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

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



Case Details

This is page 125 out of 172

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VAERS ID: 1390545 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Nasopharyngitis, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: Body temperature; Result Unstructured Data: Test Result:fever (unknown value)
CDC Split Type: PHPFIZER INC2021653381

Write-up: Fever, cough, common cold; Fever, cough, common cold; Fever, cough, common cold; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300078504. A 77-year-old male patient received BNT162b2 (COMIRNATY), intramuscular on 15May2021 (Lot Number: EY4834) (at the age of 77-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, cough, common cold on 17May2021. The events were serious, fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fever, cough, common cold; Fever, cough, common cold; Fever, cough, common cold


VAERS ID: 1390558 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-17
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (hypertension treated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021622587

Write-up: cardiac arrest; This is a spontaneous report from a contactable consumer received via the Agency. A 56-years-old male patient received bnt162b2 (COMIRNATY), dose 1 administered in Arm Left on 05May2021 (Lot Number: EY7015; Expiration Date: Aug2021) at age of 56-year-old as 1st dose, single for covid-19 immunisation . Medical history included hypertension treated. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescription medicines within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced cardiac arrest on 17May2021 10:30. The patient died on 17May2021. An autopsy was performed and results were not provided.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1390559 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW912707 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Muscular weakness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Parkinson''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021639122

Write-up: A few days after vaccination muscle pain and weakness; A few days after vaccination muscle pain and weakness/Muscle weakness; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number PL-URPL-3-623-2021. The reporter is contactable to Health Authority only. A 73-year-old male patient received 1st dose of BNT162B2 (COMIRNATY, lot number EW912707, expiration date 24Apr2021) at 0.3 mL, single at 73-year-old on 19Apr2021 13:35 intramuscular in left arm for COVID-19 immunisation. Medical history included ongoing arterial hypertension , ongoing Parkinson''s disease, , and pacemaker implantation. Concomitant drug was not provided. In Apr2021, patient experienced muscle pain and weakness. On 28Apr2021, at 9:00 a post-vaccination reaction occurred. Outcome of the events was fatal. The clinical course was reported as follows: A few days after vaccination, patient experienced muscle aches and weakness. On the morning of 28Apr2021 patient was found dead in the bathroom. The reporting person classified them as serious. The Regulatory Authority also classified the application as serious. Sender Comment: Muscle weakness and aches are expected adverse effects of the vaccine. There is a time relationship between the administration of the vaccine and the occurrence of the reaction. On the other hand, it is difficult, based on the information provided, to determine whether the vaccine administration was related to death. The reporting person classified them as serious. The Regulatory Authority also classified the application as serious. There is a time relationship between the administration of the vaccine and the occurrence of the reaction. Source of assessment: Regulatory Authority. Method of assessment: WHO. Result of Assessment was possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: A few days after vaccination muscle pain and weakness; A few days after vaccination muscle pain and weakness/Muscle weakness


VAERS ID: 1390560 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebral infarction, Hemiplegia
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021627516

Write-up: Global aphasia; Right hemiplegia; Cerebral infarction; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB PL-URPL-3-665-2021. A 93-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 26Apr2021 16:15 (Lot Number: EX3510; Expiration Date: 31Aug2021) as 1st dose 0.3 mL, single dose at vaccination age 93 years old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Apr2021, the patient experienced cerebral infarction in the form of right hemiplegia and total/global aphasia. The patient died on 02May2021. It was not reported if an autopsy was performed. Senders comment: Cerebral infarction in the form of right hemiplegia and total aphasia is an unexpected side effect for the vaccine. The infarction occurred in an elderly person, there are no data on medical history, but the role of the vaccine in the occurrence of adverse events cannot be ruled out. Various cerebral infarctions after Comirnaty vaccination have already been reported in the database. The temporal relationship speaks for a cause-and-effect relationship. The person reporting adverse vaccination reactions (NOP) classified it as severe. Regulatory Authority assessed the NOP as heavy. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Global aphasia; Right hemiplegia; Cerebral infarction


VAERS ID: 1390564 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Leg amputation, Postoperative wound complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: A few days after the second dose, the family found that the surgical wound had stopped healing; Amputation above knee; This regulatory authority case was reported by a consumer and describes the occurrence of POSTOPERATIVE WOUND COMPLICATION (A few days after the second dose, the family found that the surgical wound had stopped healing) and LEG AMPUTATION (Amputation above knee) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced LEG AMPUTATION (Amputation above knee) (seriousness criteria death and hospitalization prolonged). On an unknown date, the patient experienced POSTOPERATIVE WOUND COMPLICATION (A few days after the second dose, the family found that the surgical wound had stopped healing) (seriousness criteria death and hospitalization prolonged). The patient died on 29-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information provided. Company comment: Very limited information has been provided at this time. No further information is expected. This case was linked to PL-URPL-DML-MLP.4401.2.307.2021 (E2B Linked Report).; Sender''s Comments: Very limited information has been provided at this time. No further information is expected. PL-URPL-DML-MLP.4401.2.307.2021:; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1390565 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021627671

Write-up: Death immediately cause unknown; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB [PL-URPL-DML-MLP.4401.2.326.2021]. A 74-year-old male patient received bnt162b2 (COMIRNATY), at same age, intramuscular on 11Feb2021 as UNKNOWN, 0.3ML SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death immediately cause unknown on 16Feb2021. The patient died on 16Feb2021. An autopsy was not performed. Senders comment: No adverse reactions were listed in the report. Only death of unknown cause is reported. HA does not have information on the patients medical history, no autopsy has been performed, and the cause of death is unknown. There is a temporal relationship between the administration of the vaccine and the occurrence of the patients death. However, due to the lack of information on adverse reactions following the administration of Comirnaty vaccine, URPL assessed the death as occurring in temporal coincidence with the vaccination. The person reporting the NOP classified the NOP as severe. HA assessed the NOP as severe. Source of assessment NCA Method of assessment WHO-HA Result of Assessment Unlikely No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death immediately cause unknown


VAERS ID: 1390566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dyspnoea, Metastases to lung, Neoplasm recurrence
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 20
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: INSULIN
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy; Oxygen therapy; Pneumonia (After Coronavirus - November / December for oxygen therapy - strong pneumonia, antibiotic therapy); Radiotherapy; Squamous cell carcinoma of lung (2019 - small nodule, inoperable - radiotherapy and chemotherapy for about 2 months. Then checks - in July 2020, PET - information that the disease has been defeated.)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Computerised tomography; Result Unstructured Data: Test Result:Postcovid changes withdrew; Comments: no neoplastic changes; Test Date: 20210412; Test Name: Computerised tomography; Result Unstructured Data: Test Result:Numerous metastases in both lungs; Comments: also in the healthy one
CDC Split Type: PLPFIZER INC2021627650

Write-up: numerous metastases in both lungs; numerous metastases in both lungs (Squamous cell carcinoma of lung - disease defeated before vaccination); shortness of breath/ difficult to breathe independently; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number PL-URPL-DML-MLP.4401.2.327.2021. A 60-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection), dose 1 intramuscular on 02Apr2021 (Lot Number: ET3674) as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing hypertension, pneumonia (After Coronavirus - November/December for oxygen therapy - strong pneumonia, antibiotic therapy), oxygen therapy, squamous cell carcinoma of lung from 2019 to 2020 (2019 - small nodule, inoperable - radiotherapy and chemotherapy for about 2 months. Then checks - in July 2020, PET - information that the disease has been defeated. Before vaccination, the patient was in good condition, without any complaints). Concomitant medications included insulin, other drugs for hypertension, inhalation, very small doses of a steroid. The patient experienced dyspnoea (death, hospitalization) on 03Apr2021, lung metastases (death, hospitalization) on 12Apr2021. The event clinical course was as follows: after about 20 hours, shortness of breath, it is difficult to breathe independently, he went to the emergency room - was admitted to the pulmonary department - in CT 12Apr2021 - numerous metastases in both lungs (also in the healthy one). 23Apr2021 death after returning home from hospital (on the same day). Health result: death. The patient underwent lab tests and procedures which included Computerised tomography: postcovid changes withdrew (cloudy pane, no neoplastic changes) on Feb2021, Computerised tomography: numerous metastases in both lungs (also in the healthy one) on 12Apr2021. The patient died on 23Apr2021. An autopsy was not performed. Outcome of the events was fatal. Causality assessment: Dyspnoea/ Possible; Lung metastases/ Unlikely. Senders comment: Dyspnoea and lung metastases are not expected symptoms described in Comirnaty''s. Until 18May2021, 3641 cases of dyspnoea have been reported in the database. There are no cases of metastases to lung. They believes that lung metastases are rather related to cancer recurrence. Dyspnoea could be a sign of a relapse, but an effect of the vaccine cannot be excluded. An autopsy was not performed. There is a time relationship between the administration of the vaccine and the occurrence of side effects. due to the health result - death assessed the application as severe. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: dyspnoea; Lung metastases


VAERS ID: 1390567 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Body temperature fluctuation, Chills, Fatigue, Feeling cold, Malaise, Myalgia, Pyrexia, Teething, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: Test Date: 2021; Test Name: temperature changes; Result Unstructured Data: Test Result:37.4-41.4 Centigrade; Test Date: 2021; Test Name: temperature changes; Result Unstructured Data: Test Result:37.4-37.8 Centigrade
CDC Split Type: PLPFIZER INC2021627534

Write-up: Body temperature fluctuation; Vaccination site pain; Fever; Muscle pain; General malaise; Feeling cold; Chills; Arthralgia; Teething pain; Fatigue; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number PL-URPL-DML-MLP.4401.2.335.2021. A 44-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 26Jan2021 14:40 (Batch/Lot Number: EJ6795) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Historical Vaccine included Comirnaty for covid-19 immunization (1st dose of vaccine). In 2021, The patient experienced body temperature fluctuation for 36 hrs, which was serious due to death, medically significant; vaccination site pain and fever was serious due to medically significant with outcome of recovered in 2021, , muscle pain, general malaise, feeling cold, chills, arthralgia, teething pain, fatigue with outcome of recovered in 2021. The patient underwent lab tests and procedures which included body temperature: 37.4-41.4 centigrade on 2021, body temperature: 37.4-37.8 centigrade on 2021. Therapeutic measures were taken as a result of body temperature fluctuation and fever. The patient died in 2021. It was not reported if an autopsy was performed. The description of the report stated: sudden and prolonged temperature jumps in the range of 37.4-41.4 degrees Celsius (lasting 36 hours, despite the use of measures to reduce the temperature), pain in the hand at the site of the injection, general fatigue and breakdown, joint pain, muscles and teeth. When the temperature drops to the level of 37.4-37.8 feeling cold and strong chills. Result: symptoms disappear in the process. Additional information: no previous reactions to drugs and vaccines. The reporting person did not classify the severity of the report. Due to the nature of the side effects and the patient''s death, the Regulatory Authority classified the report as "severe". The data contained in the electronic report is all at the disposal of the Regulatory Authority - in the case of obtaining additional information, another version will be sent. Sendres comment: Report related to PL-URPL-DML-MLP.4401.2.334.2021 (applies to the same Patient) Comirnates is an mRNA vaccine against COVID-19 (with modified nucleosides) Vaccine injection site reactions, increase in body temperature, chills, arthralgia, muscle pain, fatigue and malaise are expected side effects after the administration of Comirnaty. The feeling of cold often accompanies chills, i.e. the feeling of cold, combined with involuntary, slight and uncoordinated trembling of the muscles, often occurs during a rapid increase in fever and is an expression of stimulation of the thermoregulatory center in the midbrain and change of the set point to a higher one. Due to the related report and the context of all information, it can be concluded that on 26Jan2021 the patient took the second dose of Comirnaty vaccine. The temporal relationship speaks for a cause-and-effect relationship. The reporting person did not classify the severity of the report. The Regulatory Authority, due to the nature of side effects (temperature jumps over 40 degrees Celsius and no reaction to the antipyretic agent paracetamol for 36 hours) classified the application as "severe". Reaction(s) / Event(s) Assessed / Relatedness of drug to reaction: Teething pain: Source of assessment: The Regulatory Authority Method of assessment : WHO Result of Assessment : possible Reaction(s) / Event(s) Assessed / Relatedness of drug to reaction: Muscle pain, General malaise, Feeling cold, Body temperature fluctuation, Vaccination site pain, Chills, Fever, Arthralgia, Fatigue: Source of assessment: The Regulatory Authority Method of assessment : WHO Result of Assessment : probable; Reported Cause(s) of Death: Body temperature fluctuation


VAERS ID: 1390568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021645226

Write-up: cardiac arrest; This is a spontaneous report from a contactable consumer (patient''s son-in-law). This is a report received from a regulatory authority. Regulatory authority report number PL-URPL-DML-MLP.4401.2.355.2021. An 80-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) (age at vaccination: unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. 2 days after vaccination, the patient experienced cardiac arrest-suspected temporal correlation with vaccination, which resulted in death. It was unknown if an autopsy was performed. Sender Comment: Cardiac arrest is an unexpected side effect for the vaccine. The medical history of the patient is unknown, taking into account the age it cannot be clearly stated to what extent the vaccine contributed to the adverse effects. The temporal relationship speaks for a cause-and-effect relationship. A regulatory authority assessed the application as serious (death). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1390569 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Asthenia, Gait disturbance, General physical health deterioration, Laboratory test, Oedema peripheral, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NEBIL; METFORMAX; MILURIT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Hyperuricemia; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20201030; Test Name: laboratory test; Result Unstructured Data: Test Result:normal; Test Date: 20210411; Test Name: laboratory test; Result Unstructured Data: Test Result:renal failure and anemia
CDC Split Type: PLPFIZER INC2021645218

Write-up: Walking difficulty; General physical health deterioration; Weakness; Oedema limbs; Renal failure; Anaemia; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from the Regulatory Authority via pharmacovigilance. Regulatory authority report number PL-URPL-DML-MLP.4401.2.356.2021. The reporter is contactable to Health Agency only. The report PL-URPL-DML-MLP.4401.2.356.2021 was sent to the Regulatory Authority on 21May2021 by the patient''s daughter. An 83-year-old female patient received her second dose of BNT162B2 (COMIRNATY) as intramuscular single dose, on 24Mar2021 (lot number unknown), at age of 83-year-old, for COVID-19 immunisation. The first dose was received on 24Feb2021 at the same age. The patient''s medical history included hyperuricemia, type 2 diabetes mellitus, and hypertension. Concomitant medications included nebivolol hydrochloride (NEBIL) for Hypertension, metformin hydrochloride (METFORMAX) for Type 2 diabetes mellitus, and allopurinol (MILURIT) for hyperuricemia. The patient experienced walking difficulty (death, hospitalization) on 26Mar2021, general physical health deterioration (death, hospitalization) on 26Mar2021, renal failure (death) on 11Apr2021, anaemia (death) on 11Apr2021, weakness (death, hospitalization) on 26Mar2021, oedema limbs (death, hospitalization) on 26Mar2021. The patient died on 06May2021. An autopsy was not performed. Description of adverse effects: 2 days after the 2nd vaccination - health deterioration, severe weakness, problem with walking, limb swelling. Hospitalized 7 days. Death on 06May2021 (cause of death reported as "renal failure, anemia"). Additional information: 30Oct2020 laboratory test results normal, results on 11Apr2021 - renal failure and anemia. Health result: death. The data contained in the electronic report is all at the disposal of the Regulatory Authority - in the case of obtaining additional information, another version will be sent. Sender Comment: Weakness, muscle pain, joint pain are expected adverse effects for the vaccine. Deterioration of health, limb edema is an unexpected adverse effect for the vaccine. Anemia and renal failure could have coincided with vaccination. Taking into account the medical history, the patient''s age cannot be unequivocally determined whether and to what extent the vaccine contributed to the adverse reactions. The temporal relationship speaks for a cause-and-effect relationship. The Regulatory Authority assessed the application as serious (death). No follow-up attempts are possible; information about lot/ batch number cannot be obtained.; Reported Cause(s) of Death: Walking difficulty; General physical health deterioration; Weakness; Oedema limbs; Renal failure; Anaemia


VAERS ID: 1390574 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7083 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Condition aggravated, Death, Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: TERCIAN [CYAMEMAZINE]; BUNIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021627710

Write-up: bedridden; unknown cause of death; Left lower limb edema; Left lower limb redness and oedema with a progressive increase; Left lower limb redness; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB [PT-INFARMED-B202105-2534]. A 68-year-old male patient received bnt162b2 (COMIRNATY), the second dose via intramuscular on 23May2021 (lot number: FA7083) at 0.3ml single for COVID-19 immunisation. The relevant medical history was not reported. Concomitant medications included cyamemazine (TERCIAN) and melperone hydrochloride (BUNIL). The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number: ET6956), on 23Apr2021 for COVID-19 immunization and had no adverse effect (although no adverse reactions to the first dose have been recorded in the clinical file, it did not exclude the possibility that non-serious reactions have occurred). The patient experienced left lower limb redness and edema on 24May2021. The adverse reaction (ADR) started 1 day after the administration of the 2nd dose of the suspect vaccine. According to the notifier, the patient sent a photograph to the family nurse, in which the presence of redness and edema in the left lower limb was visible. According to the patient''s family, this redness started in the afternoon of the day following the administration of the vaccine, with a progressive increase. The family nurse tried to find out more information, but family members did not respond again, as the specific evolution was unknown. The notifier stated that the patient did not go to the Emergency Room. The notifier became aware of the occurrence with the request of emission of a death certificate on the following day. Given the situation and the absence in the clinical process of pathology that could justify the death, a certificate with unknown cause of death was issued, so the notifier refers to the possibility of an autopsy, of which she is not aware of the result. According to the notifier, the patient was not previous infected by SARS-CoV-2. Notifier also states that the patient was bedridden, but with no described history to justify the event, with no documented allergies and no history of adverse reactions. The patient died on 25May2021. It was unknow if an autopsy was performed. Relatedness of drug to reactions/events for all events: Source of assessment: Notifier; Method of assessment: Unknown; Result of Assessment: Possible. The outcome of the event unknown cause of death was fatal, while the other events were unknown. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1390605 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW5279 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiomyopathy, Cardiopulmonary failure
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cerebral disorder (cerebral ischemic disorders); Chronic ischemic heart disease, unspecified; Lumbar disc herniation (Lumbar disc herniation L5-S1)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021648454

Write-up: Acute cardiorespiratory failure; Mixed chronic cardiomyopathy; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number RO-NMA-2021-SPCOV11078. A 70-year-old male patient received BNT162B2 (COMIRNATY, lot number: EW5279), intramuscularly on 28Apr2021 09:45 (at 70-year-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included lumbar disc herniation L5-S1, cerebral disorder (cerebral ischemic disorders), arterial hypertension, chronic ischemic heart disease, unspecified. The patient''s concomitant medications were not reported. The patient experienced Acute cardiorespiratory failure and Mixed chronic cardiomyopathy on 28Apr2021. The outcome of the events was fatal. The patient died on 28Apr2021. It was not reported if an autopsy was performed. Clinical details: On 28Apr2021 (09:45), the patient received a 2nd dose of Comirnaty administered intramuscularly for active immunisation. On the same day (28 April 2021), the patient died at home in the afternoon. Comirnaty lot for the second dose: EW5279. Personal pathological history: arterial hypertension, cerebral ischemic disorders, chronic ischemic heart disease, lumbar disc herniation L5-S1. On 29Apr2021, the medical certificate confirming the death was completed: Actual causes of death: Acute cardiorespiratory failure and Mixed chronic cardiomyopathy. Other important morbid condition: Following investigation of the case, the conclusions were: coincidental AEFI.; Reported Cause(s) of Death: Acute cardiorespiratory failure; Mixed chronic cardiomyopathy


VAERS ID: 1390621 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW5279 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Myalgia, Nausea, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 virus test positive
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021627931

Write-up: Cough; Nausea; Fever/fever of 38.9 degrees; Heart pounding; Muscle pain/pain in every muscle; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority report number SE-MPA-2021-040374. Safety report unique identifier SE-VISMA-1621342348024. A 70-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration in Apr2021 (Batch/Lot Number: EW5279) as 1st dose, single for covid-19 immunisation. Medical history included positive COVID-19 infection. The patient''s concomitant medications were not reported. The patient experienced cough, muscle pain, nausea, heart pounding, fever in Apr2021. It was stated that the patient was snug at the time of the vaccination, but he was considered to be okay to receive the vaccine. The day after the vaccination, the man had a fever of 38.9 degrees, coughed, and experienced pain in every muscle in his body. The reporter mentioned that the man a few days later contacted emergency and was told to wait the symptoms out, but unfortunately a few hours later the man was found dead in his home three days after vaccination. Positive covid-19 infection was stated as the cause of death in the report but there was no additional information emerging from the report related to the death of the man. It was not reported if an autopsy was performed. The event was reported as serious with seriousness criteria of fatal. The outcome of events was fatal. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cough; Nausea; Fever; Heart pounding; Muscle pain; COVID-19


VAERS ID: 1390626 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cough, Fatigue, Malaise, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker user; Atrial fibrillation; Cardiac failure; Hypertension; Hypothyroidism; Liver disorder; Renal failure; Sick sinus syndrome; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to analgesics; Contrast media allergy; COVID-19; COVID-19 pneumonia (post-covid issue: difficulty walking without support of a walker and had problems with balance); Sinus node dysfunction (with a pacemaker)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021627900

Write-up: fever; cough; tired; cardiac arrest; GENERAL FEELING OF ILLNESS; Vomiting; This is a spontaneous report from a contactable physician and a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-041678. A 75-year-old female patient received BNT162B2 (COMIRNATY) dose 1 via an unspecified route of administration in May2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included ongoing Type-2 diabetes mellitus, cardiac failure from 2017 and ongoing, sinus node dysfunction with a pacemaker, Sick sinus syndrome and artificial cardiac pacemaker user both from 2012 and ongoing, atrial fibrillation form 2013 and ongoing, hypertension from 2015 and ongoing, ongoing hypothyroidism, ongoing an unspecified liver disorder and renal failure. The patient had previously experienced allergic reactions to contract medium, influenza vaccination and drug hypersensitivity to acetylsalicylic acid, PC 1946 and Atorvastatin. The patient had also undergone a Covid-19 infection in Mar2021 and had become acutely ill with pneumonia. The patient was hospitalised in intensive care for 4 weeks with required respiratory support. Since the Covid-19 infection, the patient has suffered from post-covid issues including difficulty walking without support of a walker and had problems with balance. Before the covid-19 infection, the patient could look after herself but following the Coivd-19 infection, the women required home help. The patient''s concomitant medications were not reported. COMIRNATY was given four weeks after the patient came home from the hospital. Reported suspect adverse events were cardiac arrest, vomiting and malaise and caused death. Prior to vaccination, the patient appeared well. Within a few hours of vaccination, the patient felt ill and tired. The patient vomited several times and a home care assistant rang for medical advice. The patient was advised to take Alvedon and rest. A few hours later, the patient''s condition worsened, and she developed fever and a cough. In the evening, the patient was found dead in bed at home. The reporting consumer considered it inappropriate to vaccinate the patient so shortly after a severe covid-19 infection. The reporting consumer strongly suspected that the patient has suffered form an acute cytokine release. The outcome of events cardiac arrest, vomiting and malaise was fatal and other events was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. The report was assessed as serious with death. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest; vomiting; malaise


