National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts.org
Search Results

From the 1/14/2022 release of VAERS data:

Found 22,193 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

This is page 185 out of 222

Result pages: prev   86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222   next


VAERS ID: 1698015 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-05-26
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchial aspiration procedure, C-reactive protein, COVID-19, Computerised tomogram, Culture urine, Femoral neck fracture, Glomerular filtration rate, Pneumonia bacterial, SARS-CoV-2 test, Sepsis, Vaccination failure, White blood cell count, X-ray
SMQs:, Lack of efficacy/effect (narrow), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal failure; Dementia; Hypertension; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: bronchial aspirate; Result Unstructured Data: Test Result:Kleibsella aerogenes isolated; Test Date: 20210611; Test Name: CT; Result Unstructured Data: Test Result:frosted glass-type areas and sharp condensations; Comments: in both lungs. In addition, in both lungs have areas of consolidation, mostly in the lower lobes.; Test Name: CRP; Result Unstructured Data: Test Result:significant increase; Test Name: urine culture; Result Unstructured Data: Test Result:E. coli and Enterococcus faecium isolated; Test Name: eGFR; Result Unstructured Data: Test Result:45; Test Date: 20210529; Test Name: eGFR; Result Unstructured Data: Test Result:9; Test Date: 20210526; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Name: White blood cell count; Result Unstructured Data: Test Result:leukocytosis; Test Name: X-ray; Result Unstructured Data: Test Result:perthrochanteric fragment of the right femur with; Comments: fragmented displacement. In addition, on the right VII and VIII ribs with low displacement fractions on the axillary line.
CDC Split Type: EEPFIZER INC202101155468

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number EE-SAM-48632108191. A 88-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Feb2021 (Batch/Lot Number: EJ6789; Expiration Date: 31May2021) as 0.3 ML SINGLE, dose 1 intramuscular on 22Jan2021 (Batch/Lot Number: EL1491; Expiration Date: 30Apr2021) as 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing dementia, ongoing chronic kidney disease, ongoing type 2 diabetes, ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and COVID-19 (death, hospitalization, medically significant) on 26May2021, sepsis and bacterial pneumonia (death, hospitalization, medically significant) on an unspecified date, fracture of the femoral neck (hospitalization) on an unspecified date. The clinical course as following: The patient was vaccinated with the first and second dose of Comirnaty vaccine on 22Jan2021 and 12Feb2021 respectively. The patient was hospitalized as an emergency due to a fracture of the femoral neck. X-ray perthrochanteric fragment of the right femur with fragmented displacement. In addition, on the right VII and VIII ribs with low displacement fractions on the axillary line. In the emergency department, the patient is also consulted by an orthopedist: indicated for surgical treatment, which is possible when there are no other problems. There were no focal-infiltrative changes in the lungs on arrival at the hospital. eGFR was 45; 29May2021: eGFR was 9. In addition, leukocytosis and a significant increase in CRP occurred. Antibacterial therapy was initiated with an adjusted renal dose of cefuroxime i/v. As the SARS-CoV-2 test was positive on 26May2021, the patient was initially hospitalized in the Infectious Diseases Department. At the end of the isolation, she was transferred to the pulmonology department on 08Jun. In the CT examination performed on 11Jun2021, frosted glass-type areas and sharp condensations in both lungs. In addition, in both lungs have areas of consolidation, mostly in the lower lobes. Clinically, this was considered to be bacterial pneumonia in the setting of post-SARS-2 lung injury. In consideration of age, concomitant dementia and other chronic diseases, the patient was not included in stage III intensive care with deterioration. The patient''s concomitant conditions: hypertension, chronic renal failure, type 2 diabetes, dementia. E. coli and Enterococcus faecium were isolated from urine, and Kleibsella aerogenes was isolated from bronchial aspirate. From 02Jun2021 she received antibacterial treatment with piperacillin/tazobactam and from 12Jun, with imipenem i/v. Against this background, clinically negative dynamics. The course of the disease was severe and the patient died on 18Jun2021 due to sepsis and bacterial pneumonia. The outcome of the events vaccination failure and COVID-19, sepsis and bacterial pneumonia was fatal and the outcome of the event fracture of the femoral neck was unknown. Investigation results received on 06Sep2021: Lot-#: EL1491; Batch-Expiry Year: 2021; Batch-Expiry Month: 04; Batch-Expiry Day: 30. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1491. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Lot-#: EJ6789; Batch-Expiry Year: 2021; Batch-Expiry Month: 05; Batch-Expiry Day: 31. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6789. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender Comment: Serious vaccine ineffectiveness report with fatal outcome. However, the patient was hospitalized due to fracture of the femoral neck instead. COVID, which was complicated by bacterial pneumonia and sepsis, was reported to be concomitant. As a result, the patient died. The course of the disease was assessed as severe. Thus, the causal relationship cannot be assessed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19; Sepsis; Bacterial pneumonia, unspecified


VAERS ID: 1698104 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101135890

Write-up: Sudden death unexplained; Cardiorespiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Report number ES-AEMPS-985191. A 15-year-old male patient received unknown dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: unknown), via an unspecified route on 02Aug2021 as a single dose for covid-19 immunization. The patient has no prior history medical history. The patient concomitant medications were not reported. On 09Aug2021 at 09:02, with no prior pathology family found the patient without a pulse. Upon arrival of the emergency team, he has no pulse. Some stiffness of limbs. There is no prior Cardiorespiratory arrest. Time of evolution of Cardiorespiratory arrest is unknown. Judicial protocol is activated. Sudden death unexplained on 09Aug2021 00:00. It was unknown if autopsy has been done. The outcome of the events was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1698139 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

