Aug2021: Based on the limited information provided, the causal role of company drug to cause the event cannot be excluded but lack of information regarding past medication, therapy details, any family history and any and indication of the drug precludes comprehensive case assessment. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ever, diff. respiratory and temporal disorientation, high DDimer value, angiography evidenced pulmonary embolism acute abdomen picture with more than of LDH and ind of myocardial necrosis 27.06; ever, diff. respiratory and temporal disorientation, hi


VAERS ID: 1680842 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-25
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-27
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Familial hypercholesterolaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Acute myocardial infarction; This case was received via Pharmaceutical Company (Reference number: JP-TAKEDA-2021TJP083998) on 01-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21126070). The patient was under medication for depression. On 31-Jul-2021, the patient received the 1st dose of this vaccine. On 25-Aug-2021, 07:00, vomiting, and chest and back pain developed. At 09:00, the patient visited a nearby hospital. Electrocardiography revealed suspected acute myocardial infarction, and the patient was transported to the reporting hospital by ambulance. Emergency cardiac catheterization showed acute occlusion of two branches of the left anterior descending and right coronary arteries. The patient was in cardiogenic shock and underwent emergency percutaneous coronary intervention after IABP insertion. Recirculation was successful, and the patient was admitted to the hospital. The patient had postoperative CPK elevation to 11,059 and extensive myocardial damage. The patient experienced low cardiac output syndrome and severe cardiac failure. Although NPPV was used, the respiratory condition could not be maintained, and endotracheal intubation was performed. Although high-dose pressure-boosting drugs were used afterwards, the blood pressure could not be maintained, and acidosis progressed. On 27-Aug-2021, 19:28, the patient was confirmed dead. The outcome of Acute myocardial infarction was reported as fatal. Follow-up investigation will be made. Reporter comments continuation: Because of familial hypercholesterolemia, myocardial infarction can occur at an early age, but it is possible that the patient had simultaneous occlusion of two artery branches and was prone to thrombosis. A causal relationship with this vaccine could not be ruled out. The platelet count was normal. The autopsy was not performed by the intention of the family. Other factors may include familial hypercholesterolemia and depression. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected. However, the patients medical history of familial hypercholesterolemia is a confounder.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1680975 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-08-23
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Death; Pyrexia; This case was received via Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP082397 ) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This case was reported to Pharmaceutical Company. On 18-Jul-2021, the patient received the 1st dose of this vaccine (lot number: 3003657). On 22-Aug-2021, the patient received the 2nd dose of this vaccine (lot number: 3004734). On 23-Aug-2021, pyrexia developed, and the patient was absent from work. On 24-Aug-2021, pyrexia resolved, and the patient went to work. After returning home, the patient went to bed. On 25-Aug-2021, in the morning, death was confirmed. Cause of death was unknown: information is being collected. The outcome of pyrexia was reported as resolved. No follow-up information was available due to non-cooperation of the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.No further information is available for this case; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1680984 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute pulmonary oedema, Body temperature, Cardio-respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple myeloma
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.3 degree Celcius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Cardio-respiratory arrest; Acute pulmonary oedema; This case was received via Pharmaceuticals (Reference number: 2021TJP083556) on 30-Aug-2021 and was forwarded to Moderna on 01-Sep-2021. This case, initially reported to the Pharmaceuticals and appropriate authorities by a physician, was received via the PMDA (Ref, v21125438). On 06-Aug-2021, the patient had no problems and was able to walk on his/her own. On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 07-Aug-2021, at 08:50, the patient received the 1st dose of this vaccine. The patient went to the vaccination venue alone. Around 10:00, in the adjacent parking lot, the patient contacted a friend to ask for help because the patient was not feeling well after the vaccination and was unable to find the location of the parked car. When the friend rushed to the scene, the patient was in a sitting position and appeared to be struggling to breathe. The friend temporarily left the patient to look for the car, but when the friend returned later, the patient had become limp and collapsed. Hence, after the friend called for help from the people around the place, an emergency call was made. The patient was judged to be in cardiopulmonary arrest, and cardiac massage was started. AED shock was not indicated for the patient''s symptoms, so the patient continued to be resuscitated, and then the ambulance team arrived. At that time, the patient was in cardiac arrest. Adrenaline administration was started, but there was no response, and the patient was transported to hospital. At 10:26, the patient was still in cardiopulmonary arrest on arrival at the hospital. At 11:24, The patient was confirmed dead at the hospital. The postmortem pathological diagnostic CT imaging showed findings that should not be surprising if there was acute pulmonary edema. The outcome of cardio-respiratory arrest and acute pulmonary oedema was reported as fatal. Follow-up investigation will be made. Reporter comments continuation: The patient had been in this condition for several days, so there is a possibility that some sort of new clinical conditions had appeared. However, on the day of the vaccination, the patient visited the venue by himself/herself, there were no problems during the interview for vaccination, and the patient was able to receive the vaccination. Since the patient subsequently went into cardio-respiratory arrest, the impact of the dose of this vaccine could not be denied on a time-series basis. With regard to the disease state that led to cardio-respiratory arrest, the differential diagnosis was difficult, and the causal relationship with this vaccine could not be evaluated. Company Comment: Although the events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), it is also considered that the events are due to effects from past medical history and patient background, etc.; Reporter''s Comments: The patient had a past medical history of multiple myeloma, and according to the patient''s son, there was blood in the tissue every day for about 2 weeks, and the patient had complained of backache and sore throat for the last several days. Therefore, the possibility of an association with multiple myeloma cannot be denied because there was this recent change in the patient''s symptoms. See "narrative" section; Sender''s Comments: Very limited information regarding the events have been provided at this time. No further information will be received as it is a RA report.; Reported Cause(s) of Death: Cardio-respiratory arrest; Acute pulmonary oedema


VAERS ID: 1681002 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood culture, Blood pressure measurement, Capillary leak syndrome, Chills, Computerised tomogram, Computerised tomogram abdomen, Dizziness, Heart rate, Imaging procedure, Investigation, Pyrexia, SARS-CoV-2 test, Shock, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoldering myeloma (Diagnosed 1.5 years before)
Preexisting Conditions: Medical History/Concurrent Conditions: Capillary leak syndrome (Occurred 1.5 years earlier); Fever; Hospitalisation (the patient in our study had been admitted 1.5 years earlier for fever, vomiting, myalgia, generalized edema and hypotension (blood pressure 90/60 mm Hg). Laboratory results showed hemoconcentration (hematocrit 58.4%) and hypoalbuminemia (3.03 g/dL at nadir), but diagnosis was unclear, and the patient recovered spontaneously after fluid administration. He revisited hospital 5 months earlier and no laboratory abnormalities found.); Hypoalbuminemia; Vomiting
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: 130 {beats}/min; Test Name: Blood pressure; Result Unstructured Data: 100/90 mmHg; Test Name: Imaging procedure; Result Unstructured Data: Not reported; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Negative; Test Name: Investigation; Result Unstructured Data: Showed marked hemoconcentration and hypoalbuminemia; Test Name: Computerised tomogram abdomen; Result Unstructured Data: Unremarkable; Test Name: Heart rate; Result Unstructured Data: 132 {beats}/min; Test Name: Blood pressure; Result Unstructured Data: 60/40 mmHg; Test Name: Blood culture; Result Unstructured Data: Negative; Test Name: Computerised tomography; Result Unstructured Data: Unremarkable
CDC Split Type: KRJNJFOC20210901548

Write-up: HYPOTENSIVE SHOCK WORSENING; SUSPECTED SYSTEMIC CAPILLARY LEAK SYNDROME; DIZZINESS; CHILLS; RECURRENT VOMITING; FEVER; GENERAL WEAKNESS; This spontaneous report was received from literature:, Fatal Systemic Capillary Leak Syndrome after SARS-CoV-2 Vaccination in Patient with Multiple Myeloma. 2021 Aug 30; 27. This report concerned a 38-year-old male. The patient''s height, and weight were not reported. The patient''s past medical history included: Hospitalization 1.5 years earlier for fever, vomiting, myalgia, generalized edema and hypotension (blood pressure 90/60 mm Hg). Laboratory results showed hemoconcentration (hematocrit 58.4%) and hypoalbuminemia (3.03 g/dL at nadir), but diagnosis was unclear, and the patient recovered spontaneously after fluid administration which was retrospectively assumed as flare episode of systemic capillary leak syndrome (SCLS), he revisited hospital 5 months earlier and no laboratory abnormalities found. Concurrent conditions included: smoldering multiple myeloma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number Unknown and expiry was unknown), 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date,12?24 hours post-vaccination, the patient experienced fever, chills, and myalgia and 24-48 hours post-vaccination the patient had nausea, recurrent vomiting and general weakness. The patient had emergency room visit and got treatment for vomiting and dizziness. At the time of admission, he was afebrile, his heart rate was 130 beats/min, and his blood pressure was 100/90 mm Hg, with no noticeable edema. Isotonic saline was administered and initiated diagnostic evaluation: Laboratory tests, Imaging. COVID-19 reverse transcription polymerase chain reaction (PCR) showed negative results. Test results showed marked hemoconcentration and hypoalbuminemia. Chest and abdominal computed tomography results were unremarkable. 6 hours after admission, the patient was hypotensive, blood pressure was 60/40 mm Hg, had a heart rate of 132 beats/min, and reported dyspnea. The blood culture was found negative. The patient was treated with broad-spectrum antimicrobials, intravenous fluids, and inotropes. Despite these measures, the patient''s hypotensive shock got worsened, and he died 10 hours after admission. Although at admission the patient showed neither peripheral edema nor severe hypoalbuminemia, SCLS was suspected as blood cultures and COVID-19 testing were negative. On an unspecified date, the patient died from hypotensive shock worsening. An autopsy was performed on an unspecified date showed no evidence of acute infection or cardiovascular disease in the internal organs. Pulmonary edema, pleural effusion, and pericardial effusion were identified. Although pulmonary edema was atypical in acute SCLS attacks (leak phase), prolonged cardiopulmonary resuscitation and fluid administration might have affected the autopsy findings. Histopathologic findings in both kidneys suggested autolysis or acute tubular necrosis, which helped exclude other possible etiologies of refractory hypotensive shock. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the recurrent vomiting, dizziness, fever, chills, general weakness and suspected systemic capillary leak syndrome was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: This spontaneous report from literature concerned a 38-year old man who experienced worsening hypotensive shock with fatal progression 2 days after vaccination, and suspected systemic capillary leak syndrome (SCLS). Medical history included smoldering multiple myeloma and previous hospital admission (1.5 years prior) for suspected SCLS. Lab results showed hemoconcentration and hypoalbuminemia but diagnosis was unclear (flare episode of systemic capillary leak syndrome assumed by authors), and recovery was spontaneous after fluid administration. COVID-19 test was negative. Normal chest and abdominal CT. No concomitant medications reported. The patient experienced fever, chills, and myalgia 12?24 hours post vaccination; nausea, recurrent vomiting, and general weakness 24?48 later. The patient was admitted to the ED 2 days after vaccination with HR of130/min, BP of 100/90 mm Hg; no fever and noticeable edema, and received isotonic saline. Six hours after admission, BP was 60/40 mm Hg, HR was 132/min, and dyspnea was reported. Blood was cultured (negative) and broad-spectrum antimicrobials, intravenous fluids, and inotropes were given. Hypotensive shock worsened, and patient died 10 hours after admission. Autopsy: no evidence of acute infection or cardiovascular disease. Pulmonary edema, pleural effusion, and pericardial effusion due to prolonged cardiopulmonary resuscitation were noted. Kidney histopathology: autolysis or acute tubular necrosis. The patient''s previous history of suspected SCLS and concurrent multiple myeloma may have increased the risk for the event to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.; Reported Cause(s) of Death: HYPOTENSIVE SHOCK WORSENING


VAERS ID: 1681153 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-08-10
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oxygen saturation, 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: 2021-08-15
   Days after onset: 5
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: LOSARTAN; SIMVASTATIN; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Arterial hypertension; Benign prostatic hypertrophy; Constipation chronic; Dyslipidemia; Hemiparesis (left); Ischemic stroke; Typhoid fever
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:<90 %; Comments: <90 % percent; Test Date: 20210810; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101125804

Write-up: Vaccination failure; SARS-CoV-2; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-F202108-2044. An 89-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), second dose via intramuscular on 15Feb2021 (Batch/Lot Number: EM6950), as a 0.3 ml single, first dose via intramuscular on 25Jan2021 (Batch/Lot Number: EJ6134), as a 0.3 ml single for COVID-19 immunisation. Medical history included hypertension, dyslipidaemia, benign prostatic hyperplasia, constipation from an unknown date and unknown if ongoing, ischaemic stroke from 2011 to an unknown date, hemiparesis from 2011 to an unknown date, typhoid fever from 1947 to an unknown date, appendicectomy from 1952 to an unknown date. Concomitant medications included losartan (LOSARTAN); simvastatin (SIMVASTATIN); clopidogrel (CLOPIDOGREL) taken for an unspecified indication, start and stop date were not reported. On 10Aug2021, the patient experienced vaccination failure, Sars-Cov-2. The patient underwent lab tests and procedures which included oxygen saturation: <90 % on 10Aug2021 <90 % percent, Sars-Cov-2 test: positive on 10Aug2021 positive IU international units. The patient was institutionalized in a home, where an outbreak happened. Death occurred on 15Aug2021. No attributed cause of death, most likely due to SARS-CoV-2 pneumonia. Autopsy Evolution of adverse drug reaction: death is unknown. The patient died on 15Aug2021. It was not reported if an autopsy was performed. The reporter''s assessment of the causal relationship of the vaccination failure, COVID-19 with the suspect product was relatedness of drug to reactions/events: Source of assessment: reporter, method of assessment: Unknown, Result of Assessment: Definitive. Reporter''s comments: Concomitant Medication-Clopidogrel 75 mg once a day; Losartan 100mg twice a day; Simvastatin 40 mg once a day medication error occurred no further information attachment. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2


VAERS ID: 1681283 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2020-07-21
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Private       Purchased by: ?
Symptoms: Carbon monoxide poisoning, Cervical vertebral fracture, Death, Rib fracture, Spinal cord haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 365
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: TWMODERNATX, INC.MOD20213

Write-up: Unknown cause of Death; Fracture and bleeding in cervical spine at the level of C6/7; Fracture of left front 3rd~7th rib; Intraspinal haemorrhage; The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Unknown cause of Death), CARBON MONOXIDE POISONING (The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected), CERVICAL VERTEBRAL FRACTURE (Fracture and bleeding in cervical spine at the level of C6/7), RIB FRACTURE (Fracture of left front 3rd~7th rib) and SPINAL CORD HAEMORRHAGE (Intraspinal haemorrhage) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2020, the patient experienced CARBON MONOXIDE POISONING (The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected) (seriousness criterion death) and SPINAL CORD HAEMORRHAGE (Intraspinal haemorrhage) (seriousness criteria death and medically significant). On 21-Jul-2021, the patient experienced DEATH (Unknown cause of Death) (seriousness criteria death and medically significant), CERVICAL VERTEBRAL FRACTURE (Fracture and bleeding in cervical spine at the level of C6/7) (seriousness criteria death and medically significant) and RIB FRACTURE (Fracture of left front 3rd~7th rib) (seriousness criterion death). The patient died on 21-Jul-2021. The cause of death was not reported. An autopsy was performed. The autopsy-determined cause of death was the patient''s left chest rib was fractured left front 3rd~7th rib, the skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected and fractured cervical spine and intraspinal haemorrhage. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication not provided. Treatment medication not provided. On 21-Jul-2021, the patient was found dead in the driver''s seat of the passenger car, in a sitting position, with the gear shifted in N, and the front left portion of the car slightly collided with the flower bed in front of the temple. During the autopsy, it was found that the patient''s left chest rib was fractured and the police on the spot said that they had done CPR for the patient. The family members believed that the cause of death was related to the vaccine, so the autopsy was required to find out the cause of death. On 29-Jul-2021, the judicial autopsy was performed. After the autopsy, the forensic doctor initially judged that: 1. The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected. 2. Fracture and bleeding in cervical spine at the level of C6/7. 3. Fracture of left front 3rd-7th rib. This is a case of a 67-year-old male patient who received first dose of mRNA-1273 and was found dead two weeks later in the driver''s seat of the passenger car. Autopsy was performed and revealed skin of the limbs appeared cherry red (carbon monoxide poisoning was suspected), fracture and bleeding in cervical spine at the level of C6/7 and fracture of left front 3rd-7th rib. The exact cause of death was not provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: This is a case of a 67-year-old male patient who received first dose of mRNA-1273 and was found dead two weeks later in the driver''s seat of the passenger car. Autopsy was performed and revealed skin of the limbs appeared cherry red (carbon monoxide poisoning was suspected), fracture and bleeding in cervical spine at the level of C6/7 and fracture of left front 3rd-7th rib. The exact cause of death was not provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of Death; intraspinal hemerage; Autopsy-determined Cause(s) of Death: The patient''s left chest rib was fractured left front 3rd~7th rib; The skin of the limbs appeared cherry red, and carbon monoxide poisoning was suspected; Fractured cervical spine and Intraspinal haemorrhage


VAERS ID: 1681284 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Psoriasis
Preexisting Conditions: Medical History/Concurrent Conditions: Motor vehicle accident (30 Jun)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; Fever; This regulatory authority case was reported by an other and describes the occurrence of DEATH (Death) and PYREXIA (Fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The patient''s past medical history included Motor vehicle accident (30 Jun). Concurrent medical conditions included Heart failure and Psoriasis. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion death). The patient died on 19-Jul-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. No concomitant medication was provided. No treatment information was provided. Company Comment: Although a temporal association exist between the fatal outcome and the administration of mRNA-1273 vaccine, critical details such as the actual cause of death was not provided. No further information is expected. The patient had fever on the day of vaccination with o reported complications. Patient also had significant history of heart failure and recent motor accident for which there was frequent need to visit the hospital Symptoms; Sender''s Comments: Although a temporal association exist between the fatal outcome and the administration of mRNA-1273 vaccine, critical details such as the actual cause of death was not provided. No further information is expected. The patient had fever on the day of vaccination with o reported complications. Patient also had significant history of heart failure and recent motor accident for which there was frequent need to visit the hospital Symptoms; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1681288 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Discomfort; This regulatory authority case was reported by an other health care professional and describes the occurrence of DISCOMFORT (Discomfort) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced DISCOMFORT (Discomfort) (seriousness criteria death and hospitalization). The patient was hospitalized on 26-Jul-2021 due to DISCOMFORT. The patient died on 29-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided. Treatment information was not provided. It was reported that t patient was hospitalized for medical treatment of discomfort on 26-Jul-2021 and was admitted to the intensive care unit. Company Comment: Very limited information regarding this event has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1681290 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dizziness, Fatigue, Headache, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 20
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: 20210720; Test Name: COVID-19 nucleic acid test; Test Result: Negative ; Result Unstructured Data: COVID-19 nucleic acid test result was negative.
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Fatigue; Generalized weakness; Syncope; Dizziness; Headache; This regulatory authority case was reported by an other and describes the occurrence of SYNCOPE (Syncope), FATIGUE (Fatigue), DIZZINESS (Dizziness), HEADACHE (Headache) and ASTHENIA (Generalized weakness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criteria death, hospitalization and medically significant), DIZZINESS (Dizziness) (seriousness criteria death and hospitalization) and HEADACHE (Headache) (seriousness criteria death and hospitalization). On 08-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criteria death and hospitalization) and ASTHENIA (Generalized weakness) (seriousness criteria death and hospitalization). The patient died on 27-Jul-2021. The reported cause of death was Syncope, Fatigue, Dizziness, Headache and generalized weakness. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: negative (Negative) COVID-19 nucleic acid test result was negative.. Patient was hospitalized for treatment after visiting the Emergency Department on 10 JUL 2021. Concomitant medication of the patient was not reported. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Syncope; Fatigue; Dizziness; Headache; Generalized weakness


VAERS ID: 1681291 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Dyspnoea, Pleural effusion, Pyrexia, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hyperglycemia; Hyperlipidemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Breathing difficulty; urinary tract infection; pleural effusion; Fever; Loss of appetite; This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA (Breathing difficulty), URINARY TRACT INFECTION (urinary tract infection ), PLEURAL EFFUSION (pleural effusion) and PYREXIA (Fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Hyperlipidemia, Hyperglycemia and Diabetes. On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Jul-2021, the patient experienced DECREASED APPETITE (Loss of appetite). On 11-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion death). On 12-Jul-2021, the patient experienced DYSPNOEA (Breathing difficulty) (seriousness criteria death and hospitalization), URINARY TRACT INFECTION (urinary tract infection ) (seriousness criteria death and hospitalization) and PLEURAL EFFUSION (pleural effusion) (seriousness criteria death and hospitalization). The patient was hospitalized on 12-Jul-2021 due to DYSPNOEA, PLEURAL EFFUSION and URINARY TRACT INFECTION. On 09-Jul-2021, DECREASED APPETITE (Loss of appetite) had resolved. The patient died on 26-Jul-2021. The reported cause of death was breathing difficulty, Urinary tract infection, Pleural effusion and Fever. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. The patient developed fever on 11Jul2021. The patient visited the Emergency Department of Hospital due to breathing difficulty on 12Jul2021, and she was hospitalized (suspected urinary tract infection and pleural effusion). The patient died on 26Jul2021. This is a case of death in a 85-year-old female subject, with a history of HTN, DM and Hyperlipidemia, who died 20 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 85-year-old female subject, with a history of HTN, DM and Hyperlipidemia, who died 20 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Fever; Breathing difficulty; urinary tract infection; pleural effusion


VAERS ID: 1685823 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Atelectasis, Blood fibrinogen, Brain contusion, Brain death, Brain oedema, Cardiac arrest, Central nervous system necrosis, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Congestive hepatopathy, Deep vein thrombosis, Fibrin D dimer, Haematoma, Haemorrhage subcutaneous, Haemorrhagic ovarian cyst, Haemothorax, Heparin-induced thrombocytopenia test positive, Immune thrombocytopenia, Laryngeal haematoma, Magnetic resonance imaging, Platelet count, Pleural effusion, Pulmonary embolism, Pupils unequal, Right ventricular dilatation, Subarachnoid haemorrhage, Vena cava thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Adiposity; Cardiovascular disease, unspecified; Chronic renal insufficiency (with suspected vascular neuropathy); Hirsutism (Hirsutism in the chin area. Tumorous pituitary enlargement (18:12:6 mm) - suspected pituitary adenoma.); Hypertension arterial (arterial hypertension); Left ventricular hypertrophy (left ventricular hypertrophy); Leukoencephalopathy (Leukoencephalopathy DD vasculitis. Cadasil genetic test negative.); Mitral valve prolapse (mitral valve prolapse, tricuspid insufficiency); Pituitary tumour (Tumorous pituitary enlargement (18:12:6 mm) - suspected putuitary adenoma.); Renal vascular disorder NOS (with suspected vascular neuropathy); Splenomegaly (Splenomegaly (14 cm MR 14.2.18)); Struma nodosa (Small-nodule goiter, both sides); Tricuspid valve incompetence (tricuspid insufficiency); Uterine myomatosis (Uterus myomatosus); Vasculitis (Leukoencephalopathy DD vasculitis. Cadasil genetic test negative.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20180214; Test Name: MRI; Result Unstructured Data: Splenomegaly (14 cm); Test Date: 20210811; Test Name: Fibrinogen; Result Unstructured Data: 118 mg/dL; Test Date: 20210811; Test Name: Platelet count; Result Unstructured Data: 29000 G/l; Test Date: 20210811; Test Name: Antibody test; Result Unstructured Data: 2.46; Test Date: 20210811; Test Name: Fibrin D dimer; Result Unstructured Data: less than 20
CDC Split Type: ATJNJFOC20210845391

Write-up: HEPARIN-PLATELET FACTOR 4 ANTIBODY COMPLEX TEST POSITIVE; CARDIAC ARREST; IMMUNE THROMBOCYTOPENIA; BRAIN DEATH; INTRACEREBRAL HEMORRHAGE (ICH); HAEMATOMA; INFERIOR VENACAVAL THROMBOSIS; BRAIN CONTUSION; RECURRENT PULMONARY EMBOLISM; EFFUSION PLEURAL; HEPATIC CONGESTION; BLEEDING SPOT SUBCUTANEOUS; DEEP VEIN THROMBOSIS LEG; RIGHT VENTRICULAR DILATATION; HAEMORRHAGE INTO OVARIAN CYST; PARTIAL ATELECTASIS; CEREBRAL VENOUS SINUS THROMBOSIS; PLEURAL HAEMORRHAGE; BRAIN EDEMA; CENTRAL NERVOUS SYSTEM NECROSIS; LARYNGEAL HAEMATOMA; HAEMORRHAGE SUBARACHNOID; RIGHT PUPIL CONSIDERABLY WIDER THAN LEFT ONE; This spontaneous report received from a physician by a Regulatory Authority (AT-EMA-DD-20210831-banala_s-154341) on 03-SEP-2021 and concerned a 35 year old female of unknown race and ethinicity. Initial information was processed with additional information received on 06-Sep-2021. The patient''s weight was 90 kilograms, and height was 160 centimeters. The patient''s concurrent conditions included: mitral valve prolapse, chronic renal insufficiency, vasculitis, splenomegaly, left ventricular hypertrophy, renal vascular disorder nos, hypertension arterial, leukoencephalopathy, tricuspid valve incompetence, pituitary tumour, hirsutism, adiposity, uterine myomatosis, struma nodosa, and cardiovascular disease, unspecified. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 0.5 ml, 1 dosage forms, 1 total administered on 31-JUL-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-FEB-2018, Laboratory data included: MRI (NR: not provided) Splenomegaly (14 cm). On AUG-2021, the patient experienced haematoma, inferior venacaval thrombosis, brain contusion, recurrent pulmonary embolism, effusion pleural, hepatic congestion, bleeding spot subcutaneous, deep vein thrombosis leg, right ventricular dilatation, haemorrhage into ovarian cyst, partial atelectasis, cerebral venous sinus thrombosis, pleural haemorrhage, brain edema, central nervous system necrosis, laryngeal haematoma, haemorrhage subarachnoid, immune thrombocytopenia. On 11-AUG-2021, the patient experienced brain death, intracerebral hemorrhage (ich), right pupil considerably wider than left one. The patient was hospitalized (date unspecified). Laboratory data included: Antibody test (NR: not provided) 2.46, Fibrin D dimer (NR: not provided) less than 20, Fibrinogen (NR: not provided) 118 mg/dL, and Platelet count (NR: not provided) 29000 G/l. On 14-AUG-2021, the patient experienced cardiac arrest. On an unspecified date, the patient experienced heparin-platelet factor 4 antibody complex test positive, and was hospitalized. On 14-AUG-2021, the patient died from intracerebral haemorrhage, and cardiac arrest. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of immune thrombocytopenia, brain death, intracerebral hemorrhage (ICH), brain contusion, recurrent pulmonary embolism, right ventricular dilatation, brain edema and central nervous system necrosis on 14-AUG-2021, had not recovered from right pupil considerably wider than left one, haematoma, inferior venacaval thrombosis, effusion pleural, hepatic congestion, bleeding spot subcutaneous, deep vein thrombosis leg, haemorrhage into ovarian cyst, partial atelectasis, cerebral venous sinus thrombosis, pleural haemorrhage, laryngeal haematoma, and haemorrhage subarachnoid, and the outcome of heparin-platelet factor 4 antibody complex test positive was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition) Additional information was received from Physician on 03-Sep-2021. The following information was updated and incorporated into the case narrative: New reporter added (consumer), New patient medical history was added under disease which are pituitary tumour, hirsutism, adiposity, uterine myomatosis, struma nodosa, and cardiovascular disease, unspecified, in Event tab new events were added which are haematoma, inferior venacaval thrombosis, brain contusion, recurrent pulmonary embolism, effusion pleural, hepatic congestion, bleeding spot subcutaneous, deep vein thrombosis leg, right ventricular dilatation, haemorrhage into ovarian cyst, partial atelectasis, cerebral venous sinus thrombosis, pleural haemorrhage, brain edema, central nervous system necrosis, laryngeal haematoma, haemorrhage subarachnoid, right pupil considerably wider than left one, heparin-platelet factor 4 antibody complex test positive and cardiac arrest.; Reported Cause(s) of Death: INTRACEREBRAL HAEMORRHAGE; CARDIAC ARREST