VAERS ID: 1390630 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Duodenal ulcer, Fall, Pulmonary embolism, Small intestinal haemorrhage, Splenic infarction, Truncus coeliacus thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Accidents and injuries (narrow)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN/HYDROCHLOROTHIAZIDE; ALLOPURINOL; SPIOLTO RESPIMAT; MIRTAZAPINE; GIONA; BISOPROLOL; ACETYLCYSTEINE; SIMVASTATIN
Current Illness: Artificial cardiac pacemaker user; Chronic obstructive lung disease; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Sick sinus syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: trauma CT; Result Unstructured Data: Test Result:splenic infarction; Comments: embolization to truncus coeliacus with splenic infarction
CDC Split Type: SEPFIZER INC2021639363

Write-up: fall incident; had embolization to truncus coeliacus; duodenal ulcers; Duodenal bleeding; embolization to truncus coeliacus with splenic infarction/Splenic infarction; Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-042995. An 87-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EP2166), via an unspecified route of administration on 23Mar2021 as single dose for covid-19 immunisation. Medical history included cardiac assistance device (artificial cardiac pacemaker user) due to sick sinus syndrome, chronic obstructive pulmonary disease, hypertension, which were ongoing. Concomitant medications were budesonide (GIONA), olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT), acetylcysteine, allopurinol, bisoprolol, losartan/hydrochlortiazide, mirtazapine, simvastatin. Reported suspect adverse events were pulmonary embolism, duodenal bleeding and splenic infarction occurred in April 2021. The physician has also reported that the woman arrived at the emergency clinic on 19th of April 2021 due to fall incident. On trauma CT was found that that woman had embolization to truncus coeliacus with splenic infarction. The woman received a high dose of tinzaparin sodium (INNOHEP). The woman died a few days later (in Apr2021), the death was probably caused by bleeding from duodenal ulcers. In addition to the splenic infarction, according to postmortem examination the patient had pulmonary embolism, which has caused or contributed to the death. Report assessed as serious, death. Outcome was fatal for events pulmonary embolism, duodenal bleeding and splenic infarction, for fall, duodenal ulcers and embolization to truncus coeliacus was unknown. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Pulmonary embolism; Duodenal bleeding; Splenic infarction; Autopsy-determined Cause(s) of Death: pulmonary embolism; splenic infarction


VAERS ID: 1390640 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Body temperature, Fatigue, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data: Test Date: 20210217; Test Name: Body temperature; Result Unstructured Data: Fever- 38.3?C; Test Name: SARS-CoV-2 IgG antibody test; Test Result: Positive ; Result Unstructured Data: After death; Test Name: SARS-CoV-2 IgM antibody test; Test Result: Negative ; Result Unstructured Data: After death; Test Name: COVID-19 antigen test; Test Result: Negative ; Result Unstructured Data: After death; Test Date: 20210202; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210224; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: SKMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of ASTHENIA, FATIGUE and PYREXIA in a 79-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 vaccination. The patient''s past medical history included Pacemaker insertion (cardiac) on 09-Dec-2014. On 16-Feb-2021 at 11:13 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ASTHENIA (seriousness criterion death), FATIGUE (seriousness criterion death) and PYREXIA (seriousness criterion death). The patient died on 17-Feb-2021. The reported cause of death was Weakness generalised, Fatigue and Fever. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17-Feb-2021, Body temperature: 38.3 (High) Fever- 38.3?C. On 24-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) After death and negative (Negative) After death. On an unknown date, SARS-CoV-2 test: negative (Negative) After death. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ASTHENIA, FATIGUE and PYREXIA to be possibly related. Relevant concomitant medications was not provided. Treatment medication was not provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of sudden death in a 79-year-old female with hx of Pacemaker insertion, who developed asthenia, fatigue and pyrexia on the day of vaccination and died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reporter''s Comments: Tha causality was assessed as possible.; Sender''s Comments: This is a case of sudden death in a 79-year-old female with hx of Pacemaker insertion, who developed asthenia, fatigue and pyrexia on the day of vaccination and died 1 day after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Weakness generalised; fatigue; fever


VAERS ID: 1391223 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
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: ZAPFIZER INC2021640434

Write-up: died of covid-19 disease; died of covid-19 disease; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) 2 weeks ago at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced died of covid-19 disease. The patient died on 02Jun2021. It was unknown if an autopsy was performed. The reporter enquired if the vaccine was only effective after the second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died of covid-19 disease; died of covid-19 disease


VAERS ID: 1391229 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-26
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Diarrhoea, Frequent bowel movements, Intestinal ischaemia, Muscle spasms, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   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: CO-BISOPROLOL; OXAZEPAM; AMLODIPIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Hormone therapy; Lumpectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210616258

Write-up: DEATH; EXTENSIVE ISCHEMIA OF SMALL INTESTINE AND COLON; DIFFUSION ABDOMINAL PAIN; DIFFUSION ABDOMINAL PAIN; FREQUENT BOWEL MOVEMENTS; NAUSEA; CRAMPS; WATERY DIARRHEA; This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-94284] concerned a 79 year old female of unspecified race and ethnicity. The patient''s weight was 68 kilograms, and height was not reported. The patient''s past medical history included in 2002, lumpectomy followed by post-radiation, hormonal therapy based on Nolvadex (tamoxifen), and on 11-JUN-2007 laparoscopic cholecystectomy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: unknown) dose was not reported, administered on 26-MAY-2021 for covid-19 immunization. Concomitant medications included Amlodipine, Bisoprolol fumarate/hydrochlorothiazide, and Oxazepam for unknown indication. On 26-MAY-2021, the patient experienced extensive ischemia of small intestine and colon, diffusion abdominal pain (Abdominal pain), diffusion abdominal pain (Diffuse pain), frequent bowel movements, nausea, cramps and watery diarrhea. The patient died from laparoscopic exploration with determination of extensive ischemia of small intestine and colon (treatment received on 30-MAY). It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, extensive ischemia of small intestine and colon, diffusion abdominal pain, diffusion abdominal pain, frequent bowel movements, nausea, cramps and watery diarrhea on 26-MAY-2021. This report was serious (Death).; Reporter''s Comments: Treatment - Ja 30/05 :Evolution of the ADR; Sender''s Comments: V0-20210616258-COVID-19 vaccine ad26.COV2.S-Death, extensive ishchamia of small intestine and colon, diffusion abdominal pain, diffusion abdominal pain, frequent bowel movements, nausea, cramps, watery diarrhea. 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: LAPAROSCOPIC EXPLORATION WITH DETERMINATION OF EXTENSIVE ISCHEMIA OF SMALL INTESTINE AND COLON


VAERS ID: 1391230 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-30
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Cerebral haematoma, Cerebral haemorrhage, Coagulopathy, Computerised tomogram, Computerised tomogram head, Death, Hepatic failure, Hypovolaemic shock, Immunology test, Mesenteric vein thrombosis, Multiple organ dysfunction syndrome, Platelet count, Platelet factor 4, Pneumothorax, Portal vein thrombosis, Pulmonary embolism, Renal infarct, Renal vein thrombosis, Shock, Splenic infarction, Splenic vein thrombosis, Thrombocytopenia, Ultrasound scan, Venous occlusion
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (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 (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (broad), Renovascular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TARGAXAN; DOBUTAMINE; CALCIUM;COLECALCIFEROL; ALDACTONE [SPIRONOLACTONE]; CLAFORAN [CEFOTAXIME SODIUM]; SUFENTA; OBRACIN; BIFITERAL; VESIPAQUE; OMEPRAZOLE; ATROPINE; MANNITOL; SEVOFLURANE; TRACRIUM; LINISOL; ENALAPRIL; EZETROL; CLAMOXYL [AM
Current Illness: Arterial hypertension; Diabetes; Esophageal varices; Hepatic cirrhosis; Hepatic disease (Decompensation liver disease; late February/early March 2021: 4 day hospital admission. No exposure to heparin or LMWH (low-molecular-weight heparins) at that time.); Hepatic encephalopathy; Idiopathic thrombocytopenic purpura (chronic); Non-alcoholic steatohepatitis; Portal hypertension; Splenomegaly; Thrombopenia
Preexisting Conditions: Medical History/Concurrent Conditions: Splenorenal shunt; Therapeutic embolization
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT scan; Result Unstructured Data: unspecified; Test Date: 2021; Test Name: Head CT; Result Unstructured Data: possible thrombus; Comments: possible thrombus thv torcula, dd artefact). Also active bleeding with voluminous hematoma.; Test Date: 2021; Test Name: Platelet count; Result Unstructured Data: 59000; Test Date: 2021; Test Name: Platelet factor 4; Result Unstructured Data: HIT test negative (0.0 U/ml); Test Date: 2021; Test Name: ELISA; Result Unstructured Data: For anti-PF4 ikv mgl VITT negative; Test Date: 2021; Test Name: CT scan; Result Unstructured Data: brain/thorax/abdomen; Test Date: 202103; Test Name: Diagnostic ultrasound; Result Unstructured Data: no portatrombosis; Test Date: 202104; Test Name: Platelet count; Result Unstructured Data: 64000
CDC Split Type: BEJNJFOC20210615725

Write-up: PORTAL VEIN THROMBOSIS; SPLENIC VEIN THROMBOSIS; PULMONARY EMBOLISM; MESENTERIC VEIN THROMBOSIS; RENAL VEIN THROMBOSIS; THROMBOPENIA; SPLENIC INFARCTION; RENAL INFARCTION; VENOUS OBSTRUCTION; HYPOVOLAEMIC SHOCK; HEPATIC FAILURE; DEATH; CEREBRAL HEMATOMA; CEREBRAL HEMORRHAGE; MULTI ORGAN FAILURE; PULMONARY COLLAPSE; ACUTE KIDNEY FAILURE; SHOCK; COAGULATION DISORDER; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-94448] concerned an elderly male, age not specified. The patient''s weight was 100 kilograms, and height was 166 centimeters. The patient''s past medical history included splenorenal shunt and embolization (2020), and concurrent conditions included "NASH Cirrhosis" (captured as non-alcoholic steatohepatitis and cirrhosis) decompensation liver disease, portal hypertension, esophageal varices, hepatic encephalopathy, thrombopenia (2013) (initially attributed to chronic ITP (idiopathic thrombocytopenic purpura), however, also already mild splenomegaly), diabetes, and arterial hypertension. In late FEB/early MAR-2021, the patient was hospitalized for four (4) days due to decompensation liver disease. According to the patient''s chart, no exposure to heparin or LMWH (low-molecular weight heparin) at that time. The last ultrasound performed in MAR-2021 showed no "porta thrombosis". Platelet count of 64000 (no units/normal range provided) noted in APR-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAY-2021 for covid-19 immunisation. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included sufentanil citrate, albumin human, amoxicillin, atracurium besilate, atropine, calcium/colecalciferol, cefotaxime sodium, dobutamine, enalapril, ezetimibe, gluconate sodium/magnesium chloride hexahydrate/potassium chloride/sodium acetate trihydrate/sodium chloride, glucose, insulin, lactulose, lidocaine hydrochloride, mannitol, norepinephrine, nystatin, omeprazole, phenobutiodil, propofol, propranolol, rifaximin, sevoflurane, spironolactone, tobramycin sulfate, and tranexamic acid, all for unspecified indications. Serious adverse events reported by EVHuman, with an onset date of 30-MAY-2021, and a fatal outcome, included: hypovolaemic shock, hepatic failure, death, renal infarction, cerebral hematoma, portal vein thrombosis, venous obstruction, pulmonary embolism, splenic vein thrombosis, cerebral hemorrhage, splenic infarction, multi organ failure, mesenteric vein thrombosis, pulmonary collapse, renal vein thrombosis, thrombopenia, acute kidney failure, shock, and coagulation disorder. Fifteen (15) days after vaccination (30-MAY-2021), the patient was hospitalized for a liver transplant (hospitalization added as a serious criterion to the case). Peroperative diagnosis of again "porta thrombosis" during liver transplantation, for which thrombectomy was performed. Shortly after reperfusion, acute collapse of transplant liver due to pulmonary embolism, with also hyperacute obstruction of venovenous bypass due to thrombus (presumably heparin-coated circuit). Previously stable blood flow through bypass. In case of obstruction of circuit, establish thrombi in pump, afferent and efferent lines. Suspicion of suction of thrombus via circuit rather than circuit thrombosis. Determine recurrence of porta thrombosis for which right thrombectomy with IVIG (in addition to corticoids I.V. transplantation) given. "Seen mgl HIT/VITT. Poly transfusion perioperatively." Postoperatively evolution to acute liver failure, with hypovolemic shock obvious major bleeding, AKI (acute kidney injury). CT brain/thorax/abdomen: bilateral pulmonary emboli, acute complete thrombosis of current gate (extra- and intrahepatic), and disseminated thrombus material in mesenteric veins, left renal vein and multiple collateral veins; disseminated spleen infarcts and bilateral renal infarcts; on CT brain possible thrombus "press dd artefact". Also active bleeding with voluminous hematoma. Revision with hemostasis and packing. Treatment medications (dates unspecified) included: "yes Cf supra IVIG Corticoids. Stop heparin (limited exposure via flush arterial line), vital support, "specific R/ after liver transplantation (immunosuppression, antimicrobial prophylaxis, etc)". Evolution of the ADR - Deceased Examination s - Cf supra: CT images HIT test negative (0.0 U/ml) Additional ELISA for anti-PF4 ikv mgl VITT negative (OD = 0.08, positive when $g0. 4) HIT/VITT test taken shortly after ICU admission (some reserve for interpretation test given possible factor dilution tg intraoperative polytransfusion)* Chronic thrombopenia in patient with cirrhosis, portal hypertension and splenomegaly (preoperative stable platelet count: 59000 vs 64000 in April 2021). Evolution to fulminant liver failure, with persistent shock and MOF (multi-organ failure), with the death of patient on 01-JUN-2021. On 01-JUN-2021, the patient died from the events. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death and Hospitalization).; Reporter''s Comments: Treatment - Ja Cf supra IVIG Corticoiden Stop heparin (limited exposure via flush arterial line) vital support, specific R/ after liver transplant (immunosuppression, antimicrobial prophylaxis)Evolution of the ADR - passed away Examinations - Cf supra: CT images HIT test negative (0.0 U/ml) additional ELISA in front of anti-PF4 ikv mgl VITT negative (OD = 0.08, positive when $g0.4) HIT/VITT test taken shortly after admission ICU (some reserve for interpretation test seen possible). Sender''s Comments: V0: This spontaneous report received from a physician via Regulatory Authority concerns a male patient, age not specified, unknown ethnicity, noted to have pulmonary emboli, thrombosis in multiple sites, infarcts, and possible thrombus in the torcula 15 days after receiving the Janssen Covid-19 vaccine. That day, the patient was hospitalized to undergo liver transplant. Patient has Nonalcoholic Steatohepatitis (NASH) Cirrhosis. Again "portatrombosis" was encountered during the liver transplantation. Shortly after reperfusion, transplanted liver collapsed. There was obstruction of venovenous bypass, which previously had stable blood flow, and pulmonary embolism. CT scan of thorax and abdomen showed: bilateral pulmonary emboli, thrombosis of vena portae (extra- and intrahepatic); thrombus in mesenteric veins, left renal vein and multiple collateral veins; spleen and bilateral renal infarcts. CT scan of the brain showed possible thrombus on the torcula. Laboratory results: HIT test negative, ELISA anti-PF4/ VITT negative, and platelet count of 59,000 (units unspecified). Patient died the following day. Height was 166 cms and weight was 100 kg (BMI: 36.6 - obese). Past medical history included: thrombocytopenia (2013), splenorenal shunt and embolization (2020); and previous hospitalization for decompensated cirrhosis (February/early March 2021). Current conditions also included: esophageal varices, mild splenomegaly, and diabetes. No exposure to any heparin. Last ultrasound in March 2021 showed no "portatrombosis". Platelet count on April 2021 was 64000 (units not specified). Patients with cirrhosis have slow blood flow which leads to thrombosis and there is platelet sequestration in the spleen that leads to thrombocytopenia. Obesity, cirrhosis and its complications could represent plausible occurrence, especially in view of the pre-existing risk factors, rendering the events inconsistent with the vaccination. Moreover, HIT and VITT tests were negative.; Reported Cause(s) of Death: HYPOVOLEMIC SHOCK; HEPATIC FAILURE; DEATH; RENAL INFARCTION; CEREBRAL HEMATOMA; PORTAL VEIN THROMBOSIS; VENOUS OBSTRUCTION; PULMONARY EMBOLISM; SPLENIC VEIN THROMBOSIS; CEREBRAL HEMORRHAGE; SPLENIC INFARCTION; MULTI ORGAN FAILURE; MESENTERIC VEIN TH


VAERS ID: 1391232 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-04-24
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Cerebral haemorrhage, Chest X-ray, Computerised tomogram head, Platelet count, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Blood test; Test Result: Inconclusive ; Result Unstructured Data: No information available; Test Date: 20210427; Test Name: Thorax X-ray; Test Result: Inconclusive ; Result Unstructured Data: No information available; Test Date: 20210427; Test Name: CT brain scan; Result Unstructured Data: Classic bleeding; Test Date: 20210427; Test Name: Thrombocyte count; Result Unstructured Data: Normal; Test Date: 20210508; Test Name: Thrombocyte count; Result Unstructured Data: Normal
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Cerebral hemorrhage with irreparable brain damage; Subdural hematoma; This regulatory authority case was reported by a physician and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral hemorrhage with irreparable brain damage) and SUBDURAL HAEMATOMA (Subdural hematoma) in an 82-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 300042722 and 3001531) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral hemorrhage with irreparable brain damage) (seriousness criteria death, medically significant and life threatening) and SUBDURAL HAEMATOMA (Subdural hematoma) (seriousness criteria death, medically significant and life threatening). The patient died on 08-May-2021. The reported cause of death was Subdural hematoma, Brain injury and Cerebral hemorrhage. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood test: inconclusive (Inconclusive) No information available. On 27-Apr-2021, Chest X-ray: inconclusive (Inconclusive) No information available. On 27-Apr-2021, Computerised tomogram head: abnormal (abnormal) Classic bleeding. On 27-Apr-2021, Platelet count: normal (normal) Normal. On 08-May-2021, Platelet count: normal (normal) Normal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication and treatment drug reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Subdural hematoma; Brain injury; Cerebral hemorrhage


VAERS ID: 1391233 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-05-08
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

Administered by: Unknown       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: 2021-05-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALIN HEXAL; LERCANIDIPINE ORION; BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]
Current Illness: Living in nursing home (The patient was a resident of a group home); Pulse increased
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Developmental delay (The patient was developmental delayed)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Cardiac function test; Result Unstructured Data: Everything looked fine
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Sudden death, cause unknown; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death, cause unknown) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 301176 and 300042722) for COVID-19 vaccination. The patient''s past medical history included Depression and Developmental delay (The patient was developmental delayed). Concurrent medical conditions included Living in nursing home (The patient was a resident of a group home) and Pulse increased. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALIN HEXAL) from 03-Oct-2012 to an unknown date for Anxiety, LERCANIDIPINE HYDROCHLORIDE (LERCANIDIPINE ORION) from 12-Mar-2021 to an unknown date for Hypertension, CYANOCOBALAMIN-TANNIN COMPLEX (BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]) from 27-Mar-2019 to an unknown date for Vitamin B12 deficiency. On 10-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. The patient died on 08-May-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Cardiac function test: normal (normal) Everything looked fine. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. It was reported that patient had a zest for life. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable. This is a case of death in a 59-year-old male subject with a history of Depression and Developmental delay who died 30 days after receiving second dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Additional information received on 07 Jun 2021, information regarding cause of death was added.; Sender''s Comments: This is a case of death in a 59-year-old male subject with a history of Depression and Developmental delay who died 30 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Death from natural causes


VAERS ID: 1392259 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-28
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEURONTIN; DONEPEZIL; CENTRUM A TO ZINC; THYREX; LAMOTRIGIN
Current Illness: Hairy cell leukaemia (for 10 years,he was controlled semi-annually,no related medication necessary,last control stable); Lumbar foraminal stenosis (lumbar vertebrostenosis); Multifocal seizure (multifocal seizures); Polyneuropathy
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm atrial (atrial septal aneurysm 2015); B-Lymphocytic, CLL (Kiel Classification) (condition after B-cell small lymphocytic lymphoma 2008); Basalioma (condition after basal cell removal at ear shortly before corona infection); Squamous cell carcinoma (squamous cell carcinoma 2020)
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Ct 21.06 variant
CDC Split Type: ATPFIZER INC2021628434

Write-up: 1st vaccination on 20FEB2021,2nd vaccination on 13MAR2021 and PCR positive on 29MAR2021; Symptom onset with fever; 1st vaccination on 20FEB2021,2nd vaccination on 13MAR2021 and PCR positive on 29MAR2021; Respiratory insufficiency in covid-19 pneumonia; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-29101. A 90-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via intramuscular on 13Mar2021 (Batch/Lot Number: unknown) as single dose, dose 1 via an unspecified route of administration on 20Feb2021 (Batch/Lot number unknown) as single dose for covid-19 immunisation. Medical history included ongoing polyneuropathy, hairy cell leukaemia from 2011 and ongoing there was a hair cell - leukemia for 10 years, he was controlled semi-annually at the hematology, no related medication in this regard necessary, last control stable, ongoing vertebral foraminal stenosis (lumbar vertebrostenosis), B-Lymphocytic, CLL (Kiel Classification), B-cell small lymphocytic lymphoma from 2008 and not ongoing, ongoing multifocal seizure, basalioma condition after basal cell removal at ear shortly before corona infection from Mar2021 and not ongoing, Aneurysm atrial, atrial septal aneurysm from 2015 and not ongoing, squamous cell carcinoma from 2020 and unknow if it was ongoing. It was not known that the patient had an immune deficiency. Concomitant medications included gabapentin (NEURONTIN) taken for an unspecified indication, start and stop date were not reported; donepezil taken for an unspecified indication, start and stop date were not reported; minerals nos, vitamins nos (CENTRUM A TO ZINC) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (THYREX) taken for an unspecified indication, start and stop date were not reported; lamotrigin taken for multifocal seizures, start and stop date were not reported. On 28Mar2021: symptom onset with fever, PCR positive on 29Mar2021 (Ct 21.06), "clinical manifestation: respiratory symptoms with/without cough", variant: -$g vaccination failure, death on 06Apr2021 from COVID-19 in the hospital. The final exact cause of death was reported as Respiratory insufficiency associated with Covid-19 pneumonia. The patient''s wife did not have the vaccination certificate anymore - but she herself was vaccinated at the same time as her deceased husband - her batch was COMIRNATY EJ 6136 and ET 1831, it could be assumed that the husband was vaccinated with the same batch, but this could no longer be traced with certainty. The husband was free of infections during both vaccinations and had no side effect after the vaccination. A good 2 weeks after the 2nd vaccination, the onset of symptoms of the Corona infection occurred, source unknown, PCR positive on 29Mar2021, death from COVID-19 in hospital on 06Apr2021. Probably a reduced immune response due to the existing leukemia and therefore infection despite vaccination and finally unfortunately death from COVID-19. An autopsy was not performed. On 28Mar2021 the patient experienced Fever, other, Vaccination failure. On 29Mar2021 the patient experienced COVID-19 PCR test positive, other, other. On 28Mar2021 the patient experienced COVID-19 pneumonia death. The patient''s outcome was unknown for Fever, unknown for Vaccination failure, unknown for COVID-19 PCR test positive, fatal for COVID-19 pneumonia. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (Ct 21.06, variant (as reported)) on 29Mar2021. The patient died on 06Apr2021. An autopsy was not performed. The outcome of the event fever was unknown, of the other events was fatal outcome. No follow-up attempts needed, batch/lot. no. will be followed-up by Regulatory Authority and automatically provided as soon as available. No further information is expected.; Reported Cause(s) of Death: PCR positive on 29Mar2021; Respiratory insufficiency associated with Covid-19 pneumonia; Respiratory insufficiency associated with Covid-19 pneumonia; vaccination failure