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: 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: Cardiac failure congestive; Cardiac valvulopathy (Degenerative aortic valve disease); Diabetes mellitus; Parkinsonism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101142614

Write-up: Cadiorespiratory arrest with EXITUS outcome; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority, regulatory authority number ES-AEMPS-986865. A 82-years-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: ET3620), via unknown route of administration, administered in Arm on 18Mar2021 (at the age of 82-years-old) as dose 2, single for covid-19 immunisation. Medical history included diabetes mellitus, cardiac valvulopathy (Degenerative aortic valve disease), cardiac failure congestive, and parkinsonism from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was unknown that the patient had passed COVID-19. It was reported that after receiving second dose of Pfizer vaccine on 18Mar2021, the patient died at dawn on 19Mar2021. She received the same vaccine. The doctor on duty certified the death as Cardiorespiratory Arrest. It was unknown if any autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cadiorespiratory arrest with EXITUS outcome


VAERS ID: 1698170 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Gastrointestinal disorder, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Arterial hypertension (systemic arterial hypertension); Chronic venous insufficiency; Dementia; Prostate carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: negative; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: severe gastrointestinal problems; breathing difficulties; COVID-19 infection 24 days after mRNA vaccine; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (severe gastrointestinal problems), DYSPNOEA (breathing difficulties) and COVID-19 (COVID-19 infection 24 days after mRNA vaccine) in an 86-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension (systemic arterial hypertension), Chronic venous insufficiency, Dementia and Prostate carcinoma. On 09-Jan-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced GASTROINTESTINAL DISORDER (severe gastrointestinal problems) (seriousness criteria death and hospitalization) and DYSPNOEA (breathing difficulties) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced COVID-19 (COVID-19 infection 24 days after mRNA vaccine) (seriousness criterion death). 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 an unknown date, SARS-CoV-2 test: negative (Negative) negative and positive (Positive) positive. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Patient was infected with COVID-19 after 24 days of vaccination, as he was sharing a room with COVID-19 infected patient and died after 4 days. The reporter reported that the vaccine does not work at all. No concomitant medications reported. No treatment medications provided. Company comment: This is a case of COVID-19 infection with fatal outcome in a 86-year-old male who died about 28 days after receiving the first dose of vaccine. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events (dyspnoea and gastrointestinal disorders)), very limited information regarding these events has been provided at this time. However, patient''s age and previous history of arterial hypertension, prostate carcinoma and dementia could be confounding factors. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Translation received on 07-sep-2021 and does not contain any new information.; Sender''s Comments: This is a case of COVID-19 infection with fatal outcome in a 86-year-old male who died about 28 days after receiving the first dose of vaccine. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events (dyspnoea and gastrointestinal disorders)), very limited information regarding these events has been provided at this time. However, patient''s age and previous history of arterial hypertension, prostate carcinoma and dementia could be confounding factors. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1698197 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration, Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 48
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101131213

Write-up: Found dead; Inappropriate schedule of vaccine administered; Reduced general condition; This is a spontaneous report from a contactable consumer downloaded from Regulatory Authority, regulatory authority number FI-FIMEA-20214219. A 74-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Jun2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on 24Mar2021 at single dose for COVID-19 immunisation and no adverse event experienced. The patient experienced reduced general condition in Jun2021. After the vaccine, she felt worse. On 19Jul2021, she was found dead at her home. The cause of death was unknown. Reporter did not know if the vaccine had anything to do with it. The patient died on 19Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Batch/Lot number cannot be obtained.; Reported Cause(s) of Death: Found dead; Reduced general condition


VAERS ID: 1698238 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 38
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: FRMODERNATX, INC.MOD20213

Write-up: Death Nos; Pain; Belly ache; This case was received via regulatory authority (Reference number: FR-AFSSAPS-BX20217434) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death Nos) in a 64-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In June 2021, the patient experienced ABDOMINAL PAIN (Belly ache). On 06-Jul-2021, the patient experienced PAIN (Pain). The patient died on 09-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ABDOMINAL PAIN (Belly ache) outcome was unknown and PAIN (Pain) had not resolved. No concomitant medications are reported. No treatment medications are reported. Follow-up received on 03-SEP-2021 included no new information Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation received on 08 Sep 2021 contains no new information.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1698385 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-08-04
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Arterial hypertension; COPD; COVID-19; Multiple myeloma (without information on a possible current treatment); Pancreatitis; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101160422

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority [FR-AFSSAPS-MP20217025]. A 89-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Batch/Lot number: EJ6788) intramuscularly on 15Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19, cerebrovascular accident, plasma cell myeloma, angina pectoris, chronic obstructive pulmonary disease, pancreatitis, hypertension. The patient''s concomitant medications were not reported. On 04Aug2021 patient experienced delta variant COVID infection who has been fully vaccinated since 15Feb2021. Cardiorespiratory decompensation requiring HAD (home hospitalization) treatment. Time interval between beginning of drug administration and start of reaction / event (number) was 171 days. Time interval between last dose of drug and start of reaction / event (number) was 171 days. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1698406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-08-10
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cardio-respiratory arrest, Lower respiratory tract congestion, PO2, SARS-CoV-2 test, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Arterial hypertension; Dependence; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: Test Result:afebrile; Test Date: 20210810; Test Name: PO2; Test Result: 92 %; Comments: 92% under O2; Test Date: 20210811; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: identified Delta Variant; Test Date: 20210810; Test Name: COVID-19 test antigen; Test Result: Positive
CDC Split Type: FRPFIZER INC202101166381