VAERS ID: 1685872 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Dyspnoea, Malaise, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101134715

Write-up: Dysphagia; Dyspnoea; Malaise; Vomiting; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 609817. A 56-year-old male patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Dysphagia, Dyspnoea, Malaise, Vomiting on unknown date. The outcome of all events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Dysphagia; Dyspnoea; Malaise; Vomiting


VAERS ID: 1685874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-11
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Lethargy, Vaccination site pain
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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 INC202101139110

Write-up: Headache; Injection site pain; Lethargy; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 610431. A 44-year-old female patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Headache, Injection site pain and Lethargy on 11Jul2021. The outcome of all events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Headache; Injection site pain; Lethargy


VAERS ID: 1685875 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-14
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Myocardial fibrosis
SMQs:, Cardiomyopathy (narrow), Other ischaemic heart disease (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 INC202101139111

Write-up: Arteriosclerosis coronary artery; Myocardial fibrosis; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 611057. A 45-year-old male patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Arteriosclerosis coronary artery and Myocardial fibrosis on 14Jun2021. The outcome of both events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Arteriosclerosis coronary artery; Myocardial fibrosis


VAERS ID: 1685876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Decreased appetite, Lethargy, Oxygen saturation, Oxygen saturation decreased, Somnolence
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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: Oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: AUPFIZER INC202101139113

Write-up: Cerebral infarction; Decreased appetite; Lethargy; Oxygen saturation decreased; Somnolence; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 613011. A 89-year-old female patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Cerebral infarction, Decreased appetite, Lethargy, Oxygen saturation decreased and Somnolence on 07Aug2021. The outcome of all events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Cerebral infarction; Decreased appetite; Lethargy; Oxygen saturation decreased; Somnolence


VAERS ID: 1685877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101139116

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable other health professional via the Agency. Regulatory authority report number is 613645. A 57-year-old female patient received BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Subarachnoid haemorrhage on unknown date. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1685878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101139117

Write-up: Cardiac arrest; This is a spontaneous report from a contactable other healthcare professional received via the agency. Regulatory authority number 613371. A 44 years old male patient received BNT162B2 (COMIRNATY) on an unspecified date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced cardiac arrest on 04Aug2021, with fatal outcome. The patient died on an unspecified date in 2021. It was unknown 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: Cardiac arrest


VAERS ID: 1685899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19, COVID-19 pneumonia, Cachexia, Computerised tomogram, Death, Dementia, Drug ineffective, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Dementia (narrow), Noninfectious encephalopathy/delirium (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
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: 20210822; Test Name: CT scan; Result Unstructured Data: Test Result:COVID-19 positive; Comments: COVID-19 positive
CDC Split Type: BEPFIZER INC202101124488

Write-up: covid 19 pneumonia complicated by superinfected pneumonia; COVID-19 infection after vaccination; Cachexia; COVID-19 infection after vaccination; Death; Urinary infection; Dementia; acute renal failure; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-105736. A 98-years-old female patient received BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on 09Feb2021 as DOSE 2, SINGLE for covid-19 immunization and dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced covid-19 pneumonia complicated by superinfected pneumonia, covid-19 infection after vaccination, which was considered as lack of efficacy, cachexia, death, urinary infection, dementia and acute renal failure. On 22Aug2021, the patient was hospitalized for covid-19 pneumonia complicated by superinfected pneumonia. The patient underwent lab tests and procedures which included computerised tomogram and covid-19 positive on 22Aug2021. Therapeutic measures were taken as a result of covid-19 pneumonia complicated by superinfected pneumonia, cachexia, covid-19 infection after vaccination, death, urinary infection, dementia, acute renal failure which included oxygen therapy, aerosol therapy, physiotherapy, antibiotic therapy. The patient died on 24Aug2021. It was not reported if an autopsy was performed. The outcome of all events was fatal. Health Authority''s comment: Treatment was given with oxygen therapy, aerosol therapy, physiotherapy, antibiotic therapy. Evolution of the ADR was Death. ADR description - hospitalized on 22Aug2021 for covid 19 pneumonia complicated by superinfected pneumonia despite complete vaccination (19Jan2021 and 09Feb2021). acute renal failure with associated urinary tract infection, dementia and cachexia No follow-up attempts possible, information about lot/batch numbers cannot be obtained. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; Drug ineffective; Cachexia; COVID-19; Urinary tract infection; Dementia; acute renal failure


VAERS ID: 1686124 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Fatigue, Intestinal haemorrhage, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac arrhythmia NOS; Diabetes mellitus NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: CZMODERNATX, INC.MOD20213

Write-up: Intestinal bleeding; ?nava; COVID-19 infection; Ka?el; This case was received via regulatory authority (Reference number: CZ-CZSUKL-21009888) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INTESTINAL HAEMORRHAGE (Intestinal bleeding) and COVID-19 (COVID-19 infection) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus NOS and Cardiac arrhythmia NOS. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COVID-19 (COVID-19 infection) (seriousness criterion medically significant) and COUGH (Ka?el). On 02-May-2021, after starting mRNA-1273 (Spikevax), the patient experienced INTESTINAL HAEMORRHAGE (Intestinal bleeding) (seriousness criteria death, medically significant and life threatening) and FATIGUE (?nava). The patient died on 03-May-2021. The reported cause of death was Intestinal bleeding. An autopsy was performed, but no results were provided. At the time of death, COVID-19 (COVID-19 infection), COUGH (Ka?el) and FATIGUE (?nava) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. Concomitant medications were not reported . Treatment information was not provided. Company Comment: Based on biological implausibility and mechanism of action of the product mRNA-1273, a causal relationship between the reported serious unexpected event of COVID-19 and the administration of mRNA-1273 assessed as unlikely. COVID-19 was more consistent with the increased risk of infections due to environmentally mediated pandemic for COVID-19 and confounded by increased risk of COVID-19 due to underlying comorbidities diabetes mellitus and cardiac arrhythmia complicated by advanced age. The serious unexpected event of Intestinal haemorrhage was more consistent with the possible complication of COVID-19. The non-serious events Cough and Fatigue were more consistent with the symptoms of COVID-19. This case was linked to CZ-CZSUKL-21010242 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: translation received contains no new information.; Sender''s Comments: Based on biological implausibility and mechanism of action of the product mRNA-1273, a causal relationship between the reported serious unexpected event of COVID-19 and the administration of mRNA-1273 assessed as unlikely. COVID-19 was more consistent with the increased risk of infections due to environmentally mediated pandemic for COVID-19 and confounded by increased risk of COVID-19 due to underlying comorbidities diabetes mellitus and cardiac arrhythmia complicated by advanced age. The serious unexpected event of Intestinal haemorrhage was more consistent with the possible complication of COVID-19. The non-serious events Cough and Fatigue were more consistent with the symptoms of COVID-19. CZ-CZSUKL-21010242:; Reported Cause(s) of Death: Intestinal bleeding


VAERS ID: 1686132 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-17
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time ratio, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood calcium, Blood chloride, Blood creatine phosphokinase MB, Blood creatinine, Blood glucose, Blood magnesium, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Gamma-glutamyltransferase, General physical health deterioration, Glomerular filtration rate, Haemoglobin, International normalised ratio, Oxygen saturation, Platelet count, Protein total, Prothrombin time, Red blood cell count, Respiratory tract infection, SARS-CoV-2 test, White blood cell count
SMQs:, Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LUSOPRESS; QUETIAPIN; TIAPRIDAL
Current Illness: Aortic valve stenosis and insufficiency (combined aortic defect, mild stenosis with regurgitation 2/4); Arthrosis multiple; Atherosclerosis generalized; Cerebral atherosclerosis; Hypertension; Incontinence; Ischaemic heart disease (no angina pectoris); Mitral regurgitation (mild, 2/4 with mild to severe pulmonary hypertension); Pulmonary hypertension; Senile dementia (loss of personality and health condition and mobility); Walking difficulty
Preexisting Conditions: Medical History/Concurrent Conditions: General physical health deterioration (according to doctors the condition corresponds to age); Mobility decreased (due to senile dementia)
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: Activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:0.97; Test Date: 20210317; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:0.29; Comments: ukat/L; Test Date: 20210317; Test Name: Blood alpha amylase; Result Unstructured Data: Test Result:2; Comments: ukat/L; Test Date: 20210317; Test Name: ASAT; Result Unstructured Data: Test Result:0.48; Comments: ukat/L; Test Date: 20210317; Test Name: Alk phos; Result Unstructured Data: Test Result:1.66; Comments: ukat/L; Test Date: 20210317; Test Name: Calcium; Result Unstructured Data: Test Result:2.14 mmol/L; Test Date: 20210317; Test Name: Chloride; Result Unstructured Data: Test Result:105 mmol/L; Test Date: 20210312; Test Name: Creatine kinase MB; Result Unstructured Data: Test Result:4.2; Comments: ukat/L; Test Date: 20210312; Test Name: Creatinine; Result Unstructured Data: Test Result:114 umol/l; Test Date: 20210317; Test Name: Creatinine; Result Unstructured Data: Test Result:106 umol/l; Test Date: 20210317; Test Name: Blood glucose; Result Unstructured Data: Test Result:6.7 mmol/L; Test Date: 20210317; Test Name: Magnesium; Result Unstructured Data: Test Result:0.86 mmol/L; Test Date: 20210312; Test Name: Potassium; Result Unstructured Data: Test Result:5 mmol/L; Test Date: 20210317; Test Name: Potassium; Result Unstructured Data: Test Result:4.4 mmol/L; Test Date: 20210317; Test Name: Blood pressure; Result Unstructured Data: Test Result:166/79 mmHg; Test Date: 20210317; Test Name: Serum sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210312; Test Name: Sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210312; Test Name: Urea; Result Unstructured Data: Test Result:8 mmol/L; Test Date: 20210317; Test Name: Urea; Result Unstructured Data: Test Result:9.4 mmol/L; Test Date: 20210317; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 202103; Test Name: CXR; Result Unstructured Data: Test Result:without signs of pneumonia; Test Date: 20210312; Test Name: C-reactive protein; Result Unstructured Data: Test Result:102 mg/l; Test Date: 20210317; Test Name: C-reactive protein; Result Unstructured Data: Test Result:231 mg/l; Test Date: 20210317; Test Name: GGT; Result Unstructured Data: Test Result:0.3; Comments: ukat/L; Test Date: 20210312; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:0.925; Test Date: 20210312; Test Name: Hemoglobin; Result Unstructured Data: Test Result:104 g/l; Test Date: 20210317; Test Name: Hemoglobin; Result Unstructured Data: Test Result:94 g/l; Test Date: 20210312; Test Name: International normalised ratio; Result Unstructured Data: Test Result:1.13; Test Date: 20210317; Test Name: Oxygen saturation; Test Result: 90 %; Comments: natively; Test Date: 20210312; Test Name: Platelet count; Result Unstructured Data: Test Result:208 x10 9/l; Test Date: 20210317; Test Name: Platelet count; Result Unstructured Data: Test Result:307 x10 9/l; Test Date: 20210317; Test Name: Protein total; Result Unstructured Data: Test Result:57 g/l; Test Date: 20210312; Test Name: Pro-thrombin time; Test Result: 12.1 s; Test Date: 20210312; Test Name: RBC count; Result Unstructured Data: Test Result:3.22 x10 12/l; Test Date: 20210317; Test Name: RBC count; Result Unstructured Data: Test Result:3.01 x10 12/l; Test Date: 20210316; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210312; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210312; Test Name: White blood cell count; Result Unstructured Data: Test Result:9.3 x10 9/l; Test Date: 20210317; Test Name: White blood cell count; Result Unstructured Data: Test Result:10.3 x10 9/l
CDC Split Type: CZPFIZER INC202101148328

Write-up: General physical health deterioration; respiratory infection; This is a spontaneous report from a contactable consumer. This is the 2nd of 2 reports. The first report was downloaded from the Regulatory Authority-WEB [Regulatory Authority number CZ-CZSUKL-21001231]. A 91-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY), intramuscular on 04Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing senile dementia (loss of personality and health condition and mobility), general physical health deterioration (according to doctors the condition corresponds to age), mobility decreased (due to senile dementia), ongoing ischaemic heart disease (no angina pectoris), ongoing mitral regurgitation (mild, 2/4 with mild to severe pulmonary hypertension), ongoing pulmonary hypertension, ongoing arthrosis multiple, ongoing cerebral atherosclerosis, ongoing atherosclerosis generalized, ongoing incontinence, ongoing walking difficulty, ongoing aortic valve stenosis and insufficiency (combined aortic defect, mild stenosis with regurgitation 2/4). Concomitant medications included nitrendipine (LUSOPRESS), quetiapine fumarate (QUETIAPIN), tiapride hydrochloride (TIAPRIDAL). Previously the patient received the 1st dose of Comirnaty on 11Feb2021 for COVID-19 immunisation and experienced pain, dysstasia, pain in extremity, gait disturbance. The patient experienced general physical health deterioration (death) on 17Mar2021 with fatal outcome on 18Mar2021 at 14:10, respiratory infection (medically significant) on 17Mar2021 with outcome of unknown. It was reported that on 12Mar2021 the patient fell down on the straight and he was brought by ambulance to the hospital, he had pertrochanteric fracture of the right femur, conservative therapy. On 17Mar2021 afternoon (day of admission) there was maybe a mild aspiration, patient was put temporarily on the oxygen therapy with nasal cannula due to hyposaturation. On 17Mar2021 the patient was moved to the after-care department. On 18Mar2021 the patient died at 14:10. The patient underwent lab tests and procedures which included activated partial thromboplastin time ratio: 0.97 on 12Mar2021, alanine aminotransferase: 0.29 on 17Mar2021 ukat/L , amylase: 2 on 17Mar2021 ukat/L, aspartate aminotransferase: 0.48 on 17Mar2021 Units:ukat/L, blood alkaline phosphatase: 1.66 on 17Mar2021 ukat/L, blood calcium: 2.14 mmol/l on 17Mar2021, blood chloride: 105 mmol/l on 17Mar2021, blood creatine phosphokinase mb: 4.2 on 12Mar2021 ukat/L, blood creatinine: 114 umol/l on 12Mar2021, blood creatinine: 106 umol/l on 17Mar2021, blood glucose: 6.7 mmol/l on 17Mar2021, blood magnesium: 0.86 mmol/l on 17Mar2021, blood potassium: 5 mmol/l on 12Mar2021, blood potassium: 4.4 mmol/l on 17Mar2021, blood pressure measurement: 166/79 mmhg on 17Mar2021. PCR test for COVID-19 was negative on 12Mar2021, antigen test for COVID-19 was negative on 16Mar2021. Therapeutic measures were taken as a result of the events and included treatment with Augmentin and analgotherapy. An autopsy was not performed. The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-2021250302 Same patient/drug, different dose/events; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1686147 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101125215

Write-up: Death; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority DE-PEI-202100137316. A 74-year-old male patient received bnt162b2 (COMIRNATY; Lot Number: Unknown), via an unspecified route of administration on 01May2021 (at 74 years) as single dose for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The patient experienced death on an unspecified date in May2021.It was not reported if an autopsy was performed. Sender Comment: Report of the Police Directorate: on 15May2021 a male corpse was found; the corpse has not been conclusively identified due to an advanced corpse appearance. It is assumed that the person died a few days after the vaccination.Relatedness of drug to reaction/event (Source of assessment PEI) was Assessment B. Indeterminate. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Death


VAERS ID: 1686595 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 055E21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Chills, Dyspnoea, Headache, Heart rate increased, Injection site pain, Pyrexia, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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 (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Moderna Covid19 vaccine
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cardiac/respiratory arrest at home resulting to death on 08/23/2021 after receiving first dose of Moderna Covid19 vaccine last 08/21/2021. The next day, he also had suffered side effect of headache, fever, chill, and pain on injection side. And on the second day when he got the heart attack, he had difficulty breathing, chest pain, and fast heartbeats leading to cardiac arrest. His wife tried to contact an ambulance to bring him to the hospital but never made to the emergency room.


VAERS ID: 1686696 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-03-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Antineutrophil cytoplasmic antibody, Arthralgia, Atrial fibrillation, Auscultation, Biopsy, Bleeding time prolonged, Blood cortisol, Blood electrolytes, Blood pressure measurement, Blood sodium, Blood test, Body temperature, C-reactive protein, Cerebral atrophy, Clostridium test, Coma scale, Computerised tomogram, Computerised tomogram abdomen, Computerised tomogram head, Coxiella test, Culture stool, Death, Discomfort, Dysphonia, Fatigue, General physical health deterioration, Guillain-Barre syndrome, HIV test, Heart rate, Hepatitis B virus test, Hepatitis C virus test, Hypertension, Hyponatraemia, Inflammation, Inflammatory marker increased, Investigation, Lumbar puncture, Magnetic resonance imaging head, Mobility decreased, Nasopharyngoscopy, Neck pain, Neurological examination, Neutrophil count, Oxygen saturation, Pain, Physical examination, Serum ferritin, Spinal myelogram, Tachypnoea, Treponema test, Tularaemia, Urinary retention, Urine analysis, Vocal cord paralysis, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hypertension (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 46
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Basal cell carcinoma; Cognitive disturbance; Dyslipidaemia; Hypertension arterial; Hyperuricaemia; Periarthritis scapulohumeralis
Allergies:
Diagnostic Lab Data: Test Name: antineutrophil cytoplasmic antibodies; Result Unstructured Data: Test Result:not found; Test Date: 20210320; Test Name: Cardiovascular; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210320; Test Name: digestive; Result Unstructured Data: Test Result:Nothing to report.; Test Date: 20210320; Test Name: pulmonary; Result Unstructured Data: Test Result:Nothing to report; Test Name: temporal artery biopsy; Result Unstructured Data: Test Result:Negative; Test Name: haemostasis; Result Unstructured Data: Test Result:normal; Test Name: cortisol levels; Result Unstructured Data: Test Result:normal; Test Name: ionogram; Result Unstructured Data: Test Result:normal; Test Date: 20210320; Test Name: blood pressure; Result Unstructured Data: Test Result:180/80; Test Name: hyponatremia; Result Unstructured Data: Test Result:124; Test Name: Blood test; Result Unstructured Data: Test Result:Serum protein electrophoresis compatible with mode; Comments: Serum protein electrophoresis compatible with moderate inflammatory syndrome; Test Name: Blood test upon admission; Result Unstructured Data: Test Result:slight disturbance of liver function with cholesta; Comments: slight disturbance of liver function with cholestasis.; Test Date: 20210320; Test Name: patient referred; Result Unstructured Data: Test Result:Apyrexia; Test Date: 20210320; Test Name: investigation for clostridium; Result Unstructured Data: Test Result:Negative; Test Date: 20210320; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Date: 20210320; Test Name: chest computed tomography; Result Unstructured Data: Test Result:Strictly normal; Test Name: Thoracic-abdominal-pelvic computed tomography; Result Unstructured Data: Test Result:no abnormal hypermetabolic lesion detectable in th; Comments: no abnormal hypermetabolic lesion detectable in the ear, nose throat region and at the cricoarytenoid level.; Test Date: 20210320; Test Name: pelvic abdominal computed tomography; Result Unstructured Data: Test Result:Normal; Test Date: 20210320; Test Name: Cerebral computed tomography; Result Unstructured Data: Test Result:cortico-subcortical atrophy only; Test Name: Coxiella; Result Unstructured Data: Test Result:negative.; Test Name: c-reactive protein; Result Unstructured Data: Test Result:123; Comments: Blood test upon admission; Test Date: 20210316; Test Name: c-reactive protein; Result Unstructured Data: Test Result:117; Test Date: 20210320; Test Name: stool cultures; Result Unstructured Data: Test Result:negative; Test Date: 20210320; Test Name: Pulse; Result Unstructured Data: Test Result:80; Comments: beats per minute; Test Name: Hepatitis B; Result Unstructured Data: Test Result:negative; Test Name: Hepatitis / C; Result Unstructured Data: Test Result:negative; Test Name: Human Immunodeficiency Virus; Result Unstructured Data: Test Result:negative; Test Name: bartonellosis; Result Unstructured Data: Test Result:negative; Test Name: Burnetli; Result Unstructured Data: Test Result:negative; Test Date: 20210320; Test Name: rheumatoid; Result Unstructured Data: Test Result:Nothing to report; Test Name: Wipple serologies; Result Unstructured Data: Test Result:negative; Test Name: lumbar puncture; Result Unstructured Data: Test Result:Normal; Test Date: 20210320; Test Name: Brain magnetic resonance imaging; Result Unstructured Data: Test Result:no haemorrhagic or ischemic lesion; Test Name: Nasofibroscopy; Result Unstructured Data: Test Result:complete diplegia of the vocal cords without local; Comments: complete diplegia of the vocal cords without local lesion. Guillain Barre syndrome or a viral cause is evoked.; Test Name: Nasofibroscopy; Result Unstructured Data: Test Result:same diplegia of the vocal cords; Comments: Performing a 2nd nasofibroscopy due to a new episode of dyspnea; Test Date: 20210320; Test Name: neurological; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210316; Test Name: neutrophil; Result Unstructured Data: Test Result:18.5 g/l; Test Name: neutrophils; Result Unstructured Data: Test Result:19.68 g/l; Comments: Blood test upon admission; Test Date: 20210320; Test Name: oxygen saturation; Test Result: 97 %; Test Date: 20210320; Test Name: dermatological; Result Unstructured Data: Test Result:Nothing to report; Test Date: 20210320; Test Name: Ear, nose, and throat examination; Result Unstructured Data: Test Result:dysphonia for 4-5 days; Test Name: serum ferritin; Result Unstructured Data: Test Result:1138; Comments: increased Blood test upon admission; Test Name: Myelogram; Result Unstructured Data: Test Result:normal; Test Name: syphilis; Result Unstructured Data: Test Result:not found; Test Name: tularemia; Result Unstructured Data: Test Result:negative; Test Date: 20210320; Test Name: urine examination; Result Unstructured Data: Test Result:Negative cytobacteriological
CDC Split Type: FRPFIZER INC202101107871

Write-up: Paralysis vocal cord; Inflammatory marker increased; Diffuse pain; deterioration of general state of health; arthralgia, knee pain; neck pain; fatigue; inflammatory syndrome; hyponatremia; Atrial fibrillation; surge in hypertension; motor paralysis; acute retention of urine and occlusion; Guillain Barre syndrome; patient died which remains unexplained; wheezing; discomfort with vomiting +++; discomfort with vomiting +++; polypnea; cortico-subcortical atrophy; dysphonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BR20213265. An 81-year-old male patient received second dose of BNT162B2 (COMIRNATY) (Lot Number: EM6950) intramuscular single dose for COVID-19 immunisation on 15Feb2021. Medical history included hypertension arterial, cognitive disturbance, hyperuricaemia, basal cell carcinoma, dyslipidaemia, periarthritis scapulohumeralis. The patient''s concomitant medications were not reported. The patient experienced paralysis vocal cord on 22Mar2021 with outcome of not recovered, inflammatory marker increased on 16Mar2021 with outcome of recovering, atrial fibrillation in Mar2021 with outcome of recovered, diffuse pain on 01Mar2021 with outcome of recovering; all hospitalization from Mar2021 to 13Apr2021. In the following 2 weeks, the patient experienced deterioration of general state of health with onset of arthralgia, knee pain, neck pain, fatigue and inflammatory syndrome with polynucleosis (c-reactive protein at 117, neutrophils at 18.5 G/l on 16Mar) with hyponatremia at 124, prompting hospitalisation by the general practitioner. Male patient referred to the emergency room on 20Mar2021, pulse 80 beats per minute, blood pressure 180/80, apyrexia, oxygen saturation 97%, glasgow 15. Blood test upon admission: increased serum ferritin at 1138, neutrophils at 19.68 G/l, c-reactive protein at 123, slight disturbance of liver function with cholestasis. Transfer to Multipurpose Medicine on 20Mar2021. Cardiovascular, pulmonary, digestive, dermatological, rheumatoid, and neurological examinations: Nothing to report. Ear, nose, and throat examination: dysphonia for 4-5 days. Normal pelvic abdominal computed tomography. On 20Mar2021: discomfort with vomiting +++, polypnea. Strictly normal chest computed tomography. Cerebral computed tomography: cortico-subcortical atrophy only. Brain magnetic resonance imaging: no haemorrhagic or ischemic lesion. Negative cytobacteriological urine examination, investigation for clostridium, negative stool cultures. On 22Mar2021: episode of polypnea with wheezing and right neck pain associated with dyspnea. Nasofibroscopy: complete diplegia of the vocal cords without local lesion. Guillain Barre syndrome or a viral cause is evoked. A brain computed tomography enables phlegmon to be eliminated. Hypothesis of cricoarytenoid arthritis rejected after revaluation. Negative temporal artery biopsy. Performing a 2nd nasofibroscopy due to a new episode of dyspnea: same diplegia of the vocal cords. Thoracic-abdominal-pelvic computed tomography: no abnormal hypermetabolic lesion detectable in the ear, nose throat region and at the cricoarytenoid level. Normal lumbar puncture. Myelogram: normal. Blood test: Serum protein electrophoresis compatible with moderate inflammatory syndrome, normal ionogram, normal haemostasis, normal cortisol levels, antineutrophil cytoplasmic antibodies not found, syphilis not found. Hepatitis B, C, Human Immunodeficiency Virus, Coxiella, Burnetli, tularemia, bartonellosis, and Wipple serologies negative. After advice by a specialist in internal medicine, recommendation to continue the paraneoplastic assessment if we consider that the only persistent clinical point is atypical mononeuritis, with colonoscopy and fibroscopie gastro-duodenale to be performed externally. Transition to atrial fibrillation during the stay, introduction of XARELTO 20 mg/day + bisoprolol 5 mg/day. Faced with this negative aetiological assessment, introduction of corticosteroid therapy 1 mg/kg for 10 days allowing a decrease in asthenia and a resumption of walking as well as an improvement in blood test findings with decrease in white blood cells and c-reactive protein. Returned home on 13Apr2021 on a decreasing dose of corticosteroid. Ear, nose throat consultations, multipurpose medicine, hepatogastroenterologists, scheduled respectively on 15Apr, 29Apr, and 12May. Patient died at home on 17Apr2021 without explanation. It was unknown if an autopsy was performed. Conclusion was reported as: According to the reporting general practitioner, the surge in hypertension, diplegia of the vocal cords, the inflammatory syndrome, the transition to persistent atrial fibrillation, as well as a motor paralysis with acute retention of urine and occlusion would support a Guillain Barre syndrome. According to the head of the Polyvalent Medicine ward contacted on 19Aug2021, the Guillain Barre syndrome mentioned initially due to the diplegia of the vocal cords was not subsequently retained. Moreover, no motor or intestinal or bladder paralysis was found during the hospital stay. Outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: patient died which remains unexplained


VAERS ID: 1686778 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-08-03
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Choking, Cough, Death
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HALOPERIDOL; SEROQUEL; LAMICTAL; TERCIAN [CYAMEMAZINE]; LOXAPAC [LOXAPINE]; SERESTA; ZOCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol dependence syndrome; Dyslipidaemia; Hospitalization (in June-July 2021/Regular hospitalization about once a year); Hypertension arterial; Overweight (overweight, not very active but still independent); Schizophrenia (since the age of 18)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101142794