VAERS ID: 1392262 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Myeloproliferative neoplasm
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas; Coronary heart disease; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: Antigentest; Test Result: Positive ; Result Unstructured Data: positive; Test Date: 20210420; Test Name: PCR Test; Test Result: Positive ; Result Unstructured Data: positive; Ct value = 13 SARS-COV2 lineage B.1.1.7
CDC Split Type: ATMODERNATX, INC.MOD20212

Write-up: COVID-19; Vaccination failure; inappropriate schedule of vaccination; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Myeloproliferative neoplasm since an unknown date, Adipositas, Hypertension arterial and Coronary heart disease. On 20-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccination). On 20-Apr-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion death). On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccination) outcome was unknown. The patient died on 24-Apr-2021. The reported cause of death was Respiratory failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: positive (Positive) positive and positive (Positive) positive; Ct value = 13 SARS-COV2 lineage B.1.1.7. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Company Comments: This case concerns a 74-year-old female patient who experienced inappropriate schedule of vaccination and fatal event of COVID-19 13 days post last dose of mRNA-1273 vaccination. Patient had significant underlying co-morbidities to include neoplastic disease in addition to advancing age. Based in biological implausibility, causal relationship between the reported events and product use is unlikely.; Sender''s Comments: This case concerns a 74-year-old female patient who experienced inappropriate schedule of vaccination and fatal event of COVID-19 13 days post last dose of mRNA-1273 vaccination. Patient had significant underlying co-morbidities to include neoplastic disease in addition to advancing age. Based in biological implausibility, causal relationship between the reported events and product use is unlikely.; Reported Cause(s) of Death: Respiratory failure


VAERS ID: 1392263 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-05-19
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac failure, Circulatory collapse, Dyspnoea, General physical health deterioration, Malaise, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOMEXOR; ZANIDIP; BLOPRESS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021638883

Write-up: Collapsed at home on 19May2021, suspected pulmonary embolism, cardiovascular arrest; Collapsed at home on 19May21, suspected pulmonary embolism, cardiovascular arrest; Collapsed at home on 19May21, suspected pulmonary embolism, cardiovascular arrest; since 2. Biontech vaccine increasing shortness of breath, malaise, general physician condition decreased; Since the 2nd BIONTECH vaccination, pre-existing cardiac insufficiency has deteriorated rapidly; since 2. Biontech vaccine increasing shortness of breath, malaise, general physician condition decreased; since 2. Biontech vaccine increasing shortness of breath, malaise, general physician condition decreased; This is a spontaneous report from a contactable physician, received from regulatory authority, downloaded from the Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-29433. An 88-year-old male patient (weight: 75 kg, height: 175 cm) received the second dose bnt162b2 (COMIRNATY, Batch/Lot Number: EW2239; Expiration Date: 31Jul2021), via an unspecified route of administration on 08Apr2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included cardiac failure. Concomitant medications included nebivolol hydrochloride (NOMEXOR); lercanidipine hydrochloride (ZANIDIP); candesartan cilexetil (BLOPRESS). The patient previously the first dose of bnt162b2 (COMIRNATY, batch number ET1831) on 18Mar2021 (unknown age at time of vaccination) for COVID-19 immunisation. The patient experienced "collapsed at home on 19May2021, suspected pulmonary embolism, cardiovascular arrest" on 19May2021 11:00; experienced "since 2. biontech vaccine increasing shortness of breath, malaise, general physician condition decreased" and "since the 2nd biontech vaccination, pre-existing cardiac insufficiency has deteriorated rapidly" in 2021. The following was also reported: "Strong patient, was recently mobile, traveling with own car; On 2021 the patient experienced Cardiac failure aggravated, other, Dyspnea; On 19.01.2021 11:00 the patient experienced Pulmonary embolism death, other; On 2021 the patient experienced Malaise death, other, other, General physical condition decreased; On 19.01.2021 11:00 the patient experienced Cardiac arrest death, Circulatory failure." Events cardiac failure aggravated, dyspnea, pulmonary embolism, malaise, general physical condition decreased were reported as Other medically important condition. The patient died on 19May2021 12:05. The outcome of "collapsed at home on 19May2021, suspected pulmonary embolism, cardiovascular arrest" was fatal; outcome of other events was not recovered. It was unknown if an autopsy was performed. Cause of death was "collapsed at home on 19May2021, suspected pulmonary embolism, cardiovascular arrest". No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Collapsed at home on 19May21, suspected pulmonary embolism, cardiovascular arrest; Collapsed at home on 19May2021, suspected pulmonary embolism, cardiovascular arrest; Collapsed at home on 19May2021, suspected pulmonary embolism, cardiovascular arres


VAERS ID: 1392267 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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 INC2021669729

Write-up: Deep vein thrombosis; Pulmonary thrombosis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 563002. A 70-year-old female patient received bnt162b2(COVID-19 VACCINE (Type not specified) - MANUFACTURER UNKNOWN) via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) at unknown dose number single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced deep vein thrombosis, and pulmonary thrombosis on an unknown date. The events resulted in death. The patient died on an unknown date. It was not reported if an autopsy was performed. The cause of death were deep vein thrombosis, and pulmonary thrombosis. The outcome of events was fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Deep vein thrombosis; Pulmonary thrombosis


VAERS ID: 1392268 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021669739

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority. Regulatory authority report number is 563694. A 92-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident on 08Apr2021. The event was serious, fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1392279 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021627715

Write-up: Death from cardiac arrest 24 hours after first dose; This is a spontaneous report from a contactable physician, received via the authorities, downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-92928. A 73-year-old male patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date unknown) via an unspecified route of administration on 16May2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced "death from cardiac arrest 24 hours after first dose" on 17May2021. Treatment was unknown. Impossible to make the link of cause and effect. The outcome of the event was fatal. The patient died on 17May2021. It was unknown if an autopsy was performed. The cause of death was cardiac arrest. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1392280 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-28
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy skin, Face oedema, Foetal death, High foetal head, Palatal disorder
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Skin biopsy; Result Unstructured Data: Not reported
CDC Split Type: BEJNJFOC20210615237

Write-up: DEATH; HIGH FOETAL HEAD/ EDEMATOUS ENLARGED HEAD; NOTABLE PALATE WITH OPEN MOUTH; EDEMATOUS ENLARGED HEAD; This spontaneous pregnancy report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-94484] concerned a foetus of unspecified sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient''s mother received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C10-01 expiry: UNKNOWN) 1 total, dose was not reported, administered on 25-MAY-2021 for covid-19 immunisation. No concomitant medications were reported. It was reported that, the mother was 19-week pregnant and visited delivery room on 28-MAY-2021 with vaginal red blood loss and she no longer felt the child''s movement. The diagnosis was made as fetal death, high foetal head/edematous enlarged head (pre or post-mortem) and notable palate with open mouth on the same day. The examination undergone was skin biopsy genetics fetus bacteria wiper placenta. It was reported that foetus died from high foetal head/ edematous enlarged head, notable palate with open mouth, and edematous enlarged head. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This parent/child case is linked to 20210617564.; Reporter''s Comments: Treatment. Examinations placenta ADR description - (pre-of postmortem?) Sender''s Comments: V0: 20210615237-COVID-19 VACCINE AD26.COV2.S- death, high foetal head, notable palate with open mouth, edematous enlarged head. 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: HIGH FOETAL HEAD/ EDEMATOUS ENLARGED HEAD; DEATH; NOTABLE PALATE WITH OPEN MOUTH; EDEMATOUS ENLARGED HEAD


VAERS ID: 1392299 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Gastrointestinal haemorrhage, SARS-CoV-2 test positive
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021619262

Write-up: GI bleed; 1 resident who tested positive died-also fully vaccinated; 1 resident who tested positive died-also fully vaccinated; This is a spontaneous report from a contactable nurse and physician via a Company sales representative. This nurse and physician reported similar events for 17 patients including 13 residents (12 were fully vaccinated in which 1 died, and 1 received the first dose) and 4 staffs (3 were fully vaccinated and 1 received the first dose). This is the 12th of 17 reports corresponding to the resident who was fully vaccinated and died. A patient of unspecified age and gender received the second dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not provided), both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. One (1) resident who tested positive died was also fully vaccinated on an unspecified date. The resident who died did not die from COVID though. GI bleed was put as cause. The course of events was as follows: A COVID-19 outbreak was reported post vaccination with patient''s experiencing mild to moderate symptoms. So far, they have 7 positive staff in which 3 were fully vaccinated, 3 were not vaccinated, and 1 received the first dose 4 days prior to testing positive. They also have 15 positive residents, 2 were not vaccinated, 1 received the first dose, and 12 were fully vaccinated. 1 resident who was fully vaccinated and tested positive, died and 1 person required high dose dexamethasone. All positive staffs and residents were vaccinated with Pfizer. It was not reported if an autopsy was performed. The outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: The patient received full dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified dates and tested positive, and died from gastrointestinal (GI) bleeding. Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient was possible. However, the fatal event (GI) bleeding was unlikely causally related to the vaccine of BNT162B2. Further information like vaccination/COVID infection date, medical history and clinical course needed for a meaningful medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : CA-PFIZER INC-2021619711 same reporter and drug, similar event, different patient; Reported Cause(s) of Death: GI bleed


VAERS ID: 1392315 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure, Death, Headache
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; SIMCORA; CONCOR; CALCIMAGONA D3; BECOZYM-F; LEXOTANIL
Current Illness: Adiposis; Arterial hypertension; Nicotine abuse
Preexisting Conditions: Medical History/Concurrent Conditions: Breast ductal carcinoma (no recurrence until 2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: heart failure; Death NOS; headache; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death NOS) and CARDIAC FAILURE (heart failure) in an 80-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 300042460 and 300042723) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Breast ductal carcinoma (no recurrence until 2020) in 2010. Concurrent medical conditions included Arterial hypertension, Adiposis and Nicotine abuse. Concomitant products included LISINOPRIL, SIMVASTATIN (SIMCORA), BISOPROLOL FUMARATE (CONCOR), CALCIUM CARBONATE, COLECALCIFEROL (CALCIMAGONA D3), NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (BECOZYM-F) and BROMAZEPAM (LEXOTANIL) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion death). The patient died on 02-Mar-2021. The reported cause of death was Acute heart failure. It is unknown if an autopsy was performed. At the time of death, HEADACHE (headache) outcome was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death NOS) to be unlikely related. No further causality assessments were provided for CARDIAC FAILURE (heart failure) and HEADACHE (headache). The patient developed headache 3 hours after the first dose of vaccine. It was reported that the patient died Half an hour to two hours before legal inspection. Action taken with mRNA-1273 in response to the event was Not Applicable Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events: headache and heart failure, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the events. Regarding the Event "Death", based on reporter''s causality (and medical history) the event is assessed as unlikely related to mRNA-1273. This case was linked to MOD-2021-166506 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Translation document received on 01JUN2021: Concomitant medication dosage details were updated and inspecting physicians notes in narrative.; Reporter''s Comments: Death occurred 4.5 days after the second vaccination of the Moderna Covid-19 vaccine, in an 80-year-old polymorbid patient with several cardiovascular risk factors (smoking, overweight, hypertension and previous breast cancer). The monographs for the Moderna Covid-19 vaccine, do not list sudden death following the administration of the vaccine under possible adverse events. In the immediate aftermath of the two administrations, the patient showed no signs compatible with an allergic reaction and with the exception of a headache reported following the first administration, no adverse reactions were observed. The medical examiner believes possible cause of death was cardiac arrest due to natural causes ("Natural internal event"). There is no objective, laboratory or imaging evidence, let alone autopsy evidence to support a causal link between administration of the vaccine and the death. Therefore, considering the health status of the patient and her age, in spite of the temporal link between the administration of the vaccine and the event, based on the current state of knowledge we consider the causal role of the vaccine with the death of the patient unlikely.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1392318 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   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: ACIDE FOLIQUE; METFIN; CONDROSULF; TOPIRAMATO; OLANZAPINA; REDORMIN [HUMULUS LUPULUS HOPS;VALERIANA OFFICINALIS ROOT]; STILNOX; TEMESTA [LORAZEPAM]; TRANXILIUM; PARONEX; SYMFONA [GINKGO BILOBA ACETONE EXTRACT]; BENERVA; CALCIMAGON D3; LACRY
Current Illness: Chronic depression; Deaf; Diabetes; Epilepsy; Hypercholesterolemia; Hypertensive cardiomyopathy; Mental retardation
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse chronic; Cholecystectomy; Deep vein thrombosis; Encephalopathy chronic; Equilibrium trouble; Facial paresis; Fall; Head injury; Head injury; Hernia inguinal; Hypernatremia; Pulmonary embolism; Rhabdomyolysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 66-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Head injury on 12-Mar-2021, Folate deficiency, Head injury in 1965, Fal, Equilibrium trouble, Encephalopathy chronic, Alcohol abuse chronic, Facial paresis in 1979, Cholecystectomy in 2012, Hypernatremia on 23-Jul-2019, Deep vein thrombosis in 2012, Hernia inguinal, Pulmonary embolism in 2020 and Rhabdomyolysis. Concurrent medical conditions included Epilepsy, Hypertensive cardiomyopathy, Diabetes, Mental retardation since 1965, Hypercholesterolemia since 1965, Deaf since 1979 and Chronic depression. Concomitant products included FOLIC ACID (ACIDE FOLIQUE) from 13-Mar-2021 to 13-Apr-2021, METFORMIN HYDROCHLORIDE (METFIN), CHONDROITIN SULFATE SODIUM (CONDROSULF), TOPIRAMATE (TOPIRAMATO), OLANZAPINE (OLANZAPINA), HUMULUS LUPULUS HOPS, VALERIANA OFFICINALIS ROOT (REDORMIN [HUMULUS LUPULUS HOPS;VALERIANA OFFICINALIS ROOT]), ZOLPIDEM TARTRATE (STILNOX), LORAZEPAM (TEMESTA [LORAZEPAM]), CLORAZEPATE DIPOTASSIUM (TRANXILIUM), PAROXETINE HYDROCHLORIDE (PARONEX), GINKGO BILOBA ACETONE EXTRACT (SYMFONA [GINKGO BILOBA ACETONE EXTRACT]), THIAMINE HYDROCHLORIDE (BENERVA), CALCIUM CARBONATE, COLECALCIFEROL (CALCIMAGON D3), GLYCEROL, HYALURONATE SODIUM, POLYACRYLATE SODIUM (LACRYCON [GLYCEROL;HYALURONATE SODIUM;POLYACRYLATE SODIUM]), PARACETAMOL (DAFALGAN) and MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) for an unknown indication. On 01-May-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 02-May-2021 The patient died on 02-May-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) to be unlikely related. Action taken with mRNA-1273 in response to the events was not Applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Nevertheless, concomitant diseases and medications could be potentially confounders/co-suspects.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Nevertheless, concomitant diseases and medications could be potentially confounders/co-suspects.; Reported Cause(s) of Death: unknown casue of death


VAERS ID: 1392321 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-07
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Lymphocyte count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: ATORVASTATIN; XARELTO; TORASEMID; SPIRICORT; MALTOFER [FERRIC HYDROXIDE POLYMALTOSE COMPLEX]; KCL; PANTOPRAZOLE; LAXOBERON
Current Illness: Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cholecystolithiasis; Gastroesophageal reflux; Glaucoma; Hernia hiatal; Hypertension arterial; Hypertensive cardiomyopathy (tendency towards hypokalemia; on diuretic therapy); Hypokalemia; Intertrigo; Lymphopenia (relative lymphopaenia); Macrocytosis; Myocardial infarction; Obesity (BMI 44 Kg/m2); Polymyalgia rheumatica; Polytrauma
Allergies:
Diagnostic Lab Data: Test Name: Absolute lymphocyte count; Result Unstructured Data: 19.8%; Test Date: 2018; Test Name: Absolute lymphocyte count; Result Unstructured Data: 14.5% decreased; Test Date: 2019; Test Name: Absolute lymphocyte count; Result Unstructured Data: 15.6% decreased
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: (Found Dead); This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Found Dead)) in an 88-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cholecystolithiasis, Gastroesophageal reflux, Polytrauma in 2016, Glaucoma, Hernia hiatal, Macrocytosis, Intertrigo, Obesity (BMI 44 Kg/m2), Hypokalemia , Hypertensive cardiomyopathy (tendency towards hypokalemia; on diuretic therapy), Myocardial infarction in 2014, Hypertension arterial, Atrial fibrillation, Polymyalgia rheumatica and Lymphopenia (relative lymphopaenia) in 2018. Concurrent medical conditions included Penicillin allergy. Concomitant products included ATORVASTATIN, RIVAROXABAN (XARELTO), TORASEMIDE (TORASEMID), PREDNISOLONE (SPIRICORT), FERRIC HYDROXIDE POLYMALTOSE COMPLEX (MALTOFER [FERRIC HYDROXIDE POLYMALTOSE COMPLEX]), POTASSIUM CHLORIDE (KCL), PANTOPRAZOLE and SODIUM PICOSULFATE (LAXOBERON) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 07-May-2021 The patient died on 07-May-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2018, Lymphocyte count: 14.5 (Low) 14.5% decreased. In 2019, Lymphocyte count: 15.6 (Low) 15.6% decreased. On an unknown date, Lymphocyte count: 19.8 (normal) 19.8%. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH . (Found Dead)) to be unlikely related. Sender''s Comment: 88-year-old obese polymorbid patient, under multiple chronic therapies?. Death following the second dose of mRNA Covid-19 vaccines in elderly and fragile patients is not reported in the monographs for vaccines, nor in international literature. In light of the available data and considering the patient''s comorbidities (known heart disease, high blood pressure and multiple medications), the causal link between death and the vaccine is considered unlikely (non-causal temporal correlation). However, this view regarding the causal link cannot entirely rule out the vaccine''s contribution. The hypothesis could be an immune reaction following the vaccine with a deterioration in the general conditions of a polymorbid patient (known lymphopaenia revealed in tests carried out before the event since 2018). Treatment information was not applicable. The patient was polymorbid patient, under multiple chronic therapies. The diagnostic tests not carried out. This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Translation document attached: updated with autopsy information and senders comment.; Sender''s Comments: This a report of dead one day after the second dose of the product in an old polymorbid patient with many confounders. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1392333 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-03-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AGEN; TORVACARD
Current Illness: Eyelid ptosis (ptosis of one eyelid); Hypercholesterolaemia; Hypertension; Hypertension ocular (intraocular hypertension); Mixed dementia (advanced); Steatosis hepatic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021627782

Write-up: Heart Failure; Thromboembolism of the lung and left pulmonary artery; This is a spontaneous report from a contactable consumer, received from regulatory authority, downloaded from a regulatory authority-WEB. The regulatory authority report number is CZ-CZSUKL-21006039. An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date unknown) via an unspecified route of administration on 23Feb2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient''s medical history included hypertension, hypercholesterolemia, steatosis hepatic, eyelid ptosis (ptosis of one eyelid), mixed dementia (advanced), and hypertension ocular (intraocular hypertension), all ongoing. The patient had no risk factors for thrombosis. Concomitant medications included atorvastatin calcium (TORVACARD) and amlodipine besilate (AGEN). The patient experienced heart failure and thromboembolism of the lung and left pulmonary artery on 14Mar2021. Events was assessed as serious with criteria of Results in death, Life threatening, and Other medically important condition. The patient died on the 14Mar2021 after the vaccination with COMIRNATY. "FU from 25May2021: physician contacted, he provided additional information about the patient''s medical history and concomitant medication, according to him, the patient had no risk factors for thrombosis." The outcome of the events was fatal. An autopsy was performed. Autopsy result was not available. Cause of death was cardiac failure and pulmonary embolism (also reported as "heart failure with massive thromboembolism of lung and left major pulmonary artery"). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism; Cardiac failure


VAERS ID: 1393046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, Fatigue, Malaise
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: 2021-04-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATINE ACCORD; KARDEGIC; BISOCE; SPIRONOLACTONE ARROW; MIRTAZAPIN MYLAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clostridium difficile infection (Very satisfactory recovery); Stroke (10 years before)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021645492

Write-up: Death NOS; cardiac arrest; malaise; Fatigue; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021050794. An 87-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection), via intramuscular administered in left arm on 13Apr2021 (Lot Number: EW2246) as a single dose for covid-19 immunization. General condition good. Very healthy lifestyle. Medical history included Stroke from an unknown date (10 years before unknown date), severe Clostridium difficile infection in Nov2020. Very satisfactory recovery. Concomitant medication(s) included atorvastatin calcium (ATORVASTATINE ACCORD); acetylsalicylate lysine (KARDEGIC) taken for Stroke; bisoprolol fumarate (BISOCE); spironolactone (SPIRONOLACTONE ARROW); mirtazapine (MIRTAZAPIN MYLAN). The patient occurrence of fatigue on 14Apr2021 but resolved on 17Apr2021 according to the statements of his relatives. Without news of the patient, the family contacted the firefighters, death noted on 19Apr2021 but probable death on 18Apr2021. Doctor''s report: malaise during the meal and cardiac arrest because the patient was found at a table, sitting in her seat. It was unknown if an autopsy was performed. The outcome of the event fatigue was resolved on 17Apr2021, outcome of others was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Arrest cardiac; Death NOS; malaise


VAERS ID: 1393057 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Asthenia, Auscultation, Blood creatinine, Blood pressure measurement, Blood pressure systolic, Blood urea, Body temperature, Brain natriuretic peptide, Cardiac failure, Crepitations, Feeling abnormal, Haemoglobin, Heart rate, Investigation, Neurological examination, Oxygen saturation, Pallor, Physical examination, Positron emission tomogram, Respiratory rate, Scan, Yellow skin
SMQs:, Cardiac failure (narrow), Cholestasis and jaundice of hepatic origin (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia (in the context of occult gastrointestinal bleeding); Aortic valve incompetence (mild aortic valve regurgitation); Arterial hypertension; Cardiac dilatation (dilated hypertrophic heart disease); Cardiac failure (stable cardiac failure on dilated hypertrophic heart disease, with hypertensive etiology); CVA; Gastrointestinal bleeding (occult gastrointestinal bleeding); Hemiparesis (left) (hemiparesis of the left hand); Hiatal hernia (voluminous hiatal hernia with unremarkable fibroscopy in Jul2020); Hypertrophic heart disease (dilated hypertrophic heart disease); Hypoesthesia (loss of mouth''s sensitivity); Mitral incompetence (mild mitral regurgitation); Transfusion (transfusions and iron)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Cardio-pulmonary examination; Result Unstructured Data: Test Result:unremarkable; Comments: No clinical signs of heart failure; Test Date: 20210308; Test Name: Cardio-pulmonary examination; Result Unstructured Data: Test Result:Crackles were heard over both pulmonary fields up; Comments: Crackles were heard over both pulmonary fields up to 2/3 of lungs; Test Date: 202012; Test Name: creatinine; Result Unstructured Data: Test Result:65 umol/l; Test Date: 20210301; Test Name: creatinine; Result Unstructured Data: Test Result:75 umol/l; Test Date: 202102; Test Name: blood pressure; Result Unstructured Data: Test Result:130/55 mmHg; Test Date: 20210308; Test Name: blood pressure; Result Unstructured Data: Test Result:110/70 mmHg; Test Date: 20210308; Test Name: blood pressure; Result Unstructured Data: Test Result:unmeasurable on both arms mmHg; Comments: Around mid-day; Test Date: 20210308; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:finally measured at 70 mmHg; Test Date: 20210308; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:increased to 90 mmHg; Test Date: 20210301; Test Name: urea; Test Result: 7 mmol; Comments: stable; Test Date: 20210308; Test Name: body temperature; Result Unstructured Data: Test Result:no fever; Test Date: 20210301; Test Name: BNP; Result Unstructured Data: Test Result:326; Comments: increased; Test Date: 20210301; Test Name: hemoglobin; Result Unstructured Data: Test Result:143; Test Date: 202103; Test Name: hemoglobin; Test Result: 143 g; Test Date: 202102; Test Name: heart rate; Result Unstructured Data: Test Result:75; Comments: 75 beats/min; Test Date: 20210308; Test Name: heart rate; Result Unstructured Data: Test Result:89; Comments: 89 beats/min; Test Date: 20210308; Test Name: heart rate; Result Unstructured Data: Test Result:60; Comments: 60 beats/min, Around mid-day; Test Name: dependency assessment/groups iso-ressources scale; Result Unstructured Data: Test Result:4; Test Date: 202102; Test Name: neurological examination; Result Unstructured Data: Test Result:unremarkable; Test Date: 202102; Test Name: oxygen saturation; Test Result: 95 %; Test Date: 20210308; Test Name: oxygen saturation; Result Unstructured Data: Test Result:no desaturation %; Test Date: 20210308; Test Name: oxygen saturation; Test Result: 92 %; Comments: Around mid-day; Test Date: 202102; Test Name: abdominal examination; Result Unstructured Data: Test Result:unremarkable; Test Date: 2021; Test Name: physical examination; Result Unstructured Data: Test Result:unremarkable; Comments: the patient presented asthenia; Test Date: 202008; Test Name: PET scan; Result Unstructured Data: Test Result:unremarkable; Test Date: 20210308; Test Name: respiration rate; Result Unstructured Data: Test Result:36; Comments: polypnea at 36/min, Around mid-day; Test Date: 202007; Test Name: fibroscopy; Result Unstructured Data: Test Result:unremarkable
CDC Split Type: FRPFIZER INC2021645752