Write-up: Cardio-respiratory arrest; COVID-19; bronchial congestion; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority; FR-AFSSAPS-NC20213970. A 91-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EJ6789), intramuscular, administered in arm left on 04Feb2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EM0477), intramuscular, administered in arm right on 03Jan2021 as dose 1, single for covid-19 immunisation. The patient''s medical history included pulmonary embolism from Mar2019, advanced old alzheimer''s, total dependence (GIR1) and arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced bronchial congestion, afebrile, SAT 92% under O2 on 10Aug2021, cluster of COVID-19 in progress and positive test on 11Aug2021. Patient was living in home. The patient underwent lab tests and procedures on 10Aug2021 included body temperature resulted into afebrile, PO2 and resulted into 92% under O2, antigen test for COVID-19 and resulted into positive and on 11Aug2021, COVID-19 PCR test resulted into positive and identified Delta Variant. She received treatments included oxygen therapy at 5L / min, lovenox, ceftriaxone 1g, anticoagulant. The patient seemed to be doing better with regression of the bronchial congestion. However, on 21Aug2021, she died suddenly from cardiopulmonary arrest without any other symptoms prior to the end of nursing care, that was 11 days after the onset of the COVID-19 infection. No resuscitation or additional investigation. Death by cardiopulmonary arrest in a context of COVID-19 despite a vaccination schedule completed with a 2nd dose of Comirnaty 6 months previously. The autopsy was not performed. The outcome of events covid-19 and bronchial congestion was unknown and outcome of events vaccination failure and cardio-respiratory arrest was fatal on 21Aug2021. No follow-up attempts were possible. No further information was expected.; Reported Cause(s) of Death: cardiopulmonary arrest


VAERS ID: 1698479 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003610 / 1 - / OT

Administered by: Unknown       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: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus inadequate control; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Triple vessel bypass graft
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Arrest cardiac; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-PS20211985) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Arrest cardiac) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003610) for COVID-19 immunisation. The patient''s past medical history included Triple vessel bypass graft. Concurrent medical conditions included Diabetes mellitus inadequate control and Hypertension arterial. On 30-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The reported cause of death was Arrest cardiac. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not reported. Very limited information regarding this event has been provided at this time. Further information has been requested. However, this patient''s multiple underlying medical conditions (Diabetes mellitus inadequately control, arterial hypertension, triple vessels bypass) remains a contributory factor.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. However, this patient''s multiple underlying medical conditions (Diabetes mellitus inadequately control, arterial hypertension, triple vessels bypass) remains a contributory factor.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1698527 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-08-15
   Days after vaccination:165
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, General physical health deterioration, Oxygen saturation, Pneumonitis, Respiratory disorder, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ESCITALOPRAM; FUROSEMIDE; KARDEGIC; MIRTAZAPINE; SERESTA; FINASTERIDE; MACROGOL; PARACETAMOL; ZYMAD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Basal cell carcinoma (basal cell carcinoma of the nose); Benign prostatic hypertrophy; Conduction disorders (Cardiac conductive disorders); Depression (depressive syndrome); Diffuse Lewy body disease (Lewy body disease); Glaucoma both eyes (bilateral glaucoma); Hypertension arterial; Hyperuricaemia; Obstructive sleep apnea syndrome (Obstructive sleep apnea syndrome with a machine)
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: saturation; Test Result: 88 %; Comments: SAT 88; Test Date: 20210818; Test Name: PCR positive; Test Result: Positive ; Comments: positive nucleocapsid RNA strong CT value 20.4, positive polymerase RNA strong CT value 20.8
CDC Split Type: FRPFIZER INC202101155535

Write-up: asthenic; respiratory deterioration; Vaccination failure; covid-19; Alteration of general condition; pneumonitis without signs of severity; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-SE20212328. A 92-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Injection site: unspecified, Lot Number: EP2166), intramuscularly on 03Mar2021 as dose 2, single and first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Injection site: unspecified, Lot Number: EJ6789), intramuscularly on 10Feb2021 as dose 1, single for covid-19 immunisation. The patient''s medical history included Hyperuricaemia, basal cell carcinoma of the nose, benign prostatic hypertrophy, Lewy body disease, Hypertension arterial, Obstructive sleep apnea syndrome with a machine, depressive syndrome, bilateral glaucoma and Cardiac conductive disorders from unspecified date. COVID-19 ANTECEDENTS: person at risk of developing a severe form of COVID-19: Yes, person who had COVID-19: Yes (vaccine failure), person who has been tested: 18Aug2021 (PCR positive, Delta variant). Concomitant medications included allopurinol (ALLOPURINOL) taken for an unspecified indication, escitalopram (ESCITALOPRAM) taken for an unspecified indication, furosemide (FUROSEMIDE) taken for an unspecified indication, acetylsalicylate lysine (KARDEGIC), 75mg taken for an unspecified indication, mirtazapine (MIRTAZAPINE) taken for an unspecified indication, oxazepam (SERESTA) taken for an unspecified indication, finasteride (FINASTERIDE) taken for an unspecified indication, macrogol (MACROGOL) taken for an unspecified indication, paracetamol (PARACETAMOL) taken for an unspecified indication and colecalciferol (ZYMAD) taken for an unspecified indication from unspecified date. It was reported that 1st signs of infection on 15Aug21 with cough, fever, Alteration of general condition, pneumonitis without signs of severity. Vaccine failure attested by PCR on 18Aug21 (positive nucleocapsid RNA strong CT value 20.4, positive polymerase RNA strong CT value 20.8). Treatment included ROCEPHINE 1g/d, LOVENOX 4000UI/d, SOLUMEDROL 40mg/d, Oxygen therapy 2l/min, hydration was started. On an unspecified date, the patient remained asthenic for 2 weeks with good vitals and no signs of respiratory distress. On 26Aug2021, a respiratory deterioration was noted with SAT 88, improved by corrective measures, but sudden death on 28Aug2021. The patient underwent lab tests and procedures which included saturation (oxygen saturation): 88 % (SAT 88) on 26Aug2021, PCR positive (sars-cov-2 test): positive on 18Aug2021 (positive nucleocapsid RNA strong CT value 20.4, positive polymerase RNA strong CT value 20.8.). The case was medically confirmed. Evolution: death. Conclusion was reported as confirmed vaccine failure (COMIRNATY vaccine), leading to the patient''s death. It was not reported if an autopsy was performed. The outcome of event, respiratory deterioration was recovered, vaccination failure and covid-19 resulting in death and other events was unknown. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: covid-19 infection