Write-up: Death unexplained; The coroner ruled that the patient died of suffocation/by choking; cough; This is a spontaneous report from a contactable consumer (patient''s father) and a physician, downloaded from the Regulatory Authority. The regulatory authority report number FR-AFSSAPS-DJ20213347. A 44-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 22Jul2021 (Batch/Lot Number: FE3065) as dose 2, single for covid-19 immunisation. Medical history included schizophrenia (since the age of 18), alcohol dependence syndrome, Hypertension arterial, dyslipidaemia and hospitalization (in June-July 2021/Regular hospitalization about once a year), patient was overweight, not very active but still independent. Concomitant medication included haloperidol; quetiapine fumarate (SEROQUEL); lamotrigine (LAMICTAL); cyamemazine (TERCIAN [CYAMEMAZINE]); loxapine (LOXAPAC [LOXAPINE]); oxazepam (SERESTA); simvastatin (ZOCOR). The patient experienced death unexplained on 03Aug2021, choking on 03Aug2021, cough on an unspecified date. It was a medically confirmed case. additional documentation carried out the patient''s psychiatrist included background: Severe schizophrenia since the age of 18, alcohol dependence, high blood pressure, dyslipidemia. habitual treatment no recent modification, old treatment: Haloperidol 20 mg/day, Seroquel 800 mg/day, Lamictal 100 mg/day, Tercian 400 mg/day, Loxapac 100 mg/day, Seresta 150 mg/day, Zocor 10 mg/day. Triatec recently discontinued during a hospitalization in June-July 2021. History of illness: Patient with history of severe schizophrenia, difficult to balance therapeutically. In addition, chronic alcohol consumption with massive consumption episodes. Regular hospitalization about once a year for management of this problem. Patient who received a second injection of COMIRNATY on 22Jul2021 (lot FE3065). The father reported the death of his son on August 7 by a medical examiner. In the absence of news of his son, the call to the fire department was made and the patient was found dead in his bed on August 7. The doctor estimated the date of death in the night of August 3 to August 4, 2021. No other information in the initial statement. Call from the psychiatrist following the patient who stated that this patient was overweight, not very active but still independent. Not aware of whether or not an autopsy was performed. Had only learned of the patient''s death after a call from the father but without any details. He also specified that the patient had no particular cardiovascular history apart from a slight arterial hypertension which had not been found during the last hospitalization, hence the discontinuation of Triatec. He was discharged from his last hospitalization on 09Jul2021. No history of rhythm disorder. No diabetes. Additional information requested from the father, who stated that the firefighters had intervened through the balcony and found him in bed. The police made an investigation in the building. The neighbors said that for several days, the patient had strong coughing attacks. The coroner ruled that the patient died of suffocation. No answer on the question of the autopsy (notion of examination by a forensic doctor on 07Aug2021). In total, unexplained death (by choking?) in a schizophrenic patient with an important neuroleptic treatment, occurring at about Day 13 (as reported) of the 2nd injection of COMIRNATY. The patient died on 03Aug2021 (The doctor estimated the date of death in the night of 03Aug2021 to 04Aug2021). Outcome of cough was unknown. An autopsy was performed and results were not provided. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained; The coroner ruled that the patient died of suffocation/by choking


VAERS ID: 1686779 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-15
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Automated external defibrillator user; Cardiac aneurysm (of the inferior wall of the left ventricle with thrombus and complicated by an ischemic stroke ? resolved); Cardiac failure; Hip prosthesis insertion; Hypertension arterial; Ischaemic heart disease (Strictures at multiple levels Distally thrombosed right coronary artery); Ischaemic stroke NOS (sur FA); Renal disease (chronic stage 4); Smoker; Sternotomy (for VG aneurysm cure); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210909320

Write-up: Vaccination failure; This spontaneous report received from a consumer via regulatory authority [FR-AFSSAPS-DJ20213409)] on 06-SEP-2021 and concerned an 83 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included automated external defibrillator user, cardiac failure, ischaemic heart disease, hypertension arterial, type 2 diabetes mellitus, hip prosthesis insertion, smoking, renal disease, sternotomy, cardiac aneurysm, and ischaemic stroke nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-02 expiry: unknown) 1 dosage forms, 1 total, administered on 29-MAY-2021 for covid-19 vaccination. The drug start period was 79 days. No concomitant medications were reported. On 15-AUG-2021, the patient died from vaccination failure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: VACCINATION FAILURE


VAERS ID: 1686802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Atrial fibrillation, Body temperature, Bronchopneumopathy, Cardiac flutter, Cardiopulmonary failure, Hypercapnia, Inflammation, Oxygen saturation, Pneumonia, Respiratory distress, Septic shock, Supraventricular tachycardia, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Interstitial lung disease (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial stent insertion; COPD (Post-smoking Chronic obstructive pulmonary disease with emphysema (last pulmonary follow-up in 2017)); Emphysema (last pulmonary follow-up in 2017); Ex-smoker (Former smoker 50 packs annually, cessation for 3 years); Myocardial infarction (Stented arteriopathy obliterating the myocardial infarction); Prostate cancer (Neoplasia of the prostate under surveillance)
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210517; Test Name: Saturation; Test Result: 90 %; Comments: under 5L O2
CDC Split Type: FRPFIZER INC202101149715

Write-up: acute respiratory distress; supraventricular tachycardia; Cardiac flutter; Acute bronchopneumopathy; acute hypoxemic community-acquired pneumonia complicated by hypercapnic respiratory distress with signs of septic shock; acute hypoxemic community-acquired pneumonia complicated by hypercapnic respiratory distress with signs of septic shock; acute hypoxemic community-acquired pneumonia complicated by hypercapnic respiratory distress with signs of septic shock; Septic shock; complete arrhythmia due to atrial fibrillation in the aftermath of the sepsis; Persistent inflammatory syndrome; cardio-respiratory decompensation; vomiting; This is a spontaneous report from a contactable consumer and other health professional downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-LM20212449. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13May2021 (Lot Number: Unknown) as single dose (at the age of unknown) for COVID-19 immunisation. Medical history included ex-tobacco user (Former smoker 50 packs annually, cessation for 3 years), post-smoking Chronic obstructive pulmonary disease with emphysema (last pulmonary follow-up in 2017), stented arteriopathy obliterating the myocardial infarction, neoplasia of the prostate under surveillance. The patient''s concomitant medications were not reported. The day after vaccination (14May2021): vomiting. Then appearance of a fever at 39 degree Celsius at Day 3 with still vomiting on 16May2021. Admission to pneumology (17May2021) for dyspnea, with mottling, labial cyanosis, Sat 90% under 5L O2, right crepitus, polypnea. Acute bronchopneumopathy on 17May2021. Then transfer to intensive care: acute hypoxemic community-acquired pneumonia complicated by hypercapnic respiratory distress with signs of septic shock (inhalation pneumopathy?) on 17May2021. Management with dual antibiotic therapy and non-invasive ventilation. Some passages in complete arrhythmia due to atrial fibrillation in the aftermath of the sepsis on 17May2021. Discharge from hospital on 15Jun2021 (after 1 month). Readmission to cardiology on 19Jun2021 for acute respiratory distress. On admission marbling with polypnea and signs of struggle, with evidence of supraventricular tachycardia on 19Jun2021. There is a strong suspicion of rapid atrial flutter with incomplete left bundle branch block initially becoming complete with acceleration of the rhythm on 19Jun2021. Persistent inflammatory syndrome, crackles on 19Jun2021. Regular transition to atrial fibrillation at the Telemonitoring. Oxygen therapy, furosemide. Death on 30Jun2021 due to cardio-respiratory decompensation, outcome of cardiac flutter was not resolved, Septic shock was resolved on 31May2021, acute bronchopneumopathy was resolving, the other events was unknown. An autopsy was not 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: cardio-respiratory decompensation


VAERS ID: 1686856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Asphyxia, Asthenia, Blood test, Completed suicide, Computerised tomogram coronary artery, Dizziness, Fatigue, Feeling drunk, Insomnia, Magnetic resonance imaging head, Neurological examination, Paraesthesia, Scan brain, Somnolence, Tremor
SMQs:, Peripheral neuropathy (broad), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Vestibular disorders (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 139
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: blood test; Result Unstructured Data: Test Result:discrete inflammatory syndrome; Test Date: 20210707; Test Name: coronary scan; Result Unstructured Data: Test Result:within normal limits; Test Date: 20210624; Test Name: MRI cerebral; Result Unstructured Data: Test Result:No detectable signal abnormality; Comments: No detectable signal abnormality at the subtentorial level. At the supratentorial level: fairly marked periventricular leukopathy with numerous hyper signals in the white matter. Moderate cortical and subcortical atrophy without predominance in the medial temporal structures. Right hippocampal millimetric hypersignal. No significant dilatation of the ventricular system. No cerebral edema.; Test Date: 20210613; Test Name: neurological examination; Result Unstructured Data: Test Result:No visible signs of radicular or neuropathic damag; Comments: No visible signs of radicular or neuropathic damage in the lower limbs; Test Date: 20210701; Test Name: neurological examination; Result Unstructured Data: Test Result:global hypokinesia; Comments: global hypokinesia but no patent extrapyramidal syndrome, no systematized muscle weakness, no orthostatic hypotension. Describes a more important drowsiness with Xanax that she does not wish to decrease for fear of a reappearance of the anguish phenomena. Decision to decrease aprazolam and prazepam anyway.; Test Date: 20210613; Test Name: scan head; Result Unstructured Data: Test Result:atrophy; Comments: discrete bi-frontotemporal and mesencephalic atrophy
CDC Split Type: FRPFIZER INC202101142859

Write-up: suicide / asphyxia; asphyxia; morning tremors lasting 3/4 of an hour / legs shaking 45 min every morning / trembling of the lower limbs; physical and moral exhaustion; paresthesias of the lower legs and the back of the 2 feet; important asthenia; Dizziness; Anguish / anxiety; Insomnia; sensation of drunkenness; desire to sleep all the time; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-NC20213788. An 81-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on the left arm on 25Feb2021 (Lot Number: EP9598) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 28Jan2021 (Lot Number: EJ6788) as single dose for COVID-19 immunization. For 4 months, describes morning tremors lasting 3/4 of an hour, persisting when getting up, with sensation of drunkenness, trembling of the lower limbs, paresthesias of the lower legs and the back of the 2 feet. Recurrence at the end of the afternoon with important asthenia. This began suddenly after a dizziness that occurred on returning from the beach on 01Mar2021, 4 days after vaccination. On 01Mar2021, the patient also experienced physical and moral exhaustion, dizziness, insomnia. The patient''s legs shaking 45min every morning, desire to sleep all the time and anxiety. Phenomena of anguish 4 days after vaccination leading to moral and physical exhaustion resulting in suicide by VMI (voluntary drug intoxication) and asphyxia. On 19Jul2021, the patient died as asphyxia on suicide, intentionally took several sleeping pills before asphyxiating herself with a bag on the head. Biology / complementary examinations / etiological research: Neurological examination on 13Jun2021: No signs of radicular or neuropathic involvement visible in the lower extremities. Brain scan: discrete bi-frontotemporal and mesencephalic atrophy. Brain MRI on 24Jun2021: No detectable signal abnormality at the subtentorial level. At the supratentorial level: fairly marked periventricular leukopathy with numerous hyper signals in the white matter. No sign of recent ischemic or hemorrhagic lesion. Moderate cortical and subcortical atrophy without predominance in the medial temporal structures. Right hippocampal millimetric hypersignal. No significant dilatation of the ventricular system. No cerebral edema. Neurological examination on 01Jul2021: global hypokinesia but no patent extrapyramidal syndrome, no systematized muscle weakness, no orthostatic hypotension. Describes a more important drowsiness with Xanax that she does not wish to decrease for fear of a reappearance of the anguish phenomena. Decision to decrease aprazolam and prazepam anyway. Coronary scan on 07Jul2021: within normal limits. Biological check-up of 16Jul2021: discrete inflammatory syndrome. On 13Jun2021, the patient admission to the emergency room. Prescriptions: On 06Apr2021: Prazepam 10mg 1 tablet /d. On 16Apr2021 Seresta 10mg 1-0-1 stop prazepam. On 06May2021: Tanganil 200mg 2-2-2 for 3 days; prazepam 1/2 tablet morning; escitalopram 5mg 1 tablet evening. On 03Jun2021 : gabapentin 100. On13Jun2021: alprazolam 0.5mg 1-1-0. On 23Jun2021 : alprazolam 0.25 2 tablets/day.On 25Jun2021 : Brintellix 10mg 1 tablet / day. On 01Jul2021 : prazepam 1/2 tablet during 3 days then stop ; alprazolam 0.25 decrease from 4.5 tablets to 2 tablets / day in 3 weeks. On 13Jul2021: alprazolam 0.25mg 2cp/d. The cause of death included suicide and asphyxia. Autopsy was unknown. The outcome of suicide and asphyxia was fatal. The outcome of feeling drunk and drowsiness was unknown. The outcome of other events was not recovered.; Reported Cause(s) of Death: Asphyxia; suicide


VAERS ID: 1686883 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-13
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain natriuretic peptide, C-reactive protein, COVID-19 pneumonia, Drug ineffective, Echocardiogram, Platelet count, SARS-CoV-2 test, Troponin
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   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: LEVOTHYROX; MIANSERINE [MIANSERIN HYDROCHLORIDE]; TEMERIT; TRAMADOL [TRAMADOL HYDROCHLORIDE]; SILODOSINE; HYDREA; LASILIX [FUROSEMIDE]; XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cardiac failure; Cardiomyopathy; Chronic renal failure; COVID-19 pneumonia (hospitalization); Kyphoscoliosis; Pulmonary arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: BNP; Result Unstructured Data: Test Result:695 ng/L; Test Date: 20210813; Test Name: C-reactive protein; Result Unstructured Data: Test Result:21.9 mg/l; Test Date: 20210813; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:right heart failure; Comments: Non-dilated left ventricle with preserved left ventricular ejection fraction in atrial fibrillation, grade 2 mitral insufficiency, dilated left atrium, preserved flow, very dilated right ventricle 2X the left ventricle without paradoxical septum, global hypokinesia of the right ventricle with Tricuspid annular plane systolic excursion at 11mm, inferior vena cava at 28mm non compliant, dry pericardium, no pleural effusion, moderate B line. Conclusion: right heart failure on probable chromic pulmonary heart on chronic respiratory failure, without left-sided failure explaining the hypoxemia.; Test Date: 20210813; Test Name: Platelet count; Result Unstructured Data: Test Result:89000 /mm3; Test Date: 20210813; Test Name: Test PCR covid-19; Test Result: Positive ; Comments: DELTA variant; Test Date: 20210813; Test Name: Troponin; Result Unstructured Data: Test Result:3344 ug/L
CDC Split Type: FRPFIZER INC202101142820

Write-up: Vaccination failure; Covid-19 pneumonia; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Agency-WEB, regulatory authority number FR-AFSSAPS-NY20213973. A 78-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on Jun2021 (Lot Number: ET6956) as DOSE 1, SINGLE for covid-19 immunisation . Medical history included chronic kidney disease, cardiomyopathy, COVID-19 pneumonia and hospitalization , kyphoscoliosis, cardiac failure, pulmonary arterial hypertension, atrial fibrillation. Concomitant medications included levothyroxine sodium (LEVOTHYROX) taken for hypothyroidism; mianserin hydrochloride (MIANSERINE [MIANSERIN HYDROCHLORIDE]) taken for depression; nebivolol hydrochloride (TEMERIT) taken for cardiac failure; tramadol hydrochloride (TRAMADOL [TRAMADOL HYDROCHLORIDE]) taken for pain; silodosine taken for benign prostatic hyperplasia; hydroxycarbamide (HYDREA); furosemide (LASILIX [FUROSEMIDE]) taken for chronic kidney disease; rivaroxaban (XARELTO) taken for atrial fibrillation. On 13Aug2021, Vaccination failure which led to death on 15Aug2021. Hospitalization on 13Aug2021 for pneumonia COVID-19 (VARIANT DELTA) complicating chronic respiratory failure and right heart failure. Unfavourable evolution with an increase in oxygen requirements up to 100% FiO2, unfavourable evolution on the hemodynamic level. Background of cardiopulmonary history, intubation with unreasonable mechanical ventilation. Comfort care reinforced by sedation. Died on 15Aug2021. On 13Aug2021, PCR covid-19 test: Positive; On 13Aug2021, Transthoracic echocardiography: Non-dilated left ventricle with preserved left ventricular ejection fraction in atrial fibrillation, grade 2 mitral insufficiency, dilated left atrium, preserved flow, very dilated right ventricle 2X the left ventricle without paradoxical septum, global hypokinesia of the right ventricle with Tricuspid annular plane systolic excursion at 11mm, inferior vena cava at 28mm non compliant, dry pericardium, no pleural effusion, moderate B line. Conclusion: right heart failure on probable chromic pulmonary heart on chronic respiratory failure, without left-sided failure explaining the hypoxemia.On 13Aug2021, Platelet count: 89000 per cubic millimetre; On 13Aug2021, Troponin: 3344 microgram per litre; 13Aug2021, BNP: 695 nanogram per litre; 13Aug2021, C-reactive protein: 21.9 milligram per litre. The patient died on 15Aug2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; Covid-19 pneumonia


VAERS ID: 1686990 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alpha 1 globulin, Asthenia, Auscultation, Blood albumin, Blood gases, Bronchiectasis, C-reactive protein, Cardiac failure, Cardio-respiratory arrest, Cardiovascular examination, Chromaturia, Condition aggravated, Deep vein thrombosis, Ejection fraction, Electrocardiogram, Electrocardiogram repolarisation abnormality, Gait disturbance, General physical health deterioration, Haematoma muscle, Heart rate increased, Heart sounds, Heart sounds abnormal, Hepatitis A virus test, Hypocapnia, Hypoxia, Inappropriate schedule of product administration, Inflammation, Investigation, Malnutrition, Pallor, Respiratory disorder, Scan, Scan parathyroid, Spinal fracture, Superior vena cava syndrome, Ultrasound Doppler, Urine abnormality, Urine analysis, Weight
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (narrow), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related conditions (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (broad), Hypotonic-hyporesponsive episode (broad), Proteinuria (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute coronary syndrome; Adenomyosis; Adnexectomy; AFib; Algodystrophy; Alphaglobulin abnormal (hyperalphaglobulinemia); Cardiac failure; Cementoplasty (L2 in 2016, D12 and L1 in 2017, D1 L3 and L4 in 2017); Chronic renal failure; Chronic venous insufficiency; Dyslipidaemia; Essential hypertension; Foot fracture (and of the right and left 3rd metatarsals); Hepatitis A; Hypercalcaemia; Hyperparathyroidism; Hypoalbuminemia (appearance of hypoalbuminemia since the beginning of 2021 at 23 g/L); Hysterectomy; Inflammatory reaction (with low-noise biological inflammatory syndrome (CRP at 5 mg/L, hyperalphaglobulinemia)); Ischemic heart disease (ST- Tropo); Lymphoedema; Macroscopic haematuria; Malnutrition; Myocardial infarction (transseptal myocardial infarction on tight anterior interventricular stenosis); Nephroangiosclerosis (benign nephroangiosclerosis); Nephropathy tubular (probable chronic tubulointerstitial nephropathy); Omarthrosis; Orthopaedic procedure; Osteoporosis with fracture (on bisphosphonates); Parathyroid adenoma; Saphenectomy (in 1984, 1991, 2001 for chronic venous insufficiency with bilateral lymphoedema); Shoulder arthroplasty (right); Starvation; Ventricular aneurysm (extensive); Wrist fracture (orthopaedic treatment)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: alphaglobulin; Result Unstructured Data: Test Result:hyperalphaglobulinemia; Test Date: 20210707; Test Name: Auscultation; Result Unstructured Data: Test Result:fine crackles in the left base; Test Date: 20210728; Test Name: Auscultation; Result Unstructured Data: Test Result:decreased vesicular murmur with adventitia,; Comments: crackles at the bases; Test Name: albumin; Result Unstructured Data: Test Result:18 g/l; Test Date: 2021; Test Name: albumin; Result Unstructured Data: Test Result:23 g/l; Comments: hypoalbuminemia; Test Date: 20210728; Test Name: Gasometry; Result Unstructured Data: Test Result:slight hypoxia PCO2 = 77.9 mmHg, clear hypocapnia; Comments: PCO2 = 31.4 mmHg; Test Date: 20210707; Test Name: Cardiovascular examination; Result Unstructured Data: Test Result:oedema of the lower limbs; Comments: known lymphoedema of the lower limbs with haematoma of the L +++ thigh, warm and tense. Mobilisation of the toes is sp, with no disturbance of sensitivity. The pedal pulses are not perceived (oedemas too significant); Test Date: 2021; Test Name: CRP; Result Unstructured Data: Test Result:5 mg/l; Test Date: 20210728; Test Name: CRP; Result Unstructured Data: Test Result:107.9 mg/l; Test Name: LVEF; Test Result: 54 %; Test Date: 20210707; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:regular sinus rhythm, 150 bpm, left axis, no; Comments: repolarisation or conduction disorder; Test Date: 20210728; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:atrial fibrillation with ventricular response at; Comments: 117 BPM. Non-specific diffuse repolarization abnormality. Sequela of inferior necrosis; Test Date: 20210728; Test Name: heart sound; Result Unstructured Data: Test Result:Irregular heart sounds; Test Name: Hepatitis A virus; Result Unstructured Data: Test Result:serology positive; Test Date: 20210707; Test Name: Pulmonary examination; Result Unstructured Data: Test Result:no dyspnoea, no cough; Test Name: vitamin; Result Unstructured Data: Test Result:The assessment did not reveal any vitamin B9 and; Comments: B12 deficiency; Test Date: 20210707; Test Name: Thorax, Abdomen and Pelvis scan; Result Unstructured Data: Test Result:left quadriceps muscle compressive haematoma; Comments: measuring 10 x 8.5 x 25 cm (length, width, height) with venolymphatic stasis with no arterial or venous supply detected. No Thorax, Abdomen and Pelvis pathological process detected. Ventilatory disorders with varicose bronchestasis of sequential appearance at both lung bases without infectious focus should be noted.; Test Name: parathyroid scan; Result Unstructured Data: Test Result:primary hyperparathyroidism with presence of a le; Test Date: 20210712; Test Name: Ultrasound of the upper limbs; Result Unstructured Data: Test Result:The humeral artery is well identified; Comments: normally permeable, no humeral vein in its vicinity, it is probably thrombosed. The whole picture suggests, at the very least, a superior vena cava syndrome. Suspicion of deep venous thrombosis in the right upper limb not visualised on ultrasound because of the significant upper limb oedema.; Test Date: 20210728; Test Name: Cytobacteriological examination of the urine; Result Unstructured Data: Test Result:very cloudy, brown coloured urine.; Comments: Leukocytes = 159 G/L; haematopoietic 97 G/L; polymorphic bacterial flora $g10^3 CFU/mL.; Test Date: 20210729; Test Name: Cytobacteriological examination of the urine; Result Unstructured Data: Test Result:polymorphic bacterial flora $g10^3 CFU/mL.; Test Name: weight; Result Unstructured Data: Test Result:10% weight loss in 6 months
CDC Split Type: FRPFIZER INC202101149789

Write-up: left thigh hematoma/left quadriceps muscle compressive haematoma measuring 10 x 8.5 x 25 cm (length, width, height) with venolymphatic stasis/Compressive muscle haematoma; Ventilatory disorders with varicose bronchestasis of sequential appearance at both lung bases without infectious focus; Suspicion of deep venous thrombosis in the right upper limb; dorsal fracture; cardiac decompensation (upper and lower limb oedema); Ventilatory disorders with varicose bronchestasis of sequential appearance at both lung bases without infectious focus; Protein-energy malnutrition with albumin at 18 g/L,; Loss of autonomy with difficulty in walking; Cardio-respiratory arrest; diffuse repolarization abnormality; hypoxia; poor general condition; pallor; asthenia; Irregular heart sounds; Inflammatory syndrome with CRP 107.9 mg/L; Inflammatory syndrome with CRP 107.9 mg/L; hypocapnia; urine with very cloudy; brown coloured urine; a superior vena cava syndrome; 150 bpm; dose 1 on 12May2021/dose 2 on 01Jul2021; This is a spontaneous report from a contactable consumer and other hcp downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-ST20213182. A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 01Jul2021 (Batch/Lot number was not reported) as DOSE 2, 0.3 ML SINGLE at age of 77-year-old for covid-19 immunisation; paracetamol (PARACETAMOL), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for dorsal fracture under biphosphonates antalgia; morphine sulfate (ACTISKENAN), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 5 mg/4h, as needed for unknown indication; furosemide (LASILIX), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for unknown indication; bisoprolol fumarate (BISOCE), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for Ischaemic and rhythmic heart disease, with complete arrhythmia; levofloxacin (LOVENOX), subcutaneous from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for Compressive muscle haematoma; atorvastatin calcium, ezetimibe (LIPTRUZET) and buspirone hydrochloride (BUSPIRONE), both via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for unknown indication; fentanyl (DUROGESIC), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 1 patch every 3 days for unknown indication; potassium chloride (DIFFU K); phloroglucinol, trimethylphloroglucinol (SPASFON); risedronate sodium (RISEDRONATE SODIUM); metoclopramide hydrochloride, pancreatin (PRIMPERAN COMPOSITUM); macrogol (MACROGOL), all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for unknown indication; amiodarone hydrochloride (CORDARONE), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unknown dose for Ischaemic and rhythmic heart disease, with complete arrhythmia. No COVID-19. Medical history included Dyslipidaemia, Starvation, Essential hypertension all from unknown date, Nephrological: - Chronic renal failure (Severe chronic renal failure stage IV) secondary to probable chronic tubulointerstitial nephropathy +/- benign nephroangiosclerosis; - Chronic hypercalcaemia since at least 2019 secondary to primary hyperparathyroidism with presence of a left lower parathyroid adenoma on parathyroid scan; - Recurrent macroscopic haematuria since February 2021. Cardiovascular: - Heart failure with moderately preserved LVEF at 54% without LVH with moderate anterior wall hypokinesia and apical akinesia secondary to ischemic heart disease in this case ST- Tropo + acute coronary syndrome with transseptal myocardial infarction on tight anterior interventricular stenosis complicated by an extensive ventricular aneurysm (1985); - Complete arrhythmia with permanent atrial fibrillation on Eliquis and amiodarone, left atrial dilatation to 48mm/24cm2; - Saphenectomy for chronic venous insufficiency with bilateral lymphoedema in 1984, 1991, 2001. Rheumatology: - Severe fractured osteoporosis on bisphosphonates: Cimentoplasty L2 in 2016, D12 and L1 in 2017, D1 L3 and L4 in 2017; Fatigue fracture of the right foot complicated by algodystrophy (2012) and of the right and left 3rd metatarsals; Fracture of the right wrist in 2011: orthopaedic treatment; - Arhtroplasty right shoulder following eccentric omarthrosis. Other: - Severe malnutrition: 10% weight loss in 6 months, appearance of hypoalbuminemia since the beginning of 2021 at 23 g/L with low-noise biological inflammatory syndrome (CRP at 5 mg/L, hyperalphaglobulinemia) concomitant with an altered general state; - Hysterectomy with adnexectomy in 1997 for adenomyosis; - Hepatitis A virus serology positive. Concomitant medication(s) included apixaban (ELIQUIS) taken for Complete arrhythmia with permanent atrial fibrillation, start and stop date were not reported. Historical vaccine included dose 1 of bnt162b2 (COMIRNATY, lot EX7823) on 12May2021 and experienced deep vein thrombosis-pulmonary embolism (patient with recent pulmonary embolism following two DVT of the lower limbs). The patient experienced cardio-respiratory arrest on 29Jul2021, cardiac decompensation on an unspecified date. The events were reported as serious for death, hospitalization. Dose 2 COMIRNATY unknown lot on 01Jul2021. Hospitalized on 07Jul2021 for left thigh hematoma and deglobulation at 6 in the context of curative anticoagulation for pulmonary embolism and deep vein thrombosis < 3 months. On 07Jul2021, a Thorax, Abdomen and Pelvis scan showed a left quadriceps muscle compressive haematoma measuring 10 x 8.5 x 25 cm (length, width, height) with venolymphatic stasis with no arterial or venous supply detected. No Thorax, Abdomen and Pelvis pathological process detected. Ventilatory disorders with varicose bronchestasis of sequential appearance at both lung bases without infectious focus should be noted. On 07Jul2021, Cardiovascular examination: -oedema of the lower limbs: known lymphoedema of the lower limbs with haematoma of the L +++ thigh, warm and tense. Mobilisation of the toes is sp, with no disturbance of sensitivity. The pedal pulses are not perceived (oedemas too significant). Pulmonary examination: -Clinical: no dyspnoea, no cough. -Auscultation: fine crackles in the left base. On 07Jul2021, Electrocardiogram: regular sinus rhythm, 150 bpm, left axis, no repolarisation or conduction disorder. Ultrasound of the upper limbs on 12Jul2021 The humeral artery is well identified, normally permeable, no humeral vein in its vicinity, it is probably thrombosed. The whole picture suggests, at the very least, a superior vena cava syndrome. Suspicion of deep venous thrombosis in the right upper limb not visualised on ultrasound because of the significant upper limb oedema. Cardiovascular: The stay was complicated by an episode of cardiac decompensation (upper and lower limb oedema) of probably mixed aetiology between the 6 transfusions and the recent pulmonary embolism. Hydrosodic depletion was carried out by increasing doses of Lasilix, maintenance at 40mg/day and 2 Diffu-K per day. Nutritional: Protein-energy malnutrition with albumin at 18 g/L, introduction of a low-salt enriched diet with 2 oral nutritional supplements/day. The assessment did not reveal any vitamin B9 and B12 deficiency. Discharge data: Compressive muscle haematoma under Lovenox. Known macroscopic haematuria, stable without deglobulation, undergoing assessment: suspicion of underlying bladder neoplasia. Ischaemic and rhythmic heart disease, with complete arrhythmia due to atrial fibrillation known to be on BISOCE and AMIODARONE. Suspicion of deep vein thrombosis of the upper right limb (patient already anticoagulated, not visualised on ultrasound due to significant oedema/ patient with recent pulmonary embolism following two DVT of the lower limbs); Osteoporosis: dorsal fracture under biphosphonates antalgia by Paracetamol, Durogesic 50ug 1 patch every 3 days and Actiskenan 5mg/4h if needed; Severe chronic renal failure stage IV; Loss of autonomy with difficulty in walking. Transfer to follow-up and rehabilitation care on 28 July. On admission: poor general condition, asthenia, pallor. Oedema of the lower limbs, no signs of cardiac decompensation. Irregular heart sounds. Pulmonary auscultation: decreased vesicular murmur with adventitia, crackles at the bases. ECG; atrial fibrillation with ventricular response at 117 BPM. Non-specific diffuse repolarization abnormality. Sequela of inferior necrosis. Biology: Inflammatory syndrome with CRP 107.9 mg/L. Gasometry disturbed with slight hypoxia PCO2 = 77.9 mmHg, clear hypocapnia PCO2 = 31.4 mmHg. Cytobacteriological examination of the urine with very cloudy, brown coloured urine. Leukocytes = 159 G/L; haematopoietic 97 G/L; polymorphic bacterial flora $g10^3 CFU/mL. On 29Jul2021: irreversible cardiorespiratory arrest and death. The action taken in response to the events for all the suspect drugs was not applicable. The outcome of events cardiac decompensation and Cardio-respiratory arrest was fatal, of the other events was unknown. The patient died on 29Jul2021. It was not reported if an autopsy was performed. The lot number for BNT162b2 was not provided and will be requested during follow up; Reported Cause(s) of Death: Cardio-respiratory arrest; cardiac decompensation