Write-up: skin appeared to be yellow; Crackles; Pain in left iliac fossa; Decompensation cardiac/BNP 326 (increased); Feeling bad/feeling unwell; pale; asthenia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number FR-AFSSAPS-2021060227. A 94-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EJ6789), intramuscularly on 24Feb2021 at single dose for COVID-19 immunisation. Medical history included cerebrovascular accident (CVA) from 2016 with hemiparesis of the left hand and loss of mouth''s sensitivity; arterial hypertension; stable cardiac failure on dilated hypertrophic heart disease, with hypertensive etiology, left ventricle ejection fraction was preserved; mild aortic valve regurgitation and mild mitral regurgitation from Nov2018; anemia in the context of occult gastrointestinal bleeding; voluminous hiatal hernia with unremarkable fibroscopy in Jul2020 and unremarkable PET scan in Aug2020. It was decided not to follow the investigations as the patient''s weight was at 37 kg (usual weight), treatment was symptomatic with transfusions and iron. Last hemoglobin level was measured at 143 g in Mar2021. Patient''s dependency assessment was estimated at 4 according to groups iso-ressources scale, patient was able to move alone with a walker, to play cards, had no cognitive disorder. Patient had no medical history for SARS-Cov-2 infection. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY) at single does for Covid-19 immunization. The patient experienced decompensation cardiac reported as serious due to death on 08Mar2021, feeling bad reported as non-serious on 25Feb2021. It was reported that on 24Feb2021 second dose of bnt162b2 was administered. On 25Feb2021, the patient told to her health care team and her dinner companions that she was feeling unwell. Patient related it to a vaccine administration. On 27Feb2021 and 28Feb2021, patient was assessed by a general physician. Arterial blood pressure was 130/55 mmHg, heart rate 75 beats per minute, oxygen saturation at 95% in Feb2021. Cardio-pulmonary, abdominal and neurological examinations were unremarkable in Feb2021. No clinical signs of heart failure. She was pale in Feb2021. On 01Mar2021, laboratory work up showed hemoglobin 143, BNP 326 (increased), urea 7 mmol (stable), creatinine 75 umol/L (in Dec2020 was at 65 umol/L). During the week in 2021 physical examination was still unremarkable but the patient presented asthenia. On 08Mar2021, patient had difficulties to walk with important asthenia. Systolic blood pressure was at 110/70, heart rate at 89 beats per minute. Patient''s skin appeared to be yellow, but without conjunctival jaundice. Crackles were heard over both pulmonary fields up to 2/3 of lungs. No fever, no desaturation, no mottled skin were evidenced. Pain in the right upper quadrant was reported. She was diagnosed with cardiac decompensation, furosemide (unspecified trade name) was increased from 60 to 80 mg/day. Around mid-day patient experienced difficulties in talking, with polypnea at 36/minute, oxygen saturation at 92%, heart rate at 60 beats per minute under bisoprolol fumarate (unspecified trade name) 1.25 mg, and unmeasurable blood pressure on both arms. She was conscious. Systolic blood pressure was finally measured at 70 mmHg, peripheral venous catheter was inserted on the right side following an administration of 500ml of saline solution and paracetamol (PERFALGAN). Pain in left iliac fossa was reported. Systolic blood pressure increased to 90 mmHg and oxygen therapy at 6L/min was initiated. Patient was transferred to a hospital by emergency medical service. Patient passed away on 08Mar2021 on 22:30. The patient died on 08Mar2021 due to Death unexplained and Decompensation cardiac. No autopsy was performed. The outcome of the event decompensation cardiac was fatal; feeling bad and asthenia was not recovered; outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained; Decompensation cardiac/BNP 326 (increased)


VAERS ID: 1393072 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-11
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: Tobacco user (heavy tobacco user)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021661138

Write-up: cardiac arrest; This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. A 47-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing heavy tobacco user. There were no concomitant medications. The patient experienced cardiac arrest on an unspecified date 24 hours after BNT162B2 injection. The evet was serious, fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1393540 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Death, Dyspnoea, Inappropriate schedule of product administration
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 35
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: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021640757

Write-up: collapsing 3 weeks after vaccination; Death; severe difficulties in breathing; first dose on 18Mar2021/ second dose on 16Mar2021; This is a spontaneous report from a contactable consumer received by Pfizer from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106011401412420-SO6EP and Safety Report Unique Identifier GB-MHRA-ADR 25397726. A 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER1741) via unspecified route single dose for COVID-19 immunisation on 16Mar2021, at 76-year-old. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation on 08Jan2021. The patient experienced ''death'' on 23Mar2021. 2 days post vaccine (18Mar2021), patient had severe difficulties in breathing lasting until death. This led to the patient collapsing 3 weeks after vaccination, being taken to hospital where the patient died shortly afterwards. The patient died on 20Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1393609 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-09
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, COVID-19, COVID-19 pneumonia, Circulatory collapse, Computerised tomogram thorax, Drug ineffective, Guillain-Barre syndrome, Heart rate, Hypoxia, Inappropriate schedule of product administration, Lumbar puncture, Muscular weakness, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (narrow), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Medication errors (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 34
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: Chronic renal failure; Deep vein thrombosis leg; Diabetes mellitus; Hypertension; Hypothyreosis; Ischemic heart disease; Myocardial infarct; Steatosis hepatic; Ulcus cruris
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: Chest CT; Result Unstructured Data: Test Result:bilateral COVID-19 pneumonia; Test Date: 20210507; Test Name: ventricular rate; Result Unstructured Data: Test Result:high; Comments: high ventricular rate atrial fibrillation; Test Date: 20210507; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:abnormalities; Comments: abnormalities suggestive of Guillain-Barre syndrome; Test Date: 20210430; Test Name: COVID-19 antigen test; Test Result: Positive ; Comments: COVID-19 antigen rapid test showed positive
CDC Split Type: HUPFIZER INC2021654374

Write-up: Lumbal puncture showed abnormalities suggestive of Guillain-Barre syndrome; Severe hypoxia; High ventricular rate atrial fibrillation; Circulatory failure; COVID-19 pneumonia; COVID-19 antigen test positive; COVID-19 antigen test positive; Lower limb weakness/ muscle strength of her upper limbs also decreased; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB; the Regulatory Authority report number is HU-OGYI-360521. A 75-year-old female patient received BNT162B2 (COMIRNATY) [reported as 30 ug/ 0.3mL COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran Concentrate for dispersion for injection] intramuscularly, administered in the left arm on 24Mar2021 (batch/lot number: ET3620) as 1ST DOSE, 0.3mL SINGLE for COVID-19 immunization. The patient''s medical history included hypertension, diabetes mellitus, chronic renal failure, steatosis hepatic, myocardial infarct, ischemic heart disease, hypothyreosis, deep vein thrombosis of leg, and ulcus cruris, all from an unknown date. Concomitant medications were not reported. On 30Apr2021, the patient called an ambulance due to lower limb weakness, which has started 3 weeks earlier (09Apr2021). On 30Apr2021, COVID-19 antigen rapid test showed positive and urgent chest CT showed bilateral COVID-19 pneumonia and the patient was hospitalized. Antiviral, antithrombotic, and steroid treatment was started. The patient''s condition deteriorated; muscle strength of her upper limbs also decreased. On 07May2021, lumbar puncture showed abnormalities suggestive of Guillain-Barre syndrome. Mechanical ventilation was started on 07May2021 due to severe hypoxia. Cordarone (amiodarone) was given due to high ventricular rate atrial fibrillation, which was later supplemented with digoxin saturation. Severe hypoxia and circulatory failure (unknown date in May2021) were irreversible, and resuscitation was unsuccessful. The patient died on 13May2021 at 10:20 a.m; the cause of death was considered clarified. An autopsy was not performed. Senders comments: COVID-19 antigen test became positive, and COVID-19 pneumonia occurred after 5 weeks, and the patient died 7 weeks after the first dose of Comirnaty. Autopsy was not done. Immunity may have not developed after the first dose of vaccine. The case is serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 antigen rapid test; COVID-19 antigen rapid test; Guillain-Barre syndrome; Severe hypoxia; High ventricular rate atrial fibrillation; Circulatory failure


VAERS ID: 1393617 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-25
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   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: AMLODIPINE
Current Illness: COPD; Hypertension; Ischemic heart disease (IHD)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEMODERNATX, INC.MOD20212

Write-up: Unexpected death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Unexpected death) in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 immunisation. Concurrent medical conditions included Hypertension, Ischemic heart disease (IHD) and COPD. Concomitant products included AMLODIPINE from 12-Feb-2021 to 25-Apr-2021 for Hypertension. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died on 25-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of sudden death in a 75-year-old male subject with a history of Hypertension, Ischemic Heart Disease and COPD, who died 25 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 75-year-old male subject with a history of Hypertension, Ischemic Heart Disease and COPD, who died 25 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1393620 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-19
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Migraine
Preexisting Conditions: Comments: patient had no other known diseases.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISJNJFOC20210606759

Write-up: DEATH; STOMACH ACHE; This spontaneous report received from a health care professional, concerned a 41 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included migraines, and the patient had no other known diseases. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose was not reported, one total, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAY-2021, the patient called and reported that she experienced stomach ache. On the same day, she died. On 19-MAY-2021, the patient died from stomach ache. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.. This report was serious (Death).; Sender''s Comments: V0: 20210606759-covid-19 vaccine ad26.cov2.s -death and stomach ache. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. Due to insufficient information available, causality for the events was assessed as unassessable. Follow up queries have been raised and causality will be reassessed on receiving follow up information.; Reported Cause(s) of Death: DEATH; STOMACH ACHE


VAERS ID: 1393636 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Confusional state, Death, International normalised ratio, Multiple organ dysfunction syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: LASIX [FUROSEMIDE]; KCL-RETARD; CARDICOR; ANAGRELIDE HYDROCHLORIDE; COUMADIN; DEFERASIROX
Current Illness: AFib
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: C-reactive protein; Result Unstructured Data: Reported as abnormal; Test Date: 20210505; Test Name: INR; Result Unstructured Data: Reported as abnormal
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of MULTIPLE ORGAN DYSFUNCTION SYNDROME, CONFUSIONAL STATE and DEATH (Death) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included AFib. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), POTASSIUM CHLORIDE (KCL-RETARD), BISOPROLOL FUMARATE (CARDICOR), ANAGRELIDE HYDROCHLORIDE, WARFARIN SODIUM (COUMADIN) and DEFERASIROX for an unknown indication. On 27-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 05-May-2021, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (seriousness criterion death) and CONFUSIONAL STATE (seriousness criterion death). The patient died on 06-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, C-reactive protein: abnormal (abnormal) Reported as abnormal. On 05-May-2021, International normalised ratio: abnormal (abnormal) Reported as abnormal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Lab data included Activated partial thromboplastin time, Blood potassium, Chest X-ray, Computerised tomogram head, Haemoglobin and Procalcitonin. No results provided. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up document had no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.; Reported Cause(s) of Death: Unknown


VAERS ID: 1393641 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-26
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   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: LIVIAL 2,5 MG COMPRESSE; COLECALCIFEROL; VITAMIN D [ERGOCALCIFEROL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210606711

Write-up: REPORTED THAT WHEN SHE WOKE UP ON 26 MAY 21 SHE HAD EPISODES OF VOMITING, SHE THEN LAID DOWN FOR MALAISE, CALLED THE EMERGENCY SERVICE WHICH AT 11.26 ASCERTAINED A CARDIAC ARREST, IRREVERSIBLE, CPR; This spontaneous report received from a physician via a Regulatory Authority [IT-MINISAL02-735944] concerned a 56 year old female. The patient''s weight was not reported and height was 165 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: 21C11-03 expiry: 28/FEB/2023) dose was not reported, administered on 23-MAY-2021 for covid-19 vaccination. Concomitant medications included colecalciferol for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and tibolone for menopause. On 26-MAY-2021 morning, the attending physician reported that when she woke up on 26 may 21 she had episodes of vomiting, she then laid down for malaise, called the emergency service which at 11.26 ascertained a cardiac arrest, irreversible, cpr. On 26-MAY-2021, the subject died from cardio respiratory arrest. 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).; Sender''s Comments: V0 : 20210606711-COVID-19 VACCINE AD26.COV2.S -Reported that when she woke up on 26 may 21 she had episodes of vomiting, she then laid down for malaise, called the emergency service which at 11.26 ascertained a cardiac arrest, irreversible, CPR . This event is considered unassessable. The event 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.; Reported Cause(s) of Death: CARDIO RESPIRATORY ARREST


VAERS ID: 1393646 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatinine, Blood glucose, Blood pressure inadequately controlled, Blood urea, Cognitive disorder, Haemoglobin, Pyrexia, Red blood cell sedimentation rate, Sopor, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 29
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: 20210521; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:123 IU/l; Test Date: 20210521; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:54 IU/l; Test Date: 20210521; Test Name: Blood creatinine; Result Unstructured Data: Test Result:unknown results mg/dl; Test Date: 20210521; Test Name: Blood glucose; Test Result: 162 mg/dl; Test Date: 20210521; Test Name: Blood urea; Result Unstructured Data: Test Result:unknown results mg/dl; Test Date: 20210521; Test Name: Hb; Result Unstructured Data: Test Result:12.2 g/dl; Test Date: 20210521; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:23 mm/h; Test Date: 20210521; Test Name: White blood cell count; Result Unstructured Data: Test Result:11.9 10*6/mL
CDC Split Type: ITPFIZER INC2021674335

Write-up: Worsening (see reporting 738731) with further cognitive decline (patient tendentially sleepy but reawakened), new blood pressure changes as after the first dose, low-grade fever.; Worsening (see reporting 738731) with further cognitive decline (patient tendentially sleepy but reawakened), new blood pressure changes as after the first dose, low-grade fever.; Worsening (see reporting 738731) with further cognitive decline (patient tendentially sleepy but reawakened), new blood pressure changes as after the first dose, low-grade fever.; Worsening (see reporting 738731) with further cognitive decline (patient tendentially sleepy but reawakened), new blood pressure changes as after the first dose, low-grade fever.; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-738750. A 87-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EX3599), via intramuscular route of administration, on 29Apr2021, as 2nd dose, single dose for COVID-19 Immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: ER9470), via intramuscular route of administration, on 08Apr2021, as a single dose for COVID-19 Immunisation and experienced vaccination adverse reactions. Patient did not receive any other vaccines in the previous 4 weeks other than the first dose of Comirnaty. On 29Apr2021, the patient experienced worsening (see reporting 738731) of her conditions with further cognitive decline (patient tendentially sleepy but reawakened), new blood pressure changes observed after the first dose, along with low-grade fever. Therapeutic measures for the adverse events included hydration with physiological solution 500ml/day IV, low flow oxygen therapy, Lasix IV in case of pressure peaks, Ceftriaxone 1g/day, Soldesam 8mg then decreased to 4mg/day. The patient underwent lab tests and procedures on 21May2021, which included alanine aminotransferase: 123 IU/I, aspartate aminotransferase: 54 IU/I, blood creatinine (mg/dl): unknown results, blood glucose: 162 mg/dl, blood urea (mg/dl): unknown results, Haemoglobin (Hb): 12.2 g/dl, Erythrocyte sedimentation rate: 23 mm/h, White blood cell count: 11.99 x 10^9/l. On 28May2021, the patient died, with unknown cause of death. Autopsy performed was unknown. The clinical outcome of all the events was fatal.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-2021666974 same patient, different event, 1st dose; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1393841 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-29
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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: MICAFUNGIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep mycosis; Pyelonephritis acute (required hospitalization (02May2021-15May2021)); Renal transplant (living donor)
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021631233

Write-up: Haematemesis; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21110453. The patient was a 73-year and 6-month-old male. Body temperature before vaccination was 36.9 degrees Centigrade. Medical history included (living donor) renal transplant (2013), deep pulmonary mycoses (from Feb2021) and pyelonephritis acute (required hospitalization [02May2021-15May2021]). Concomitant medications included micafungin sodium (MICAFUNGIN) for deep pulmonary mycoses from 26Apr2021. The patient had no relevant family history. On 25May2021 at 17:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as 1st dose, single for COVID-19 immunization. On 29May2021 in the morning (4 days after the vaccination), the patient developed haematemesis, and he died on that day. It was not provided if an autopsy was performed. The course of the event was as follows: From Feb2021, the patient was admitted to a hospital (different from the reporter''s) for deep pulmonary mycoses. On 26Apr2021, the patient was discharged from the hospital. Since then, the patient had received IV drip of micafungin sodium (MICAFUNGIN) 50 mg at home. On 02May2021, he was admitted to the hospital for acute pyelonephritis (until 15May2021). On 25May2021 at 17:00, the patient received the first dose of the vaccination. On 25May2021, after the vaccination, no marked changes were noted. On 29May2021 in the morning, the patient vomited blood (haematemesis) and was found lying down by his family. He was transferred to a hospital by an ambulance where the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. He considered that there was other possible cause of the event. The reporting physician commented as follows: Since the patient had underlying diseases, the possibility of the event being an adverse reaction due to BNT162b2 was low.; Sender''s Comments: Based on the current available information, the event Haematemesis is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162b2. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Haematemesis


VAERS ID: 1393845 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bilateral pleural effusion; Brain stem infarction; Cardiac failure chronic; Diabetes mellitus (ongoing insulin therapy); Dysphagia; Gastrostomy; Hospitalisation (under discharge support); Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210516; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210516; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Comments: at 04:55; Test Date: 20210516; Test Name: SpO2; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC2021653829

Write-up: Blood pressure decreased; Cardiac arrest; pyrexia of 38.4 degrees Centigrade; SpO2 decreased; This is a spontaneous report from a contactable healthcare professional received via Agency Regulatory Authority. This report is received from the Regulatory Authority. Regulatory authority report number is v21111815. A 94-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), intramuscularly in the left arm on 11May2021 at 11:00 at a single dose for covid-19 immunisation. The patient had been hospitalized for a long term in the reporting hospital since 11Dec2020 for brain stem infarction in Dec2020 (under discharge support), pneumonia aspiration, dysphagia (post-gastrostomy), diabetes mellitus with ongoing insulin therapy, cardiac failure chronic, and bilateral pleural effusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included insulin (MANUFACTURER UNKNOWN) taken for diabetes mellitus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16May2021 at 04:55, the patient experienced blood pressure decreased, cardiac arrest, pyrexia of 38.4 degrees centigrade, and SPO2 decreased. The clinical course was as follows: on 11May2021 at 11:00 (the day of vaccination), the patient received the first single dose of BNT162b2. On 16May2021 at 04:55 (5 days after the vaccination), the patient experienced pyrexia of 38.4 degrees Centigrade and SpO2 decreased. Fasting, oxygen therapy, fluid replacement and administration of antibiotic were performed based on the instruction from the an on-call doctor. Cardiopulmonary resuscitation was performed, the patient did not recover. At 12:27, death of the patient was confirmed. The patient underwent lab tests and procedures which included blood pressure: decreased on 16May2021, body temperature: 38.4 degrees Centigrade on 16May2021 at 04:55, oxygen saturation: decreased on 16May2021. Therapeutic measures were taken as a result of blood pressure decreased, cardiac arrest, pyrexia of 38.4 degrees Centigrade, and SPO2 decreased. The clinical outcome of the events, blood pressure decreased, cardiac arrest, pyrexia of 38.4 degrees centigrade, and SPO2 decreased, was fatal. The patient died on 16May2021 due to blood pressure decreased, cardiac arrest, pyrexia of 38.4 degrees centigrade, and SPO2 decreased. An autopsy was not performed. The reporting physician classified the events as serious (death) and the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were brain stem infarction and pneumonia aspiration. REPORTER COMMENT: because the patient had pneumonia aspiration before, the patient was likely considered to have suddenly died due to pneumonia aspiration this time.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the pyrexia and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Blood pressure decreased; cardiac arrest; pyrexia of 38.4 degrees centigrade; SPO2 decreased


VAERS ID: 1393846 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death, Cardio-respiratory arrest, Computerised tomogram, Hypertension, Troponin T
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hypertension (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: Medical History/Concurrent Conditions: Breast cancer female; Cancer surgery; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: CT; Result Unstructured Data: Test Result:revealed pericardial effusion; Test Date: 20210603; Test Name: Troponin T; Result Unstructured Data: Test Result:increase in troponin T
CDC Split Type: JPPFIZER INC2021653958

Write-up: Hypertension; Cardio-respiratory arrest; Acute cardiac death; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number is v21111646. An 81-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 31May2021 at 11:00 (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) at 81-years-old as a single dose for COVID-19 immunisation. The patient''s medical history included diabetes mellitus from an unknown date and unknown if ongoing, and surgery for right sided breast cancer from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the patient experienced hypertension (death). On 03Jun2021 at 16:35, the patient experienced: cardio-respiratory arrest (death, medically significant), and acute cardiac death (death, medically significant). The clinical course was reported as follows: The patient was an 81-year and 10-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade. Family history was not reported. Medical history included diabetes mellitus and surgery for right sided breast cancer. On 31May2021 at 11:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jun2021 at around 16:35 (around 3 days 5 hours 35 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 03Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 02Jun2021, the patient had no abnormality and underwent rehabilitation. On 03Jun2021 at noon, the patient went out with her friend and at 16:35, consciousness disturbed was noticed, for which the reporting hospital was visited. At 16:48, cardiopulmonary resuscitation was initiated; however, resuscitation was not possible and spontaneous circulation did not return. At 18:02, the patient died. Computerised tomogram (CT) revealed pericardial effusion and there was an increase in troponin T; thus, it was assessed as acute cardiac death. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were type 2 diabetes mellitus and hypertension. The reporting physician commented as follows: The patient had risk of heart disease; thus, causality assessment was difficult. The patient underwent lab tests and procedures which included body temperature: 36.7 Centigrade on 31May2021 (before vaccination), CT: revealed pericardial effusion on 03Jun2021, troponin T: increase in troponin T on 03Jun2021. Therapeutic measures were taken as a result of cardio-respiratory arrest and acute cardiac death. The clinical outcome of the events, cardio-respiratory arrest, acute cardiac death, and hypertension was fatal. The patient died on 03Jun2021 at 18:02 due to cardio-respiratory arrest, acute cardiac death, type 2 diabetes mellitus and hypertension. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest; Acute cardiac death; Type 2 diabetes mellitus; Hypertension