VAERS ID: 1698619 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Faecaloma, Fatigue, Haematoma, International normalised ratio, International normalised ratio increased, Myocardial infarction, Skin ulcer, Ultrasound scan
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 84
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer; Renal cancer
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: body temperature; Result Unstructured Data: Test Result:No fever; Test Date: 20210601; Test Name: INR; Result Unstructured Data: Test Result:3; Test Date: 20210604; Test Name: INR; Result Unstructured Data: Test Result:6.8; Test Date: 202106; Test Name: INR; Result Unstructured Data: Test Result:normal; Test Date: 202106; Test Name: abdominal echography; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021701505

Write-up: fecal impaction; heart attack; Patient died on 24Aug2021 from an outbreak of his kidney cancer, which metastasized to his lungs.; Giant hematoma on the half of torso and back; INR Increased; extreme fatigue; Small spot of few millimeters, like an ulceration, of greenish color, in the back; This is a spontaneous report from a contactable consumer or other non-health care professional (patient''s wife) on behalf of her husband who is a physician. A 74-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection, Lot Number: FA8016/Batch number was not reported) via an unspecified route of administration on 02Jun2021 (at the age of 74 years old) as single dose for COVID-19 immunisation. The patient''s medical history included renal cancer and lung cancer. The patient''s concomitant medications were not reported. The patient experienced INR increased (international normalised ratio increased) on 04Jun2021, giant hematoma on the half of torso and back on 05Jun2021, Patient died on 24Aug2021 from an outbreak of his kidney cancer, which metastasized to his lungs, extreme fatigue (2-3 days after injection), small spot of fewmillimeters, like an ulceration, of greenish color, in the back on an unspecified date in Jun2021, fecal impaction and heart attack on an unspecified date in 2021. The case assessed as serios death (death, medically significant) and fecal impaction, heart attack (hospitalized, medically significant). The patient went to emergencies. The patient underwent lab tests and procedures which included body temperature: no fever in Jun2021, international normalised ratio: normal in Jun2021, international normalised ratio: 3 on 01Jun2021 (the day before injection), international normalised ratio: 6.8 on 04Jun2021, abdominal ultrasound scan: normal on an unspecified date in Jun2021. The outcome of the event Patient died on 24Aug2021 from an outbreak of his kidney cancer, which metastasized to his lungs was fatal, hematoma on the half of torso and back was resolving, not resolved for extreme fatigue, unknown for small spot of fewmillimeters, like an ulceration, of greenish color, in the back, and for INR increased (international normalised ratio increased) resolved on an unspecified date in Jun2021 and other events was unknown. It was not reported if an autopsy was performed. Follow up (07Sep2021): This is a follow up report received from the wife of the deceased patient. New information included: Added new events Fecal impaction and Heart attack. Cause of death (Metastasized to lungs) was added. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: kidney cancer; metastasized to lungs


VAERS ID: 1698647 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Fatigue, Feeling cold, Gait inability, Headache, Hypersensitivity, Muscular weakness, Myocardial infarction, Pain, Pain in jaw, Palpitations, Pharyngeal swelling, Swelling face
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101138068

Write-up: Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains; Feeling cold; Swelling face; Hypersensitivity; suspected heart attack; .This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00259479, Safety Report Unique Identifier GB-MHRA-ADR 25865853. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE3380), parenterally on 24Aug2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced heart palpitations, swollen throat, headache, chest pain, jaw pain, tiredness, unable to walk, weak legs, stabbing pains, feeling cold, swelling face and hypersensitivity. On receipt of the first vaccine the patient had a cold feeling in body and stabbing pains all over. After 4 hours the patient was unsteady on feet, headache, chest pains, face swelling, throat swelling, heart palpitations and unable to walk. Symptoms improved after 2 hours. After 24 hours symptoms came back worse, admitted to hospital with suspected heart attack. After 5 days symptoms still present but starting to subside. Advised by health care workers and doctor that the patient had an allergic reaction to the vaccination and not to take second dose. The event palpitations caused death, hospitalization and considered medically significant and all other events caused hospitalization and considered medically significant. At the time of the death, the outcome of all the events was recovering except for the event heart attack it was unknown. The patient died on an unspecified date due to heart palpitations. 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: Heart Palpitations


VAERS ID: 1699123 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 8
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210214; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101152208

Write-up: Stroke; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109021900415440-ZXL2Y, Safety Report Unique Identifier GB-MHRA-ADR 25888589. A 70-year-old male patient (age at vaccination: 70-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 11Feb2021 11:00 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced stroke on 11Feb2021. It was further reported that the patient had dose 1 of the vaccine and the same night he had stroke and was hospitalized the following Sunday (14Feb2021) and died the following Friday, 19Feb2021. The event was reported as serious, hospitalization and disability. The patient underwent laboratory test which included Sars-cov-2 test: negative on 14Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1699162 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REGORAFENIB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatic cancer; Sepsis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101161098