VAERS ID: 1687011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-08-13
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cardio-respiratory arrest, Drug ineffective, General physical health deterioration, Hyperthermia, Rhinitis, Rhonchi, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (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: 2021-08-20
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy (of the lower limbs, obliterating); Arteritis (lower limb); Cognitive disorders; Deep vein thrombosis (chronic); Dementia; Dyslipidemia; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210813; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101156031

Write-up: cardio respiratory arrest leading to death; rhinitis; hyperthermia at 38.5; deterioration of general condition; rhonchi; Drug ineffective; COVID-19; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-TO20217469. A 92-year-old female patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6788), Solution for injection, intramuscular, administered in Arm Left on 11Feb2021 as single dose for covid-19 immunisation. Medical history included obliterating arteriopathy of the lower limbs, lower limb arteritis, dementia, dyslipidemia, hypertension arterial, cognitive disorders and chronic deep vein thrombosis. The patient''s concomitant medications were not reported. On 13Aug2021, the patient experienced vaccination failure, covid-19, cardiorespiratory arrest leading to death, rhinitis, hyperthermia at 38.5, deterioration of general condition and rhonchi. The patient underwent lab tests and procedures which included body temperature: 38.5 centigrade on 13Aug2021, sars-cov-2 test: positive on 13Aug2021. The patient died on 20Aug2021. An autopsy was not performed. The outcome of drug ineffective, COVID-19 and cardio respiratory arrest leading to death was fatal and outcome of all other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonitis


VAERS ID: 1687031 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal growth restriction, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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: FRPFIZER INC202101152931

Write-up: Maternal exposure during pregnancy, first trimester; hypotrophic embryo; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PC20213053. This physician reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 24May2021 (Lot Number: FA8016) as dose 1, single for covid-19 immunisation. The fetus medical history and concomitant medications were not reported. The fetus experienced hypotrophic embryo on an unspecified date , maternal exposure during pregnancy, first trimester on 24May2021. It was reported that a 36-year-old mother received first dose bnt162b2 (COMIRNATY) Intramuscular on 24May2021 at her 36-year-old in the left arm, her last period date was 25Apr2021. The mother is at 4 weeks of gestation when taking the vaccine. On 26Jun2021: Days + 34: spontaneous miscarriage without history, with hypotrophic embryo. The mother was taking medication for a voluntary termination of pregnancy. Evolution was healing without sequelae. In total: Spontaneous miscarriage at months + 1 of the Dose1 of the vaccine. Healing. The fetus died on an unspecified date. It was not reported if an autopsy was performed. Outcome of hypotrophic embryo was fatal.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101108010 mother; Reported Cause(s) of Death: hypotrophic embryo


VAERS ID: 1687045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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 INC202101118582

Write-up: Cardiac death; This is a spontaneous report from a contactable other Health care professional. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-APPCOVID-20210824094928. Safety Report Unique Identifier is GB-MHRA-ADR 25860276. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on 10Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial.On 15Aug2021 (5days after vaccination) the patient experienced cardiac death. The Outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1687740 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
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: 2021-08-11
   Days after onset: 24
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: 20210718; Test Name: COVID test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101126141

Write-up: died from COVID/positive for COVID; died from COVID/positive for COVID; received BNT162B2 dose 1 on 14May2021 and dose 2 on 12Jul2021; This is a spontaneous report from a contactable consumer (parent) via Pfizer. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 as dose 1, single for COVID-19 immunisation. The reporter stated, "Our son who was 39 years old, fit and healthy, died from COVID on 11Aug2021. He had his first pfizer vaccine on 14May2021 and his 2nd on the 12Jul2021. He tested positive for COVID on 18Jul2021, was admitted to hospital on 24Jul2021, but despite every effort he died. There appeared to be no protection whatsoever from his vaccines. We are devastated and we really need an answer to this - we hope you can help". The patient received BNT162B2 dose 1 on 14May2021 and dose 2 on 12Jul2021. The patient was hospitalized for COVID from 24Jul2021 to an unknown date. The patient underwent lab tests and procedures which included COVID test: positive on 18Jul2021. The patient died on 11Aug2021. It was unknown if an autopsy was performed. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: died from COVID; died from COVID


VAERS ID: 1687765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Congenital anomaly
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? Yes
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 INC202101152690

Write-up: Congenital anomaly; This is a spontaneous report from a contactable consumer (parent) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108251046184020-KSCHI. Safety Report Unique Identifier GB-MHRA-ADR 25846459. This is the second of two reports (Baby). A patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380) via an unspecified route of administration on 20Aug2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced congenital anomaly (death, medically significant, congenital anomaly) on an unspecified date, It was not reported if an autopsy was performed. Clinical course: Patient'' mother found out she was around 6 weeks pregnant a couple of days after the vaccine, and then started to experience the symptoms of a miscarriage around 3 days later. She went to a&e yesterday and they confirmed it was a probable miscarriage and she has to return next week for a scan. She would not have had the vaccine if she had known she was pregnant. Patient''s mother has not tested positive for COVID-19 since having the vaccine. Patient''s mother is not enrolled in clinical trial. She had a miscarriage 3-4 days after. She did not take folic acid supplement during pregnancy. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101111379 Mother/baby case; Reported Cause(s) of Death: Congenital anomaly


VAERS ID: 1687789 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Thrombosis
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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
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: Drug addict
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20210913720

Write-up: LEG THROMBOSIS; CARDIAC ARREST; This spontaneous report received from a patient via a company representative via social media concerned a 30 year old male of unknown race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: drug addict. It was unspecified whether autopsy was performed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The young man wanted to find a job, so he had to be vaccinated. He was reluctant to get the vaccine, as he was afraid of the side effects. The patient said to a friend that this situation obliged him to get vaccinated. In the video, it was reported that the young men died of cardiac arrest, provoked by the thrombosis. The patient wrote on social media that his leg became hard, like a stone. The patient also wrote that all his veins are almost blocked and only a small quantity of blood flows in his veins. The patient wrote that he was 30 years old but he is going to die in a few days because some angiologists hesitate to open me. Under the information of the reportage, some comments of the people mention that the young man had already problems and he should not have been vaccinated. One of them says that he knew the young man and that he was a drug addict. On an unspecified date, the patient experienced leg thrombosis after 20 days of vaccination and cardiac arrest, and a 30 year old, who was hospitalized (date unspecified) that happened some days after his vaccination. The patient reported that his leg became hard, like a stone and all his veins are almost blocked and only a small quantity of blood flows in his veins. On 02-SEP-2021, the patient died from cardiac arrest, and leg thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210913720-COVID-19 VACCINE AD26.COV2.S-Leg thrombosis,Cardiac arrest. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: Cardiac arrest; LEG THROMBOSIS


VAERS ID: 1687790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-02
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRJNJFOC20210914006

Write-up: THROMBOSIS IN LEG; DEATH; This spontaneous report received from a patient via a company representative concerned a 4 decade (30 or 31) old male of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date (a few days after the coronavirus vaccination), it was reported that the patient''s leg was rocky as all his veins were blocked (reported as thrombosis in the leg) and was hospitalized . He was alive because enough blood was flowing into his heart was reported. On 02-SEP-2021 (Thursday), the patient died from an unknown cause of death. It was unknown if autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 02-SEP-2021, and the outcome of thrombosis in leg was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210914006-Covid-19 vaccine ad26.cov2.s-Death, Thrombosis in leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1687802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: HKPFIZER INC202101150140

Write-up: This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003246), license party for bnt162b2 (COMIRNATY). This is 1 of 4 reports. This is a spontaneous report received from a non-contactable HCP received Regulatory Authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 22-Aug-2021, Regulatory Authority received four death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved four males aged from 50 to 82. This case was split for 1 of 4 death cases. A male patient with unknown age started to receive COVID-19 vaccine on unspecified date via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The case was pending assessment by the Expert Committee. The event unknown cause of death met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done. Initial report was received on 26-Aug-2021. This is one of nine reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003242 (master case), 2021FOS003243, 2021FOS003244, 2021FOS003245, 2021FOS003246, 2021FOS003247, 2021FOS003248, 2021FOS003249, and 2021FOS003250. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. The reporter and company assessed the event as possibly related with Comirnaty. BioNTech SE Comment: The medical review comments of Department on the reports of Death is as follows: The seriousness of Death is: serious. Death is not a common adverse event in the package insert of COMIRNATY, so its expectedness is: unexpected. Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between Death and COMIRNATY is considered as possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101150133 same reporter, suspect drug and adverse event, different patient; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1687803 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: HKPFIZER INC202101150133

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003247), license party for bnt162b2 (COMIRNATY). This is one of four reports. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 22-Aug-2021, received four death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved four males aged from 50 to 82. This case was split for 1 of 4 death cases. A male patient with unknown age started to receive COVID-19 vaccine on unspecified date via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The case was pending assessment by the Expert Committee. The event unknown cause of death met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done. The reporter and company assessed the event as possibly related with Comirnaty. Initial report was received on 26-Aug-2021. This is one of nine reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003242 (master case), 2021FOS003243, 2021FOS003244, 2021FOS003245, 2021FOS003246, 2021FOS003247, 2021FOS003248, 2021FOS003249, and 2021FOS003250. Fosun is a marketing authorization holder of one of COVID-19 vaccine Tozinameran. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. BioNTech SE Comment: The medical review comments on the reports of Death is as follows: The seriousness of Death is: serious. Death is not a common adverse event in the package insert of COMIRNATY, so its expectedness is: unexpected. Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between Death and COMIRNATY is considered as possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101150140 same reporter, suspect drug and adverse event, different patient;HK-PFIZER INC-202101150136 same reporter, suspect drug and adverse event, different patient;HK-PFIZER INC-202101150166 same reporter, suspect drug and adverse event, different patient; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1687804 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: HKPFIZER INC202101150136

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (regulatory authority number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003248), license party for bnt162b2 (COMIRNATY). This is one of four reports. This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 22-Aug-2021, regulatory authority received four death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved four males aged from 50 to 82. This case was split for 1 of 4 death cases. A male patient with unknown age started to receive COVID-19 vaccine on unspecified date via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The case was pending assessment by the regulatory authority. The event unknown cause of death met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done. Initial report was received on 26-Aug-2021. This is one of nine reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003242 (master case), 2021FOS003243, 2021FOS003244, 2021FOS003245, 2021FOS003246, 2021FOS003247, 2021FOS003248, 2021FOS003249, and 2021FOS003250. regulatory authority is a marketing authorization holder of one of COVID-19 vaccine. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. BioNTech SE Comment: The medical review comments of regulatory authority on the reports of Death is as follows: The seriousness of Death is: serious. Death is not a common adverse event in the package insert of COMIRNATY, so its expectedness is: unexpected. Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between Death and COMIRNATY is considered as possible. Causality Assessment: The reporter and company assessed the event as possibly related with Comirnaty. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101150133 same reporter, suspect drug and adverse event, different patient; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1687805 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: HKPFIZER INC202101150166

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority, (regulatory authority number: not applicable), based on information received by Pfizer from BioNTech (manufacturer control number: HK-Fosun-2021FOS003249), license party for bnt162b2 (COMIRNATY). This is the one of four reports. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 22-Aug-2021, received four death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved four males aged from 50 to 82. This case was split for 1 of 4 death cases. A male patient with unknown age started to receive COVID-19 vaccine on unspecified date via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The case was pending assessment by the Expert Committee. The event unknown cause of death met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done. Initial report was received on 26-Aug-2021. This is one of nine reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003242 (master case), 2021FOS003243, 2021FOS003244, 2021FOS003245, 2021FOS003246, 2021FOS003247, 2021FOS003248, 2021FOS003249, and 2021FOS003250. Fosun is a marketing authorization holder of one of COVID-19 vaccine Tozinameran. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. BioNTech Comment: The medical review comments of Department on the reports of Death is as follows: The seriousness of Death is: serious. Death is not a common adverse event in the package insert of COMIRNATY, so its expectedness is: unexpected. Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between Death and COMIRNATY is considered as possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101150133 same reporter, suspect drug and adverse event, different patient; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1687969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-01-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Overdose, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (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: 2021-03-11
   Days after onset: 39
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: Senile dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101155270

Write-up: This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. A 86-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EJ6136)via intramuscular route of administration on 31Jan2021 as Dose 2,0.45mL, Single for COVID-19 immunization. The patient''s medical history included senile dementia. The patient''s concomitant medication was not reported. After second dose of Comirnaty vaccine on 31Jan2021, resulted first positive swab on 12Feb2021 covid end date 11Mar2021. The patient experienced dyspnea, fever, cough on 12Feb2021. The patient received overdose of Comirnaty vaccine of 0.45 ml. The patient underwent lab test and procedure of COVID-19 PCR test positive and resulted into positive on 12Feb2021. The outcome of events COVID-19 PCR test positive, dyspnea, fever, cough was death on 11Mar2021. The autopsy of death was unknown. No follow-up attempts were possible. No further information was expected.; Reported Cause(s) of Death: Dyspnea; Fever; Cough; COVID-19 PCR test positive


VAERS ID: 1687971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-08
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Dyspnoea, Hyperpyrexia, Pneumonia, Sepsis, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210915026

Write-up: DYSPNEA; AFIB; URINARY TRACT INFECTION; SEPSIS; HYPERPYREXIA; BRONCHOPULMONARY INFECTION; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, IT-MINISAL02-779822) was received on 08-SEP-2021 and concerned a 91 year old female. The patient''s weight was 60 kilograms, and height was 148 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03EX expiry: 28-FEB-23) 1 dosage forms, 1 total, administered on 19-MAY-2021 for Covid-19 immunisation. No concomitant medications were reported. On 08-JUL-2021, the patient experienced dyspnea, AFIB (Atrial fibrillation), infection of the urinary tract (urinary tract infection), sepsis, hyperpyrexia, right bronchopneumonic outbreak (bronchopulmonary infection) and had oral anticoagulant therapy. On an unspecified date, the patient died from dyspnea, AFIB (Atrial fibrillation), urinary tract infection, sepsis, hyperpyrexia, and bronchopulmonary infection. It was unknown if an autopsy was performed. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 19-MAY-2021. This report was serious (Death).; Reporter''s Comments: No drug allergies. Arterial hypertension. Chronic AF. Previous thyroidectomy for goiter in 1994. 2001 quadrantectomy and radiotherapy x K. Polymyalgia rheumatica. Bilateral hearing loss (prosthesis carrier).; Reported Cause(s) of Death: DYSPNEA; AFIB; URINARY TRACT INFECTION; SEPSIS; HYPERPYREXIA; BRONCHOPULMONARY INFECTION


VAERS ID: 1688206 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Ileus paralytic
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cystic kidney disease; Dialysis (for over 10 years)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101128120

Write-up: unknown cause of death; Paralysis intestinal; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 71-year-old female patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number was not reported) via an unspecified route of administration on 25May2021 (at 71 years) for covid-19 immunisation. The patient medical history included dialysis and cystic kidney, both ongoing. The patient''s concomitant medications were not reported. On 02Jun2021 (8 days after the vaccination), the patient experienced paralysis intestinal. The patient died approximately on 16Aug2021 (date also reported as unknown). The outcome was fatal (death). The cause of death was unknown (as reported).The course of the event was as follows: The patient had received dialysis as an underlying disease for over 10 years. On 25May2021 (the day of vaccination), the patient received the first dose of the vaccine. On 02Jun2021 (8 days after the vaccination), swelling of the rectus abdominis was noted. Paralysis intestinal was diagnosed by the reporting physician, and the patient was immediately transported to another hospital. Afterward, the reporting physician was informed that the patient underwent operations four times at another hospital, but details about operations were not informed. In addition, as the patient died while on hospitalization, the reporting physician was not sure about the date of the death. The reporting physician stated that it was approximately 16Aug2021. The reporting physician classified the event as serious (death) and assessed that the event was probably related to BNT162b2.It was not reported if an autopsy was performed. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the information provided the causal association/triggering of the event paralysis intestinal and unknown cause of death with the usage of the vaccine cannot be completely excluded. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Paralysis intestinal


VAERS ID: 1688207 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dehydration, Gait disturbance, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 3
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: Alcohol dependence syndrome (Severe); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101128138

Write-up: Weakness of limbs; They went limp; Dehydration; Unknown cause of death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 59-year-old male received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not provided, Expiration date not provided) via an unspecified route of administration on 26Aug2021 (the day of vaccination) (at the age of 59-year-old) at single dose for COVID-19 immunization. On 05Aug2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# not provided, Expiration date not provided) for COVID-19 immunization. The family history was not provided. The patient had medical histories of severe alcohol dependence and hypertension. On 26Aug2021 (the day of the vaccination), the extremities became motionless, and they went limp. The patient experienced weakness of limbs. On the same day, the patient was emergently transferred to a hospital. At the hospital, the patient was suspected to have dehydration, and received drip infusion. The patient felt better, and he went home. On 27Aug2021 (one day after vaccination), the extremities became motionless again, and the patient was transferred to another hospital. Two drip infusions were provided. After the drip infusion, the patient was encouraged to go home by the hospital, and he left the hospital. However, the patient''s wife who attended with him got worried, and contacted the reporting clinic. The patient was transferred by car and was admitted to the hospital (at that time, the patient was able to speak). On 28Aug2021 (2 days after vaccination), no particular abnormalities were observed. On 29Aug2021 (3 days after vaccination), at 04:00, the patient was confirmed to survive at the time of round by a nurse. However, at 07:00, when the nurse went to the patient''s room, the patient was found to tumble down from the bed, and he was dead on his stomach. It was unknown if an autopsy was performed. Outcome for muscular weakness, gait disturbance and dehydration was unknown. The events were classified as serious (death, as reported). The physician assessed that the events were probably related to BNT162b2 vaccination. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported events cannot be completely excluded.The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1688210 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-26
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101129589

Write-up: Respiratory condition was aggravated; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21125306. A 72-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported), via an unspecified route of administration on 24Jul2021 as dose 2, single for covid-19 immunisation. Body temperature before vaccination and family history were not reported. The patient medical history and concomitant medications were not reported. The patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported), via an unspecified route of administration on 03Jul2021 as dose 1, single for covid-19 immunisation. On 26Aug2021 (1 month 2 days after the vaccination), the respiratory condition was aggravated at 22:00, and emergency service was requested. The emergency squad arrived at the site, after which cardio-respiratory arrest occurred. The patient was transported to the reporting hospital and died on 26Aug2021. It was reported whether autopsy was done or not. The outcome of the events was fatal. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported whether there were other possible causes of the events such as any other diseases. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Respiratory condition was aggravated; Cardio-respiratory arrest


VAERS ID: 1688306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-31
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KPMODERNATX, INC.MOD20213

Write-up: Death; This spontaneous case was reported by an other and describes the occurrence of DEATH (Death) in an adult male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 18-Aug-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 31-Aug-2021 The patient died on 31-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The reporter stated that the patient was in his 50s and had an unknown underlying disease. No concomitant medications were provided by the reporter. Company Comment: Very limited information regarding this event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1688315 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Anuria, Basophil count, Blood albumin, Blood calcium, Blood chloride, Blood creatinine, Blood glucose, Blood magnesium, Blood osmolarity, Blood phosphorus, Blood pressure measurement, Blood pressure systolic, Blood sodium, Blood urea, C-reactive protein, COVID-19, Eosinophil count, Glomerular filtration rate, Granulocyte count, Haematocrit, Haemoglobin, Hypoxia, Imaging procedure, Investigation, Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Monocyte count, Neutrophil count, Oxygen saturation, Platelet count, Prothrombin time, Red blood cell count, Red cell distribution width, Respiratory failure, SARS-CoV-2 test, Septic shock, Tachypnoea, Urine analysis, Urosepsis, Vaccination failure, White blood cell count, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), 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: 2021-08-16
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: DIPYRIDAMOLE; MIRTAZAPINE; VITAMIN B COMPLEX; THIAMINE; ATARAX [HYDROXYZINE HYDROCHLORIDE]; HALOPERIDOL; AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes; Non-smoker; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210815; Test Name: APTT; Result Unstructured Data: Test Result:normal; Test Date: 20210816; Test Name: Basophils; Result Unstructured Data: Test Result:0.13 x10 9/l; Test Date: 20210816; Test Name: Serum albumin; Result Unstructured Data: Test Result:26 g/l; Comments: low; Test Date: 20210815; Test Name: calcium serum; Result Unstructured Data: Test Result:2.07 mmol/L; Test Date: 20210816; Test Name: calcium serum; Result Unstructured Data: Test Result:2.00 mmol/L; Test Date: 20210815; Test Name: serum chloride; Result Unstructured Data: Test Result:95.3 mmol/L; Test Date: 20210813; Test Name: creatinine; Result Unstructured Data: Test Result:106 umol/l; Test Date: 20210815; Test Name: creatinine; Result Unstructured Data: Test Result:163 umol/l; Test Date: 20210816; Test Name: creatinine; Result Unstructured Data: Test Result:214 umol/l; Test Date: 20210815; Test Name: glucose random; Result Unstructured Data: Test Result:22.98 mmol/L; Test Date: 20210815; Test Name: serum magnesium; Result Unstructured Data: Test Result:1.19 mmol/L; Test Date: 20210816; Test Name: serum magnesium; Result Unstructured Data: Test Result:1.23 mmol/L; Test Date: 20210815; Test Name: osmolality; Result Unstructured Data: Test Result:307 mosm/kg; Test Date: 20210813; Test Name: phosphate serum; Result Unstructured Data: Test Result:0.81 mmol/L; Test Date: 20210815; Test Name: blood pressure; Result Unstructured Data: Test Result:95/61; Test Name: blood pressure systolic; Result Unstructured Data: Test Result:76; Test Date: 20210815; Test Name: serum sodium; Result Unstructured Data: Test Result:131 mmol/L; Test Date: 20210816; Test Name: serum sodium; Result Unstructured Data: Test Result:135 mmol/L; Test Date: 20210813; Test Name: urea serum; Result Unstructured Data: Test Result:12.4 mmol/L; Test Date: 20210815; Test Name: urea serum; Result Unstructured Data: Test Result:22 mmol/L; Test Date: 20210816; Test Name: urea serum; Result Unstructured Data: Test Result:25.7 mmol/L; Test Date: 20210813; Test Name: C-reactive protein; Result Unstructured Data: Test Result:8.6 mg/l; Test Date: 20210815; Test Name: C-reactive protein; Result Unstructured Data: Test Result:188.6 mg/l; Test Date: 20210816; Test Name: C-reactive protein; Result Unstructured Data: Test Result:120 mg/l; Test Date: 20210815; Test Name: eosinophils; Result Unstructured Data: Test Result:0.0 x10 9/l; Test Date: 20210813; Test Name: GFR; Result Unstructured Data: Test Result:60; Test Date: 20210815; Test Name: GFR; Result Unstructured Data: Test Result:37; Test Date: 20210816; Test Name: GFR; Result Unstructured Data: Test Result:30; Test Date: 20210815; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.32 x10 9/l; Test Date: 20210813; Test Name: haematocrit; Test Result: 36 %; Test Date: 20210813; Test Name: haemoglobin; Result Unstructured Data: Test Result:12 g/dl; Test Date: 20210815; Test Name: haemoglobin; Result Unstructured Data: Test Result:15.2 g/dl; Test Date: 20210816; Test Name: haemoglobin; Result Unstructured Data: Test Result:16.7 g/dl; Test Date: 20210813; Test Name: Imaging for COVID-Pneumonia; Result Unstructured Data: Test Result:No signs of pneumonia; Test Date: 20210815; Test Name: Imaging for COVID-Pneumonia; Result Unstructured Data: Test Result:No signs of pneumonia; Test Date: 20210815; Test Name: Catheter specimen urine MCS; Result Unstructured Data: Test Result:No significant bacteriuria; Test Date: 20210815; Test Name: Liver Profile; Result Unstructured Data: Test Result:normal; Test Date: 20210816; Test Name: Liver Profile; Result Unstructured Data: Test Result:normal; Test Date: 20210813; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1.76 x10 9/l; Test Date: 20210815; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1.14 x10 9/l; Test Date: 20210816; Test Name: Lymphocytes; Result Unstructured Data: Test Result:2.06 x10 9/l; Test Date: 20210815; Test Name: mean cell haemoglobin; Test Result: 32.2 pg; Test Date: 20210813; Test Name: mean cell volume; Result Unstructured Data: Test Result:95.2; Test Date: 20210816; Test Name: mean cell volume; Result Unstructured Data: Test Result:94.2; Test Date: 20210815; Test Name: Monocytes; Result Unstructured Data: Test Result:1.66 x10 9/l; Test Date: 20210816; Test Name: Monocytes; Result Unstructured Data: Test Result:3.34 x10 9/l; Test Date: 20210813; Test Name: Neutrophils; Result Unstructured Data: Test Result:10.8 x10 9/l; Test Date: 20210815; Test Name: Neutrophils; Result Unstructured Data: Test Result:27.10 x10 9/l; Test Date: 20210816; Test Name: Neutrophils; Result Unstructured Data: Test Result:28.2 x10 9/l; Test Name: SpO2; Test Result: 86 %; Test Date: 20210815; Test Name: SpO2; Test Result: 98 %; Test Date: 20210815; Test Name: pH; Result Unstructured Data: Test Result:7.26; Comments: low; Test Date: 20210813; Test Name: Platelets; Result Unstructured Data: Test Result:178 x10 9/l; Test Date: 20210815; Test Name: Platelets; Result Unstructured Data: Test Result:289 x10 9/l; Test Date: 20210816; Test Name: Platelets; Result Unstructured Data: Test Result:354 x10 9/l; Test Date: 20210815; Test Name: PT; Result Unstructured Data: Test Result:normal; Test Date: 20210813; Test Name: red cell count; Result Unstructured Data: Test Result:3.78 x10 12/l; Test Date: 20210813; Test Name: red cell distribution width; Test Result: 15.3 %; Test Date: 20210815; Test Name: red cell distribution width; Test Result: 15.4 %; Test Date: 20210816; Test Name: red cell distribution width; Test Result: 15.7 %; Test Date: 20210803; Test Name: Sars cov-2 RT-PCR; Test Result: Positive ; Comments: nasal swab, new infection; Test Date: 20210813; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:positive; Comments: CT35 detected; Test Date: 20210815; Test Name: Urinalysis; Result Unstructured Data: Test Result:500 WBC/microL; Comments: elevated; Test Date: 20210813; Test Name: WBC; Result Unstructured Data: Test Result:13.4 x10 9/l; Test Date: 20210815; Test Name: WBC; Result Unstructured Data: Test Result:30.3 x10 9/l; Test Date: 20210816; Test Name: WBC; Result Unstructured Data: Test Result:34.2 x10 9/l
CDC Split Type: MTPFIZER INC202101138821