VAERS ID: 1393847 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose decreased, Body temperature, Pneumonia aspiration, Respiratory arrest, Stool analysis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   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: Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Aspiration (became severe since JAN2021); Hypoalbuminaemia; Malnutrition; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: Blood sugar; Result Unstructured Data: Test Result:51; Comments: 17:30; Test Date: 20210526; Test Name: Blood sugar; Result Unstructured Data: Test Result:125; Comments: 19:00; Test Date: 20210524; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: Before vaccination; Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: 10:00; Test Date: 20210527; Test Name: Stool examination; Test Result: Positive ; Comments: for pneumonia aspiration, suggesting a possibility that there was something in his digestive organs
CDC Split Type: JPPFIZER INC2021653989

Write-up: Respiratory arrest; pneumonia aspiration; blood sugar of 51; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority. The regulatory authority report number is v21111753. An 86-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EY2173; Expiration Date: 31Aug2021), via an unspecified route of administration in the left arm, on 24May2021 at 15:00 (at the age of 86-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing dementia, type 2 diabetes mellitus, hypoalbuminaemia, anaemia from Jan2021, aspiration (became severe since Jan2021), and undernutrition from Jan2021. The patient''s concomitant medications were not reported. The patient experienced respiratory arrest on 28May2021 at 12:47, which was reported as fatal. The patient also experienced blood sugar of 51 on 26May2021 at 17:30 and pneumonia aspiration on 27May2021 at 17:00. The clinical course was reported as follows: The body temperature before vaccination on 24May2021 was 35.9 degrees centigrade. On 25May2021 at 10:00, body temperature was 35.8 degrees centigrade. There was no change in the injection site. On 26May2021, when having breakfast, he had trouble swallowing, he just ate yogurt and after that, he stopped eating. He ate 40 percent of his lunch. At 17:30 on 26May2021, he had trouble swallowing and blood sugar was 51, so sugar at 20 grams was given. At 19:00, blood sugar was 125. A staff member told his family about his condition. At night, suction was performed. On 27May2021 at 17:00, the first stool examination tested positive for pneumonia aspiration, suggesting a possibility that there was something in his digestive organs. Domiciliary oxygen therapy was started. Deathwatch was started. Pudding was started to be given. At 18:00, his eldest daughter and grandchildren visited him. At night, suction was performed. On 28May2021 at 07:00, breathing with movement of the shoulders and jaw breathing were noted. At 09:50, his family members visited to see him. At 12:47, respiratory arrest developed. Therapeutic measures were taken as a result of blood sugar of 51 and pneumonia aspiration as aforementioned. The clinical outcome of respiratory arrest was fatal, blood sugar of 51 was recovered on 26May2021 at 19:00, and of pneumonia aspiration was unknown. The patient died on 28May2021 at 12:47 (4 days after the vaccination). The cause of death was reported as respiratory arrest. It was not reported if an autopsy was performed. The reporting healthcare professional assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event included pneumonia aspiration.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1393848 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021655929

Write-up: Myocardial infarction; The neighbor found the patient lying on the floor at her house; This is a spontaneous report from a contactable other healthcare professional (HCP) received from the regulatory authority. Regulatory authority number v21111759. An 88-year and 1-month-old female received the first single dose of BNT162B2 (COMIRNATY; lot EX3617, expiry date 31Aug2021) on 12May2021, for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees centigrade. Medical history and family history were not reported. Concomitant medications included unspecified stomach medicines. On 12May2021 in the afternoon (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 15May2021 at unknown time (3 days after the vaccination), the patient experienced loss of consciousness and myocardial infarction. As of the reporting date, the outcome of the events was fatal. Autopsy was performed. The course of the events was as follows: on 13May2021 (thursday) in the late afternoon (1 day after the vaccination), a staff of the comprehensive support center visited the patient; the patient said that she had not experienced particular changes after the injection and was working in the field. On 15May2021 in the morning (3 days after the vaccination), being worried about not having seen the patient taking the morning newspaper, the neighbor visited her house. The neighbor found the patient lying on the floor at her house and called an ambulance. However, the patient was already dead when the ambulance arrived. When asked, the physician of other Clinic, who was in charge of the autopsy, said that the death was due to myocardial infarction and assessed that it was not related with the vaccine. The reporting other HCP classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was unknown whether there was other possible cause of the events such as any other diseases.; Reported Cause(s) of Death: The neighbor found the patient lying on the floor at her house; Autopsy-determined Cause(s) of Death: Myocardial infarction


VAERS ID: 1393849 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein, Chest X-ray, Feeling hot, Heart rate, Lymphocyte percentage, Neutrophil percentage, Oxygen saturation, Pneumonia, Pyrexia, Somnolence, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAGMITT; ACETAMINOPHEN; BETANIS; TSUMURA SHAKUYAKUKANZOTO
Current Illness: Emphysema; Hypertension (complications); Lumbago; Overactive bladder (complications)
Preexisting Conditions: Medical History/Concurrent Conditions: Arachnoid cyst; Ex-smoker (60 cigarettes/day until the age of 85); Living in nursing home (admitted in Nov2019)
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Blood pressure; Result Unstructured Data: Test Result:196/96 mmHg; Comments: at 15:20; Test Date: 20210511; Test Name: Blood pressure; Result Unstructured Data: Test Result:149/59 mmHg; Comments: at 20:00; Test Date: 20210512; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/100 mmHg; Comments: at 12:30; Test Date: 20210518; Test Name: Blood pressure; Result Unstructured Data: Test Result:199/103 mmHg; Comments: at 9:20; Test Date: 20210523; Test Name: Blood pressure; Result Unstructured Data: Test Result:155/87 mmHg; Comments: at 17:00; Test Date: 20210526; Test Name: Blood pressure; Result Unstructured Data: Test Result:102/54 mmHg; Comments: at 5:00; Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Comments: at 15:20; Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Comments: at 20:00; Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at 00:30; Test Date: 20210512; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: at 12:30; Test Date: 20210518; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: at 9:20; Test Date: 20210523; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: at 17:00; Test Date: 20210524; Test Name: Body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Comments: at 2:00; Test Date: 20210526; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: at 5:00; Test Date: 20210513; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pneumonia in the middle area of the left lung; Comments: at 16:00; Test Date: 20210513; Test Name: CRP; Test Result: 20.33 mg/dl; Comments: at 16:00; Test Date: 20210511; Test Name: Pulse rate; Result Unstructured Data: Test Result:88 times/min; Comments: at 15:20; Test Date: 20210511; Test Name: Pulse rate; Result Unstructured Data: Test Result:88 times/min; Comments: at 20:00; Test Date: 20210512; Test Name: Pulse rate; Result Unstructured Data: Test Result:81 times/min; Comments: at 12:30; Test Date: 20210518; Test Name: Pulse rate; Result Unstructured Data: Test Result:108 times/min; Comments: at 9:20; Test Date: 20210523; Test Name: Pulse rate; Result Unstructured Data: Test Result:112 times/min; Comments: at 17:00; Test Date: 20210524; Test Name: Pulse rate; Result Unstructured Data: Test Result:126 times/min; Comments: at 2:00; Test Date: 20210526; Test Name: Pulse rate; Result Unstructured Data: Test Result:98 times/min; Comments: at 5:00; Test Date: 20210513; Test Name: Lymphocytes; Test Result: 11.6 %; Test Date: 20210513; Test Name: Neutrophils; Test Result: 83.4 %; Test Date: 20210511; Test Name: SpO2; Test Result: 98 %; Comments: at 15:20; Test Date: 20210511; Test Name: SpO2; Test Result: 95 %; Comments: at 20:00; Test Date: 20210512; Test Name: SpO2; Test Result: 81 %; Comments: at 12:30; Test Date: 20210512; Test Name: SpO2; Result Unstructured Data: Test Result:88-90 %; Comments: at 17:15; Test Date: 20210518; Test Name: SpO2; Test Result: 98 %; Comments: at 9:20; Test Date: 20210523; Test Name: SpO2; Result Unstructured Data: Test Result:91-92 %; Comments: at 17:00; Test Date: 20210524; Test Name: SpO2; Result Unstructured Data: Test Result:88-90 %; Comments: at 2:00; Test Date: 20210526; Test Name: SpO2; Result Unstructured Data: Test Result:97-99 %; Comments: at 5:00; Test Date: 20210513; Test Name: White blood cell count; Result Unstructured Data: Test Result:9300 /mm3
CDC Split Type: JPPFIZER INC2021656069

Write-up: Pneumonia; Pyrexia (38.2 ?C, 38.5 ?C, 39.4 ?C, 37.1 ?C, 37.4 ?C); feeling hot of the body; Drowsiness; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority number v21111756. A 90-year and 4-month-old male received the second single dose of BNT162B2 (COMIRNATY; lot ET3674, expiry date 31Jul2021) on 10May2021 around 14:20 (at the age of 90 years), for COVID-19 immunisation. Body temperature before vaccination was 36.7 degrees centigrade. "Family history was nothing in particular. Medical history included sacral arachnoid cyst (not ongoing), ongoing hypertension (complications), ongoing overactive bladder (complications) and ongoing lumbago. Patient background included height of 169 cm and weight of 49.8 kg. Smoking history included 60 cigarettes/day (until the age of 85). Concurrent emphysema was suspected. The patient was staying in the geriatric health services facility (admitted in Nov2019). Treatments and others were performed inside the facility. Concomitant medications included magnesium oxide (MAGMITT 330 mg tablet), acetaminophen (200 mg tablet) twice a day in the morning and evening, mirabegron (BETANIS 25 mg tablet), glycyrrhiza spp. root, paeonia lactiflora root (TSUMURA SHAKUYAKUKANZOTO); after the onset, all drugs except acetaminophen were discontinued. On 20Apr2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown). On 10May2021 around 14:20 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ET3674, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 11May2021 at 16:00 (1 day after the vaccination), the patient experienced pneumonia. On 26May2021 at 20:10 (16 days after the vaccination), the patient died. It was unknown whether autopsy was done. Pneumonia was reported with fatal outcome. The other events outcome was unknown. The course of the events was as follows: On 20Apr2021, the patient received the first dose of the vaccination. On 10May2021 around 14:20 (the day of vaccination), the patient received the second dose of BNT162b2. The body temperature before vaccination was 36.4 degrees centigrade (it was also reported as 36.7 degrees centigrade). On 11May2021 (1 day after the vaccination) at 15:20, the patient had feeling hot of the body. No subjective symptoms such as chills were noted. The body temperature was 38.2 degrees centigrade, the blood pressure 196/96 mmHg, the pulse rate 88 times/min, and the SpO2 98%. On the same day at 16:15, the patient took acetaminophen 200 mg 2 tablets orally (regularly taking the drug twice a day in the morning and evening). On the same day at 20:00, the body temperature was 38.2 degrees centigrade, the blood pressure 149/59 mmHg, the pulse rate 88 times/min, and the SpO2 95%. On 12May2021 at 00:30 (2 days after the vaccination), body temperature was 38.5 degrees centigrade. One ANHIBA 200 mg suppository was given. On the same day at 12:30, the body temperature was 39.4 degrees centigrade, the blood pressure 180/100 mmHg, the pulse rate 81 times/min, and the SpO2 81%. Sticking of sputum was noted. Significant amount of white sputum was present, and it was aspirated through the nasal cavity. Administration of oxygen was started at 2L/min. At 17:15, after the start of oxygen administration, the SpO2 was 88-90%. No respiratory discomfort was noted. A large volume of yellow sputum was aspirated. On 13May2021 at 16:00 (3 days after the vaccination), chest X-ray revealed pneumonia in the middle area of the left lung. The blood test revealed white blood cell count 9300/ul (neutrophils 83.4%, lymphocytes 11.6%) and C-reactive protein (CRP) 20.33 mg/dL. A drip infusion of ceftriaxone sodium Na (1 g, 2x/day) was started. On 14May2021 at 10:50 (4 days after the vaccination), a drip infusion of SOLDEM 3AG infusion fluid 500 mL once a day was started. Drowsiness was noted. On 18May2021 at 09:20 (8 days after the vaccination), the body temperature was 37.1 degrees centigrade, the blood pressure 199/103 mmHg, the pulse rate 108 times/min, and the SpO2 98%. The drip infusion of ceftriaxone Na was terminated. On 23May2021 at 17:00 (13 days after the vaccination), the body temperature was 36.4 degrees centigrade, the blood pressure 155/87 mmHg, the pulse rate 112 times/min, and the SpO2 91-92%. The oxygen was increased to 3L/min. No sputum was noted. The patient responded to verbal stimuli by only opening his eyes. On 24May2021 at 02:00 (14 days after the vaccination), the body temperature was 37.4 degrees centigrade, the pulse rate 126 times/min, and the SpO2 88-90%. The oxygen was increased to 5L/min. The patient was breathing with shoulder movements. At 15:15, a drip infusion of ampicillin Na/sulbactam Na was started (1.6 g, 1x/day). On 26May2021 at 05:00 (16 days after the vaccination), jaw breathing was noted. Mild peripheral coldness was present. The body temperature was 36.6 degrees centigrade, the blood pressure 102/54 mmHg, the pulse rate 98 times/min, and the SpO2 97-99%. On the same day at 20:10, the patient died. The reporting physician classified the event pneumonia as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was reported as pneumonia. The reporting physician commented as follows: Pyrexia after the vaccination could be an adverse reaction of BNT162b2, but the ensuing pneumonia was highly likely to have been present since before. It was conceivable that the symptoms of pneumonia had been not apparent at the vaccination.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1393850 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Back pain
SMQs:, Retroperitoneal fibrosis (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: JPPFIZER INC2021658275

Write-up: Acute aortic dissection; Back pain; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 79-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) on 20May2021 (the day of vaccination), at the age of 79-years-old, via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was not reported. Family history, medical history, and concomitant medication were not reported. On around 24May2021 (around 4 days after the vaccination), the patient experienced back pain and on an unspecified date, the patient experienced acute aortic dissection. The outcome of the event, acute aortic dissection was fatal. The course of the event was as follows: On 20May2021, the patient was vaccinated. On around 24May2021, the patient said to have back pain. Subsequently, family member informed the physician that the patient died of acute aortic dissection. Details were unknown. It was unknown if an autopsy was performed. Seriousness criteria, causality assessment, and other possible cause of the event such as any other diseases were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Aortic dissection, fatal, is considered an accidental occurrence, unrelated to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: Acute aortic dissection


VAERS ID: 1393851 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-29
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (since around March); Palpitations (since around March)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021658377

Write-up: Ventricular fibrillation; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. The patient was a 31-year-old male. Body temperature before vaccination was not reported. Family history and concomitant medication were not reported. Medical history included suspected arrhythmia including palpitations since around March. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot # and Expiration date were not reported). On 19May2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 29May2021 (10 days after the vaccination), the patient experienced ventricular fibrillation. On 29May2021 (10 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 19May2021, the patient received the second dose of COMIRNATY. On 29May2021, the patient died of ventricular fibrillation. Since around March, the patient had underlying disease of suspected arrhythmia including palpitations. The patient was vaccinated at the reporting physician''s hospital. The patient was taken to another hospital by ambulance. Seriousness criteria, causality assessment, and other possible cause of the event such as any other diseases were not provided.; Reported Cause(s) of Death: Ventricular fibrillation


VAERS ID: 1393968 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram, 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: 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: SIOFOR; FORXIGA; ASPIRIN [ACETYLSALICYLIC ACID]; ATORIS
Current Illness: Hypertension arterial; Peripheral arterial occlusive disease (PAOB with left AIC stenosis); Stenosis (left AIC stenosis); Type II diabetes mellitus (on per os therapy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Angiogram; Test Result: Inconclusive ; Result Unstructured Data: without a clear cause on coronary angiography; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: In ECG after ROSC STEMI of the lower wall, on coronary angiography without substrate
CDC Split Type: SIMODERNATX, INC.MOD20212

Write-up: Heart arrest; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Heart arrest) in a 72-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Peripheral arterial occlusive disease (PAOB with left AIC stenosis), Hypertension arterial, Type II diabetes mellitus (on per os therapy) and Stenosis (left AIC stenosis). Concomitant products included METFORMIN HYDROCHLORIDE (SIOFOR), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FORXIGA), ASPIRIN [ACETYLSALICYLIC ACID] and ATORVASTATIN CALCIUM (ATORIS) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (Heart arrest) (seriousness criteria death and medically significant). The reported cause of death was Heart arrest. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: inconclusive (Inconclusive) without a clear cause on coronary angiography. On an unknown date, Electrocardiogram: inconclusive (Inconclusive) In ECG after ROSC STEMI of the lower wall, on coronary angiography without substrate. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. Treatment medication was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: This is a case of sudden death in a 72-year-old male with hx of Peripheral arterial occlusive disease, Hypertension arterial, Type II diabetes mellitus and Stenosis, who died of Cardiac Arrest, 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 72-year-old male with hx of Peripheral arterial occlusive disease, Hypertension arterial, Type II diabetes mellitus and Stenosis, who died of Cardiac Arrest, 2 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1396138 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Cardiovascular 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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRANXENE; BISOPROLOL; METFORMINE [METFORMIN]; AMLOR; UNI DIAMICRON; ESTIVAN
Current Illness: Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: asystolie; Cardiovasculair probleem; This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIAC ARREST (asystolie) and CARDIOVASCULAR DISORDER (Cardiovasculair probleem) in a 69-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus. Concomitant products included CLORAZEPATE DIPOTASSIUM (TRANXENE), BISOPROLOL, METFORMINE [METFORMIN], AMLODIPINE BESILATE (AMLOR), GLICLAZIDE (UNI DIAMICRON) and EBASTINE (ESTIVAN) for an unknown indication. On 20-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced CARDIAC ARREST (asystolie) (seriousness criteria death and medically significant) and CARDIOVASCULAR DISORDER (Cardiovasculair probleem) (seriousness criterion death). The patient died on 22-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided.; Reporter''s Comments: Treatment - Evolution of the ADR - Overleden Examinations - reanimatie; Sender''s Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. However, the patient''s history of diabetes is a risk factor and confounds causality assessment.; Reported Cause(s) of Death: Death


VAERS ID: 1396140 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Cardio-respiratory arrest, Death, Dyspnoea, Loss of consciousness, Malaise, Pyrexia, Septic shock, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), 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), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PRAMIPEXOL TEVA [PRAMIPEXOLE]; AMANTADINE; TRULICITY; GLURENORM; XADAGO; VALTRAN [VALACICLOVIR HYDROCHLORIDE]; LANTUS; PROLOPA; METOPROLOL TARTRATE; METFORMIN HYDROCHLORIDE; CO-ENALAPRIL; ASAFLOW; SIMVASTATINE EG; AMLODIPIN SANDOZ [AMLODIPI
Current Illness: Back disorder; Back pain; Degenerative disc disease; Gonarthrosis; Hypertensive end-organ damage; Hypotension; Mixed hyperlipidemia; Non-insulin-dependent diabetes mellitus; Parkinson''s disease; Stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210617905

Write-up: DEATH; CARDIOPULMONARY ARREST; UNCONSCIOUS ON HIS CHAIR; SEPTIC (CAUSE OF INFECTION UNKNOWN) SHOCK; CRP OF 399; FELT UNWELL; FEVER; SHORT OF BREATH; LARGE POOL OF VOMIT AROUND THE PATIENT AND VOMIT ISSUED FROM MOUTH DURING THE HEART MASSAGE.; This spontaneous report received from a physician via a Regulatory Authority [BE-FAMHP-DHH-N2021-94260] concerned a 63year old male. The patient''s weight was 95 kilograms, and height was 183 centimeters. The patient''s concurrent conditions included back syndrome with radiating pain, degenerative disc disease, canal stenosis, gonarthrosis left diagnosed on date 08-SEP-2016, non-insulin dependent diabetes, ZTD (Zorgtraject diabetes [diabetes care trajectory]) diagnosed on 2000, hypotension diagnosed on 2000, mixed hyperlipidemia, parkinson''s disease diagnosed on 12-OCT-2009, hypertension with organ damage, and extensive low back problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21620J expiry: UNKNOWN) dose was not reported, 1 total administered on 30-APR-2021 for covid-19 immunization. Concomitant medications included acetylsalicylic acid, amantadine, amlodipine Besilate, Benserazide hydrochloride/levodopa, dulaglutide, enalapril maleate/hydrochlorothiazide, gliquidone, insulin glargine, metformin hydrochloride, metoprolol tartrate, pramipexole, safinamide mesilate, Glurenorm, simvastatin, and valaciclovir hydrochloride. General physician mentioned, the patient had placed a phone call on an unspecified date around 9:35 am and reported he had fever for which he had taken COVID-19 Swab test. The patient called again on unspecified date around 9:10 am and reported that he was feeling unwell. On an unspecified date, the patient experienced death, cardiopulmonary arrest, unconscious on his chair, septic (cause of infection unknown) shock, CRP of 399, short of breath, and large pool of vomit around the subject and vomit issued from mouth during the heart massage. The patient Blood glucose level wass 87 mg/dl (finger prick), the physician said no pulse, it showed as flat line during respiration monitor when the patient was taken into the ambulance. Cardio pulmonary resuscitation and EET flat line. After 24 minutes 2 cycles of Pulseless electrical activity (PEA) shows no pulse and when it was checked again pulse renewed. The patient had taken Paracetamol and ibuprofen as a treatment drug. Biochemistry result shows CRP 399 and COVID-19 negative, cause of infection was unknown septic shock with cardio pulmonary arrest. On 20-MAY-2021, the patient died from cardiopulmonary arrest, unconscious on his chair, CRP of 399, fever, death, septic (cause of infection unknown) shock, short of breath, felt unwell, and large pool of vomit around the subject and vomit issued from mouth during the heart massage. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reporter''s Comments: The patient had taken Paracetamol and ibuprofen as a treatment drug. General physician reports, the patient had placed a phone call on 6-JUN-2021 around 9:35 am and reported he had fever for which he had taken COVID-19 Swab test. The patient called again on 7-JUN-2021 at 9:10 am and reports he is feeling unwell.; Sender''s Comments: V0: 20210617905-covid-19 vaccine ad26.cov2.s -death,cardio-respiratory arrest, Loss of consciousness, septic shock, C-reactive protein increased, malaise, fever, shortness of breath, vomiting. 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: CARDIOPULMONARY ARREST; UNCONSCIOUS ON HIS CHAIR; CRP OF 399; FEVER; DEATH; SEPTIC (CAUSE OF INFECTION UNKNOWN) SHOCK; SHORT OF BREATH; FELT UNWELL; LARGE POOL OF VOMIT AROUND THE PATIENT AND VOMIT ISSUED FROM MOUTH DURING THE HEART MASSAGE.