Write-up: Sepsis; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109042228180330-2PBXF. Safety Report Unique Identifier GB-MHRA-ADR 25896866. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Apr2021 (Batch/Lot Number: ER1749) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sepsis, hepatic cancer from an unknown date. Patient had not had symptoms associated with COVID-19. Concomitant medication included regorafenib taken for hepatic cancer, start and stop date were not reported. The patient experienced sepsis on 17Apr2021. The patient was admitted to hospital 8 days after vaccination. He was discharged after 9 days. He was still very poorly. He was readmitted 2 weeks later. He died of sepsis after two nights in hospital. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, No - Negative COVID-19 test on an unspecified date. The patient died on 21May2021. It was not reported if an autopsy was performed. The outcome of event sepsis was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1699204 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Fibrin D dimer, Heparin-induced thrombocytopenia test, Platelet count, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   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: Malignant breast neoplasm; Non-smoker; Transplant (Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l...)
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown Result; Test Name: Anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown Result; Test Name: Platelet count; Result Unstructured Data: Test Result:Unknown Result; Comments: <150 A- 109/L; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210831; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101168194

Write-up: Slightly debilitating; SARS-CoV-2 infection; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109062226036260-XM9XT, Safety Report Unique Identifier is GB-MHRA-ADR 25903681. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included malignant breast neoplasm, transplant (recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l), non-smoker all from an unknown date. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient is not enrolled in clinical trial. The patient experienced SARS-COV-2 infection on 31Aug2021 and slightly debilitating on an unspecified date. The patient underwent lab tests and procedures which included D-dimer $g4000 with unknown result, anti-PF4 antibodies identified with unknown result, platelet count <150 A- 109/L with unknown result, SARS-COV-2 test with negative result all on an unspecified date; positive on 31Aug2021. The patient died on 01Sep2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Slightly debilitating


VAERS ID: 1699287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Acute myocardial infarction, Angiocardiogram, Angiogram, Anti-GAD antibody, Anti-neuronal antibody, Antibody test, Aphasia, Blood immunoglobulin G, Blood pressure increased, Blood pressure measurement, Brain death, Brain oedema, Carbohydrate antigen 125, Carbohydrate antigen 15-3, Carbohydrate antigen 19-9, Cerebral artery thrombosis, Cerebral haemorrhage, Cerebrovascular accident, Chest pain, Coma, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Demyelination, Depressed level of consciousness, Fibrin D dimer, Haematoma, Hypertensive crisis, Hyperventilation, Hypoaesthesia, Intracranial pressure increased, Lumbar puncture, Magnetic resonance imaging head, Methylenetetrahydrofolate reductase gene mutation, Muscular weakness, Platelet count, Prothrombin time, Pulmonary thrombosis, Pyramidal tract syndrome, Stress cardiomyopathy, Subarachnoid haemorrhage, Troponin increased, Ultrasound Doppler, Weight
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Congenital, familial and genetic disorders (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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker; SARS-CoV-2 infection
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: coronary angiography; Test Result: Negative ; Comments: normal; Test Date: 20210816; Test Name: Angiography; Result Unstructured Data: Test Result:ABNORMAL: Showed thrombosis; Comments: ABNORMAL: Showed thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung. Computed tomography angiography; Test Date: 20210816; Test Name: brain CTA; Result Unstructured Data: Test Result:1 cm thrombus in the M1 branch of the left MCA; Comments: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively.; Test Name: antibodies against membrane neuronic antigens; Result Unstructured Data: Test Result:Unknown results; Test Name: antibodies IgG against NMDA-R; Result Unstructured Data: Test Result:Unknown results; Test Name: detection of antibodies against anti-glutamic acid decarboxylase; Result Unstructured Data: Test Result:Unknown results; Test Name: antibodies (IgG) against neuronal antigens; Test Result: Negative ; Test Name: detection of immunoglobulin oligoclonal bands igg of cerebrospinal fluid/anososphere and albumines IgG determination of cerebrospinal fluid and serum; Result Unstructured Data: Test Result:Unknown results; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/10 mmHg; Comments: increased: systolic 180 mmHg and diastolic 10 mmHg; Test Date: 20210816; Test Name: Cancer antigen 125; Result Unstructured Data: Test Result:5995 IU/ml; Test Date: 20210819; Test Name: Cancer antigen 125; Result Unstructured Data: Test Result:2916 IU/ml; Test Date: 20210816; Test Name: Cancer antigen 15-3; Result Unstructured Data: Test Result:800 IU/ml; Test Date: 20210819; Test Name: Cancer antigen 15-3; Result Unstructured Data: Test Result:460.10 IU/ml; Test Date: 20210816; Test Name: Cancer antigen 19-9; Result Unstructured Data: Test Result:449 IU/ml; Test Date: 20210819; Test Name: Cancer antigen 19-9; Result Unstructured Data: Test Result:403.57 IU/ml; Test Name: CT upper-lower abdomen; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210816; Test Name: brain CT; Result Unstructured Data: Test Result:1 cm thrombus in the M1 branch of the left MCA; Comments: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively.; Test Date: 20210816; Test Name: brain CT; Result Unstructured Data: Test Result:subarachnoid hemorrhage, intracerebral hematomas; Comments: revealed subarachnoid hemorrhage, mainly on the left, and large intracerebral hematomas on the right frontobrachial, left frontobrachial and left basal ganglia, as well as edema.; Test Date: 20210817; Test Name: brain CT; Result Unstructured Data: Test Result:slightly hyponuclear imaging; Comments: a new brain CT was performed which revealed slightly hyponuclear imaging of the cerebral parenchyma right temporal occipitally, improvement in terms of hyponuclear imaging of the brainstem and no differentiation of the hemorrhagic elements.; Test Name: CT chest; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210816; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:1 cm thrombus in the M1 branch of the left MCA; Comments: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively.; Test Date: 20210814; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:7.87 mg/l; Test Date: 20210814; Test Name: Lumbar puncture/spinal tap; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI brain; Result Unstructured Data: Test Result:localized demyelination (mainly on the right); Test Date: 20210810; Test Name: MRI brain; Result Unstructured Data: Test Result:indicated acute diffused encephalomyelitis; Comments: showed scattered foci of abnormal signal intensity in both cerebral hemispheres, especially on the right side with lesions affecting both the ciliary cortex and the semicircular centers, as well as the subcortical white matter with an enhancement pattern more indicative of subcortical enrichment, without clear subarachnoid dispersion. The lesions are characterized by increased signal intensity in the DWI sequence, and a nodular focus of enhancement in the right ethusocochlear nerve is highlighted. The whole picture is suspicious of active demyelination, possibly in the context of acute diffuse encephalomyelitis (ADEM); Test Date: 202108; Test Name: MTHFR gene mutation; Result Unstructured Data: Test Result:HETEROZYGOUS (A1298C); Test Name: count of platelets; Result Unstructured Data: Test Result:normal; Test Date: 20210814; Test Name: Prothrombin time; Test Result: 13.8 s; Test Date: 20210727; Test Name: carotid TRIPLEX; Result Unstructured Data: Test Result:without findings; Test Name: weight; Test Result: 78 kg
CDC Split Type: GRPFIZER INC202101155998