Write-up: Sars cov-2 RT-PCR positive; Sars cov-2 RT-PCR positive; urosepsis; acute kidney injury; septic shock; Tachypnea; hypoxemia; Type 1 Respiratory Failure; Renal failure /Oligoanuria; This is a spontaneous report from a contactable physician. A 91-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: ET7205), via intramuscular route, administered in Arm Right on 30Mar2021 (at the age of 90-years-old) as dose2, single for COVID-19 immunization and received bnt162b2 (COMIRNATY, Lot Number: ET9605), intramuscular, administered in Arm Right on 09Mar2021 (at the age of 90-years-old) as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus, stroke, dementia, non-smoker. Concomitant medication(s) included dipyridamole; mirtazapine; vitamin b complex; thiamine; hydroxyzine hydrochloride (ATARAX [HYDROXYZINE HYDROCHLORIDE]); haloperidol; amoxicillin sodium, clavulanate potassium (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]). The patient had Sars cov-2 RT-PCR positive, urosepsis, acute kidney injury (Bicarb of 15, elevated creatinine), septic shock, tachypnea (Rate of 30/min), hypoxemia (SpO2 86% on NRM), type 1 respiratory failure, renal failure /oligoanuria on an unspecified date. The patient did not have SARS-CoV2 antibodies at diagnosis. Patient admitted on 15Aug2021, had an acute kidney injury and septic shock, and died on the 16Aug2021 (hospitalised for one day). The patient was not admitted to an Intensive Care Unit. The patient required Non-rebreather mask at 15 L/min. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient was not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Therapeutic interventions included treatment with corticosteroids from 16Aug2021 to 16Aug2021 at 6mg iv, then patient passed away. The patient underwent lab tests and procedures which included on 03Aug2021: Nasal swab (RT-PCR) - positive (new infection). On 13Aug2021: Sars cov-2 PCR test - positive (CT35 detected), chest X-Ray: No signs of pneumonia, WBC 13.42 [4.30 - 11.40 x 10^9/L, Neutrophils 10.78 [2.10 - 7.20 x 10^9/L, Lymphocytes 1.76 [1.30 - 3.60 x 10^9/L], red cell count 3.78 [4.60 - 5.90 x 10^12/L], haemoglobin 12 [14.1 - 17.2 g/dl], haematocrit 36 [40.4 - 50.4 %], mean cell volume 95.2 [79 - 93 fL], red cell distribution width 15.3 [11.9 - 14.6 %], platelets 178 [146 - 302 x 10^9/L], C-reactive protein 8.6 [0-5 mg/L], urea (serum) 12.4 [1.7 - 8.3 mmol/L, creatinine 106 [59 - 104 umol/l], phosphate 0.81 [0.87 - 1.45 mmol/l]. On 15Aug2021: BP on admission 95/61, deteriorated to 76 systolic SPO2 on admission 98%, deteriorated to 86% on nonrebreather mask 15L/min, chest X-Ray: No signs of pneumonia, WBC 30.29 [4.30 - 11.40 x 10^9/L, Neutrophils 27.10 [2.10 - 7.20 x 10^9/L, Lymphocytes 1.14 [1.30 - 3.60 x 10^9/L], immature granulocytes 0.32 [0.0 - 0.09x10^9/L], Monocytes 1.66 [0.40 - 1.10 x 10^9/L], Eosinophils 0.0 [0.10 - 0.70 x 10^9/L], mean cell Hb 32.2 [27 - 32 pg], red cell distribution width 15.4 [11.9 - 14.6 %], PT normal, APTT normal, liver profile normal, Urinalysis 500 WBC/microL (elevated), pH 7.26 (low), Catheter specimen urine MCS - No significant bacteriuria, C-reactive protein 188.6 [0-5 mg/L], urea (serum) 22 [1.7 - 8.3 mmol/L, creatinine 163 [59 - 104 umol/l], sodium (serum) 131 [136 - 145 mmol/L], chloride (serum) 95.3 [98-107 mmol/l], glucose random 22.98 [3.9 - 9 mmol/L], calcium (serum) 2.07 [2.15 - 2.55 mmol/l], magnesium (serum) 1.19 [0.65 - 1.05 mmol/l], osmolality 307 [275-299 mOsm/kg]. On 16Aug2021: WBC 34.24 [4.30 - 11.40 x 10^9/L, Neutrophils 28.20 [2.10 - 7.20 x 10^9/L], immature granulocytes 0.48 [0.0 - 0.09x10^9/L], Monocytes 3.34 [0.40 - 1.10 x 10^9/L], Eosinophils 0.03 [0.10 - 0.70 x 10^9/L], Basophils 0.13 [0.0 - 0.10x10^9/L], mean cell volume 94.2 [79 - 93 fL], red cell distribution width 15.7 [11.9 - 14.6 %], platelets 354 [146 - 302x10^9/L], liver profile normal, serum albumin 26 (low), C-reactive protein 120 [0-5 mg/L], urea (serum) 25.7 [1.7 - 8.3 mmol/L, creatinine 214 [59 - 104 umol/l], sodium (serum) 135 [136 - 145 mmol/L], calcium (serum) 2.00 [2.15 - 2.55 mmol/l], magnesium (serum) 1.23 [0.65 - 1.05 mmol/l], serum albumin 26 [32-52 g/l]. The patient died on 16Aug2021. An autopsy was not performed. Primary cause of death: Urosepsis and Acute Kidney Injury. Other contributory causes: Dementia, Cerebrovascular accident, Diabetes Mellitus. No further information expected.; Sender''s Comments: As per the information in the case provided, the causal association between the events COVID-19, Vaccination failure, Urosepsis, Acute kidney injury, Septic shock, Tachypnoea, Hypoxia, Respiratory failure, Anuria and the suspect drug bnt162b2 cannot be excluded. 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: Urosepsis; Acute Kidney Injury


VAERS ID: 1688316 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-07-26
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood albumin, Blood alkaline phosphatase, Blood calcium, Blood chloride, Blood creatinine, Blood phosphorus, Blood potassium, Blood sodium, C-reactive protein, COVID-19, Chest X-ray, Fibrin D dimer, Gamma-glutamyltransferase, Globulin, Glomerular filtration rate, Haematocrit, Haemoglobin, Hypoxia, Lymphocyte count, Mean cell haemoglobin concentration, Neutrophil count, Platelet count, Protein total, Red blood cell count, Red cell distribution width, SARS-CoV-2 test, Seizure, Sepsis, Tachypnoea, Urinary tract infection, Vaccination failure, White blood cell count
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; Cholelithiasis; Dementia; Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: serum albumin; Result Unstructured Data: Test Result:31 g/l; Test Date: 20210730; Test Name: serum albumin; Result Unstructured Data: Test Result:31 g/l; Test Date: 20210801; Test Name: serum albumin; Result Unstructured Data: Test Result:27 g/l; Test Date: 20210803; Test Name: serum albumin; Result Unstructured Data: Test Result:26.7 g/l; Test Date: 20210726; Test Name: Alk phospatase; Result Unstructured Data: Test Result:386 IU/l; Test Date: 20210726; Test Name: serum calcium; Result Unstructured Data: Test Result:1.84 mmol/L; Test Date: 20210730; Test Name: serum calcium; Result Unstructured Data: Test Result:1.73 mmol/L; Test Date: 20210801; Test Name: serum calcium; Result Unstructured Data: Test Result:1.61 mmol/L; Test Date: 20210803; Test Name: serum calcium; Result Unstructured Data: Test Result:1.59 mmol/L; Test Date: 20210726; Test Name: serum chloride; Result Unstructured Data: Test Result:95.8 mmol/L; Test Date: 20210801; Test Name: serum chloride; Result Unstructured Data: Test Result:107.8 mmol/L; Test Date: 20210726; Test Name: creatinine; Result Unstructured Data: Test Result:59 umol/l; Test Date: 20210730; Test Name: creatinine; Result Unstructured Data: Test Result:61 umol/l; Test Date: 20210801; Test Name: creatinine; Result Unstructured Data: Test Result:60 umol/l; Test Date: 20210803; Test Name: creatinine; Result Unstructured Data: Test Result:67 umol/l; Test Date: 20210726; Test Name: serum phosphate; Result Unstructured Data: Test Result:0.70 mmol/L; Test Date: 20210730; Test Name: serum phosphate; Result Unstructured Data: Test Result:0.50 mmol/L; Test Date: 20210801; Test Name: serum phosphate; Result Unstructured Data: Test Result:0.63 mmol/L; Test Date: 20210801; Test Name: serum potassium; Result Unstructured Data: Test Result:3.40 mmol/L; Test Date: 20210801; Test Name: serum sodium; Result Unstructured Data: Test Result:151 mmol/L; Test Date: 20210803; Test Name: serum sodium; Result Unstructured Data: Test Result:148 mmol/L; Test Date: 20210728; Test Name: chest X-Ray; Result Unstructured Data: Test Result:Moderate Rt pleural effusion with; Comments: Moderate Rt pleural effusion with overlying consolidation/collapse upper & middle zones; Test Date: 20210801; Test Name: chest X-Ray; Result Unstructured Data: Test Result:Moderate Rt pleural effusion with; Comments: Moderate Rt pleural effusion with overlying consolidation/collapse upper & middle zones; Test Date: 20210726; Test Name: C-Reactive protein; Result Unstructured Data: Test Result:140.3 mg/l; Test Date: 20210730; Test Name: C-Reactive protein; Result Unstructured Data: Test Result:106.4 mg/l; Test Date: 20210801; Test Name: C-Reactive protein; Result Unstructured Data: Test Result:323 mg/l; Test Date: 20210803; Test Name: C-Reactive protein; Result Unstructured Data: Test Result:322.7 mg/l; Test Date: 20210730; Test Name: D-Dimer; Result Unstructured Data: Test Result:5363 ng/ml; Test Date: 20210726; Test Name: GGT; Result Unstructured Data: Test Result:317 IU/l; Test Date: 20210726; Test Name: serum globulin; Result Unstructured Data: Test Result:36.1 g/l; Test Date: 20210726; Test Name: EGFR; Result Unstructured Data: Test Result:89 mls/min/1.73m2; Test Date: 20210730; Test Name: EGFR; Result Unstructured Data: Test Result:85 mls/min/1.73m2; Test Date: 20210801; Test Name: EGFR; Result Unstructured Data: Test Result:87 mls/min/1.73m2; Test Date: 20210803; Test Name: EGFR; Result Unstructured Data: Test Result:77 mls/min/1.73m2; Test Date: 20210726; Test Name: haematocrit; Test Result: 33.1 %; Test Date: 20210730; Test Name: haematocrit; Test Result: 35.4 %; Test Date: 20210801; Test Name: haematocrit; Test Result: 28.9 %; Test Date: 20210726; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.8 g/dl; Test Date: 20210730; Test Name: haemoglobin; Result Unstructured Data: Test Result:11.3 g/dl; Test Date: 20210801; Test Name: haemoglobin; Result Unstructured Data: Test Result:9.1 g/dl; Test Date: 20210726; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.05 x10 9/l; Test Date: 20210730; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.47 x10 9/l; Test Date: 20210801; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.02 x10 9/l; Test Date: 20210730; Test Name: mean cell Hb conc; Result Unstructured Data: Test Result:31.9 g/dl; Test Date: 20210801; Test Name: mean cell Hb conc; Result Unstructured Data: Test Result:31.5 g/dl; Test Date: 20210726; Test Name: neutrophils; Result Unstructured Data: Test Result:7.02 x10 9/l; Test Date: 20210730; Test Name: neutrophils; Result Unstructured Data: Test Result:6.38 x10 9/l; Test Date: 20210801; Test Name: neutrophils; Result Unstructured Data: Test Result:9.65 x10 9/l; Test Date: 20210726; Test Name: platelets; Result Unstructured Data: Test Result:235 x10 9/l; Test Date: 20210730; Test Name: platelets; Result Unstructured Data: Test Result:154 x10 9/l; Test Date: 20210801; Test Name: platelets; Result Unstructured Data: Test Result:218 x10 9/l; Test Date: 20210730; Test Name: total protein; Result Unstructured Data: Test Result:62.4 g/l; Test Date: 20210803; Test Name: total protein; Result Unstructured Data: Test Result:57.6 g/l; Test Date: 20210726; Test Name: red cell count; Result Unstructured Data: Test Result:3.69 x10 12/l; Test Date: 20210801; Test Name: red cell count; Result Unstructured Data: Test Result:3.11 x10 12/l; Test Date: 20210726; Test Name: red cell distribution width; Test Result: 15.6 %; Test Date: 20210730; Test Name: red cell distribution width; Test Result: 15.8 %; Test Date: 20210801; Test Name: red cell distribution width; Test Result: 16.4 %; Test Date: 20210726; Test Name: Sars Cov-2 RT-PCR; Result Unstructured Data: Test Result:positive; Comments: new infection, CT 30 detected; Test Date: 20210726; Test Name: WBC; Result Unstructured Data: Test Result:9.06 x10 9/l; Comments: normal; Test Date: 20210730; Test Name: WBC; Result Unstructured Data: Test Result:8.51 x10 9/l; Comments: normal; Test Date: 20210801; Test Name: WBC; Result Unstructured Data: Test Result:11.27 x10 9/l; Comments: normal
CDC Split Type: MTPFIZER INC202101138823

Write-up: Urinary Tract Infection; tachypnea (RR 26 breaths per min); hypoxemia (SpO2 88-92%); Sepsis; Convulsions/seizures; Sars-Cov-2 RT-PCR positive; Sars-Cov-2 RT-PCR positive; This is a spontaneous report from a contactable physician. An 88-years-old female patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EJ6796, expiry date: unknown) via intramuscular route on 15Jan2021 (age at vaccination: 87-years) as single dose and second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EJ6788, expiry date: unknown), via intramuscular route, administered in left arm on 05Feb2021 (age at vaccination: 87-years) as single dose for COVID-19 immunisation. Medical history included cholelithiasis, non-tobacco user, cerebrovascular accident, dementia from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. The patient experienced sars-cov-2 rt-pcr positive on 26Jul2021, urinary tract infection, tachypnea (rr 26 breaths per min), hypoxemia (spo2 88-92%), sepsis on an unspecified date and convulsions/seizures [2 short-lived seizures on 30Jul2021 which self-terminated] on 30Jul2021. Therapeutic interventions included dexamethasone on 03Aug2021 at 6mg daily po. Patient was a resident in a long term residential care facility. She was relocated to the COVID unit at the same facility on testing Covid positive, i.e. from the 27Jul2021 to the 05Aug2021 (date of death). The patient was not admitted to an Intensive Care Unit. The patient display clinical signs at rest indicative of severe systemic illness: Tachypnoea, SpO2 less than 93% on RA. The patient received Oxygen via NRM at 15L/min, with SpO2 88 - 92% on above. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient died on 05Aug2021. An autopsy was not performed. Primary cause of death: Sepsis due to Urinary Tract Infection consequent upon Covid infection. Contributory causes: Cerebrovascular accident and Dementia. The patient underwent lab tests and procedures which included: 26Jul2021: WBC 9.06 [4.30 - 11.40x10^9/L], Neutrophils 7.02 [1.90 - 7.70 x 10^9/L], lymphocytes 1.05 [1.30 - 3.60x10^9/L], red cell count 3.69 [3.90 - 5.40x10^12/L], haemoglobin 10.8 [12-15.5 g/dl], haematocrit 33.1 [35.6 - 46%], platelets 235 [132 - 349x10^9/L], red cell distribution width 15.6 [11.9 - 14.6%], serum chloride 95.8 [98-107 mmol/l], serum calcium 1.84 [2.15-2.55 mmol/l], serum phosphate 0.70 [0.87 - 1.45 mmol/l], alkaline phosphatase (serum) 386 [40-104 IU/l], GGT (serum) 317 [5-36 IU/L], serum glob-ulin 36.1 [20-35 g/l], serum albumin 31 [32-52 g/l], C-reactive protein 140.3 [0-5 mg/l], EGFR 89 mls/min/1.73m2, creatinine 59 [45-84 umol/l]; 28Jul2021: Chest X-Ray [Right shoulder (lung visual-ized)]: Moderate Rt pleural effusion with overlying consolidation/collapse upper and middle zones; 30Jul2021: WBC 8.51 [4.30 - 11.40x10^9/L], Neutrophils 6.38 [1.90 - 7.70 x 10^9/L], lymphocytes 1.47 [1.30 - 3.60x10^9/L], haemoglobin 11.3 [12-15.5 g/dl], haematocrit 35.4 [35.6 - 46%], platelets 154 [132 - 349x10^9/L], red cell distribution width 15.8 [11.9 - 14.6%], Mean cell Hb conc 31.9 [32 - 36 g/dl], D-Dimer 5363 [0-500 ng/ml], serum calcium 1.73 [2.15-2.55 mmol/l], serum phosphate 0.50 [0.87 - 1.45 mmol/l], serum albumin 31 [32-52 g/l], C-reactive protein 106.4 [0-5 mg/l], total protein 62.4 [66-87 g/l], EGFR 85 mls/min/1.73m2, creatinine 61 [45-84 umol/l]; 01Aug2021: Chest X-Ray [Right shoulder (lung visualized)]: Moderate Rt pleural effusion with overlying consolidation/collapse upper and middle zones, WBC 11.27 [4.30 - 11.40x10^9/L], Neutrophils 9.65 [1.90 - 7.70 x 10^9/L], lymphocytes 1.02 [1.30 - 3.60x10^9/L], red cell count 3.11 [3.90 - 5.40x10^12/L], haemoglobin 9.1 [12-15.5 g/dl], haematocrit 28.9 [35.6 - 46%], platelets 218 [132 - 349x10^9/L], red cell distribution width 16.4 [11.9 - 14.6%], Mean cell Hb conc 31.5 [32 - 36 g/dl], serum calcium 1.61 [2.15-2.55 mmol/l], serum phosphate 0.63 [0.87 - 1.45 mmol/l], serum albumin 27 [32-52 g/l], serum sodium 151 [136-145 mmol/l], serum potassium 3.40 [3.5 - 5.1 mmol/l], serum chloride 107.8 [98-107 mmol/l], EGFR 87 mls/min/1.73m2, creatinine 60 [45-84 umol/l]; 03Aug2021: serum calcium 1.59 [2.15-2.55 mmol/l], serum sodium 148 [136-145 mmol/l], C-reactive protein 322.7 [0-5 mg/l], serum albumin 26.7 [32-52 g/l], total protein 57.6 [66-87 g/l], EGFR 77 mls/min/1.73m2, 67. The outcome of the events was fatal. Follow-up activities completed. no further information expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded. 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: Sepsis; urinary tract infection; covid infection


VAERS ID: 1688720 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Raynaud''s syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101144750

Write-up: had a reaction and is hospitalized in serious condition / the patient had died; This is a spontaneous report from a contactable consumer received through COVAES portal (firstly by logistic colleague). A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date (age at the vaccination: 17-years-old) as DOSE 1, SINGLE for covid-19 immunisation. At the time of vaccination, pregnancy was reported as unknown. Medical history included raynaud''s phenomenon from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Other vaccine in four weeks was reported as unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. The reporter reported an adverse event that occurred in the school where she worked, a student took the 1st dose of the pfizer vaccine and she had a reaction and was hospitalized in serious condition in the hospital. The reporter informed that the patient had died on an unspecified date for an unspecified reason. Treatment AE was reported as unknown. It was unknown if any autopsy was performed.; Reported Cause(s) of Death: had a reaction and is hospitalized in serious condition / the patient had died


VAERS ID: 1688782 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-29
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Cardiovascular disorder, Circulatory collapse, Condition aggravated, Nausea, Pneumonia, Sepsis, Venous thrombosis limb, Vertigo
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 107
Permanent Disability? Yes
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: Blood pressure high; Diabetes mellitus; High cholesterol
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20213

Write-up: Condition aggravated; Circulatory instability; Lower extremities phlebothrombus; Sepsis; Circulatory collapse; Pneumonia; Circulatory collapse; Weakness generalized; Head spinning; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), SEPSIS (Sepsis), PNEUMONIA (Pneumonia), the second episode of CIRCULATORY COLLAPSE (Circulatory collapse), VENOUS THROMBOSIS LIMB (Lower extremities phlebothrombus), the first episode of CIRCULATORY COLLAPSE (Circulatory collapse) and CARDIOVASCULAR DISORDER (Circulatory instability) in an 86-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included High cholesterol, Diabetes mellitus and Blood pressure high. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ASTHENIA (Weakness generalized), VERTIGO (Head spinning) and NAUSEA (Nausea). On 01-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization, medically significant and life threatening) and the first episode of CIRCULATORY COLLAPSE (Circulatory collapse) (seriousness criteria hospitalization, medically significant and life threatening). On 16-Apr-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization, disability, medically significant and life threatening) and the second episode of CIRCULATORY COLLAPSE (Circulatory collapse) (seriousness criteria hospitalization, medically significant and life threatening). On 11-Jun-2021, the patient experienced VENOUS THROMBOSIS LIMB (Lower extremities phlebothrombus) (seriousness criteria hospitalization, disability, medically significant and life threatening). On 09-Jul-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated) (seriousness criteria death, hospitalization, disability, medically significant and life threatening) and CARDIOVASCULAR DISORDER (Circulatory instability) (seriousness criteria hospitalization, medically significant and life threatening). The patient died on 14-Jul-2021. The reported cause of death was Sepsis and Condition aggravated. It is unknown if an autopsy was performed. At the time of death, SEPSIS (Sepsis) and PNEUMONIA (Pneumonia) had not resolved, last episode of CIRCULATORY COLLAPSE (Circulatory collapse) had resolved and VENOUS THROMBOSIS LIMB (Lower extremities phlebothrombus), CARDIOVASCULAR DISORDER (Circulatory instability), ASTHENIA (Weakness generalized), VERTIGO (Head spinning) and NAUSEA (Nausea) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. This is a case of death in a 86-year-old male subject with a history of high cholesterol, diabetes mellitus and high blood pressure, who experienced the serious unexpected events of pneumonia, sepsis, circulatory collapse (onset date on 16-Apr-2021), venous thrombosis limb, circulatory collapse (onset date on 01-Apr-2021), condition aggravated and cardiovascular disorder. The event of sepsis and condition aggravated were reported as patient''s cause of death. Additionally, the patient experienced the non-serious unexpected events of vertigo and asthenia and a non-serious expected event of nausea. The events of asthenia, vertigo and nausea occurred within 24 hours after the second dose of mRNA-1273 [Spikevax]. The outcome of the events was not provided. The events are consistent with the current understanding of the mechanism of action of mRNA-1273 [Spikevax]. The events of pneumonia and circulatory collapse occurred within 72 hours, the events of sepsis and circulatory collapse approximately 18 days, and the events of venous thrombosis limp approximately 1.5 months, and the events of condition aggravated and cardiovascular disorder approximately 2.5 months after the second dose of mRNA-1273 [Spikevax]. Considering patient''s advanced age, comorbidities and very limited information provided regarding these events it is considered unfeasible to establish causal association between these events and the vaccine. The reporter''s assessment was nor provided for the events. The benefit-risk relationship of mRNA-1273 [Spikevax] in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Translation received on 07-Sep-2021 included no new information.; Sender''s Comments: This is a case of death in a 86-year-old male subject with a history of high cholesterol, diabetes mellitus and high blood pressure, who experienced the serious unexpected events of pneumonia, sepsis, circulatory collapse (onset date on 16-Apr-2021), venous thrombosis limb, circulatory collapse (onset date on 01-Apr-2021), condition aggravated and cardiovascular disorder. The event of sepsis and condition aggravated were reported as patient''s cause of death. Additionally, the patient experienced the non-serious unexpected events of vertigo and asthenia and a non-serious expected event of nausea. The events of asthenia, vertigo and nausea occurred within 24 hours after the second dose of mRNA-1273 [Spikevax]. The outcome of the events was not provided. The events are consistent with the current understanding of the mechanism of action of mRNA-1273 [Spikevax]. The events of pneumonia and circulatory collapse occurred within 72 hours, the events of sepsis and circulatory collapse approximately 18 days, and the events of venous thrombosis limp approximately 1.5 months, and the events of condition aggravated and cardiovascular disorder approximately 2.5 months after the second dose of mRNA-1273 [Spikevax]. Considering patient''s advanced age, comorbidities and very limited information provided regarding these events it is considered unfeasible to establish causal association between these events and the vaccine. The reporter''s assessment was nor provided for the events. The benefit-risk relationship of mRNA-1273 [Spikevax] in not affected by this report.; Reported Cause(s) of Death: Sepsis; Condition aggravated


VAERS ID: 1688796 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-14
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101124655

Write-up: COVID-19 pneumonitis; COVID-19 pneumonitis; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB [Regulatory Authority number DE-PEI-202100129281]. A 99-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Apr2021 (Lot Number: ET3045) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced covid-19 pneumonitis (death) on 14Apr2021 with fatal outcome on unknown date. It was not reported if an autopsy was performed. Event assessment: Comirnaty/ event /HA /Result of Assessment: D. Unclassifiable.; Reported Cause(s) of Death: COVID-19 pneumonitis; COVID-19 pneumonitis