VAERS ID: 1396141 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-03
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Death, Fatigue, Headache, Malaise, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hernia; Parkinson''s disease; Type 3 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210616286

Write-up: DEATH; NAUSEA; FATIGUE; FEVER; CHILLS; MUSCLE PAIN; HEADACHE; FEELING UNWELL; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-94326] concerned a 63 year old male. The patient''s weight was 80 kilograms, and height was 185 centimeters. The patient''s past medical history included Parkinson''s disease, hernia, and type 3 Diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21620J expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 30-APR-2021 for covid-19 immunisation. No concomitant medications were reported. On 03-MAY-2021, the patient experienced nausea, fatigue, fever, chills, muscle pain, headache and feeling unwell. Treatment-Unknown evolution of the ADR (Adverse Drug Reaction)-Deceased. It first started with fever after which he got chills paired with fatigue, muscle pain, headache and nausea; all those complications ultimately caused his death. It was unknown whether autopsy was performed or not. On 20-MAY-2021, the patient died from fever, chills, fatigue, muscle pain, headache, nausea, and feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210616286-covid-19 vaccine ad26.cov2.s-fever, chills, fatigue, muscle pain, headache, nausea, feeling unwell.. This event(s) is considered un-assessable. The event(s) has an unknown/unclear 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: FEVER; CHILLS; FATIGUE; MUSCLE PAIN; HEADACHE; NAUSEA; FEELING UNWELL


VAERS ID: 1396162 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002186 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose, Blood lactic acid, Blood pH, Cardio-respiratory arrest, Coma scale, Fall, Fibrin D dimer, Loss of consciousness, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JANUMET; GLIMEPIRIDE; ENALAPRIL; DICLOFENAC; Diprosone
Current Illness: Arterial hypertension; Cognitive impairment (Fluctuating cognitive problems for several months, with disorientation of the sense of time and space.); Dehydration (Low water intake, in the last 7-10 days.); Diabetic retinopathy; Polyarthralgia; Somnolence (During the last 7-10 days, patient was drowsy.); Treatment nonadherence (Problems with medication compliance.); Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: Blood glucose; Result Unstructured Data: 40mmol/L; Test Date: 20210515; Test Name: Lactate; Result Unstructured Data: 18 mmol /L; Test Date: 20210515; Test Name: Arterial blood pH; Result Unstructured Data: 6.67; Test Date: 20210515; Test Name: Glasgow coma scale; Test Result: Inconclusive ; Result Unstructured Data: Neurological evaluation she has a coma scale score of 3/15, pupils were in reactive mydriasis, without corneal reflex and with swallowing reflex.; Test Date: 20210515; Test Name: Fibrin D dimer; Result Unstructured Data: 10000 nanogram per milliliter
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Cardiorespiratory arrest; Pulmonary embolism; fall with head trauma; loses consciousness; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardiorespiratory arrest), PULMONARY EMBOLISM (Pulmonary embolism) and LOSS OF CONSCIOUSNESS (loses consciousness) in a 78-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3002186) for SARS-CoV-2 immunization. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type II diabetes mellitus, Diabetic retinopathy, Arterial hypertension, Polyarthralgia, Cognitive impairment (Fluctuating cognitive problems for several months, with disorientation of the sense of time and space.), Treatment nonadherence (Problems with medication compliance.), Somnolence (During the last 7-10 days, patient was drowsy.) since May 2021 and Dehydration (Low water intake, in the last 7-10 days.) since May 2021. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), GLIMEPIRIDE, ENALAPRIL, DICLOFENAC and Betamethasone dipropionate (Diprosone) for an unknown indication. On 14-May-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardiorespiratory arrest) (seriousness criteria death and medically significant), PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant), FALL (fall with head trauma) and LOSS OF CONSCIOUSNESS (loses consciousness) (seriousness criterion medically significant). On 15-May-2021, FALL (fall with head trauma) and LOSS OF CONSCIOUSNESS (loses consciousness) had resolved. The patient died on 16-May-2021. The reported cause of death was cardio-respiratory arrest and pulmonary embolism. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Blood glucose (4.1-6): 40 (High) 40mmol/L. On 15-May-2021, Blood lactic acid (0.4-1.9): 18 (High) 18 mmol /L. On 15-May-2021, Blood pH (7.35-7.45): 6.67 (Low) 6.67. On 15-May-2021, Coma scale: 3/15 (Inconclusive) Neurological evaluation she has a coma scale score of 3/15, pupils were in reactive mydriasis, without corneal reflex and with swallowing reflex.. On 15-May-2021, Fibrin D dimer (Unknown-500): 10000 (High) 10000 nanogram per milliliter. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIO-RESPIRATORY ARREST (Cardiorespiratory arrest) and PULMONARY EMBOLISM (Pulmonary embolism) to be possibly related. No further causality assessments were provided for FALL (fall with head trauma) and LOSS OF CONSCIOUSNESS (loses consciousness). On 15-May-2021, the patient had a fall, with head trauma, with loss of consciousness. When the ambulance arrived, she was in cardiorespiratory arrest and was resuscitated. She had a cardiorespiratory arrest at the emergency room and regained spontaneous circulation. She has echocardiographic signs of pulmonary embolism, without radiological confirmation. Neurological evaluation was done. Treatment medications were not reported. Company comment: This is a case of sudden death in a 78-year-old female patient with a history of Type II diabetes mellitus, Diabetic retinopathy, Arterial hypertension, Polyarthralgia, Cognitive impairment (Fluctuating cognitive problems for several months, with disorientation of the sense of time and space, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Translation uploaded; added 2 new events and lab findings; Reported Cause(s) of Death: Cardio-respiratory arrest; Pulmonary embolism


VAERS ID: 1396177 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MARCUMAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Lung embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021645383

Write-up: Death; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB, DE-DCGMA-21189641. A non-contactable physician reported a 76-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Apr2021 (Lot Number: ET3045) as 0.3ml single dose for covid-19 immunisation. Medical history included lung embolism from 2013 to an unknown date and not ongoing at the time od event, arterial hypertension from an unknown date and unknown if ongoing. Concomitant medication included phenprocoumon (MARCUMAR). The patient experienced death on 19Apr2021. The patient died on 19Apr2021. It was not reported if an autopsy was performed. Regulatory Authority causality assessment was D. Unclassifiable. No follow-up attempts are needed. No further information is expected. ; Reported Cause(s) of Death: Death


VAERS ID: 1396183 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021653464

Write-up: Sudden death, cause unknown; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100086142. A 58-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: 1C007A), via an unspecified route of administration on 20May2021 (at age of 58 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. This report is serious-death. On 23May2021 the patient experienced Sudden death, cause unknown. It was unknown if an autopsy was performed. The patient''s outcome was fatal. Relatedness of drug to reaction(s)/event(s) D. Unclassifiable No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1396184 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210617975

Write-up: CARDIAC ARRHYTHMIA NOS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP] concerned a 60 year old male of unspecified race and ethnicity. 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, route of admin, and batch number: unknown, expiry date: unknown) dose was not reported, administered on 21-MAY-2021 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 22-MAY-2021, the patient experienced cardiac arrhythmia nos which led to death. On 22-MAY-2021, the patient died from cardiac arrhythmia, and acute myocardial reinfarction. An autopsy was performed on an unspecified date. Determined cause(s) of death was most likely a malignant heart rhytm disorder with at least a 7 x 4 cm large scar in the front/side wall of the heart up to the septum, possibly recently re-occurred infarction; already advanced changes due to decomposition; so far no known pathophysiological relation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0;20210617975- covid-19 vaccine ad26.cov2.s-Cardiac arrhythmia NOS. 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 ARRHYTHMIA; ACUTE MYOCARDIAL REINFARCTION; Autopsy-determined Cause(s) of Death: ACUTE MYOCARDIAL REINFARCTION


VAERS ID: 1396236 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-02-11
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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: PARACETAMOL PENSA; BUSCAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; Ischemic stroke; Mixed dementia (Severe); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021653477

Write-up: Aspiration into bronchus; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-889367. An 86-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EJ6796), intramuscular on 17Jan2021 (at unknown age) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included Severe mixed dementia, Chronic renal failure, Right middle cerebral ischemic stroke from Sep2018, Type II diabetes mellitus. Concomitant medications included PARACETAMOL PENSA from 29Oct2019 to 11Feb2021; BUSCAPINE from 20Jan2021 to 21Jan2021. The patient previously took first dose of BNT162B2 (COMIRNATY) as single dose for COVID-19 immunisation. The patient experienced Aspiration into bronchus (death) on 11Feb2021. The patient died on 11Feb2021. It was unknown if an autopsy was performed. CAUSATION ASSESSMENT: Chronology not completely compatible with the vaccine (26 days). The participation of the vaccine in death cannot be ruled out or confirmed, since according to the notifying doctor, due to his history, the trigger for his death may have been natural. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Aspiration into bronchus


VAERS ID: 1396237 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-06
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: LANSOPRAZOL; BISOPROLOL; PRAVASTATIN; FOLI-DOCE; SINTROM; VILDAGLIPTIN; NICARDIPINE; PARACETAMOL; DULOXETINE; LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Cardiac failure congestive; Dyslipidaemia; Fibrillation atrial; Hypertension arterial; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210612815

Write-up: DECOMPENSATED HEART FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-889699] concerned an 89 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included fibrillation atrial, hypertension arterial, cardiac failure congestive, type 2 diabetes mellitus, dyslipidaemia, and sulfa drug allergy. The patient experienced allergic reaction when treated with amoxicillin trihydrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-APR-2021 for covid-19 vaccination. Concomitant medications included duloxetine for depression, vildagliptin for diabetes mellitus, bisoprolol for fibrillation atrial, cyanocobalamin/folic acid for glossitis, lansoprazole for hiatus hernia, pravastatin for hypercholesterolaemia, nicardipine for hypertension arterial, acenocoumarol, lorazepam, and paracetamol. On 06-MAY-2021, the patient experienced decompensated heart failure and died from sudden death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210612815-covid-19 vaccine ad26.cov2.s-decompensated heart failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: SUDDEN DEATH


VAERS ID: 1396257 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002335 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: Psychosis
Preexisting Conditions: Medical History/Concurrent Conditions: Polydypsia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002335) for COVID-19 vaccination. The patient''s past medical history included Polydypsia. Concurrent medical conditions included Psychosis. On 22-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 23-May-2021 The patient died on 23-May-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication were provided. No concomitant medication were provided. Action taken with mRNA-1273 in response to the event was not applicable Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Sender''s Comments: This a report of dead one day after the second dose of the product in a psychotic patient. Autopsy was not performed. Very limited information regarding the event has been provided for inferring causality. Further information is not expected.; Reported Cause(s) of Death:


VAERS ID: 1396264 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-22
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021653425

Write-up: sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority FR-AFSSAPS-2021063682. A 77-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EX7389), intramuscular, administered in Arm Left on 04May2021 (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection) as single dose for COVID-19 immunisation. No COVID-19. No PCR test. The patient experienced sudden death on 22May2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Sudden death


VAERS ID: 1396273 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Aortic rupture, Blood pressure decreased, Blood pressure measurement, Computerised tomogram, Dizziness, Fatigue, Muscle tightness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   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: Hypertension arterial ((treated for 10 years))
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: BP; Result Unstructured Data: Test Result:7; Test Date: 20210415; Test Name: CT scan; Result Unstructured Data: Test Result:a ruptured aorta
CDC Split Type: FRPFIZER INC2021662140

Write-up: Aortic rupture; jaw "tightening; abdominal pain; drop in BP; dizziness; fatigue; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MA20212090. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 08Apr2021 (Lot Number: Unknown) as single dose (at 76 years old) for COVID-19 immunisation. Medical history included hypertension arterial (treated for 10 years). Concomitant medications were not reported. The patient developed abdominal pain on 12Apr2021, drop in bp on 08Apr2021, jaw "tightening" on 14Apr2021, dizziness on 08Apr2021, fatigue on 08Apr2021, all with outcome of unknown. On 15Apr2021, the patient experienced aortic rupture with fatal outcome. The patient underwent lab tests and procedures which included blood pressure measurement: 7 on 14Apr2021, computerised tomogram: a ruptured aorta on 15Apr2021. Therapeutic measures were taken as a result of abdominal pain. The patient died on 15Apr2021. An autopsy was not performed. The clinical course was reported as follows: 08Apr2021, dizziness, fatigue, drop in BP. On 12Apr2021, medical consultation because the appearance of abdominal pain on the right (ultrasound appointment made for 19Apr2021). On 14Apr2021 in the morning, jaw "tightening" and BP at 7, firefighters call, but ultimately no emergency room consultation. Around 8 p.m., recurrence of severe abdominal pain and emergency room consultation around 9 p.m. The patient was put on Morphine. The CT scan on 15Apr2021 at 12 noon found a ruptured aorta, resulting in the death of the patient. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Aortic rupture


VAERS ID: 1396857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Bronchitis chronic, Cardiac hypertrophy, Cardiomegaly, Congenital cystic kidney disease, Myocardial fibrosis, Nephrosclerosis, Oedema peripheral, Peripheral venous disease, Pigmentation disorder, Poor dental condition, Pulmonary embolism, Pulmonary oedema, Rib fracture, Scar, Uterine leiomyoma, Venous thrombosis limb
SMQs:, Cardiac failure (narrow), Angioedema (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, venous (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Osteoporosis/osteopenia (broad), Chronic kidney disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; LEKOPTIN; TRITACE
Current Illness: Hypertension; Type II diabetes mellitus (treated by peroral antidiabetics)
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract operation (bilateral); Superficial thrombophlebitis (massive, right lower limb)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021627817

Write-up: Nephrosclerosis; Oedema pulmonary; Kidney polycystic; Rib fracture; Poor dental condition; Chronic bronchitis; right thigh Venous thrombosis (limbs); disperse heart myofibrosis; acute of right heart dilatation; Skin pigmentation; Uterine leiomyoma; Venostasis; Cicatrix skin; Edema of lower extremities; central atherosclerosis grade III, coronary arteries atherosclerosis grade III, basal brain arteries atherosclerosis grade II; Cardiac hypertrophy; bilateral massive pulmonary embolism - nausea, weakness, presyncope and dyspnea, unconsciousness; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is [CZ-CZSUKL-21006037]. A 73-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: ET7205), intramuscular on 30Mar2021 (at unknown age) as single dose for COVID-19 immunisation. Medical history included bilateral cataract surgery, ongoing Type II diabetes mellitus (treated by peroral antidiabetics), ongoing Hypertension, in 2007 massive superficial thrombophlebitis of the right lower limb. Concomitant medications included metformin; verapamil hydrochloride (LEKOPTIN); ramipril (TRITACE). Historical vaccine included: in 2018 Prevenar 13 for Pneumococcal immunization with no problems, in 2012 tetanus for Tetanus immunization. A COMIRNATY vaccination (30Mar2021) of a 73-year-old female patient was complicated by nausea, weakness in the morning. In the afternoon, she had presyncope and dyspnea, patient''s daughter called an ambulance. She was communicating with the ambulance crew, but she fell unconscious. Resuscitation by ambulance crew was not successful. The cause of death according to the autopsy was a massive bilateral pulmonary embolism. Emergency room visit for massive bilateral pulmonary embolism. The patient died on 31Mar2021. An autopsy was performed that revealed Poor dental condition, Chronic bronchitis, right thigh Venous thrombosis (limbs), Rib fracture, Nephrosclerosis, disperse heart myofibrosis, acute of right heart dilatation, Kidney polycystic, Skin pigmentation, Oedema pulmonary, Uterine leiomyoma, Venostasis, Cicatrix skin, Edema of lower extremities, central atherosclerosis grade III, coronary arteries atherosclerosis grade III, basal brain arteries atherosclerosis grade III, Cardiac hypertrophy. The outcome of the event bilateral massive pulmonary embolism was fatal, for other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: bilateral massive pulmonary embolism; Autopsy-determined Cause(s) of Death: Poor dental condition; Chronic bronchitis; right thigh Venous thrombosis (limbs); Rib fracture; Nephrosclerosis; disperse heart myofibrosis; acute of right heart dilatation; Kidney polycystic; Skin pigmentation; Oedema pulmonary; Uterine leiomyoma; V


VAERS ID: 1396952 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-07
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21DR21002 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Pulmonary embolism
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, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrest; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210622836

Write-up: CARDIAC ARREST; PULMONARY EMBOLISM; This spontaneous report received from a physician concerned a 62 year old of unspecified sex with unknown ethnicity and race. The patient''s height, and weight were not reported. The patient''s concurrent conditions included cause of death is pulmonary embolism and cardiac arrest. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21DR21002, and expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. Physician reported that, patient experienced pulmonary embolism on 07-JUN-2021 and cardiac arrest on 08-JUN-2021 which led to death. Physician was not sure if the patient died from the vaccine. On 08-JUN-2021, the patient died from pulmonary embolism and cardiac arrest. 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 pulmonary embolism and cardiac arrest on 08-JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210622836-covid-19 vaccine ad26.cov2.s- pulmonary embolism and 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: CAUSE OF DEATH IS PULMONARY EMBOLISM


VAERS ID: 1397950 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Brain oedema, Cardio-respiratory arrest, Death, Fatigue, Hypoxic-ischaemic encephalopathy, Myocardial infarction, Pain in extremity
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Heart attack; cardiopulmonary arrest; cerebral edema; hypoxic-ischemic encephalopathy; Death; Abdominal pain; Exhaustion; Hand pain; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), MYOCARDIAL INFARCTION (Heart attack), ABDOMINAL PAIN (Abdominal pain), FATIGUE (Exhaustion), PAIN IN EXTREMITY (Hand pain), CARDIO-RESPIRATORY ARREST (cardiopulmonary arrest), BRAIN OEDEMA (cerebral edema) and HYPOXIC-ISCHAEMIC ENCEPHALOPATHY (hypoxic-ischemic encephalopathy) in a 75-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Hand pain) (seriousness criterion medically significant). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced CARDIO-RESPIRATORY ARREST (cardiopulmonary arrest) (seriousness criteria death and medically significant), BRAIN OEDEMA (cerebral edema) (seriousness criteria death and medically significant) and HYPOXIC-ISCHAEMIC ENCEPHALOPATHY (hypoxic-ischemic encephalopathy) (seriousness criteria death and medically significant). On 16-Mar-2021, ABDOMINAL PAIN (Abdominal pain), FATIGUE (Exhaustion) and PAIN IN EXTREMITY (Hand pain) had resolved. The patient died on 06-Apr-2021. The reported cause of death was Cardiopulmonary arrest, Cerebral edema, Myocardial infarction and Hypoxic-ischemic encephalopathy. An autopsy was performed, but no results were provided. At the time of death, MYOCARDIAL INFARCTION (Heart attack) had not resolved. Concomitant product was not provided by the reporter. Treatment information was not provided. This is a case of death in a 75 -years-old female subject with no reported medical hx, who died on the 34 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Sender''s Comments: This is a case of death in a 75 -years-old female subject with no reported medical hx, who died on the 34 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Cardiopulmonary arrest; Cerebral edema; Myocardial infarction; Hypoxic-ischemic encephalopathy


VAERS ID: 1397952 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agnosia, Aphasia, Blood pressure measurement, Computerised tomogram, Haemorrhage intracranial, Hemiplegia, Hypertensive crisis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No Medical history was reported. No previous bleeding tendency.
Allergies:
Diagnostic Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Her lifetime value were around 110/70 mmHg.; Test Name: Blood Pressure; Result Unstructured Data: Her lifetime value were around 110/70 mmHg.; Test Name: Computerized tomography scan; Result Unstructured Data: Intracranial hemorrhage in the left basal ganglia.
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Hypertensive crisis; Intracranial hemorrhage; collapsed; Right hemiplegia; Aphasia; Agnosia; This literature-non-study case was reported in a literature article and describes the occurrence of HYPERTENSIVE CRISIS (Hypertensive crisis), HAEMORRHAGE INTRACRANIAL (Intracranial hemorrhage), LOSS OF CONSCIOUSNESS (collapsed), HEMIPLEGIA (Right hemiplegia), APHASIA (Aphasia) and AGNOSIA (Agnosia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical history was reported. No previous bleeding tendency. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSIVE CRISIS (Hypertensive crisis) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE INTRACRANIAL (Intracranial hemorrhage) (seriousness criteria death, hospitalization and medically significant), LOSS OF CONSCIOUSNESS (collapsed) (seriousness criteria hospitalization and medically significant), HEMIPLEGIA (Right hemiplegia) (seriousness criteria hospitalization and medically significant), APHASIA (Aphasia) (seriousness criterion hospitalization) and AGNOSIA (Agnosia) (seriousness criterion hospitalization). The patient was treated with CLONIDINE HYDROCHLORIDE (intravenous) for Adverse event, at a dose of 0.15 mg and FUROSEMIDE (intravenous) for Adverse event, at a dose of 20 mg. The patient died on an unknown date. The reported cause of death was Hypertensive crisis and Intracranial hemorrhage. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (collapsed), HEMIPLEGIA (Right hemiplegia), APHASIA (Aphasia) and AGNOSIA (Agnosia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 210/110 mmHg (High) Her lifetime value were around 110/70 mmHg. and 180/100 mmHg (High) Her lifetime value were around 110/70 mmHg.. On an unknown date, Computerised tomogram: intracranial hemorrhage (abnormal) Intracranial hemorrhage in the left basal ganglia.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERTENSIVE CRISIS (Hypertensive crisis), HAEMORRHAGE INTRACRANIAL (Intracranial hemorrhage), LOSS OF CONSCIOUSNESS (collapsed), HEMIPLEGIA (Right hemiplegia), APHASIA (Aphasia) and AGNOSIA (Agnosia) to be possibly related. Patient had no history of thrombocytopenia or any other abnormal blood test. Patient was not taking any previous medication at the time of vaccination. On an unspecified date, the patient Blood pressure remained over 180/100 mmHg, despite treatment during hospitalization. On an unspecified date, 9 days after the event onset patient passed away without any improvement. Company Comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Hypertensive crisis; intracranial hemorrhage


VAERS ID: 1397967 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-30
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, SARS-CoV-2 test negative
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery calcification; Hypertension; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021661664

Write-up: Heart failure; This is as spontaneous report received from a contactable physician downloaded from the Regualtory Authority-WEB. The regulatory authority report number HU-OGYI-345921. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 12Apr2021 (Batch/Lot Number: EJ6790) as 0.3ml single dose at the age of 79-year-old for COVID-19 immunisation. Medical history included ischemic heart disease, coronary artery calcification, hypertension. The patient''s concomitant medications were not reported. The patient experienced heart failure (death) on 30Apr2021. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 05May2021. On 30Apr2021 the patient died in his home. Autopsy was done, cause of death was heart failure due to coronary artery calcification and hypertension, no signs of extraordinary death were observed. Postmortem COVID-19 PCR test was negative. Left ventricule hypertrophy, arteriosclerotic nephrosclerosis, prostatic hyperplasia and adenoma, thyroid lobectomy of struma were also found during autopsy. Sender Comment: The 79-year-old patient died 18 days after Comirnaty vaccination. Cause of death was heart failure due to coronary artery calcification and hypertension according to the autopsy. The causal relationship between the reported death and Comirnaty is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Heart failure; Autopsy-determined Cause(s) of Death: Left ventricule hypertrophy; arteriosclerotic nephrosclerosis; prostatic hyperplasia; prostatic adenoma; thyroid lobectomy of struma