Write-up: Blood pressure increased: systolic 180 mmHg and diastolic 10 mmHg.; Localized demyelination (mainly on the right); Intraparenchymal hematomas; Possible acute disseminated encephalomyelitis; Cerebral hemorrhage; Subarachnoid hemorrhage; Cerebral edema; increased intracranial pressure; drop in level of consciousness; hyperpnea; Coma; Takotsubo cardiomyopathy; Precordial pain; Cerebrovascular event; non-STEMI infarction; Numbness of extremities; Serum troponin increased; Brain death; Difficulty in holding items; Hypertensive crisis; Aphasic disorders; Thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung.; Thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung.; Pyramidal tract syndrome; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number GR-GREOF-20217168. A 48-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 17Jul2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included SARS-CoV-2 infection and she had been infected with COVID-19 in Nov2020 (mild hospitalization) and Non-smoker. She had not used Alcohol and no allergies. Brother passed away at age 26 from seminoma (testicular cancer). The patient''s concomitant medications were not reported. The patient experienced brain death on an unspecified date (considered as serious with death, medically significant and life-threatening). The patient experienced thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung on 16Aug2021 with outcome of unknown, blood pressure increased: systolic 180 mmhg and diastolic 10 mmhg on an unspecified date with outcome of unknown, localized demyelination (mainly on the right) on an unspecified date with outcome of unknown, numbness of extremities on 27Jul2021 with outcome of unknown, serum troponin increased on 27Jul2021 with outcome of unknown, intraparenchymal hematomas on an unspecified date with outcome of unknown, possible acute disseminated encephalomyelitis on an unspecified date with outcome of unknown, pyramidal tract syndrome on 16Aug2021 with outcome of unknown, difficulty in holding items on an unspecified date with outcome of unknown, aphasic disorders on 16Aug2021 with outcome of unknown, cerebral hemorrhage on an unspecified date with outcome of unknown, cerebrovascular event on 27Jul2021 with outcome of unknown, non-stemi infarction on 27Jul2021 with outcome of unknown, subarachnoid hemorrhage on an unspecified date with outcome of unknown, cerebral edema on an unspecified date with outcome of unknown, precordial pain on 27Jul2021 with outcome of unknown, hypertensive crisis on an unspecified date with outcome of unknown, coma on 16Aug2021 with outcome of unknown, considered as serious with medically significant and life-threatening. The patient also experienced Takotsubo cardiomyopathy on 27Jul2021, increased intracranial pressure, drop in level of consciousness and hyperpnea. The patient underwent lab tests and procedures which included: Angiography on 16Aug2021 ABNORMAL: Showed thrombosis of the left middle cerebral artery and a segmental branch of the right upper lobe of the lung; Computed tomography angiography: brain CTA on 16Aug2021: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively; carbohydrate antigen 125: 5995 iu/ml on 16Aug2021; carbohydrate antigen 125: 2916 iu/ml on 19Aug2021; carbohydrate antigen 15-3: 800 iu/ml on 16Aug2021; carbohydrate antigen 15-3: 460.10 iu/ml on 19Aug2021; carbohydrate antigen 19-9: 449 iu/ml on 16Aug2021; carbohydrate antigen 19-9: 403.57 iu/ml on 19Aug2021; brain computerised tomogram on 16Aug2021: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively, brain computerised tomogram on 16Aug2021: subarachnoid hemorrhage, intracerebral hematomas revealed subarachnoid hemorrhage, mainly on the left, and large intracerebral hematomas on the right frontobrachial, left frontobrachial and left basal ganglia, as well as edema; brain computerised tomogram on 17Aug2021: a new brain CT was performed which revealed slightly hyponuclear imaging of the cerebral parenchyma right temporal occipitally, improvement in terms of hyponuclear imaging of the brainstem and no differentiation of the hemorrhagic elements; CT pulmonary angiogram on 16Aug2021: 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively, fibrin d dimer: 7.87 mg/l on 14Aug2021, lumbar puncture on 14Aug2021; methylenetetrahydrofolate reductase gene mutation: heterozygous (a1298c) on Aug2021. On 27Jul2021, Ten days after the vaccination, the patient developed increased serum troponin (she was hospitalized and there she underwent coronary angiography which was negative). Also, she underwent carotid TRIPLEX which was also without findings. She also developed numbness of left upper limb with difficulty in holding items. Blood pressure increased (180/10) and furthermore she underwent MRI of brain with image of localized demyelination (mainly on the right). She was transferred to another hospital, where she underwent a complete check (spinal tap). She subsequently suffered from a cerebrovascular event, ending up in brain death. During her hospitalization she suffered from a cerebrovascular event, diagnosed also with thrombosis (normal count of platelets), despite the fact that she was on anticoagulation medication and she underwent thrombolysis. She was then transferred to another hospital for a thrombectomy and after the onset of a cerebral haemorrhage she was admitted to an intensive care unit. On 27Jul2021 hospitalization in a cardiology clinic with diagnosis non-STEMI infarction. On 10Aug2021 she underwent MRI due to the appearance of signs of left pyramidal tract syndrome. The findings were suspicious for active demyelination, possibly in the context of acute diffuse encephalomyelitis. On 13Aug2021 admission to the Hospital for further examination. On 16Aug2021 the female patient suffered from pyramidal tract syndrome (right) with aphasic disorders. The CTA showed thrombosis of the left middle cerebral artery (M1) and a segmental branch of the right upper lobe of the lung. On the same day