VAERS ID: 1688797 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101125223

Write-up: Decompensation cardiac; Pyrexia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100130786. A 60-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Jun2021 (Batch/Lot Number: FD7958) as DOSE 2, SINGLE for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine was Comirnaty on 26May2021 for Covid-19 immunization. On 24Jun2021 the patient experienced pyrexia and decompensation cardiac. The patient died on an unspecified date. It as unknown if an autopsy was performed. This report is serious - death. Causal relationship between the event/s and the administration of CORMINATY was assessed as "Unclassifiable (D)" by the PEI.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1688798 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101124681

Write-up: Diarrhea; Nausea; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100142241. A 75-years-old female patient received BNT162b2 (Comirnaty, Solution for injection, Lot Number: EX8679, Expiration date was not reported), via an unspecified route of administration on 06May2021 as dose 2, single (at the age of 75-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07May2021, patient experienced nausea and diarrhea. Therapeutic measures were taken as a result of diarrhea and nausea treatment included Vomex prescribed. The patient died on an unspecified date of 2021, due to nausea and diarrhea. This report is serious - death. It was not reported if an autopsy was performed. Assessment: Comirnaty/ Diarrhea /ADR: B. Indeterminate Assessment: Comirnaty/ Nausea /ADR: B. Indeterminate Health Authority Comment: Clinical examination by medical service; Vomex prescribed No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Clinical examination by medical service; Vomex prescribed; Reported Cause(s) of Death: nausea; Diarrhea


VAERS ID: 1688806 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dementia, Dyspepsia, Urinary incontinence
SMQs:, Dementia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 32
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 INC202101124799

Write-up: severe physical weakness, mobility impairment; and indigestion/Incontinence of urine; mental degradation; indigestion; This is a spontaneous report received from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100168608. An 89-year-old female patient received bnt162b2 (COMIRNATY, lot ET3045), intramuscularly on 14Apr2021 as dose 2, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. She had her dose 1 of bnt162b2 (COMIRNATY, lot ER2659) on 22Mar2021 via IM route. The patient experienced severe physical weakness/mobility impairment, indigestion, urinary incontinence and mental degradation (dementia) (all reported as serious life threatening, fatal) on 01May2021. The patient died on 02Jun2021. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events Source of assessment: HA Result of Assessment: D. Unclassifiable No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Weakness generalized; Dementia; Incontinence of urine; indigestion


VAERS ID: 1688807 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-04
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cor pulmonale
SMQs:, Cardiac failure (narrow), Pulmonary hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101125237

Write-up: cardiac decompensation; This is a spontaneous report from a non-contactable consumer downloaded from the Agency (EMA) EudraVigilance-WEB, regulatory authority number is DE-PEI-202100168623. An 81-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 18May2021 (Batch/Lot Number: 1C007A) as dose number unknown, single (at the age of 81 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Jun2021 the patient experienced cor pulmonale (cardiac decompensation). The event led to hospitalization. The outcome was fatal. Patient died on an unspecified date. it was unknown if autopsy was performed. Per PEI assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cor pulmonale


VAERS ID: 1688808 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Hypotension, Hypothermia, Malaise, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal haemorrhage (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Ischemic cardiomyopathy; Mitral valve repair (MK reconstitution); Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101125230

Write-up: Gastrointestinal bleeding; Hypothermia; Hypotension; Malaise; Vomiting; Nausea; This is a spontaneous report from a non-contactable consumer downloaded from the Agency EudraVigilance-WEB, regulatory authority number DE-PEI-202100168662. A 76-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: EM0477), intramuscular on 02Feb2021 (at the age of 76-years-old) as dose 2, single for covid-19 immunisation. The patient medical history included severe heart failure, status after MK reconstitution/mitral valve reconstruction, ischemic cardiomyopathy, renal insufficiency. The patient''s concomitant medications were not reported. On 02Feb2021, the patient experienced malaise, vomiting and nausea. On 06Feb2021, the patient experienced gastrointestinal bleeding, hypothermia and hypotension. Clinical course details: After the 2nd vaccination, gastrointestinal problems, increasing general deterioration of the condition since 05Feb2021 at night, 06Feb2021 at home, necessary treatment in the hospital was refused by the patient. The outcome of hypothermia and hypotension was recovered on 06Feb2021; outcome of the rest of the events was unknown; outcome of gastrointestinal bleeding was fatal. The patient died on an unspecified date. Cause of death was gastrointestinal bleeding. It was unknown if an autopsy was performed. Result of assessment (all events; source: PEI): indeterminate. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Gastrointestinal bleeding


VAERS ID: 1689849 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E0291 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Acute myocardial infarction, Cold sweat, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol addiction; Aortic valve disease; Arterial hypertension; COPD; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101125314

Write-up: Dyspnea; Cold sweat; Belly ache; Acute myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number is DE-PEI-202100175612. A 66-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 20Jul2021 (Batch/Lot Number: 1E0291) (at the age of 66-years-old) as dose 2, single for COVID-19 immunisation. Medical history included arterial hypertension, chronic obstructive pulmonary disease (COPD), alcohol addiction, nicotine abuse and aortic valve disease. The patient was previously administered with BNT162B2 (COMIRNATY) on 15Jun2021 (at the age of 66-years-old) as dose 1, 0.3 mL, single for COVID-19 immunisation. The patient''s concomitant medications were not reported. On 21Jul2021, the patient experienced dyspnea, cold sweat, belly ache and acute myocardial infarction. Outcome of events was fatal. The patient died on 21Jul2021. It was not reported if an autopsy was performed. The Regulatory Authority assessment for all the events (Dyspnea, Cold sweat, Belly ache, Acute myocardial infarction) with the suspect product Comirnaty was B. Indeterminate.; Reported Cause(s) of Death: Dyspnea; Cold sweat; Belly ache; Acute myocardial infarction


VAERS ID: 1689851 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101124363

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency EudraVigilance-WEB, regulatory authority number DE-PEI-202100175631. An 86-year-old female patient received bnt162b2 (COMIRNATY; also reported as mRNA TOZINAMERAN), dose 2 via an unspecified route of administration on 26Jan2021 (Batch/Lot Number: EK9788) at 86-years-old as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY) as DOSE 1, SINGLE for COVID-19 immunisation on 05Jan2021 at 86-years-old. On 26Jan2021, the patient experienced: unknown cause of death (death, medically significant). The clinical outcome of the event, unknown cause of death, was fatal. The patient died on 26Jan2021 due to unknown cause of death. It was unknown if an autopsy was performed. The causal relationship between the event and the administration of CORMINATY was assessed as "Unclassifiable (D)" by the PEI. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1689858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Guillain-Barre syndrome, Haematoma, Petechiae, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (narrow), Accidents and injuries (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; Hypothyreosis; Renal insufficiency; Sick sinus syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101125365

Write-up: Guillain Barre syndrome; Petechiae; Hematoma; Thrombocytopenia; Fall; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100175680. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 20Jun2021 (at the age of 77years) as dose number unknown, 0.3ml single for Covid-19 immunization. Medical history included atrial fibrillation, arterial hypertension, renal insufficiency, hypothyreosis, and sick sinus syndrome. The patient''s concomitant medications were not reported. On 26Jun2021, the patient experienced fall. On 06Jul2021 the patient experienced petechiae, hematoma, and thrombocytopenia. On 01Aug2021 the patient experienced Guillain Barre syndrome. The patient was hospitalized on an unspecified date in response to the events. The patient died on 09Aug2021. It was unknown if an autopsy was performed. This report is serious - death, hospitalization, life threatening. Event assessment: hematoma, Guillain barre syndrome, fall, thrombocytopenia, petechiae/PEI: D. Unclassifiable No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Septic shock; Fulminant hepatic failure


VAERS ID: 1689872 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-21
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocardial rupture, Pulmonary embolism, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery sclerosis; Diffuse idiopathic pulmonary neuroendocrine cell hyperplasia; Gastroenteropathy NOS; Myocardial infarction; Pericardial tamponade
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101125253

Write-up: Inappropriate schedule of vaccine administered; Thrombosis; Pulmonary embolism; myocardial rupture; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency (RA)-WEB DE-PEI-202100176695. A 69-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FA5833), via an unspecified route of administration on 14Jun2021 (at the age of 69-years-old) as dose 2, 0.3 mL single for COVID-19 immunisation. Medical history included bloody pericardial tamponade, ruptured myocardial infarction, focal high-grade coronary artery sclerosis, shock gastroenteropathy and diffuse idiopathic pulmonary neuroendocrine cell hyperplasia from an unknown date. The patient''s concomitant medications were not reported. The patient previously received the first dose of COMIRNATY (strength: 0.3ml), on 03May2021 for COVID-19 immunisation. The patient experienced thrombosis and pulmonary embolism on 21Jun2021. An autopsy was performed that revealed myocardial rupture. The patient died on 21Jun2021. The outcome of the events thrombosis and pulmonary embolism was fatal. Causal relationship between the adverse events Thrombosis and Pulmonary embolism and the administration of COMIRNATY was assessed as "Inconsistent causal association to immunization" by the agency. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Thrombosis; Pulmonary embolism; Autopsy-determined Cause(s) of Death: Myocardial rupture (post infarct)


VAERS ID: 1689924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer female (7 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101125484

Write-up: coma; Death; This is a spontaneous report received from a consumer (patient''s spouse) downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-CADR2021168324, Safety report unique identifier DE-PEI-202100173778. An 84-year-old female patient received bnt162b2 (COMIRNATY, solution for injection) via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER7812) as dose number unknown, single for COVID-19 immunisation. Medical history included breast cancer female in 2004 (onset reported as 7 years ago). The patient had no known allergies. The patient''s concomitant medications were not reported. Patient fell into a coma in the night of 03/04Apr2021, died (unknown cause of death) in the clinic 4 days later. The patient''s outcome was fatal for Unknown cause of death, for coma was unknown. The patient died on Apr2021. It was unknown if an autopsy was performed. Relatedness of drug to reaction(s)/event(s): Reaction(s) / Event(s) Assessed: Unknown cause of death. Source of assessment: PEI. Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1689925 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: DEPFIZER INC202101125168

Write-up: Herpes zoster; lung infection; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority, regulatory authority number is DE-PEI-CADR2021168326, Safety Report Unique Identifier is DE-PEI-202100174160. An 84-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 06Jul2021 (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 09Jul2021, the patient experienced herpes zoster, lung infection and unknown cause of death. The patient was hospitalized on 09Jul2021 due to herpes zoster and lung infection. Outcome of events herpes zoster and lung infection was not recovered while unknown cause of death was fatal. The patient died on 09Jul2021. It was not reported if an autopsy was performed. Result of assessment for all events (herpes zoster, lung infection and unknown cause of death) /PEI / D. Unclassifiable. No follow-up attempts are possible, information on batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1689927 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cachexia, Dysphagia, Fatigue, Myasthenia gravis, Weight, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Immune-mediated/autoimmune disorders (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: Myasthenia gravis (an autoimmune disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Weight; Result Unstructured Data: Test Result:loss
CDC Split Type: DEPFIZER INC202101124956

Write-up: Recurrence of the autoimmune disease myasthenia gravis/ Myasthenia gravis aggravated; Difficulty swallowing as a result of emaciation and fatigue; Difficulty swallowing as a result of emaciation and fatigue; Difficulty swallowing as a result of emaciation and fatigue/ Lassitude; Difficulty swallowing as a result of emaciation and fatigue/ Weight loss; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-CADR2021169226 and the safety report unique identifiers are DE-PEI-202100176321 and DE-CADRPEI-2021169226. An 80-year-old female patient received BNT162B2 (COMIRNATY, 0.3 mL strength, lot number and expiration date were unknown), via an unspecified route of administration on 30May2021 at dose number unknown, single for COVID-19 immunisation. Medical history included ongoing myasthenia gravis, an autoimmune disease. She has no known allergies. The patient''s concomitant medications were not reported. On an unspecified date in 2021, the patient experienced myasthenia gravis aggravated which was also reported as recurrence of the autoimmune disease, myasthenia gravis and difficulty swallowing as a result of emaciation and fatigue/ lassitude, as well as weight loss. "Stands" (as reported) were inserted into her oesophagus. The patient died on an unspecified date in 2021. The cause of death was "Recurrence of the autoimmune disease myasthenia gravis/ Myasthenia gravis aggravated." It was unknown if an autopsy was performed. The outcome of all other events was not recovered. Relatedness of COMIRNATY to the events Myasthenia gravis aggravated, Swallowing disorder, Lassitude, and Weight loss was reported as D, unclassifiable by the regulatory authority (PEI). Sender''s Comment: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous illnesses: Autoimmune disease/ Stands were inserted into oesophagus. No follow-up attempts are possible; information about lot/ batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Recurrence of the autoimmune disease myasthenia gravis/ Myasthenia gravis aggravated


VAERS ID: 1689928 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D014A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Back pain, Balance disorder, Blood urine present, Dizziness, Headache, Inappropriate schedule of product administration, Internal haemorrhage, Limb discomfort, Malaise, Myalgia, Nausea, Renal impairment, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 86
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal insufficiency (Mild renal insufficiency); Functional blood flow disorder (circulatory disorders in the head); Hypertension (high blood pressure); Infarct myocardial (heart attack); Malignant lymphoma NOS (lymph gland cancer)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101124979

Write-up: Internal bleeding; Running became almost impossible because the balance was disturbed; Constant back pain; Kidney function abnormal; Blood in urine; Anemia; Tachycardia; Limb discomfort; Nausea; Dizziness; Myalgia; Headache; Malaise; inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority, regulatory authority number DE-PEI-CADR2021169387. An 82-year-old male patient received bnt162b2 (COMIRNATY, Strength: 0.3 mL; Lot Number: 1D014A), via an unspecified route of administration on 25May2021 (at the age of 82-years-old) as dose 2, 0.3 mL single for covid-19 immunisation. The patient medical history included hypertension/high blood pressure, infarct myocardial/heart attack, functional blood flow disorder/circulatory disorders in the head, malignant lymphoma/lymph gland cancer and mild renal insufficiency/chronic renal insufficiency; all in 2015 (approximately 6 years ago) and ongoing. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY, Lot number was not reported) on 08Apr2021 as dose 1, 0.3 mL single for covid-19 immunisation. On 25May2021, patient experienced inappropriate schedule of vaccine administered. On 01Jul2021, the patient experienced nausea, malaise, headache, dizziness, myalgia, limb discomfort and tachycardia. On 25Jul2021, the patient experienced anemia, blood in urine and kidney function abnormal. Clinical course details: After the vaccination, the indicated symptoms started. Running became almost impossible because the balance was disturbed. Constant malaise and nausea. Constant back pain. Operation of an old vertebral fracture - no improvement. Significant deterioration in kidney function, blood in the urine of unknown origin. Internal bleeding that could not be localized. The start dates were approximate. Some things started shortly after the vaccination, others only a short time afterwards. Treatment and diagnostics were discontinued as soon as it became clear that there could be no recovery. Therapeutic measures were taken as a result of the events. The outcome of anemia, blood in urine and kidney function abnormal was fatal; outcome of internal bleeding, back pain and disturbed balance was unknown; outcome of the other events was not recovered. The patient died on 19Aug2021. Causes of death were anemia, blood in urine and kidney function abnormal. No autopsy was performed. Relatedness of drug to event: All reported events / Source of assessment: PEI. Result of Assessment: D. Unclassifiable. No follow-up attempts possible. No further information expected. Information about batch number has been obtained.; Reported Cause(s) of Death: Anemia; Kidney function abnormal; blood in urine


VAERS ID: 1689929 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003603 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Death
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 44
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: Bypass surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: DE-PEI-CADR2021171069) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a non-health professional and describes the occurrence of DEATH and ARRHYTHMIA in a 70-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003603) for Prophylactic vaccination. The patient''s past medical history included Bypass surgery. On 30-Jun-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced ARRHYTHMIA (seriousness criterion medically significant). The patient died on 14-Aug-2021. The reported cause of death was Chest pain. It is unknown if an autopsy was performed. At the time of death, ARRHYTHMIA had not resolved. No concomitant medication information was provided. No treatment medication information was provided. Company Comment: Very limited information regarding this event has been provided at this time. Further information is not expected. Event arrhythmia is retained as serious due to the limited information provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation received on 8-Sep-2021 contains NNI; Reporter''s Comments: Bypassoperation; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected. Event arrhythmia is retained as serious due to the limited information provided.; Reported Cause(s) of Death: Unknown cause of death; Chest Pain


VAERS ID: 1690003 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142060

Write-up: The patient died two weeks after the second vaccination; This is a spontaneous report from a non-contactable physician based on information received by Pfizer from BioNTech (manufacturer reference number: 83294), license party for COMIRNATY. A male patient of an unspecified age received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) single, for an COVID-19 Immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient died two weeks after the second vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. The cause of death was unknown. No follow-up attempts are possible. Information about the lot/batch number cannot be obtained.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" is assessed as related to the suspect drug "BNT162B2" per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: The patient died two weeks after the second vaccination


VAERS ID: 1690006 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101167283

Write-up: death; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 84169], license party for Comirnaty. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 2 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 the patient''s concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. The death was not due to the vaccination. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the reported information ,a causal relationship between the event(death) and suspected drug cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1690067 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-07-19
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, COVID-19 pneumonia, Cardiac failure congestive, Chest X-ray, Dyspnoea, Respiratory tract infection, SARS-CoV-2 test, Urinary tract infection bacterial, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 5
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: Atrial fibrillation; Cardiac valvulopathy; Chronic heart failure; COVID-19; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Cardiomegaly; Comments: Cardiomegaly, pinched costophrenic angles with signs of bilateral vascular redistribution. Bilateral cottony infiltrates consistent with congestive heart failure plus bilateral pneumonia.; Test Date: 20210719; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ESPFIZER INC202101155602

Write-up: decompensation symptoms of congestive heart failure; atrial fibrillation with rapid ventricular response; associating urinary tract infection by E. Coli; probable lower respiratory tract infection; Vaccination failure; COVID-19 pneumonia; Dyspnea; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Agency (RA)-WEB ES-AEMPS-971210. A 90-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET1831), via an unspecified route of administration on 17Mar2021 as dose 2, single for COVID-19 immunisation. The patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP2163), via an unspecified route of administration on 24Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history included COVID-19 from Apr2020 to an unknown date, cardiac valve disease from an unknown date and unknown if ongoing , type 2 diabetes mellitus from an unknown date and unknown if ongoing , cardiac failure chronic from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing. The patient previously took sintrom, omeprazol, toujeo, bisoprolol. The patient concomitant medications were not reported. It was reported that the patient with the aforementioned history, referred by the point of continuous care due to an increase in her usual dyspnea from 5, according to her daughter. She denied increased edema in lower limbs and reduction in the rate of diuresis. She has not had a fever. Her daughter reported a dry cough for 48 hours, no urinary or digestive infectious symptoms. The patient was admitted contacting and droplet isolation, which was maintained after the positive result of the SARS CoV2 PCR performed in the emergency room. She also presented with bilateral SARS CoV2 pneumonia, decompensation symptoms of congestive heart failure and atrial fibrillation with rapid ventricular response, associating urinary tract infection by E. Coli and probable lower respiratory tract infection. From the first day of admission, the patient presented significant respiratory deterioration, requiring 02 at high flow and morphic chloride to control symptoms. The patient underwent lab tests and procedures which included Thorax X-ray: Cardiomegaly, pinched costophrenic angles with signs of bilateral vascular redistribution. Bilateral cottony infiltrates consistent with congestive heart failure plus bilateral pneumonia on 19Jul2021, COVID-19 PCR test: Positive on 19Jul2021. The patient received treatment with oxygen therapy, bronchodilators, corticosteroids, diuretics, LMWH and empirical antibiotic therapy with ceftriaxone and levofloxacin among others. Finally, the death of the patient was confirmed on 24Jul2021 at around 13:30 and the cause of death was significant respiratory deterioration. It was unknown if autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: significant respiratory deterioration


VAERS ID: 1690103 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-09-03
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101170757

Write-up: pulmonary edema; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patent''s uncle) through the Pfizer company doctor. A 14-year-old male patient received bnt162b2 (COMIRNATY), 1st dose on 06Jul2021 (Lot Number: EX0893) and 2nd dose on 27Jul2021 (Lot Number: EW2246, both via an unspecified route of administration as single dose for COVID-19 immunization. Medical history none. Concomitant medications were not reported. The patient experienced pulmonary edema (death) on 03Sep2021. The patient died on 03Sep2021. The autopsy revealed that the cause of death was pulmonary edema.; Reported Cause(s) of Death: pulmonary edema


VAERS ID: 1690107 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101125305

Write-up: death/ severe heart failure; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20214158. A 99-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in the left upper arm on 16Feb2021 (Batch/Lot Number: UNKNOWN) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Feb2021, the patient experienced death/ severe heart failure. The patient had severe heart failure; possibly she could not stand the vaccine. The patient died on 18Feb2021. Cause of death was severe heart failure. It was unknown 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: death/ severe heart failure


VAERS ID: 1690109 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Arthralgia, Cardiac discomfort, Condition aggravated, Death, General physical health deterioration, Peripheral vascular disorder, Skin ulcer, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis; Hypertension; Renal insufficiency; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101142861

Write-up: Death; Arrhythmia; Thrombosis leg; Arthralgia; General physical health deterioration; Cardiac discomfort; Circulatory disorder peripheral; Leg ulcer; Condition aggravated; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20214190. A 78-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: not reported) as dose 1, single for COVID-19 immunization. Medical history included hypertension, incipient vascular dementia, dialysis patient and renal insufficiency. The patient''s concomitant medications were not reported. The patient experienced arrhythmia, thrombosis leg, arthralgia, general physical health deterioration, cardiac discomfort, circulatory disorder peripheral and leg ulcer, the condition got aggravated on 17Jun2021. Due to side effects heart symptoms and arrhythmia the patient was under nitro treatment. The patient stated that she had severe pain and loss of function in the upper arm joints, cessation of blood flow to the legs, leg ulcers exploded in a week as they were successfully treated in hospital a week before the vaccination. After 2 months of vaccination the patient passed away. The cause of death was unknown. The outcome of all the events was fatal. No follow-up attempts are possible. No further information is expected. Batch/Lot number cannot be obtained. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1690112 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Dyspnoea, Fatigue, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal obesity; Cerebral infarction; Coronary artery disease; Dilated cardiomyopathy; Gout; Heart failure (due to which he was monitored by cardiology clinic); Hypertension; Left bundle branch block; Osteoarthritis knees; Prediabetes; Sleep apnea
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101131210

Write-up: Dyspnoea; Vaccination site pain; the death apparently due to heart diseases; Fatigue; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FI-FIMEA-20214242. A 60-years-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: FE3065), via intramuscular, administered in Arm on 22Jul2021 as dose number unknown, single for covid-19 immunization. The patient previously had multiple diseases of hypertension, abdominal obesity, sleep apnea, prediabetes, gout, osteoarthritis of both knees. In 2016, he suffered with a cerebral stroke. Left bundle branch block diagnosed, dilated cardiomyopathy, coronary artery disease, heart failure, due to which he was monitored by cardiology clinic. According to his wife, the vaccination did not cause problems to the husband. According to her, on 23Jul2021 his hand was a little sore on the upper arm after vaccination and in addition there was fatigue but no significant symptoms, nor did his wife notice any tendency to bruise. According to his daughter, the day after the vaccination, her father was tired and had shortness of breath and had also stopped smoking. His daughter considers it possible that her father had died of coronary artery disease but considers it important to determine whether corona vaccination has contributed to his death. This was communicated to a forensic doctor who said the death was unlikely to be vaccine related. A death certificate has already been made, the death apparently due to heart diseases. The outcome of the events dyspnea, vaccination site pain, the death apparently due to heart diseases and fatigue was reported as fatal. No follow-up attempts are possible. No further information is expected. Batch/Lot number has been obtained.; Sender''s Comments: Based on the information available the possibility of causal association between the fatal events fatigue dyspnea heart disease and the suspect drug BNT162B2 is assessed unrelated; Reported Cause(s) of Death: the death apparently due to heart diseases; Dyspnoea; Fatigue; Vaccination site pain


VAERS ID: 1690118 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-05-22
   Days after vaccination:114
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Chills, Cough, Cyanosis, Dysphagia, Hyperthermia, Oxygen saturation, Oxygen saturation decreased, Pain, Respiratory distress, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Cyst of kidney; Emphysema pulmonary; Ischaemic heart disease (with anterior interventricular stenting in 2000); Living in nursing home; Thyroid nodule; Varicose vein operation
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210524; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 20210525; Test Name: PCR covid test; Test Result: Positive ; Comments: but negative for the variants test (other locations).
CDC Split Type: FRPFIZER INC202101155071

Write-up: Respiratory distress; diffuse pain; Cyanosis of the extremities; swallowing disorders; saturation in ambient air at 96%; Vaccination failure; COVID-19; hyperthermia at 39?C; chills; hacking cough; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FR-AFSSAPS-AM20212360. A 88-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 28Jan2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE, dose 1 intramuscular on 08Jan2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Benign prostatic hyperplasia, Emphysema pulmonary, Varicose vein operation, Ischaemic heart disease (with anterior interventricular stenting in 2000), Thyroid nodule, Cyst of kidney, living in nursing home. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and covid-19 on 22May2021. On 22May2021, he presented with hyperthermia at 39?C with chills and a hacking cough. On 24May2021, Persistence of symptoms and saturation in ambient air at 96%. On 25May2021, PCR covid positive but negative for the variants test (other locations). On 26May2021, Cyanosis of the extremities and swallowing disorders. On 28May2021, Impenetrable saturation, diffuse pain. On 29May2021, Respiratory distress and cyanosis of the lower limbs. On 31May2021, Death. The patient underwent lab tests and procedures which included body temperature: 39 centigrade on 22May2021, oxygen saturation: 96 % on 24May2021, PCR covid test: positive on 25May2021 but negative for the variants test (other locations). The patient died on 31May2021 due to vaccination failure and covid-19. It was not reported if an autopsy was performed. Reporting contact by center for reconstruction of the clinical-biological history. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Covid-19; Vaccination failure


VAERS ID: 1690175 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214018 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CORTANCYL; NEORAL; ARTELAC [HYPROMELLOSE]; TOUJEO; ATORVASTATINE [ATORVASTATIN]; AMLODIPINE; CELLCEPT [MYCOPHENOLATE MOFETIL]; CHOLECALCIFEROL
Current Illness: Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Renal transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death NOS; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-BX20217553) on 04-Sep-2021 and was forwarded to Moderna on 04-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death NOS) in a 71-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214018) for Revaccination with different COVID-19 vaccine. The patient''s past medical history included Renal transplant. Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included PREDNISONE (CORTANCYL), CICLOSPORIN (NEORAL), HYPROMELLOSE (ARTELAC [HYPROMELLOSE]), INSULIN GLARGINE (TOUJEO), ATORVASTATINE [ATORVASTATIN], AMLODIPINE, MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) and CHOLECALCIFEROL for an unknown indication. On 13-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on 15-Aug-2021 The patient died on 15-Aug-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication taken by the patient included Fero Grad L P Vitamine C 500. No treatment information was provided. Company comment: Limited information regarding the event has been provided at this time and is insufficient for causality assessment. However, the patient''s comorbidities are risk factors and confounds causality assessment. Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Translation received on 07 Sep 2021 and does not contain any new information.; Sender''s Comments: Limited information regarding the event has been provided at this time and is insufficient for causality assessment. However, the patient''s comorbidities are risk factors and confounds causality assessment.; Reported Cause(s) of Death: death


VAERS ID: 1690179 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   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: Bone metastases; Prostate cancer metastatic
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101160469

Write-up: Cardio-respiratory arrest; massive pulmonary embolism; Acute dyspnea; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Agency (RA)-WEB FR-AFSSAPS-BX20218147. An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: Unknown), via intramuscular on 24Aug2021 at single dose for COVID-19 immunisation. The patient was resident in nursing home. Medical history included prostate cancer with bone metastases. The patient had no history of COVID-19. The patient''s concomitant medications were not reported. On 25Aug2021, 20 hours after first vaccination, the patient experienced acute dyspnea with cardio-respiratory arrest suggestive of massive pulmonary embolism. This report was serious - death. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 17Aug2021. The patient died on 25Aug2021. An autopsy was not 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: Cardio-respiratory arrest; massive pulmonary embolism; Acute dyspnea