VAERS ID: 1397968 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-05-12
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANTACLAST; COVERCARD; ATORVASTATIN; ACETYLSALICYLIC ACID; BENFOGAMMA; TRAMADOLOR; CARVOL; APO-FAMOTIDIN; FRONTIN
Current Illness: Angiopathy; Stroke
Preexisting Conditions: Medical History/Concurrent Conditions: Gangrene
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 60-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. The patient''s past medical history included Gangrene in March 2020. Concurrent medical conditions included Stroke since 2019 and Angiopathy. Concomitant products included CILOSTAZOL (ANTACLAST), AMLODIPINE BESILATE, PERINDOPRIL ARGININE (COVERCARD), ATORVASTATIN, ACETYLSALICYLIC ACID, BENFOTIAMINE (BENFOGAMMA), TRAMADOL HYDROCHLORIDE (TRAMADOLOR), CARVEDILOL (CARVOL), FAMOTIDINE (APO-FAMOTIDIN) and ALPRAZOLAM (FRONTIN) for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. Death occurred on 12-May-2021 The patient died on 12-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Death) to be unlikely related. Treatment information was not provided by the reporter.; Sender''s Comments: As the patient had ongoing vascular diseases and suffered from strokes before, the causal relationship is unlikely between the adverse event and the suspected drug. The case is serious because the outcome was fatal. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1397969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal X-ray, Abdominal pain, Bradycardia, Cardiac arrest, Cardiovascular insufficiency, Death, Dyspnoea, Ileus paralytic, Inflammatory marker test, Pyrexia, Renal function test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; BISOPROLOL; PANTOPRAZOLE; GLYCEROL; LAEVOLAC; KALDYUM; FURON [FUROSEMIDE]; MODUXIN MR; DIAPREL; MILURIT; CLEXANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pancreatitis; DVT; Hypertension; Kidney failure chronic; Mitral insufficiency; Myocardial infarction; NIDDM (Non-insulin-dependent diabetes mellitus); Pancreas cyst
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: abdominal X-ray; Result Unstructured Data: Test Result:implied paralytic ileus; Test Date: 20210517; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:Elevated; Test Date: 20210517; Test Name: kidney test; Result Unstructured Data: Test Result:Narrowed kidney function
CDC Split Type: HUPFIZER INC2021661674

Write-up: Death; paralytic ileus; breathing difficulties; abdominal pain; circulatory insufficiency; Bradycardia; asystole; feverish; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (regulatory authority number HU-OGYI-364721). An 88 years old female patient received the second dose of BNT162B2 (COMIRNATY) intramuscular, in left arm, on 08May2021 (lot EX6537), at 0.3 ml single, for COVID-19 immunisation. Medical history included chronic pancreatitis, mitral insufficiency, DVT, kidney failure chronic, hypertension, pancreas cyst, myocardial infarction and non-insulin-dependent diabetes mellitus (NIDDM), all from an unknown date and unknown if ongoing. The patient received the first dose of Comirnaty on an unspecified date. Concomitant medications included clopidogrel once daily, bisoprolol 2.5 mg, 1x/day, pantoprazole 40 mg, 1x/day, rectal glycerol suppositories (with palmitic and stearic acids), oral lactulose (LAEVOLAC; syrup), oral potassium chloride (KALDYUM; Prolonged-release capsule, hard) 600 mg, 1x/day, oral furosemide (FURON; tablet), oral trimetazidine hydrochloride (MODUXIN MR; Prolonged-release tablet) 35 mg, 2x/day, oral gliclazide (DIAPREL; Modified-release tablet) 60 mg, 2x/day, oral allopurinol (MILURIT; tablet) 300 mg, 1x/day, subcutaneous enoxaparin sodium (CLEXANE; Solution for injection in pre-filled syringe) 0.6 mL, 1x/day. On 17May2021 the patient was rushed to the hospital because of breathing difficulties and abdominal pain. Laboratory tests showed elevated inflammatory parameters, narrowed kidney function and abdominal X-ray implied paralytic ileus. The patient received surgery and therapy. Her condition seemed to get better, but on the 3rd day of the treatment the patient became feverish and had circulatory insufficiency. Bradycardia and asystole occurred, and after an unsuccessful reanimation, the patient passed away on 20May2021 at 06:30. It was unknown if an autopsy was performed. Sender Comment: As the patient was hospitalized due to symptoms of paralytic ileus, the causal relationship was unlikely between the suspected drug and the adverse event. The case was considered serious because the outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1397970 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-21
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Barrett''s oesophagus; Bulbar palsy; Chronic renal insufficiency; Coronary sclerosis; Gastritis; Hiatus hernia; Hyperlipidemia; Pericarditis
Allergies:
Diagnostic Lab Data: Test Date: 20210322; Test Name: Chest X-ray; Test Result: Positive ; Comments: COVID-19 pneumonia; Test Date: 20210321; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021661678

Write-up: COVID-19 pneumonia; COVID-19; COVID-19 pneumonia,Antigen test result was posiand chest X-ray confirmed covid pneumonia.,; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-365421. A 81-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot/Batch number: ET1831, expiry date: unknown), intramuscular in left arm on 08Mar2021 as 1st dose, 0.3 ml, single dose for covid-19 immunisation. Comirnaty was concentrate for dispersion for injection, tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles). Medical history included ongoing hypertension, atrial fibrillation, Barret''s oesophagus, bulbar palsy, coronary sclerosis, gas-tritis, hiatus hernia, hyperlipidemia, pericarditis and chronic renal insufficiency, all from an unknown date and unknown if ongoing. Concomitant drugs were not reported. The patient was hospitalized on 21Mar2021 because of Covid-19 symptoms. Antigen test result was positive on 21Mar2021 and chest X-ray confirmed covid pneumonia on 22Mar2021. The patient received therapy but his general condition rapidly progressed and passed away on 26Mar2021 at 02:30 due to cardiorespiratory insufficiency. Therapeutic measures were taken as a result of the events. The patient died on 26Mar2021. It was not reported if an autopsy was performed. Health authority comment: The patient got infected with Covid-19 after the first dose, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case was considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1397971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Intra-ocular injection
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021661669

Write-up: Death / passed away; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-365521. An 85-year-old female patient received bnt162b2 (COMIRNATY), intramuscularly in the left arm on 10May2021 (Lot Number: FA5829, expiry date: unknown) as 0.3 mL single dose for COVID-19 immunisation. Medical history included intravitreal treatment and hypertension. Concomitant medications were not reported. The patient experienced death, on 11May2021 at 10:15 the patient passed away. It was not reported if an autopsy was performed. Sender comment: The case is considered serious because the outcome was fatal, but due to lack of information, the case and the causality cannot be assessed. Further information is expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1397972 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021661670

Write-up: Death; Chest pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB HU-OGYI-365621. A 72-years-old male patient received bnt162b2 (COMIRNATY) unknown dose , intramuscular, administered in Arm Left on 04May2021 (Batch/Lot Number: EX6537) as 0.3 mL, single for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient died on 06May2021 ,and had chest pain causing patient''s death on 06May2021. The patient died on 06May2021. It was not reported if an autopsy was performed. Course of the event. On 06May2021 the patient experienced chest pain emitting in his left arm. His GP referred the patient to the Pulmonolgy and Cardiology Department, but the patient got unwell in his home. The paramedic tried to resuscitate the patient, but it was unsuccessful. The patient was under cardiology and pulmonology treatment. Concomitant drugs were not reported. Further information is expected. Sender Comment: The case is considered serious because the outcome was fatal, but due to lack of information, the case and the causality cannot be assessed. Further information is expected. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Death; Chest pain


VAERS ID: 1397973 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Bell''s palsy; BPH; Hypertension; Polyarthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210306; Test Name: Chest X-ray; Test Result: Positive ; Comments: covid pneumonia; Test Date: 20210301; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021661667

Write-up: COVID-19 pneumonia; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Ambulatory-WEB, regulatory authority number HU-OGYI-365721. An 83-year-old male patient received first dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm right on 17Feb2021 (Lot Number: EL0725) as 0.3 mL single dose for COVID-19 immunisation. Medical history included benign prostatic hyperplasia (BPH), polyarthritis, hypertension, arteriosclerosis all from an unknown date and unknown if ongoing; Bell''s Palsy from 2010 to an unknown date. The patient''s concomitant medications were not reported. The patient was hospitalized because of COVID-19 symptoms. On 01Mar2021 an antigen test was done with a positive result. Chest X-ray on 06Mar2021 confirmed COVID-19 pneumonia. The patient received therapy, but his respiratory insufficiency progressed and passed away on 16Mar2021 at 02:00. An autopsy was not performed. Sender Comment: the patient got infected with COVID-19 after the first dose, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal.; Reported Cause(s) of Death: COVID-19; COVID-19 pneumonia


VAERS ID: 1397974 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-05-13
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal X-ray, Abdominal pain, Blood bilirubin, Blood bilirubin increased, Chest X-ray, Death, Disease progression, Disorientation, Leukocytosis, Pain in extremity, Pulmonary congestion, White blood cell count
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Biliary system related investigations, signs and symptoms (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), 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: 2021-05-18
   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: BISOPROLOL; SPIRIVA; TENAXUM; COVERCARD PLUS; DOXAZOSIN; MEFORAL; DIGOXIN; XULTOPHY; MARFARIN
Current Illness: Atrial fibrillation; COPD; Hypertension; IDDM; Ischaemic heart disease; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: bilirubin; Result Unstructured Data: Test Result:slight increased; Test Date: 20210517; Test Name: bilirubin; Result Unstructured Data: Test Result:increased serum bilirubin levels; Test Date: 20210513; Test Name: Chest and abdominal x-ray; Result Unstructured Data: Test Result:normal; Test Date: 202105; Test Name: Chest and abdominal x-ray; Result Unstructured Data: Test Result:pulmonary congestion; Test Date: 20210513; Test Name: Chest and abdominal x-ray; Result Unstructured Data: Test Result:normal; Test Date: 20210515; Test Name: leucocytosis; Result Unstructured Data: Test Result:leucocytosis
CDC Split Type: HUPFIZER INC2021639670

Write-up: death; pulmonary congestion; progression of the patient''s primary diseases; slight leucocytosis; disoriented; pain in his leg; abdominal pain; slight bilirubin increased/ increased serum bilirubin levels; This is a spontaneous report from a contactable physician received from the Local Regulatory Authority downloaded from the Regulatory Authority-WEB HU-OGYI-366321. This is a report received from the Institute. Regulatory authority report number HU-OGYI-366321. A 79-year-old male patient received second dose of BNT162B2 (COMIRNATY, Lot Number: ET6956) intramuscular in left arm 0.3 ml single for COVID-19 immunisation on 24Apr2021. Medical history included ongoing hypertension, ongoing obesity, ongoing chronic obstructive pulmonary disease (COPD), ongoing atrial fibrillation, ongoing type 1 diabetes mellitus (IDDM), ongoing ischaemic heart disease. Concomitant medications included bisoprolol; tiotropium bromide (SPIRIVA); rilmenidine phosphate (TENAXUM); amlodipine besilate, indapamide, perindopril arginine (COVERCARD PLUS); doxazosin; metformin hydrochloride (MEFORAL); digoxin; insulin degludec, liraglutide (XULTOPHY); warfarin sodium (MARFARIN). The patient previously received first dose of BNT162B2 (COMIRNATY, Lot Number: EF2166) intramuscular in left arm 0.3 ml single for COVID-19 immunisation on unknown date. The patient experienced death (death, hospitalization) on 18May2021. On 13May2021, the patient went to the hospital due to abdominal pain. In his blood test, slight bilirubin increased was present. Chest and abdominal x-ray were normal. The patient was sent to his home. On 14May2021, the patient became disoriented. The patient was resent to the hospital. The patient had no abdominal pain but pain in his leg. On 15May2021 and 17May2021, blood tests were initiated. The results showed slight leucocytosis and increased serum bilirubin levels. Chest x-ray showed pulmonary congestion. Despite therapy, the patient''s condition gradually progressed, on 18May2021, the patient died. According to the physician, the cause of death was the progression of the patient''s primary diseases. The patient died on 18May2021. It was unknown if an autopsy was performed. Outcome of the events death, progression of the patient''s primary diseases was fatal; outcome of the event abdominal pain was resolved in May2021; outcome of the other events was unknown. Sender Comment: Death after vaccination with Comirnaty is not expected. TTO is 24 days until death. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered unlikely. The case is considered serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death; progression of the patient''s primary diseases


VAERS ID: 1397975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-04
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, Pneumonia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   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: Angiopathy; Diabetes mellitus; Diabetic nephropathy; Glaucoma; Hyperlipidemia; Hypertension; Obesity; Renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Pneumonia; Test Date: 20210304; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021661680

Write-up: Vaccination failure; COVID-19; Pneumonia; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-383421. A contactable physician 83-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EP2163 and Expiry date: Unknown), intramuscular on 26Feb2021 as 2nd dose, 0.3 ml single dose for covid-19 immunization. Medical history included hypertension, diabetic nephropathy, renal failure, angiopathy, glaucoma, hyperlipidemia, diabetes mellitus, obesity from an unknown date and unknown if ongoing. . The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, Lot Number: EJ6136), on 05Feb2021 for covid-19 immunization. On 04Mar2021, the patient experienced pneumonia, covid-19, vaccination failure. The patient was hospitalized on 04Feb2021, where covid-19 antigen test was positive and chest X-ray showed pneumonia. The patient was hospitalized for pneumonia from 04Mar2021 to an unknown date. The patient was hospitalized for covid-19 from 04Mar2021 to an unknown date. The patient was hospitalized for vaccination failure from 04Mar2021 to an unknown date. On 04Mar2021, the patient underwent lab tests and procedures which included chest x-ray: pneumonia, sars-cov-2 test: positive. Therapeutic measures were taken as a result of pneumonia, covid-19, vaccination failure and treatment included. The patient died on 06Mar2021. An autopsy was not performed. Sender Comment included According to the SmPC of Comirnaty, immunity usually develops 7 days after the second dose. The patient had a positive Covid-19 antigen test 6 days after the second dose, therefore vaccination failure is considered possible. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1397981 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-13
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute cardiac event
SMQs:, Myocardial infarction (narrow), Other ischaemic heart disease (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 7
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Idiopathic pulmonary fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021674338

Write-up: acute cardiac event; This is a spontaneous report from a contactable consumer (patient''s relative) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-073522. Initial report was received by the Regulatory Authority from a member of the public (patients relative). An 86-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection) via an unspecified route of administration on 26Mar2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included cardiac pacemaker insertion and idiopathic pulmonary fibrosis. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation. On 13Apr2021 (reported as after 18 days of second dose), the patient experienced acute cardiac event and cardiopulmonary resuscitation (CPR) was performed. Seven days later, the patient died on 20Apr2021. The reporter noted that it Just seems too much of a coincidence that having come through so much, the patient died 25 days after receiving the vaccine 2nd dose. It was not reported if an autopsy was performed. The time Interval between beginning of drug administration and start of reaction / event was 18 days. The outcome of the event was fatal. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.; Reported Cause(s) of Death: acute cardiac event


VAERS ID: 1398051 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001943 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anuria, Asthenia, Dyspnoea, Oxygen saturation
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Oxygen saturation; Result Unstructured Data: Low
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.; riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.; riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.; This regulatory authority case was reported by a physician and describes the occurrence of ASTHENIA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.), DYSPNOEA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) and ANURIA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001943) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 13-May-2021, the patient experienced ASTHENIA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) (seriousness criterion death), DYSPNOEA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) (seriousness criterion death) and ANURIA (riferito dalla familiare: da alcuni giorni astenia, dal 12/5 oligoanuria, il 13/5 dispnea con desaturazione.) (seriousness criteria death and medically significant). The patient died on 14-May-2021. The reported cause of death was Oligoanuria, Dyspnea and Asthenia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Oxygen saturation: low (Low) Low. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided. Very limited information regarding these events has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Oligoanuria; Dyspnea; Asthenia


VAERS ID: 1398053 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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: ITMODERNATX, INC.MOD20212

Write-up: ; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST and LOSS OF CONSCIOUSNESS in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 20-May-2021, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant) and LOSS OF CONSCIOUSNESS (seriousness criteria death and medically significant). The patient died on 20-May-2021. The reported cause of death was . It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: HA Report Added; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. No further information is expected.; Reported Cause(s) of Death:


VAERS ID: 1398073 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Food refusal, Hyperglycaemia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Senile dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of VOMITING, FOOD REFUSAL, HYPERGLYCAEMIA, ASTHENIA and PYREXIA in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. Concurrent medical conditions included Diabetes mellitus and Senile dementia. On 07-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 09-May-2021, the patient experienced VOMITING (seriousness criterion death), FOOD REFUSAL (seriousness criterion death), HYPERGLYCAEMIA (seriousness criterion death), ASTHENIA (seriousness criterion death) and PYREXIA (seriousness criterion death). The patient died on 30-May-2021. The reported cause of death was Vomiting, Food refusal, Hyperglycaemia, Asthenia and Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Vomiting; Food refusal; Hyperglycaemia; Asthenia; Fever


VAERS ID: 1398195 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cerebral infarction, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 22 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021659186

Write-up: Cerebral infarction; Dyspnoea; Cardiac failure; This is a spontaneous report from a contactable physician received via a Pfizer sales representative from the Regulatory Authority (RA). Regulatory authority report number is v21112311.?? A 77-year-old male patient received first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 13May2021 (Lot Number: EW4811; Expiration Date: 31Jul2021) (at the age of 77-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13May2021 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY). On 13May2021 (the day of the vaccination), the patient experienced dyspnoea and cardiac failure. On 13May2021 (the days of the vaccination), the patient was admitted to other hospital. On 02Jun2021 (20 days after the vaccination), the patient experienced cerebral infarction. On 02Jun2021 (20 days after the vaccination), the patient moved to reporting hospital. On 04Jun2021 (22 days after the vaccination), the patient discharged from reporting hospital. On 06Jun2021 (24 days after the vaccination), the patient died. It was unknown if an autopsy was performed. On 06Jun2021 (24 days after the vaccination), the outcome of cerebral infarction and cardiac failure was fatal, the outcome of dyspnoea was unknown. The course of the event was as follows: on 13May2021, the patient developed dyspnoea after the vaccination. The patient was admitted to hospital and diagnosed with cardiac failure. The patient was transferred to another hospital thereafter. On 02Jun2021, cerebral infarction developed. On 06Jun2021, the patient died. Other possible cause(s) of the event such as any other diseases were cardiac failure and the cause of cerebral infarction. The reporting physician classified the event as serious (Hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. The reporting physician commented as follows: Association between cardiac failure and the vaccination was unknown. The cause of cerebral infarction was thought to be due to cardiac failure.; Reported Cause(s) of Death: Cardiac failure; Cerebral infarction


VAERS ID: 1398196 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:fever (unknown value); Test Date: 202106; Test Name: CRP; Result Unstructured Data: Test Result:22
CDC Split Type: JPPFIZER INC2021661780

Write-up: Cardio-respiratory arrest; possibility of asphyxia; Pyrexia; This is a spontaneous report from a contactable emergency physician received from the Agency Regulatory Authority. Regulatory authority report number is v21111865. A 73-year and 5-month-old female patient received BNT162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 01Jun2021 (Lot number was not reported) (at the age of 73-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was not reported. On an unspecified date (the day of vaccination), the patient received COVID-19 Vaccine. On 04Jun2021 at 12:00 (3 days after the vaccination), the patient experienced cardio-respiratory arrest. On 04Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: on 01Jun2021, the patient received COVID-19 vaccine and subsequently developed pyrexia with outcome of unknown. On 04Jun2021, the patient experienced cardio-respiratory arrest during meal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was other possible cause of the event such as any other diseases but details were not provided. The reporting physician commented as follows: although there was a possibility of asphyxia, inflammatory response was at high value (CRP was 22).; Reported Cause(s) of Death: Cardio-respiratory arrest; Cardio-respiratory arrest; Possibility of asphyxia


VAERS ID: 1398198 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Depressed level of consciousness, Dyspnoea exertional, Nausea
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hypertension; Lung cancer; Reflux oesophagitis; Uterine myoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021662901

Write-up: Cardiac failure congestive; respiratory distress during exertion; Nausea; decreased consciousness; This is a spontaneous report from a contactable physician received via the Agency. A non-pregnant 83-year-old female received the first single dose of BNT162B2 (COMIRNATY; lot EX3617, expiry date 31Aug2021) intramuscular, in left arm, on 31May2021 at 14:45, for COVID-19 immunisation. Medical history included lung cancer, uterine myoma, hypertension, depression and reflux oesophagitis. The patient had no allergies to medications, food, or other products. The patient received other medications (unspecified product) within 2 weeks of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 31May2021 at 14:45, the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscularly in the arm left for COVID-19 immunization. After that, respiratory distress during exertion and nausea were worsened. On 04Jun2021 (4 days after the vaccination), the patient visited the hospital where she received the COVID-19 vaccine, but she was admitted to the reporting hospital because it was judged that she needed to be hospitalized. The name of the hospitalized disease was cardiac failure congestive. On 05Jun2021 (5 days after the vaccination), decreased consciousness was noted. On 07Jun2021 (7 days after the vaccination), death was confirmed. The outcome of the event was fatal. An autopsy was not performed. The reporting physician assessed the event as serious (death and hospitalization/prolongation of hospitalization). Since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the Cardiac failure congestive and other events. The reported events likely represent intercurrent medical conditions in this elderly patient with history of lung cancer and hypertension. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up 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: Cardiac failure congestive


VAERS ID: 1398199 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Body temperature, Cardiac arrest, Cardiac failure acute, Loss of consciousness, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dysphagia (started recently); Inappetence (started recently)
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210527; Test Name: Body temperature; Result Unstructured Data: Test Result:no pyrexia Centigrade; Comments: 20:00; Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:no pyrexia Centigrade; Comments: 00:00; Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:no pyrexia Centigrade; Comments: 05:00
CDC Split Type: JPPFIZER INC2021665663

Write-up: fatal arrhythmia; Cardiac failure acute; lost her consciousness; cardiac arrest; respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21112086. An 89-year and 6-month-old female patient received first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 27May2021 at 14:00 (Lot Number: EY0779; Expiration Date: 31Aug2021) (at the age of 89-year-old) as 0.3 mL single dose for COVID-19 immunisation. Medical history included inappetence (reduced swallowing function) started recently from an unknown date and unknown if ongoing. The patient was not suffering from any kind of illness nor receiving treatment or medication. The patient had not had a fever nor got sick for the previous one month. There were no parts of body that were not feeling well on the vaccination day. The patient had never had a convulsion (seizure). The patient had never experienced severe allergic symptoms (such as anaphylaxis) from medications or foods. The patient had never been sick after receiving vaccination. The patient had no vaccines within the previous two weeks. Body temperature before vaccination was 36.8 Centigrade. On 27May2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 28May2021 at 07:55 (1 day after the vaccination), the patient experienced cardiac failure acute. On 28May2021 at 11:05 (1 day after the vaccination), the patient died of cardiac failure acute. It was not reported if an autopsy was performed. The course of the event was as follows: on 27May2021 at 14:00, the patient received the vaccination and afterwards no obvious adverse reactions were noted. On 27May2021 at 17:00, the patient consumed soft bread and PROCURE (nutrient drink) for dinner without any problems. On 27May2021 at 18:00, a staff member went the round of patients (every one hour). When they confirmed the patient, she was sleeping without any significant change. At 20:00 on 27May2021, and at 00:00 and at 05:00 on 28May2021, when measuring her body temperature, no pyrexia was noted and her physical condition was good. On 28May2021 at 07:00, the patient woke up and went to the cafeteria for breakfast. She looked fine and moved actively on a wheelchair. On 28May2021 at 07:55, she suddenly lost her consciousness, and then she was carried to the resting room to receive the treatment. She developed cardiac arrest which led to respiratory arrest. On 28May2021 at 11:05, the patient''s death was confirmed by the physician of the facility. The cause of death was cardiac failure acute. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician commented that cardiac failure acute (including fatal arrhythmia) and cerebrovascular disorder as possible causes of the event. The reporting physician commented as follows: after the vaccination, no obvious adverse reactions were noted. Given the patient''s advanced age and inappetence (reduced swallowing function) which had been noted these days, cardiac failure acute (including fatal arrhythmia) or cerebrovascular disorder could be considered as the cause of death. Since the patient had neither pain nor symptoms of paralysis, there was a high possibility of cardiac failure acute being the cause. Also, the patient died before breakfast, therefore, a possibility of aspiration or asphyxia could be ruled out. Regarding the causal relationship with BNT162b2, this was a new vaccine, so it was unassessable. Unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardiac failure acute; arrhythmia; cardiac arrest; respiratory arrest; lost her consciousness