the patient underwent thrombolysis with alteplase and due to therapeutic failure she was admitted to a General Hospital. Immediately after thrombectomy, the patient fell into coma (GCSQ 7/15) and was transferred intubated to a hospital where she had been hospitalized during the previous days. Brain CT showed subarachnoid hemorrhage mainly on the left and scattered extensive intraparenchymal hematomas and cerebral edema. On 17Aug2021 she underwent a left decompressive craniotomy and immediately postoperatively admitted in the intensive care unit. They had sent via email, results from, CT-CTA-BRAIN, CT angiography of pulmonary artery, CT brain, CT chest, CT upper-lower abdomen, hemostasis control, detection of antibodies against anti-glutamic acid decarboxylase, detection of immunoglobulin oligoclonal bands igg of cerebrospinal fluid, antibodies (IgG) against neuronal antigens was negative, antibodies IgG against NMDA-R, antibodies against membrane neuronic antigens, MRI of brain (10Aug2021) indicated acute diffused encephalomyelitis, molecular control, cancer indicators and anososphere and albumines IgG determination of cerebrospinal fluid and serum. Every imaging examination or laboratory test and etc general examinations, are in our disposal in order to be assessed from The National Pharmacovigilance Committee. The patient was hospitalized at the Neurology Clinic from 13Aug2021 to 17Aug2021, when she was transferred intubated to the ICU of our hospital, after having undergone a decompressive craniectomy of the left hemisphere, due to increased intracranial pressure, by the Doctors of the Neurosurgery Clinic. On 27Jul2021, ten days after vaccination, the patient first developed hypertensive spike and was transferred a General Hospital, where a high troponin value was found, so she underwent coronary angiography which was normal. It is reported that a diagnosis of Takotsubo cardiomyopathy was made. A few days later, and after being discharged from the hospital with the recommendation to continue taking specific medication (Duoplavin 1x1, Lopresor 100 mg 1/2x3, Atrost 20 mg 1x1, Nitrong 6 mg 1x2, Copalia 5/160 mg 1x1), the patient developed persistent dysfunction of the left hand limb, which after three days was also accompanied by a drop in the angle of the mouth on the left side. A brain MRI was performed on 10Aug2021 at the Diagnostic Center, which showed scattered foci of abnormal signal intensity in both cerebral hemispheres, especially on the right side with lesions affecting both the ciliary cortex and the semicircular centers, as well as the subcortical white matter with an enhancement pattern more indicative of subcortical enrichment, without clear subarachnoid dispersion. The lesions are characterized by increased signal intensity in the DWI sequence, and a nodular focus of enhancement in the right ethusocochlear nerve is highlighted. The whole picture is suspicious of active demyelination, possibly in the context of acute diffuse encephalomyelitis (ADEM). In the differential diagnoses the possibilities of ischemic lesions or secondary localizations due to neoplasia are mentioned as more remote. The patient was admitted to the Neurology Clinic, on a general duty day, on 13Aug2021, for further investigation and treatment of the pathological findings of the brain imaging. Clinically, she presented with left pyramidal syndrome (weakness of the left upper limb and drooping of the mouth angle on the left, with plantar reflexes in flexion bilaterally). On 14Aug2021, being haemodynamically stable and unresponsive, the patient underwent lumbar puncture and subsequently started Solu-medrol 1 g/day as part of ADEM therapy. On 15Aug2021 the patient remained hemodynamically stable, unresponsive, and clinically stable. On 16Aug2021 07:40 the patient presented with right limb hemiplegia (right limb paralysis), emission aphasia (mute), gaze shift to the left, right mouth angle drop with Babinski''s sign (+) intact (NIHSS = 20/42). Emergency brain CT, brain CTA and chest CTPA were performed, which revealed the presence of a ca. 1 cm thrombus in the M1 branch of the left middle cerebral artery and a small contrast deficit in a segmental branch of the right upper lobe of the lung, respectively. Therefore, considering the patient''s clinical picture and history, thrombolysis with 70 mg alteplase (patient weight: 78 kg) was performed with a starting time of 10:15. Upon completion of thrombolysis, the patient remained haemodynamically stable with NIHSS = 19/42 (no improvement in her clinical status). Subsequently, after consultation, she was transferred to the General Hospital for mechanical thrombectomy. During the thrombectomy the patient remained alert and haemodynamically stable. However, upon completion of the procedure, and after the thrombus was removed, the patient presented a drop in level of consciousness and hyperpnea, and was intubated with GCS = 7/15. She was then returned by ambulance to our hospital, where she underwent a brain CT scan, which revealed subarachnoid hemorrhage, mainly on the left, and large intracerebral hematomas on the right frontobrachial, left frontobrachial and left basal ganglia, as well as edema. On 17Aug2021, and while the patient remained isocaloric with a positive photomotor reflex, a new brain CT was performed which revealed slightly hyponuclear imaging of the cerebral parenchyma right temporal occipitally, improvement in terms of hyponuclear imaging of the brainstem and no differentiation of the hemorrhagic elements. Subsequently, the patient underwent decompressive craniectomy by the physicians of the Department of Neurosurgery and then transferred to the ICU. During her hospitalization, her neurological situation worsened and led to brain death. She died on 25Aug2021. It was not reported if an autopsy was performed. Sender''s comments: Initial report with follow-up information. Amendment: Has been added the reaction ADEM. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Brain death