VAERS ID: 1690181 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-08-12
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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: 2021-08-29
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute heart failure; Alzheimer''s disease; Aortic dilatation; Atrial fibrillation; Atrial flutter; COPD; Hemangioma; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101160442

Write-up: drug ineffectiveness; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other health care professional downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-CN20212868. A 84-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 10Feb2021 (Batch/Lot Number: EK9788) as dose 2, single; dose 1 intramuscular, administered in arm left on 19Jan2021 (Batch/Lot Number: EM0477) as dose 1, single for covid-19 immunisation. Medical history included Alzheimer''s, hemangioma of the cecum, atrial fibrillation and flutter, acute heart failure, thoracic aortic dilation, hypertension arterial, post-smoking chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. The patient with drug ineffectiveness following COVID-19 vaccine injection. Drug Ineffectiveness: Tested positive for covid-19 on 12Aug2021 during a generalized screening conducted as part of a cluster within the Accommodation facility for dependent elderly people. Cluster start date of 03Aug2021. Patient was asymptomatic at onset. First symptoms appeared on 17Aug2021, fever and decrease in oxygen saturation. Put on oxygen from 18Aug2021. The resident with cognitive problems was unable to keep his oxygen. From 20Aug2021, appearance of agitation in connection with hypoxia and persistent hyperthermia. Corticosteroid and antibiotic therapy were started on 24Aug2021. Still febrile, in respiratory distress and agitated. Hospitalization on 26Aug2021. Decision not to perform resuscitation. The patient comes home from the hospital on 28Aug2021 with a prescription of antibiotics, antipyretics, anticoagulants and an infusion. Death on 29Aug2021. The patient died on 29Aug2021. An autopsy was not performed. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; drug ineffectiveness


VAERS ID: 1690186 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-08-06
   Days after vaccination:169
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Productive cough, SARS-CoV-2 antibody test, SARS-CoV-2 test, Suspected COVID-19
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: 2021-08-11
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210806; Test Name: SARS-CoV-2 antigenic test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC202101160559

Write-up: Suspected COVID-19; Suspected COVID-19; Productive cough; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LL20216057. An 83-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: EM6950) on 18Feb2021 and the first dose of BNT162B2 (Lot Number: EM0477) on 28Jan2021, both via intramuscular at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, appearance of a productive cough. On 06Aug2021, the patient experienced suspected COVID-19 (test unknown results). The patient was hospitalized on 10Aug2021 and died on 11Aug2021. The patient underwent lab tests and procedures which included SARS-CoV-2 antigenic test: unknown results on 06Aug2021, SARS-CoV-2 RT-PCR test: unknown results on 06Aug2021. The patient died on 11Aug2021. It was not reported if an autopsy was performed. The outcome of events suspected COVID-19 was fatal. The outcome of event productive cough was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Suspected COVID-19; Suspected COVID-19


VAERS ID: 1690194 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-20
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Myocarditis, Oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 19
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: 20210114; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101155169

Write-up: Myocarditis; cardiac decompensation; edema; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-LY20219949 A 75-years-old female patient received second dose of BNT162B2 (COMIRNATY), via intramuscular, administered in right arm on 04Feb2021 (lot number: EJ6788) as dose 2, single for COVID-19 immunisation. Medical history was not reported. No history of COVID. SARS-CoV-2 test on 14Jan2021 was negative. Concomitant medications were not reported. On 20Feb2021 appearance of myocarditis leading to cardiac decompensation leading to edema leading to the death of the patient. The patient died in Feb2021. Cause of death was reported as edema on cardiac decompensation on myocarditis. Outcome of the events was fatal. It was unknown if an autopsy was done or not. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: edema on cardiac decompensation on myocarditis; edema on cardiac decompensation on myocarditis; edema on cardiac decompensation on myocarditis


VAERS ID: 1690202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-18
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; COVID-19; Dementia; Hypertension; Hypothyreosis; Comments: Demence HTA Arthrose Hypothyroidie
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: desaturation; Result Unstructured Data: Test Result:desaturation; Test Date: 20210818; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101160522

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB FR-AFSSAPS-MP20217029. A 90-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: EJ6788) via intramuscular on 15Feb2021 and the first dose of BNT162B2 (Lot number: unknown) on an unspecified date, both at single dose for COVID-19 immunisation. Medical history included COVID 19 variant delta infection, dementia, hypertension, arthrosis, hypothyreosis. The patient''s concomitant medications were not reported. On 18Aug2021, the patient experienced COVID-19 confirmed by positive COVID-19 test, rapid change of general condition, desaturation. This report was serious - death and hospitalized. The patient underwent lab tests and procedures which included desaturation on 18Aug2021, SARS-CoV-2 test: positive on 18Aug2021. Therapeutic measures were taken as a result of covid-19 confirmed by positive covid-19 test. 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. No further information is expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1690207 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1248 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood bicarbonate, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood lactic acid, Blood pH, Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, Computerised tomogram head, Electrocardiogram, Haemorrhagic transformation stroke, Heart rate, Oxygen saturation, PCO2, PO2, Pneumonia aspiration, Prothrombin time, Respiratory rate, SARS-CoV-2 test, 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: 2021-07-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: ALAT; Result Unstructured Data: Test Result:120 IU/l; Test Date: 20210719; Test Name: ASAT; Result Unstructured Data: Test Result:69 IU/l; Test Date: 20210719; Test Name: CO3-; Result Unstructured Data: Test Result:25; Test Date: 20210719; Test Name: chloride; Result Unstructured Data: Test Result:121 mmol/L; Test Date: 20210719; Test Name: CPK; Result Unstructured Data: Test Result:237; Test Date: 20210719; Test Name: creatinine; Result Unstructured Data: Test Result:117 umol/l; Test Date: 20210719; Test Name: lactates; Result Unstructured Data: Test Result:3 mmol/L; Test Date: 20210719; Test Name: pH; Result Unstructured Data: Test Result:7.53; Test Date: 20210719; Test Name: potassium; Result Unstructured Data: Test Result:4.7 mmol/L; Test Date: 20210719; Test Name: blood pressure; Result Unstructured Data: Test Result:133/94 mmHg; Test Date: 20210719; Test Name: sodium; Result Unstructured Data: Test Result:162 mmol/L; Test Date: 20210719; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210719; Test Name: Brain CT contrasted; Result Unstructured Data: Test Result:Old vast ischemic area; Comments: deep right temporoparietal with a thin plate of hemorrhagic reworking. Mass effect with flattening of the lateral ventricles. No commitment under falcoriel. No fracture of the arch or orbital floors.; Test Date: 20210719; Test Name: C-reactive protein; Result Unstructured Data: Test Result:81 mg/l; Test Date: 20210719; Test Name: ECG; Result Unstructured Data: Test Result:sinus tachycardia; Test Date: 20210719; Test Name: heart rate; Result Unstructured Data: Test Result:86; Comments: bpm; Test Date: 20210719; Test Name: oxygen saturation; Test Result: 88 %; Test Date: 20210719; Test Name: pCO2; Result Unstructured Data: Test Result:31; Test Date: 20210719; Test Name: pO2; Result Unstructured Data: Test Result:84; Test Date: 20210719; Test Name: PT; Test Result: 71 %; Test Date: 20210719; Test Name: respiratory rate; Result Unstructured Data: Test Result:52; Comments: bpm; Test Date: 20210719; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210719; Test Name: white blood cells; Result Unstructured Data: Test Result:21.1 g/dl; Test Date: 20210719; Test Name: white blood cells; Result Unstructured Data: Test Result:18 x10 9/l
CDC Split Type: FRPFIZER INC202101155884

Write-up: Pneumonia aspiration; Hemorrhagic conversion stroke; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NC20213881. A 64-year-old male patient received first dose of bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 05Jul2021 (Batch/Lot Number: FE1248) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced pneumonia aspiration on 20Jul2021, hemorrhagic conversion stroke on 19Jul2021. The patient was hospitalized for pneumonia aspiration, hemorrhagic conversion stroke from 19Jul2021 to an unknown date. Seriousness criteria of the events was death, hospitalization. The patient underwent lab tests and procedures which included blood pressure measurement: 133/94 mmhg on 19Jul2021, heart rate: 86 on 19Jul2021 bpm, respiratory rate: 52 on 19Jul2021 bpm, oxygen saturation: 88 % on 19Jul2021, body temperature: 37.7 centigrade on 19Jul2021, blood creatinine: 117 umol/l on 19Jul2021, blood sodium: 162 mmol/l on 19Jul2021, blood potassium: 4.7 mmol/l on 19Jul2021, blood chloride: 121 mmol/l on 19Jul2021, c-reactive protein: 81 mg/l on 19Jul2021, aspartate aminotransferase: 69 iu/l on 19Jul2021, alanine aminotransferase: 120 iu/l on 19Jul2021, white blood cell count: 18 x10 9/l on 19Jul2021, white blood cell count: 21.1 g/dl on 19Jul2021, blood creatine phosphokinase: 237 on 19Jul2021. Therapeutic measures were taken as a result of pneumonia aspiration, hemorrhagic conversion stroke. The patient died on 20Jul2021. It was not reported if an autopsy was performed. Patient notes: Sporty and autonomous patient with no particular history. Case Summary and Reporter''s Comments: Medically confirmed patient declaration. Background / History of the disease: Vaccination against COVID-19 with the Comirnaty* vaccine: dose 1 on 05Jul2021 lot FE1248 in the left arm. Clinical signs and chronology of events: Additional information: 64-year-old patient was found on the ground at his home on 19Jul2021 by firefighters due to no news from his family and neighbors for 2 days. He was aware, coherent and oriented when the SMUR (emergency medical and resuscitation service) intervened. He was found prone with signs of compression on the left side of the body (petechial purpura on the left thorax and stage 3 pressure sores in the left knee and left ear). The patient was hemiplegic on the left side and clinical examination found a positive left Babinski, left hemiface facial paralysis and left hemnegligence. The rest of the clinical examination is unremarkable, especially the neurological examination on the right. During his inpatient monitoring on 20Jul, the patient worsened on the respiratory level because of a probable inhalation pneumopathy requiring the establishment of oxygen therapy, antibiotic therapy as well as anti-secretory treatment due to bronchial congestion. Finally, faced with the refractory nature of the patient''s respiratory failure and on collegial consultation, a decision to abstain from treatment was taken. Biology / additional examinations / etiological research: Review of 19Jul2021: Clinical constants: BP 133/94 mmHg / HR 86 bpm / RR 52 bpm / SpO2 88% / T 37.7 C. Biology: creatinine 117 umol/L / Na + 162 mmol/L / K + 4.7 mmol/L / Cl- 121 mmol/L / CRP 81 mg/L / ASAT 69 IU/L / ALAT 120 IU/L / White blood cells 18 G/L / 21.1 g/dL / CPK 237 / PT 71%. Gasometry: pH 7.53 / pCO2 31 / pO2 84 / CO3- 25 / Lactates 3 mmol / L. ECG: sinus tachycardia. PCR covid negative. Brain CT contrasted: Old vast ischemic area, deep right temporoparietal with a thin plate of hemorrhagic reworking. Mass effect with flattening of the lateral ventricles. No commitment under falcoriel. No fracture of the arch or orbital floors. Summary of management: Intravenous rehydration with glucose serum / management of pressure ulcers / clinical monitoring / Treatment of respiratory distress in inhalation pneumonia. Evolution: Death on 20Jul2021. Conclusion: 64-year-old patient with no significant history presenting 2 weeks after his first injection of the Comirnaty* vaccine with an overwhelmed massive ischemic stroke with secondary hemorrhagic change as well as inhalation pneumonia which led to his death. The pharmacovigilant notes: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures; Reported Cause(s) of Death: Pneumonia aspiration; Hemorrhagic conversion stroke


VAERS ID: 1690222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood bilirubin, Blood bilirubin increased, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood lactate dehydrogenase increased, Blood pressure increased, Blood pressure measurement, Cerebral haematoma, Coagulation factor VIII level, Coma scale, Coma scale abnormal, Computerised tomogram head, Electrocardiogram, Extra dose administered, Haemoglobin, Haemoglobin decreased, Haptoglobin, Haptoglobin decreased, Headache, Heart rate, Heart rate increased, Heart sounds abnormal, Loss of consciousness, Off label use, Oxygen saturation, Physical examination, Platelet count, Platelet count decreased, Prothrombin time ratio, Urinary incontinence, Vomiting, White blood cell count, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Acute pancreatitis (narrow), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Biliary system related investigations, signs and symptoms (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ANDROCUR; LOPRESSOR LP; ENALAPRIL; TRULICITY; GLIMEPIRIDE; ELIQUIS; LIPTRUZET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Aortic aneurysm; Aortic stenosis; Prostate adenoma; Spontaneous haematoma; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result:2.71; Test Date: 20210827; Test Name: bilirubin; Result Unstructured Data: Test Result:42 umol/l; Comments: including 18 of conjugate therefore predominantly free.; Test Date: 20210828; Test Name: fibrinogen; Result Unstructured Data: Test Result:1.9 g/l; Comments: fibrinogen monomer 20.23 ug / ml (N <6 ug / ml); Test Date: 20210828; Test Name: hypoglycemia; Result Unstructured Data: Test Result:no hypoglycemia; Test Date: 20210827; Test Name: LDH dosage; Result Unstructured Data: Test Result:507 IU/l; Test Date: 20210828; Test Name: Blood pressure; Result Unstructured Data: Test Result:190 / 90 mmHg; Test Date: 20210828; Test Name: factor VIII; Result Unstructured Data: Test Result:<1 %; Test Date: 20210828; Test Name: Glasgow score evaluated; Result Unstructured Data: Test Result:5; Test Date: 20210828; Test Name: Cerebral CT; Result Unstructured Data: Test Result:Subdural hematoma; Comments: of the right convexity of 22mm maximum thickness exerting a mass effect on the median structures with compression of the right lateral ventricle and falcorial engagement at 15 mm, right internal temporal engagement.; Test Date: 20210828; Test Name: ECG; Result Unstructured Data: Test Result:rhythm in AF, no conduction or repolarization dis; Test Date: 20210828; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.4 g/dl; Test Date: 20210827; Test Name: Haptoglobin; Result Unstructured Data: Test Result:<0.1 g/l; Test Date: 20210828; Test Name: Heart rate; Result Unstructured Data: Test Result:150; Comments: bpm; Test Date: 20210828; Test Name: saturation; Test Result: 98 %; Comments: in ambient air; Test Date: 20210828; Test Name: physical examination; Result Unstructured Data: Test Result:Supple, depressible and painless abdomen; Comments: Pupils areactive, left miosis; Vomiting of food. Auscultatory focus on the right. Irregular heart sounds without breath.; Test Date: 20210827; Test Name: Platelets; Result Unstructured Data: Test Result:118 x10 9/l; Test Date: 20210828; Test Name: Platelets; Result Unstructured Data: Test Result:119 x10 9/l; Test Date: 20210828; Test Name: Prothrombin Ratio; Test Result: 88 %; Test Date: 20210828; Test Name: Leukocytes; Result Unstructured Data: Test Result:18.9 x10 9/l
CDC Split Type: FRPFIZER INC202101168154

Write-up: Cerebral Hematoma; Loss of consciousness; glasgow score evaluated: 5; blood pressure: 190 / 90 mmHg; heart rate: 150 bpm; Eneuresis; hemoglobin: 9.4 g/dl; Irregular heart sounds; leukocytes: 18.9 x10 9/l; Vomiting; bilirubin: 42 (including 18 of conjugate therefore predominantly free); platelets: 118 x10 9/l, 119 x10 9/l; headache; lactate dehydrogenase (LDH) dosage: 507 IU/l; haptoglobin: <0.1 g/l; off label use; extra dose administered; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-PO20214533. This physician reported different dose and events for the same patient. This is the second of two reports for the third dose. An 83-year-old male patient received the third dose of BNT162B2 (COMIRNATY, Lot Number: Unknown) on 26Aug2021 at single dose for COVID-19 immunisation. Medical history included AFib, prostatic adenoma, aortic stenosis, spontaneous haematoma, type II diabetes mellitus, aortic aneurysm. Concomitant medications included cyproterone acetate (ANDROCUR, strength: 50 mg) at 50 mg once daily; metoprolol tartrate (LOPRESSOR LP, strength: 200 mg) at 200 mg once daily; enalapril at 20/10 mg, once daily; dulaglutide (TRULICITY, strength: 1.5 mg) at 1 DF weekly; glimepiride (strength: 3 mg) at 3 mg once daily; apixaban (ELIQUIS, strength: 5 mg) at 5 mg twice daily; atorvastatin calcium, ezetimibe (LIPTRUZET, strength: 40 mg/10 mg, formulation: tablet) at 1 tablet once daily. The patient previously received the second dose of BNT162B2 (Lot Number: Unknown), via intramuscular on 17Apr2021 at 0.3 ml single dose for COVID-19 immunisation and experienced acquired haemophilia A with anti factor VIII, urinary tract infection. The patient experienced headache on 27Aug2021. On 28Aug2021, loss of consciousness of the patient found unconscious with vomiting and enuresis with a Glasgow score evaluated at 5. The patient also experienced off label use and extra dose administered on 26Aug2021. This report was serious - death. The patient underwent lab tests and procedures which included bilirubin: 42 (including 18 of conjugate therefore predominantly free) on 27Aug2021, lactate dehydrogenase (LDH) dosage: 507 IU/l on 27Aug2021, haptoglobin: <0.1 g/l on 27Aug2021, platelets: 118 x10 9/l on 27Aug2021, activated partial thromboplastin time: 2.71 on 28Aug2021, fibrinogen: 1.9 g/l (fibrinogen monomer 20.23 ug/ml (N <6 ug/ml)) on 28Aug2021 , hypoglycemia: no hypoglycemia on 28Aug2021, blood pressure: 190/90 mmHg on 28Aug2021, factor VIII: <1 % on 28Aug2021, glasgow score evaluated: 5 on 28Aug2021, cerebral computerised tomogram (CT): subdural hematoma of the right convexity of 22mm maximum thickness exerting a mass effect on the median structures with compression of the right lateral ventricle and falcorial engagement at 15 mm, right internal temporal engagement on 28Aug2021, electrocardiogram (ECG): rhythm in AF, no conduction or repolarization dis on 28Aug2021, hemoglobin: 9.4 g/dl on 28Aug2021, heart rate: 150 bpm on 28Aug2021, saturation: 98 % (in ambient air) on 28Aug2021, physical examination: supple, depressible and painless abdomen (Pupils areactive, left miosis; Vomiting of food. Auscultatory focus on the right. Irregular heart sounds without breath) on 28Aug2021, platelets: 119 x10 9/l on 28Aug2021, prothrombin ratio: 88% on 28Aug2021, leukocytes: 18.9 x10 9/l on 28Aug2021. Therapeutic measures were taken as a result of events. The patient''s death was noted on 28Aug2021. It was not reported if an autopsy was performed. Cause of death was reported as cerebral hematoma. The outcome of event cerebral hematoma was fatal. The outcome of other events was unknown. Follow-up (06Sep2021): New information received from a contactable physician downloaded from Regulatory Authority WEB FR-AFSSAPS-PO20214533 includes seriousness criteria updated to death, cause of death updated. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101142938 same patient, different dose number( 3rd); Reported Cause(s) of Death: Cerebral Hematoma


VAERS ID: 1690234 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Atrial fibrillation, Blood pressure measurement, Body temperature, Bundle branch block right, C-reactive protein, COVID-19, COVID-19 pneumonia, Drug ineffective, Electrocardiogram, Haemoglobin, Hypotension, Metabolic acidosis, Oxygen saturation, Respiratory rate, SARS-CoV-2 test, Troponin
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Conduction defects (narrow), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRACLEER [BOSENTAN]; TADALAFIL; FUROSEMIDE; DIFFU K; CORTANCYL; CHOLECALCIFEROL; DILTIAZEM; RAMIPRIL; ALLOPURINOL; PANTOPRAZOLE; DESLORATADINE; TARDYFERON B9 [FERROUS SULFATE;FOLIC ACID]; MAGNE B6 [MAGNESIUM LACTATE;PYRIDOXINE HYDROCHLORIDE
Current Illness: Angiodysplasia; Chronic renal failure; Hemorrhage of digestive tract; Pulmonary arterial hypertension; Raynaud''s phenomenon; Scleroderma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: blood pressure; Result Unstructured Data: Test Result:arterial hypotension; Test Date: 202108; Test Name: Temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 202108; Test Name: CRP; Result Unstructured Data: Test Result:$g40 mg/l; Test Date: 202108; Test Name: ECG; Result Unstructured Data: Test Result:atrial fibrillation with right bundle branch block; Test Date: 202108; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.8 g/dl; Test Date: 202108; Test Name: SpO2; Test Result: 96 %; Comments: under 1 L/min; Test Date: 202108; Test Name: respiratory rate; Result Unstructured Data: Test Result:33; Comments: /min; Test Date: 20210809; Test Name: covid-19 PCR; Test Result: Positive ; Comments: Mutation L452R Presence, Mutation E484Q Absence, Mutation E484K Absence; Test Date: 202108; Test Name: Troponin; Result Unstructured Data: Test Result:229
CDC Split Type: FRPFIZER INC202101155948

Write-up: positive COVID-19 PCR; positive COVID-19 PCR; SARS-CoV-2 pneumonia; arterial hypotension; atrial fibrillation; abdominal pain; metabolic acidosis; right bundle branch block; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20212569. A 62-years-old female patient received the second dose of BNT162B2 (COMIRNATY) intramuscular on Mar2021 (batch/lot number: unknown) as dose 2, single; the first dose intramuscular on an unspecified date (batch/lot number: unknown) as dose 1, single for covid-19 immunisation. Medical history included ongoing angiodysplasia, ongoing dermatosclerosis/multi-complicated scleroderma, ongoing raynaud''s phenomenon, ongoing Pulmonary arterial hypertension, ongoing chronic renal failure, ongoing digestive bleeding. Medical history of allergy unknown. Medical history of COVID-19 was no. Concomitant medications included bosentan (TRACLEER); tadalafil; furosemide Tablet; potassium chloride (DIFFU K, tablet); prednisone (CORTANCYL); cholecalciferol; diltiazem tablet; ramipril tablet; allopurinol; pantoprazole; desloratadine tablet; ferrous sulfate/folic acid (TARDYFERON B9, tablet); magnesium lactate/pyridoxine hydrochloride (MAGNE B6, tablet); folic acid (SPECIAFOLDINE, tablet); alginic acid/aluminium hydroxide (GAVISCON); diosmectite (SMECTA). The patient experienced positive covid-19 PCR (death, hospitalization, medically significant) on 09Aug2021, sars-cov-2 pneumonia (death, hospitalization, medically significant) on 09Aug2021. The events covid-19 PCR and sars-cov-2 pneumonia resulted in physician office visit. The event clinical course was as follows: On 06Aug2021, the patient presents with diarrhea as well as a fever which motivates her to consult on 09Aug2021. SARS-CoV-2 pneumonia is diagnosed after a positive COVID-19 PCR. The patient was hospitalized with arterial hypotension, a transition to rapid atrial fibrillation with the need for vascular filling with 1.5L of crystalloids. She is transfused with 1 concentrated red blood cells due to hemoglobin of 6.8g/dL on chronic digestive bleeding. SpO2: 96% under 1 L/min, respiratory rate: 33 /min, Temperature: 40 Centigrade, Troponin: 229, ECG: atrial fibrillation with right bundle branch block. Initiation of an anti-inflammatory treatment in front of an oxygen dependence$g 3 L/min and a rapid increase in O requirements and a biological inflammatory syndrome (CRP $g40 mg/L) with DEXAMETHASONE 6 mg IV, day 0 on 12Aug2021. Unfavorable development with sudden worsening on the night of 11 to 12Aug2021 on the respiratory level with metabolic acidosis and associated abdominal pain, requiring the implementation of post-challenge comfort care by the medical resuscitation team in connection with the patient''s comorbidities. The patient was hospitalized from Aug2021 for the events positive covid-19 PCR, sars-cov-2 pneumonia, arterial hypotension, atrial fibrillation. The patient died on 12Aug2021. It was not reported if an autopsy was performed. Therapeutic measures were taken as a result of positive covid-19 PCR, sars-cov-2 pneumonia, arterial hypotension, atrial fibrillation. The patient underwent lab tests and procedures which included temperature: 40 centigrade on Aug2021, CRP: $g40 mg/l on Aug2021, ECG: atrial fibrillation with right bundle branch block on Aug2021, hemoglobin: 6.8 g/dl on Aug2021, SpO2: 96 % under 1 L/min on Aug2021, respiratory rate: 33/min on Aug2021, covid-19 PCR: positive (Mutation L452R Presence, Mutation E484Q Absence, Mutation E484K Absence) on 09Aug2021, troponin: 229 on Aug2021, blood pressure: arterial hypotension on Aug2021. Outcome of the events positive covid-19 PCR and sars-cov-2 pneumonia was fatal; of the events arterial hypotension, atrial fibrillation, right bundle branch block, abdominal pain, metabolic acidosis was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: positive COVID-19 PCR; positive COVID-19 PCR; SARS-CoV-2 pneumonia


VAERS ID: 1690235 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-08-09
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood lactate dehydrogenase, C-reactive protein, COVID-19, COVID-19 pneumonia, Electrocardiogram, Fibrin D dimer, Oxygen saturation, Respiratory rate, SARS-CoV-2 test, Troponin, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   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: FUROSEMIDE; DIFFU K; AMLOR; URAPIDIL; PLAVIX; TAHOR; BISOPROLOL; TOUJEO; NOVORAPID; ALLOPURINOL
Current Illness: Gout flare; Hypercholesterolaemia; Ischaemic heart disease (with bi-truncular lesions, active stent on the distal common trunk); Obesity; Type 2 diabetes mellitus (unbalanced insulin-dependent type II diabetes mellitus)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute prerenal failure (acute renal failure on acute tubular necrosis after coronary angiography); Ex-smoker (smoking cessation 25 packs annually); Haemorrhage of digestive tract (high digestive hemorrhage on ulcer of the posterior surface of the bulb Forrest 2c); Hypertension arterial (complicated hypertension); Kidney failure chronic (moderate chronic renal failure (vascular nephropathy or cardio-renal syndrome); Pneumopathy (undocumented recurrent acute community lung disease); Tabaquism (smoking cessation 25 packs annually)
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: LDH; Result Unstructured Data: Test Result:8.6 mmol/L; Test Date: 20210809; Test Name: C-reactive protein; Result Unstructured Data: Test Result:$g40 mg/l; Test Date: 20210809; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm, regular; Comments: sinus rhythm, regular, incomplete right bundle branch block; Test Date: 20210809; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1207 ng/L; Test Date: 20210809; Test Name: SpO2; Test Result: 87 %; Comments: under 15 L/min; Test Date: 20210809; Test Name: respiratory rate; Result Unstructured Data: Test Result:35/min; Test Date: 20210809; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Mutation L452R Presence Mutation E484Q Absent E484K mutation Absent; Test Date: 20210809; Test Name: Troponin; Result Unstructured Data: Test Result:173 ng/L
CDC Split Type: FRPFIZER INC202101156004