VAERS ID: 1398200 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Blood pressure measurement, Body temperature, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   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: ELNEOPA NO.2; HUMULIN R
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: 04:30; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210606; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Comments: 04:30
CDC Split Type: JPPFIZER INC2021665672

Write-up: aspiration; vomiting; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21112135. The patient was an 86-year and 10-month-old male. Body temperature before vaccination was 36.1 degrees Centigrade. Medical history included Parkinson''s disease and diabetes mellitus. Concomitant medications included high-calorie TPN solution, (ELNEOPA No.2) 1000 mL/daily and insulin human (HUMULIN R) 14 units for diabetes mellitus. No information on family history was provided. On 04Jun2021 at 10:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 06Jun2021 at 04:30 (2 days after the vaccination), the patient experienced vomiting. On 07Jun2021 at 00:09 (3 days after the vaccination), the died. It was not reported if an autopsy was performed. The course of the event was as follows: The patient was regularly visiting a previous hospital for the treatment of Parkinson''s disease and diabetes mellitus. At a nursing facility, the amount of diet was reduced. Since unspecified date of Jan2021, the patient was hospitalized. As he could not consume food, high-calorie infusion was administered into left upper arm via PICC (peripherally inserted central venous catheter). From 04Feb2021, it became difficult for the patient to communicate, he became bedridden, oxygen administration was started, and balloon catheter was inserted, and then the patient was transferred to another hospital. After transferring to the hospital, the balloon was removed, and oxygen therapy was stopped, however, resuming food intake was impossible because of sputum. Diabetes mellitus was controlled and his vital signs were stable with administration of ELNEOPA No.2 1000 mL/daily and HUMULIN R 14 units. On 04Jun2021 at 10:00, the patient received the vaccination, and there were no problems on that day. On 06Jun2021 at 04:30, vomiting was noted. A large amount of gastric acid etc was suctioned from his nasal cavity and organs. Afterwards, decreased consciousness level, decreased blood pressure and decreased SpO2 (oxygen saturation percutaneous) were noted. After administration of oxygen and antibiotics was performed, the symptoms showed temporal improvement. At 14:45, he vomited again and then his general condition was acutely aggravated. On 06Jun2021 at 23:12, he had ventricular fibrillation and then he developed cardiac arrest. He did not respond to cardiopulmonary resuscitation. On 07Jun2021 at 00:09, the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered that repeated vomiting led to acute aggravation of aspiration status.; Reported Cause(s) of Death: Aspiration


VAERS ID: 1398201 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Death, 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: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Diabetes mellitus; Heart disease, unspecified (examined every three months); Hypertension; Myocardial infarction old
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210606; Test Name: Electrocardiogram waveform; Result Unstructured Data: Test Result:was consistently asystole; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021665681

Write-up: Death; Asystole; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21112138. The patient was an 87-year and 10-month-old male. Body temperature before vaccination was 36.2 degrees centigrade. Family history was not reported. Medical history included heart disease (examined every three months), myocardial infarction old, hypertension, and diabetes mellitus. Concomitant medications included blood thinners (product name not reported). On 06Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) via an unspecified route of administration as the first single dose for COVID-19 immunisation. On 06Jun2021 at 17:00 (3 hours after the vaccination), the patient''s wife found him lying down and the patient experienced asystole. On 06Jun2021 at 18:48 (4 hours and 48 minutes), the patient died. It was unknown whether autopsy was done. The course of the events was as follows: On 06Jun2021 shortly after 14:00, the patient received a vaccine for the new coronavirus at the health center. On the same day just after 17:00 (3 hours after the vaccination), the patient''s wife found him lying down near the house''s bicycle parking lot and called an ambulance. The patient was transported to the emergency department of the reporting hospital, but his electrocardiogram waveform was consistently asystole. Resuscitation was considered difficult, and on 18:48 (4 hours and 48 minutes), the patient was confirmed dead. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases included cardiovascular events. The reporting physician commented as follows: The patient had underlying diseases including myocardial infarction old, hypertension, and diabetes mellitus, and the causal relationship between the death this time and the vaccine was unassessable.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1398202 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   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 INC2021665689

Write-up: Suspected acute myocardial infarction; Cardio-respiratory arrest; Vomiting; This is a spontaneous report from a contactable physician received via the Regulatory Authority. Regulatory Authority number v21112041. A 72-year-old male patient received BNT162B2 (COMIRNATY) on 05Jun2021 (at the age of 72 years) at single dose for COVID-19 immunisation. Body temperature before vaccination was unknown. Family history, medical history and concomitant medications were not reported. It was not provided whether there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 05Jun2021 at unknown time (the day of vaccination was heard from the family), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 06Jun2021 at 08:20 (1 day after the vaccination), the patient experienced vomiting, suspected acute myocardial infarction and cardio-respiratory arrest. On 06Jun2021 (1 day after the vaccination), the outcome of the event suspected acute myocardial infarction was fatal, while for the others was unknown. It was unknown whether autopsy was done. The course of the events was as follows: according to the family, the patient received a vaccine (lot number and other details were unknown) for the coronavirus in another prefecture on 05Jun2021 (the day of vaccination). On 06Jun2021 at 08:20 (1 day after the vaccination), the patient experienced vomiting, and an ambulance was called. The patient fell into cardio-respiratory arrest. At 10:35, the patient died. The reporting physician classified the event suspected acute myocardial infarction as serious (death) and assessed the causality between the event suspected acute myocardial infarction and BNT162b2 as unassessable. The seriousness and causality of the other events were not reported. Other possible cause(s) of the events such as any other diseases was suspected acute myocardial infarction. The reporting physician commented as follows: No inquiry was made to the medical institution that performed the vaccination. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Suspected acute myocardial infarction


VAERS ID: 1398203 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DIOVAN; CONIEL; REGUNEAL LCA; TENORMIN; ZYLORIC
Current Illness: Peritoneal dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021665729

Write-up: Pneumothorax of the left lung; This is a spontaneous report from a contactable nurse and non-contactable physician received via a company representative. This nurse reported events for two patients. This is the second of two reports. An 87-year-old male patient received first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 26May2021 (Lot Number: EY4834; Expiration Date: 31Aug2021) (at the age of 87-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing peritoneal dialysis. Concomitant medications included valsartan (DIOVAN); benidipine hydrochloride (CONIEL); calcium chloride dihydrate/glucose/hydrochloric acid/magnesium chloride hexahydrate/sodium bicarbonate/sodium chloride/sodium hydroxide/sodium lactate (REGUNEAL LCA); atenolol (TENORMIN) and allopurinol (ZYLORIC), all concomitants were taken orally for an unspecified indication, start and stop date were not reported. On 26May2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY). On 02Jun2021 at unknown time (7 days after the vaccination), the patient experienced pneumothorax of the left lung. The event was serious, fatal. On 05Jun2021 at unknown time (10 days after the vaccination), the patient died. It was unknown whether autopsy was done. The course of the event was as follows: The patient was undergoing peritoneal dialysis. He visited the reporting clinic to receive the vaccination. On 26May2021 (the day of vaccination), the patient received the first vaccination with BNT162b2. On 02Jun2021 (7 days after the vaccination), the patient felt unwell and was transported to the hospital; pneumothorax of the left lung was diagnosed. On 05Jun2021 (10 days after the vaccination), the patient died at the hospital. The physician who made the diagnosis assessed that the event was unrelated to BNT162b2. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information, the event Pneumothorax is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. ,Linked Report(s) : JP-PFIZER INC-2021665766 Same product and reporter, different patient and event; Reported Cause(s) of Death: Pneumothorax of the left lung


VAERS ID: 1398204 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia aspiration, 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: 2021-06-01
   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: RIVOTRIL; AMLODIPINE; ZYLORIC; LIPIDIL; LASIX [FUROSEMIDE]; GLYCYRON [GLYCYRRHIZIC ACID, AMMONIUM SALT]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; COPD; Dyslipidaemia; Hypertension; Hyperuricaemia; Paralysis of arms; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:39.1 Centigrade
CDC Split Type: JPPFIZER INC2021665766

Write-up: Pneumonia aspiration; pyrexia of 39.1 degree; This is a spontaneous case from a contactable other healthcare professional (nurse) received via a Pfizer sales representative. The patient was an 82-years-old male. The patient had medical histories of hypertension, cerebral haemorrhage, non-ongoing COPD, non-ongoing dyslipidemia, non-ongoing hyperuricemia, non-ongoing paralysis of right upper arm, and non-ongoing cervical spine surgery. The concomitant medications included clonazepam (RIVOTRIL, reported as RIVOTREAM), amlodipine besilate (AMLODIPINE), allopurinol (ZYLORIC), fenofibrate (LIPIDIL), furosemide (LASIX), and glycyrrhizic acid, ammonium salt (GLYCYRON). On 22May2021 at unknown time (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 (10 days after the vaccination), the patient experienced pneumonia aspiration. On 01Jun2021 (10 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 22May2021 (the day of vaccination), the patient received a dose of BNT162b2 vaccination. On 01Jun2021 (10 days after vaccination), the patient experienced pyrexia of 39.1 degrees Celsius, and he was transferred to another hospital by an ambulance. On the same day, the patient died due to pneumonia aspiration. The colleague in the company of the patient''s daughter was positive for COVID-19; however, the daughter was confirmed to be negative for PCR test. The hospital where the death was confirmed reported that the event was unrelated to BNT162b2 vaccination. The reporting other healthcare professional (nurse) classified the event as serious (death). There was no other possible cause of the event such as any other diseases. Specify in the case narrative: No follow-up attempts are possible, information about batch number have already been obtained.; Sender''s Comments: Based on the current available information, the event Pneumonia aspiration is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. ,Linked Report(s) : JP-PFIZER INC-2021665729 Same product and reporter, different patient and event; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1398206 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021665986

Write-up: Geromarasmus; This is an initial spontaneous case from a contactable pharmacist received via a Pfizer sales representative. The patient was an 89-year-old female. Body temperature before vaccination was not provided. The patient family history and was not provided. Medical history included dementia Alzheimer''s type and hypertension. The patient lived in an elderly facility. On 13May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date not reported) via an unspecified route of administration as the first single dose for COVID-19 immunization. On 03Jun2021, the patient received the second dose BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date not reported) via an unspecified route of administration as the second single dose for COVID-19 immunization. The patient experienced geromarasmus resulting in death on 05Jun2021 at 22:03. It was unknown whether autopsy was conducted. The reporting pharmacist classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. The cause of death was judged as geromarasmus, and the event was considered to be unrelated to BNT162b2 vaccination.; Sender''s Comments: Based on the available information the event "geromarasmus resulting in death" is attributed to an underlying medical condition and assessed Unrelated to BNT162b2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: Geromarasmus


VAERS ID: 1398268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac function test, Chest pain, SARS-CoV-2 test positive
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: 47
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; COLCHICINE; MAGNESIUMHYDROXIDE; NITROLINGUAL; ALLOPURINOL; BISOPROLOL; METFORMINE [METFORMIN]; PANTOPRAZOL [PANTOPRAZOLE]; LENDORMIN; AMLODIPINE; CITALOPRAM; ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; COVID-19 (with quite disease symptoms); Dyspnoea; Fatigue
Allergies:
Diagnostic Lab Data: Test Name: cardiologist check; Result Unstructured Data: Test Result:unknown results; Test Date: 20200926; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021662122

Write-up: Chest pain. Was already familiar with fatigue, shortness of breath and POB complaints, but this felt something different; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB (regulatory authority number NL-LRB-00563437). A 74 years old male patient received the first single dose of BNT162B2 (COMIRNATY) on 13Apr2021, for COVID-19 immunisation. Medical history included COVID-10 from 26Sep2020 with quite disease symptoms, fatigue, dyspnoea and chest pain. The patient underwent SARS-CoV-2 test positive on 26Sep2020 with positive result. Concomitant medications included acetylsalicylic acid 80 mg tablet, colchicine 0.5 mg tablet, magnesiumhydroxide 724 chewable tablet, glyceryl trinitrate (NITROLINGUAL; 0.4 mg oromucosal spray), allopurinol 300 mg tablet, bisoprolol 5 mg tablet, metformin 500 mg tablet, pantoprazole 20 mg modified-release tablet, brotizolam (LENDORMIN; 0.25 mg tablet), amlodipine 10 mg tablet, citalopram 1 mg tablet, enalapril 10 mg tablet. The patient experienced chest pain on 14Apr2021 with fatal outcome. Chest pain was treated with acetylsalicylacid and colchicine. Patient was known to have fatigue, dyspnoea and chest pain complaints, but this time it felt different. Patient received his second COVID vaccination on 25May2021 and died on 31May2021 possibly due to pericarditis. It was unknown if an autopsy was performed. Reporter comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Chest pain Date: 13Apr2021. Chest pain. Additional information ADR (Adverse Drug Reaction): was already familiar with fatigue, shortness of breath and POB complaints, but this felt something different. BSN available: yes. Previous COVID-19 infection: disease symptoms: quite. Diagnostic procedures: yes, check by the cardiologist. Information on the lot/batch number has been requested.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Chest pain Date: 13Apr2021. Chest pain. Additional information ADR (Adverse Drug Reaction): was already familiar with fatigue, shortness of breath and POB complaints, but this felt something different. BSN available: yes. Previous COVID-19 infection: disease symptoms: quite. Diagnostic procedures: yes, check by the cardiologist.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021698965 same patient/vaccine, different dose/event; Reported Cause(s) of Death: Possible pericarditis; Chest pain. Was already familiar with fatigue, shortness of breath and POB complaints, but this felt something different


VAERS ID: 1398273 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: Test Date: 20210601; Test Name: ECG; Result Unstructured Data: Test Result:Asystoles
CDC Split Type: NLPFIZER INC2021662134

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00564259. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 18May2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of COMIRNATY 0,3ml on an unspecified date for COVID-19 immunisation. The patient experienced acute myocardial infarction on 01Jun2021. The patient underwent lab tests and procedures which included electrocardiogram: asystoles on 01Jun2021. Acute myocardial infarction was treated with resuscitation. The outcome of acute myocardial infarction was fatal. The patient died on 01Jun2021. It was not reported if an autopsy was performed. Reporter comment: Acute myocardial infarction: Additional information ADR: Patient has died. BSN available: yes. COVID19: Previous COVID-19 infection: No. Other: diagnostic procedures: ECG: Asystoles. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Acute myocardial infarction: Additional information ADR: Patient has died. BSN available: yes. COVID19: Previous COVID-19 infection: No. Other: diagnostic procedures: ECG: Asystoles.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1398281 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac function test, Inappropriate schedule of product administration, Pericarditis, SARS-CoV-2 test positive
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; COLCHICINE; MAGNESIUMHYDROXIDE; NITROLINGUAL; ALLOPURINOL; BISOPROLOL; METFORMINE [METFORMIN]; PANTOPRAZOL [PANTOPRAZOLE]; LENDORMIN; AMLODIPINE; CITALOPRAM; ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; COVID-19 (with quite disease symptoms); Dyspnoea; Fatigue
Allergies:
Diagnostic Lab Data: Test Name: cardiologist check; Result Unstructured Data: Test Result:unknown results; Test Date: 20200926; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021698965

Write-up: pericarditis; the patient received the first dose on 13Apr2021 and the second dose on 25May2021; This is a spontaneous report from a contactable pharmacist. This is the second of two reports. The first report is a report downloaded from the regulatory authority (regulatory authority number NL-LRB-00563437). A 74-years-old male patient received the second single dose of BNT162B2 (COMIRNATY) on 25May2021 (at 74 years of age) for COVID-19 immunisation. Medical history included COVID-19 from 26Sep2020 with quite disease symptoms, fatigue, dyspnoea, chest pain. The patient received the first dose of Comirnaty on 13Apr2021 experiencing chest pain, reported with fatal outcome. Concomitant medications included acetylsalicylic acid 80 mg tablet, colchicine 0.5 mg tablet, magnesiumhydroxide 724 chewable tablet, glyceryl trinitrate (NITROLINGUAL; 0.4 mg oromucosal spray), allopurinol 300 mg tablet, bisoprolol 5 mg tablet, metformin 500 mg tablet, pantoprazole 20 mg modified-release tablet, brotizolam (LENDORMIN; 0.25 mg tablet), amlodipine 10 mg tablet, citalopram 1 mg tablet, enalapril 10 mg tablet. The patient died on 31May2021 possibly due to pericarditis, developed on an unspecified date. It was not reported if an autopsy was performed. The patient underwent cardiologist check on an unknown date with unknown results and corona, confirmed with test on 26Sep2020. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021662122 same patient/vaccine, different dose/event; Reported Cause(s) of Death: pericarditis; Chest pain. Was already familiar with fatigue, shortness of breath and POB complaints, but this felt something different


VAERS ID: 1398282 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 7
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: PLAVIX; KEPPRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Stroke (without sequelae)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021662216

Write-up: Cerebral bleeding; This is a spontaneous report from a contactable physician downloaded from -WEB (regulatory authority number NO-NOMAADVRE-FHI-2021-U5ym21). A 65-years-old female patient received the first single dose of BNT162B2 (COMIRNATY) intramuscular, on 22Apr2021 (lot: EX2405), for COVID-19 immunisation. Medical history included stroke without sequelae and epilepsy. Concomitant medications included clopidogrel bisulfate (PLAVIX; 75 mg) orally, at 75 mg daily, for stroke and levetiracetam (KEPPRA; 500 mg) orally, at 500 mg, 2x/day, for epilepsy. The patient was hospitalized on 24Apr2021 with a large cerebral bleeding in the left frontal lobe, two days after vaccination with Comirnaty, first dose. She died as a result of the bleeding on 01May2021. It was not reported if an autopsy was performed. Reporter''s comments: Large cerebral bleeding in the left frontal lobe. Died as a result of the bleeding. No specific evidence that the bleeding was caused by the vaccine. Sender''s comment: Since the vaccine was new, it was subject to special surveillance to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Reports after corona vaccination in the Adverse Reaction Register are processed by the a regulatory authority in collaboration with a regulatory authority. The regulatory authority publishes weekly summaries of reports of suspected side effects after vaccination: Relatedness of drug to reaction(s)/event(s): Source of assessment- unlisted. Result of Assessment: possible. Causality was assessed in accordance with international criteria (1). No follow-up attempts possible. No further information expected.; Reporter''s Comments: Large cerebral bleeding in the left frontal lobe. Died as a result of the bleeding. No specific evidence that the bleeding was caused by the vaccine.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1398286 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   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: NOPFIZER INC2021662205

Write-up: CARDIAC ARREST; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Ug45ra. A 79-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 25May2021 (Batch/Lot Number: FC8889) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) as single dose for COVID-19 immunisation on 14Apr2021. The patient experienced cardiac arrest (cardiac arrest) (death) on 26May2021. The patient died on 26May2021. It was not reported if an autopsy was performed. Clinical course was reported as follows. A 79 years old woman had a cardiac arrest and died less than 24 hours after vaccination with Comirnaty, second dose. Cardiopulmonary resuscitation was performed, but the patient died. Reporter''s comments: Cardiac arrest less than 24 hours after vaccination, Cardiopulmonary resuscitation was performed, No overview of previous diseases / medications. Sender''s comment: Relatedness of drug to reaction(s)/event(s): Source of assessment - Regulatory Authority, Result of Assessment - Possible; Reporter''s Comments: Cardiac arrest less than 24 hours after vaccination, Cardiopulmonary resuscitation was performed, No overview of previous diseases / medications.; Reported Cause(s) of Death: CARDIAC ARREST


VAERS ID: 1398307 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-20
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Headache, Resuscitation
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: 2021-05-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021662156

Write-up: Resuscitation; Cardio-respiratory arrest; Headache; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number PL-URPL-3-705-2021. A 37-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 06May2021 09:28 (Batch/Lot Number: EY3014; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation . Medical history included hypertension , contraception . The patient experienced resuscitation on 20May2021 , cardio-respiratory arrest on 20May2021 , headache on 20May2021. All the reported events were considered serious because caused patient''s death. The patient died on 20May2021. An autopsy was not performed. Course of the event: She entered the 4th floor with a load. Found by the family at the door of the apartment, the medical rescue teams was called for cardiac arrest, respiratory resuscitation without effect, death was called at 20:10. From the information of the doctor qualifying the patient for vaccination she did not indicate the current treatment or hypertensive disease. She was being treated for hypertension (no systematic use of medications), she was using contraceptives. No autopsy. Sender''s Comment: Headache is an expected side effect for the vaccine. It could also be the result of poor blood pressure treatment. The death occurred after exercise, it may be suspected that it could be related to hypertension, but the role of the vaccine cannot be ruled out either. There is a time relationship between vaccination and the occurrence of side effects. The person reporting ADR qualified it as serious. URPL assessed the ADR as serious. No follow-up attempts possible. No further information expected..; Reported Cause(s) of Death: Headache; Resuscitation; Cardio-respiratory arrest


VAERS ID: 1398308 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021662160

Write-up: Ischaemic stroke; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number PL-URPL-3-706-2021. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 03Mar2021 12:46 (Batch/Lot Number: ER2659; Expiration Date: 07Mar2021) as 0.3 mL single dose at the age of 86-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received bnt162b2 (COMIRNATY), dose 1 on an unknown date as 0.3 mL single dose at the age of 86-year-old for COVID-19 immunisation. The patient experienced ischaemic stroke (death) on 05Mar2021 09:30 on the second post-vaccination day resulting in death 7 days post-vaccination. The patient died on 09Mar2021. It was not reported if an autopsy was performed. Sender Comment: A stroke is an unexpected side effect for a vaccine. The stroke occurred in an elderly person, there is no information about the medical history of the patient, but due to the close temporal relationship, the role of the vaccine cannot be ruled out. 305 cases of ischaemic strokes have been reported so far to the database following the use of Comirnaty. The person reporting NOP qualified it as severe. HA assessed the vaccine adverse event as severe. HA assessed Ischaemic stroke by using HA method of assessment as Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1398350 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EFTERS?KS / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Transient ischemic attack (Tidigare biverkning av COVID-19 Vaccin Moderna)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: ISCHEMISK STROKE; This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (ISCHEMISK STROKE) in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. EFTERS?KS) for COVID-19 vaccination. The patient''s past medical history included Transient ischemic attack (Tidigare biverkning av COVID-19 Vaccin Moderna) on 30-Mar-2021. In May 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In May 2021, the patient experienced ISCHAEMIC STROKE (ISCHEMISK STROKE) (seriousness criteria death, hospitalization prolonged and medically significant). The reported cause of death was Ischaemic stroke. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. This is a case of sudden death in a 71-year-old male patient with a history of Transient ischemic attack, who died of ischaemic stroke after receiving first dose of vaccine. Very limited information has been provided at this time. This case was linked to SE-MPA-2021-025230 (E2B Linked Report).; Sender''s Comments: This is a case of sudden death in a 71-year-old male patient with a history of Transient ischemic attack, who died of ischaemic stroke after receiving first dose of vaccine. Very limited information has been provided at this time. SE-MPA-2021-025230:; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1398616 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210613222

Write-up: DEATH; This spontaneous report received from social media and a consumer via a company representative concerned a 46 year old male with unknown race and ethnicity. 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, route of admin not reported, batch number: Unknown) dose, 1 total, 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. On an unspecified date, the patient died from unknown cause of death. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210613222-Covid-19 vaccine ad26.cov2.s- Death. 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


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