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; SARS-CoV-2 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20212574. An 81-year-old male patient received BNT162B2 (COMIRNATY) second dose Intramuscular in Apr2021 at single dose, first dose Intramuscular in Mar2021 at single dose for COVID-19 immunisation. Medical history included Kidney failure chronic (moderate chronic renal failure (vascular nephropathy or cardio-renal syndrome), Pneumopathy (undocumented recurrent acute community lung disease), Hypertension arterial (complicated hypertension), Haemorrhage of digestive tract (high digestive hemorrhage on ulcer of the posterior surface of the bulb Forrest 2c), ongoing Obesity, ongoing Ischaemic heart disease (with bi-truncular lesions, active stent on the distal common trunk), ongoing Type 2 diabetes mellitus (unbalanced insulin-dependent type II diabetes mellitus), Tabaquism (smoking cessation 25 packs annually), ongoing Hypercholesterolaemia, ongoing Gout flare, Acute prerenal failure (acute renal failure on acute tubular necrosis after coronary angiography (iodine injection and Angiotensin-converting enzyme inhibitor), ex smoker (smoking cessation 25 packs annually). No history of allergy. History of COVID-19: no. Test for COVID 19: not specified. On 09Aug2021, the patient was hospitalized for fever and dyspnea. Documented SARS-CoV-2 pneumonia with a positive COVID-19 PCR was finally diagnosed. respiratory rate at 35/min, SpO2 at 87% under 15 L/min. Dyspnea related to cardiac overload, start of depletion with LASILIX 500mg IVSE. Polypneic patient on 15L/min high mask, crackles at both bases, active abdominal expiration. Muffled heart sounds, ankle edema taking the bucket, no mottling. Abdomen distended, tympanic, not painful, no transit disorder. Patient conscious. Troponin: 173 ng/L; Blood lactate dehydrogenase: 8.6 mmol/L; D-dimer: 1207 ng/L. ECG: sinus rhythm, regular, incomplete right bundle branch block. Initiation of anti-inflammatory treatment in view of oxygen dependence $g3 L/min and a rapid increase in O2 requirements and a biological inflammatory syndrome (C-reactive protein $g40 mg/L) PREDNISOLONE 1 mg/kg/d, Day 0 on 10Aug2021. Continued hydrosodic depletion, not allowing correction of hypoxemia. Unfavorable evolution with progressive desaturation despite oxygen therapy at 15L/min with associated respiratory distress, requiring the beginning of comfort care. Death on 11Aug2021. Mutation L452R Presence. Mutation E484Q Absent. E484K mutation Absent. Subject to further investigations that may be carried out in the context of legal or amicable compensation procedures. No follow-up attempts are possible, Information about lot/batch# cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; SARS-CoV-2 pneumonia


VAERS ID: 1690241 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Glomerular filtration rate, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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: ORACILLINE [PHENOXYMETHYLPENICILLIN]; LASILIX [FUROSEMIDE]; NEBIVOLOL; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Appendicitis perforated; Bronchitis chronic; Cataracts; Chronic pain; Chronic renal failure (stage IV (usual GFR 25-30ml / min)); Cognitive disorder; Dyslipidaemia; Erysipelas (repeatedly, on long-term ORACILLINE since 2018); Hospitalization; Hypertension arterial; Hypertensive heart disease NOS; Hyperuricaemia; Hyponatremia; Hypothyroidism; Hysterectomy (fibromatous uterus); Morbid obesity; Polydipsia psychogenic; Sacroiliitis
Allergies:
Diagnostic Lab Data: Test Name: GFR; Result Unstructured Data: Test Result:32 mL / min
CDC Split Type: FRPFIZER INC202101155518

Write-up: Pulmonary oedema aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-ST20213179. A 86-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 06May2021 (Batch/Lot Number: ET6956) as dose 2, 0.3 ml, single for covid-19 immunisation. Medical history included dyslipidaemia, hysterectomy, fibromatous uterus, pain, appendicitis perforated, sacroiliitis, chronic kidney disease, stage IV (usual GFR 25-30ml / min), atrial fibrillation, cataract, hypertension, cognitive disorder. The patient with a heavy cardiac history; had been hospitalized from 19Feb to 08Apr2021 for a short geriatric stay for: anti-coagulated AFib by ELIQUIS 2.5mg x2 / d. Increase in NEBIVOLOL to 3.75 mg and post-hypertension heart disease with LVEF preserved. Diastolic dysfunction justifying long-term treatment with LASILIX 20mgx2 / d. She presented with iatrogenic hyponatremia over LASILIX overdose with compensatory potomania. Previously had furosemide 250-80-0. Episode of functional acute renal failure in chronic on dehydration of favorable evolution. GFR 32 mL / min at discharge. The patient residing in EHPAD (accommodation facility for dependent elderly people) had been transferred on 05May2021 to follow-up and rehabilitation care for re-empowerment. Concomitant medication(s) included phenoxymethylpenicillin (ORACILLINE [PHENOXYMETHYLPENICILLIN]) taken for erysipelas from 2018 to an unspecified stop date; furosemide (LASILIX [FUROSEMIDE]) at 20mgx2 /day taken for diastolic dysfunction, start and stop date were not reported; nebivolol (NEBIVOLOL) at 3.75 mg taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS) at 2.5mg x2 /day taken for atrial fibrillation, start and stop date were not reported. The patient experienced pulmonary oedema aggravated (pulmonary oedema) (death) on 08May2021. The declarant reported an acute pulmonary edema on 08May2021 and death on 09May2021 (comfort care had been decided with the family). Call from the doctor who took care of the patient from 05May2021. Patient transferred from her nursing home for rehabilitation trial. Patient with many cardiovascular risk factors in particular. Following the telephone interview, we were informed of a worsening of an acute pulmonary edema (already present before her hospitalization), following the vaccination of this patient who was improving before the vaccination with a decrease in the need for diuretics. Acute pulmonary edema-type heart failure considered cause of death. The patient underwent lab tests and procedures which included glomerular filtration rate: 32 ml / min. The patient died on 09May2021. An autopsy was not performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Pulmonary oedema aggravated; heart failure type acute lung edema


VAERS ID: 1690250 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-07-12
   Days after vaccination:129
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Asthenia, Blood creatinine, Blood potassium, Blood sodium, C-reactive protein, Computerised tomogram, Condition aggravated, Diarrhoea, Disturbance in attention, Electrocardiogram, Electroencephalogram, Glomerular filtration rate, Haemoglobin, Hypernatraemia, Hypokalaemia, Investigation, Lumbar puncture, Magnetic resonance imaging, N-terminal prohormone brain natriuretic peptide, Nephrotic syndrome, Sepsis
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), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Proteinuria (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS; DAFALGAN CODEINE; ASPIRIN [ACETYLSALICYLIC ACID]; CORDARONE; URAPIDIL; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Arthrosis; Carotid artery atheroma (Carotidian atheroma at subclavian muscle); Carpal tunnel syndrome; Disease coronary artery; Femoropopliteal artery bypass; Hypertension arterial; Osteoporosis; Peripheral arterial occlusive disease; Proteinuria; Renal colic; Tumorectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Creatinine; Result Unstructured Data: Test Result:145 umol/l; Test Date: 20210726; Test Name: Kalaemia; Result Unstructured Data: Test Result:2.7 mmol/L; Test Date: 20210726; Test Name: Natremia; Result Unstructured Data: Test Result:148 mmol/L; Test Name: cerebral Computed Tomography scan; Result Unstructured Data: Test Result:not find any anomaly; Test Date: 20210726; Test Name: c-reactive protein; Result Unstructured Data: Test Result:66 mg/l; Comments: improving; Test Date: 20210726; Test Name: electrocardiogram; Result Unstructured Data: Test Result:shows a trace of known atrial fibrillation ...; Comments: shows a trace of known atrial fibrillation without disturbance of conduction and repolarization; Test Date: 20210715; Test Name: electroencephalogram; Result Unstructured Data: Test Result:eliminate a comitiality; Test Date: 20210715; Test Name: electroencephalogram; Result Unstructured Data: Test Result:eliminate a comitiality; Test Date: 20210726; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:30 ml/min; Test Date: 20210722; Test Name: anemia; Result Unstructured Data: Test Result:9.3 g/dl; Test Date: 20210726; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7 g/dl; Test Name: neurological picture; Result Unstructured Data: Test Result:remains unchanged; Test Date: 20210730; Test Name: picture of tetra pyramidal syndrome; Result Unstructured Data: Test Result:impaired vigilance; Comments: swallowing accompanied by a rapidly progressive onset nephrotic syndrome; Test Date: 20210715; Test Name: lumbar puncture; Result Unstructured Data: Test Result:does not find an abnormality; Comments: of the infectious line but a slightly increased proteinorachia; Test Name: cerebral Magnetic Resonance Imaging; Result Unstructured Data: Test Result:not find any anomaly; Test Date: 20210726; Test Name: NTproBNP; Result Unstructured Data: Test Result:20000 pg/mL
CDC Split Type: FRPFIZER INC202101155962

Write-up: Vigilance decreased; sepsis; Hypernatraemia; Hypokalaemia; acute respiratory failure; Aggravation of existing disorder; Nephrotic syndrome; asthenia; Acute diarrhea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority number FR-AFSSAPS-TO20217410. A 78-year-old female patient received bnt162b2 (COMIRNATY), second single dose intramuscularly, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EP2166) for covid-19 immunisation. Co-suspect drugs included hydrochlorothiazide (ESIDREX) 25 mg tablet, orally from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date at 1 dose form once daily for an unspecified indication and amlodipine besilate, valsartan (EXFORGE) 10mg/160mg coated tablet, orally from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 1 dose form once daily for an unspecified indication. Medical history included osteoporosis, arterial hypertension with proteinure, carotid artery atheroma (carotidian atheroma at subclavian muscle), disease coronary artery, peripheral arterial occlusive disease (arteriopathy obliterating of the lower limbs), renal colic (nephretic colic), arthrosis, bilateral femoro-popliteal bypass, carpal tunnel operated, appendectomy and right breast tumorectomy. Concomitant medications included apixaban (ELIQUIS); codeine phosphate, paracetamol (DAFALGAN CODEINE); acetylsalicylic acid] (ASPIRIN); amiodarone hydrochloride (CORDARONE); urapidil and atorvastatin. On 14Jul2021, the patient presented in a context of asthenia, a few days earlier, an episode of diarrheal debacle on 12Jul2021 followed by a delirium syndrome (cerebral Computed Tomography scan then cerebral Magnetic Resonance Imaging). The patient was hospitalization on 15Jul2021, The imaging workup will not find any anomaly. The biological assessment will highlight acute renal failure, unusual in this patient. Faced with an atypical neurological picture associating fluctuation in vigilance, language disorders, abnormal movements and suspicion of clonies, 2 EEGs (electroencephalogram) will eliminate a comitiality. The lumbar puncture does not find an abnormality of the infectious line but a slightly increased proteinorachia. The patient will present with sepsis with an unspecified starting point. Faced with the worsening of the general condition in a context of severe sepsis, the patient is transferred to intensive care. Antibiotic therapy with tazocilline and daptomycin. The neurological picture remains unchanged. On 22Jul2021: acute respiratory failure without hydro-electrolyte disturbance and anemia at 9.3g / dl. On 26Jul2021: lab test included Blood ionogram: Natremia at 148 mmol / l, Kalaemia at 2.7 mmol / l, Blood Formula Count: Hemoglobin at 7 g / dl, the patient received 3 red blood cells. Renal function: Creatinine at 145 umol / l, Glomerular filtration rate at 30 ml / min, Protein electrophoresis: NT pro BNP (N-terminal pro B-type natriuretic peptide) at 20,000 pg / ml, C-Reactive Protein at 66 mg / l, improving. The electrocardiogram (ECG) shows a trace of known atrial fibrillation without disturbance of conduction and repolarization. After specialist advice, a possible neuroinflammatory pathology is mentioned. On 30Jul2021: Biological inflammatory syndrome with favorable outcome under tazocilline. Transfer on 30Jul2021 for a picture of tetra pyramidal syndrome with impaired vigilance and swallowing accompanied by a rapidly progressive onset nephrotic syndrome. The presence of antiSSA (anti-Sjogren''s-syndrome A antibodies) justifying the initiation of corticosteroids in the hypothesis of inflammatory disease was found in the autoimmune assessment. Despite this treatment, we observed a rapid deterioration in the clinical condition with the appearance of respiratory pauses on 03Aug2021. After collegial discussion there was no harsh treatment. The death is declared on 12Aug2021. The cause of death were nephrotic syndrome and aggravation of existing disorder. No autopsy was performed. The action taken in response to the events for and amlodipine besilate, valsartan was unknown. outcome of the events vigilance decreased was not recovered, of the event acute diarrhea was recovering, while of the other events was unknown. No follow-up attempts are needed. No further information is expected. ; Reported Cause(s) of Death: Nephrotic syndrome; Aggravation of existing disorder


VAERS ID: 1690257 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-06-11
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: cardiac check-up; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC202101165167

Write-up: Sudden death; This spontaneous report is received from a contactable consumer who reported for her husband. An adult male patient received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on 10May2021 18:30 (Batch/Lot number and expiration date were not reported) as a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sudden death on 11Jun2021 09:15. The patient died on 11Jun2021. An autopsy was performed and results were not provided. The patient underwent lab tests and procedures which included cardiac check-up: unknown results on 20Apr2021. Clinical course: She reported that her husband (age not reported) died on 11Jun2021 at 9h15 am of sudden death on public road while his jogging (practiced for 10 years every 2-3 days). His heart did not re-start after cardiac massage at the place by nurse and intervention of the firefighters within 3 minutes. It had been one month (D31) since he received 1st dose of vaccine Comirnaty on 10May2021 at around 18h30. He had made cardiac check-up on 20Apr2021. An autopsy was done. Investigation was ongoing . Reporter stated that her husband was in good health and wanted to understand what happened. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1690460 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident, Headache
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: 2021-01-27
   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: INDAPAMIDA; NAPROXEN; RAMIPRIL; TAMSULOSIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Stroke; This case was received via regulatory authority MHRA-ADR 25867765) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included INDAPAMIDE (INDAPAMIDA), RAMIPRIL and TAMSULOSIN for Hypertension, NAPROXEN for Pain. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death and medically significant). On an unknown date, the patient experienced HEADACHE (Headache). The patient died on 27-Jan-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. At the time of death, HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient suffered a massive stroke. She was sedated and underwent a craniotomy to reduce pressure and she recovered. On 25 Jan 2021, she appeared to be brain dead. On 27 Jan 2021, life support was removed. Patient might not have taken blood pressure tablets prior. Patient has not tested positive for COVID-19 since having the vaccine Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: Stroke


VAERS ID: 1690607 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-08-06
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Cough, Dizziness, Hyperhidrosis, Myocardial infarction, Myocardial ischaemia, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VICTOZA; OLANZAPINE
Current Illness: Chronic obstructive pulmonary disease; Type 2 diabetes mellitus (Under medical treatment for diabetes type 2.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRMODERNATX, INC.MOD20213

Write-up: Heart attack; Myocardial ischemia; Weakness; Dizziness; Runny nose; Cough; Chest discomfort; Sweating; High fever; This case was received via the Regulatory Authority (Reference number: GR-GREOF-20216880) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), MYOCARDIAL ISCHAEMIA (Myocardial ischemia), ASTHENIA (Weakness), DIZZINESS (Dizziness), RHINORRHOEA (Runny nose), COUGH (Cough), CHEST DISCOMFORT (Chest discomfort), HYPERHIDROSIS (Sweating) and PYREXIA (High fever) in a 43-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Chronic obstructive pulmonary disease and Type 2 diabetes mellitus (Under medical treatment for diabetes type 2.). Concomitant products included LIRAGLUTIDE (VICTOZA) and OLANZAPINE for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant) and MYOCARDIAL ISCHAEMIA (Myocardial ischemia) (seriousness criteria death and medically significant). On an unknown date, the patient experienced ASTHENIA (Weakness) (seriousness criteria death and medically significant), DIZZINESS (Dizziness) (seriousness criteria death and medically significant), RHINORRHOEA (Runny nose) (seriousness criteria death and medically significant), COUGH (Cough) (seriousness criteria death and medically significant), CHEST DISCOMFORT (Chest discomfort) (seriousness criteria death and medically significant), HYPERHIDROSIS (Sweating) (seriousness criteria death and medically significant) and PYREXIA (High fever) (seriousness criteria death and medically significant). The patient died on 06-Aug-2021. The reported cause of death was Heart attack and Myocardial ischemia. An autopsy was performed, but no results were provided. No treatment information was provided. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was not applicable. Company Comment: This is a case of death in a 43 -year-old male subject with a hx of Chronic obstructive pulmonary disease and Type 2 diabetes mellitus was under medical treatment for diabetes type 2, who died 84 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No further information has been requested. Event outcome is inaccurately reported in the source document for some of the reported events; Asthenia, Dizziness, Rhinorrhoea, Cough, Chest discomfort, Hyperhidrosis and Pyrexia.; Sender''s Comments: This is a case of death in a 43 -year-old male subject with a hx of Chronic obstructive pulmonary disease and Type 2 diabetes mellitus was under medical treatment for diabetes type 2, who died 84 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No further information has been requested. Event outcome is inaccurately reported in the source document for some of the reported events; Asthenia, Dizziness, Rhinorrhoea, Cough, Chest discomfort, Hyperhidrosis and Pyrexia.; Reported Cause(s) of Death: Heart attack; Myocardial ischemia


VAERS ID: 1690769 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-14
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210915619

Write-up: INFARCTION; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, IT-MINISAL02-780373) on 08-SEP-2021 concerned a 71 year old male of unspecified race and ethnic origin. The patient''s weight was 50 kilograms, and height was 164 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: EY7065, expiry: unknown) 1 dosage forms, frequency 1 total administered on 14-MAY-2021 for covid-19 vaccination. No concomitant medications were reported. On 14-MAY-2021, the patient experienced infarction. On an unspecified date, the patient died from infarction. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of infarction. This report was serious (Death).; Reporter''s Comments: Admitted for Alzheimer''s disease, he had a heart condition with mechanical aortic valve and fell before the vaccine, breaking his hip. The vaccine was not meant to be done in those conditions.; Reported Cause(s) of Death: INFARCTION


VAERS ID: 1690771 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Fever; Product contamination; Unknown cause of death; The Regulatory Authority is investigating the deaths of two men who received Moderna coronavirus vaccines from batches which have been suspended due to contamination, the Regulatory Authority announced on Saturday. These two men, 30 and 38 years of age, died in August after receiving a second dose of Moderna from one of the three batches suspended by the government on Thursday, the Regulatory Authority explained in a statement. The cause of their death is being investigated, the Regulatory Authority reported, adding that "the cause-effect relationship with the vaccination is unknown at this time". The two men, who developed a fever after receiving the vaccine, had no underlying health conditions or history of allergies, the Regulatory Authority claimed.; Sender''s Comments: This is a case of a 30-year-old male patient who died after the second dose of Moderna vaccine that was suspended due to contamination. It is unknown if autopsy was performed. The patient developed Pyrexia, however the cause of death was not reported and it was reported that cause-effect relationship with the vaccination is unknown. Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1690772 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
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: JPMODERNATX, INC.MOD20213

Write-up: Fever; Suspect Product Contamination; The Regulatory Authority is investigating the deaths of two men who received Moderna coronavirus vaccines from batches which have been suspended due to contamination, the Regulatory Authority announced on Saturday. These two men, 30 and 38 years of age, died in August after receiving a second dose of Moderna from one of the three batches suspended by the government on Thursday, the Authority explained in a statement. The cause of their death is being investigated, the Authority reported, adding that "the cause-effect relationship with the vaccination is unknown at this time". The two men, who developed a fever after receiving the vaccine, had no underlying health conditions or history of allergies, the Authority claimed.; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1690817 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-08-28
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: initial waveform; Result Unstructured Data: Test Result:asystole
CDC Split Type: JPPFIZER INC202101129737

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21125307. A 79-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 05Jul2021 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 14Jun2021 (at the age of in his 70''s) for COVID-19 immunisation. The patient experienced cardiac arrest on 28Aug2021 (1 month 23 days after the vaccination), which was reported as fatal. The clinical course was reported as follows: The patient was last confirmed to be healthy on 27Aug2021 at around 22:00. On the following day at 05:10, the patient''s wife went to see how the patient was doing and found the patient not breathing and requested ambulance. At 05:59, the patient arrived at the reporting hospital. The initial waveform was confirmed as asystole on 28Aug2021. Cardiopulmonary resuscitation (CPR) was continued for 2 minutes, but there was no response to resuscitation. The patient had cardiac arrest without witness and resuscitation was judged as difficult; thus, CPR was discontinued and death was confirmed. Therapeutic measures were taken as a result of cardiac arrest as aforementioned. The patient died on 28Aug2021. The cause of death was reported as cardiac arrest. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1690819 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-29
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood pressure systolic, Body temperature, Chest X-ray, Electrocardiogram, Heart rate, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Platelet count, Renal function test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN; PRAZAXA; MOSAPRIDE; RIVASTIGMINE; MEMARY; SODIUM VALPROATE; DOMPERIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia Alzheimer''s type; Hypertension; Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: blood pressure; Result Unstructured Data: Test Result:unmeasurable; Test Date: 202108; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:90-110 mmHg; Comments: From 22Aug2021 to 29Aug2021; Test Date: 20210816; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:110-150 mmHg; Test Date: 20210817; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:110-150 mmHg; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210818; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no congestion; Comments: no congestion in the lung fields; Test Date: 20210829; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Asystole; Test Date: 202108; Test Name: pulse; Result Unstructured Data: Test Result:60-80; Comments: Unit:/min From 22Aug2021 to 29Aug2021; Test Date: 20210818; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:increased; Test Date: 202108; Test Name: SpO2; Result Unstructured Data: Test Result:95-98 %; Test Date: 20210827; Test Name: platelet count; Result Unstructured Data: Test Result:223,000 uL; Test Date: 20210818; Test Name: renal function; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC202101130121

Write-up: suspected thrombosis; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. The regulatory authority report number is v21125275. An 86-year-old female patient received first dose of BNT162B2 (COMIRNATY; Lot Number: FF3620; Expiration Date: 30Nov2021), via an unspecified route of administration on 25Aug2021, at 13:55 as single dose for COVID -19 immunization. Medical history included atrial fibrillation, hypertension, late effects of cerebral infarction and dementia alzheimer''s type from unknown dates. Concomitant medications included candesartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; dabigatran etexilate mesilate (PRAZAXA) taken for an unspecified indication, start and stop date were not reported; mosapride (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; rivastigmine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; memantine hydrochloride (MEMARY) taken for an unspecified indication, start and stop date were not reported; sodium valproate (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; domperidone (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. On 29Aug2021, the patient experienced suspected thrombosis, which was serious as it was medically significant and lead to death. The patient underwent lab tests and procedures which included blood pressure measurement: unmeasurable on 29Aug2021, blood pressure systolic: 90-110 mmhg in Aug2021 From 22Aug2021 to 29Aug2021 , blood pressure systolic: 110-150 mmhg on 16Aug2021, blood pressure systolic: 110-150 mmhg on 17Aug2021 , body temperature: 36.7 centigrade on 25Aug2021 Before vaccination , chest x-ray: no congestion on 18Aug2021 no congestion in the lung fields , electrocardiogram: asystole on 29Aug2021, pulse: 60-80 in Aug2021 Unit:/min From 22Aug2021 to 29Aug2021, NT-ProBNP: increased on 18Aug2021 , oxygen saturation: 95-98 % in Aug2021, platelet count: 223,000 ul on 27Aug2021 , renal function: normal on 18Aug2021. Details were as follows: On 29Aug2021 at 23:15 (4 days after the vaccination), the patient suddenly died of suspected thrombosis. It was not reported if an autopsy was performed. The course of the events was as follows: on 16Aug2021, the patient was admitted to the psychiatry department of the reporter''s hospital for the treatment of dementia Alzheimer''s type. The patient had received anticoagulant agent for atrial fibrillation at a different hospital since before hospitalization and the treatment with the anticoagulant agent was continued. On the hospitalization day and 1 day after the hospitalization, systolic blood pressure was 110-150 mmHg. The blood test performed on hospitalization (18Aug2021) showed increased NT-ProBNP. Chest X-ray did not show congestion in the lung fields and her renal function was within normal range, but angiotensin antagonist was added to the treatment. The patient had unstable appetite, but she could consume half the amount of meal on average. Considering the summertime, sufficient amount of fluid (1000-1500 mL) was administered. The patient tended to have constipation. PANTHENYL was added to the fluid infusion. On 25Aug2021 at 13:55, the patient received the first dose of the vaccination. No abnormalities were noted in her condition including vital signs for 15-30 minutes after the vaccination. From 22Aug2021 to 29Aug2021, systolic blood pressure was 90-110 mmHg, pulse was 60-80/min, and SpO2 (oxygen saturation percutaneous) was 95-98%. The patient was making a good progress without pyrexia. On 29Aug2021 at 20:50, during the round of visits, complexion ill was noted, she made no reaction to stimulation or when calling her name, there was no thoracic motion, her carotid pulse was not palpable and her blood pressure could not be measured. Electrocardiogram showed asystole. Cardiopulmonary resuscitation such as cardiac massage was performed. Oxygen administration was performed, and fluid was administered via peripheral intravenous route with wide open flow. BOSMIN and atropine sulfate were intravenously administered. However, the patient did not show any improvement and on the same day at 22:15, she passed away. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Occurrence of thrombosis was considered as a possible cause of the event. The reporting physician commented as follows: The blood pressure was well controlled. No changes were noted in the blood test compared to that on admission, and the platelet count was 223,000/uL. Sufficient fluid administration was performed under the treatment with anticoagulant agent. However, the patient''s condition suddenly changed without any signs and she died. Therefore, the possibility of developing thrombosis could not be denied. The patient died on 29Aug2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: suspected thrombosis


VAERS ID: 1690826 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-08-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101131986

Write-up: Died; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Aug2021 09:00 (Lot Number: FF4204; Expiration Date: 31Oct2021) as single dose (at age of 78-year-old) for covid-19 immunisation. Medical history included diabetes mellitus and hypertension. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took prescribed oral unspecified medication(s) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included diabetes mellitus and hypertension. On 28Aug2021 at 09:00 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF4204, Expiration date 31Oct2021) via an unspecified route of administration for COVID-19 immunization. On 31Aug2021 (3 days after the vaccination), the patient died 3 days after receiving the second vaccine. The cause of death was unknown. It was not reported if an autopsy was performed. The event resulted in visiting a clinic and It was unknown if treatment and an autopsy were performed. The reporting physician assessed the event as serious (death). The cause of death was unknown. It was not clear if the patient had been tested for COVID-19 since the vaccination.; Sender''s Comments: The Company cannot completely exclude the possible causality between the reported event death , and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. Additional information is needed to better assess the case, including complete medical history, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1690827 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine (treated at the reporting hospital since 3 years before)
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: MRI; Result Unstructured Data: Test Result:aneurysm
CDC Split Type: JPPFIZER INC202101134066

Write-up: Aneurysm ruptured; Subarachnoid haemorrhage; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 45-year-old female patient received bnt162b2 (COMIRNATY; Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as single dose for covid-19 immunisation. The family history was not provided. The patient had medical history of migraine.The patient''s concomitant medications were not reported. On unknown date in 2021 (the day of vaccination), the patient received a dose of BNT162b2.On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced aneurysm ruptured and subarachnoid haemorrhage. On unknown date in 2021 (unknown days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: The patient had been treated for migraine at the reporting hospital since 3 years before. In Jul2021, the patient complained of headache which was different from usual one. Thus, MRI was performed, which showed aneurysm. Several hours after (as reported) the patient received a dose of BNT162b2 vaccination this time, an aneurysm ruptured, and she had subarachnoid haemorrhage and died on an unknown date in 2021. It was not reported if an autopsy was performed. It was unknown whether BNT162b2 vaccination was directly related to the events. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: The information provided is very limited and does not allow for a meaningful medical assessment. Based on available information a contributory role of BNT162B2 to the reported events Aneurysm ruptured and Subarachnoid haemorrhage cannot be completely excluded. Additional information like concurrent medical conditions, medical history, treatment done, is needed to better assess this report. The case will be reassessed further upon receipt of additional 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Aneurysm ruptured; Subarachnoid haemorrhage


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