VAERS ID: 1699309 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Metastases to lung, Pulmonary imaging procedure
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 117
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: Lung lobectomy; Lung neoplasm NOS
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Pulmonary imaging procedure; Result Unstructured Data: Test Result:clean lung image; Test Date: 202104; Test Name: Pulmonary imaging procedure; Result Unstructured Data: Test Result:metastases in the right lobe of the lung; Comments: metastases in the right lobe of the lung, about 1/3 of the respiratory surface remained
CDC Split Type: HUPFIZER INC202101158299

Write-up: Metastasis in lung/dyspnoea; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB, regulatory authority number HU-OGYI-719221. This spontaneous, serious case was reported by a patient''s relative on 23/08/2021, concerning the occurrence of metastasis in lung after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). On 01/04/2021 (at the vaccination age of 60 years old), the 60-year-old female patient received the first dose of Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran) concentrate for dispersion for injection (strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, batch number: unknown) for COVID-19 immunisation. On 01/04/2021, the patient experienced dyspnoea, and in the end of 04/2021, metastases were found in the right lobe of the lung by unspecified pulmonary imaging procedure, approximately 1/3 of the lung surface remained clean. The patient died on 27/07/2021 among the symptoms of respiratory arrest. There is no information about whether autopsy was done. Medical history included lung lobectomy in 03/2021 due to a tumor. Clean image of the lung was seen in 01/2021.Concomitant medications were unspecified antihipertensive and antidiabetic medication. No further information is expected. Sender''s comments: Metastases occurred in lung within a month, and the patient died 3 months after Comirnaty vaccination. There is no information about whether autopsy was done. The causal relationship between the reported event and Comirnaty is unassessable. The case is serious due to fatal outcome. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Metastasis in lung/dyspnoea; Respiratory arrest


VAERS ID: 1699310 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Chest X-ray, Disorientation, Drug ineffective, Dyspnoea, Pyrexia, SARS-CoV-2 test, Sepsis, Somnolence
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: ELIQUIS; DIGOXIN; TANYDON HCT; MEDROL [METHYLPREDNISOLONE]; HUMA-FOLACID; CONCOR; SORBIFER DURULES [ASCORBIC ACID;FERROUS SULFATE]; TREXAN [METHOTREXATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis generalised; Chronic atrial fibrillation; Dilated cardiomyopathy; Hypertension; Seronegative rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: Chest X-ray; Result Unstructured Data: Test Result:multifocal pneumonia, right side; Test Date: 20210217; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC202101158514

Write-up: On 17Feb2021, the patient experienced dyspnoea; COVID-19 pneumonia; The patient became septic, and died; The patient was somnolent and disoriented, feverish.; The patient was somnolent and disoriented, feverish.; The patient was somnolent and disoriented, feverish.; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-729221. An 82-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EJ6134), intramuscular on 27Jan2021 as dose 1, 0.3 ml, single for covid-19 immunisation. Medical history included arteriosclerosis generalised, chronic atrial fibrillation, hypertension, seronegative rheumatoid arthritis and dilated cardiomyopathy. Concomitant medications included apixaban (ELIQUIS); digoxin (MANUFACTURER UNKNOWN); hydrochlorothiazide/telmisartan (TANYDON HCT); methylprednisolone (MEDROL); folic acid (HUMA-FOLACID); bisoprolol fumarate (CONCOR); ascorbic acid/ferrous sulfate (SORBIFER DURULES); methotrexate (TREXAN). The patient experienced COVID-19 pneumonia, dyspnoea on 17Feb2021. The patient had somnolence, disorientation, fever, drug ineffective and became septic in 2021. The patient was hospitalized from 19Feb2021. It was reported that COVID-19 pneumonia occurred after 21 days, and the patient died 28 days after the first dose of Comirnaty. Autopsy was not done. Immunity might has not developed after the first dose of the vaccine. The case was serious due to hospitalization. The patient underwent lab tests and procedures which included chest x-ray: multifocal pneumonia, right side on 19Feb2021; sars-cov-2 test: positive on 17Feb2021. Therapeutic measures were taken antibiotic and antiviral therapy. The outcome of events somnolent, dyspnoea and disoriented, feverish was unknown. The patient died on 24Feb2021. The cause of death was reported as COVID-19 pneumonia and septic. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sepsis; COVID-19 pneumonia; COVID-19 pneumonia


VAERS ID: 1699311 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Computerised tomogram thorax, Hepatic function abnormal, Hepatic lesion, Inflammation, Multiple organ dysfunction syndrome, Pancreatic enzymes, Pericardial effusion, Procalcitonin, Renal cyst, Renal mass, Sepsis
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Systemic lupus erythematosus (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), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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: CO VALSACOR; MEZITAN; TANYDON; CARDURA; CAVINTON FORTE; BETALOC [METOPROLOL SUCCINATE]
Current Illness: Cardiac insufficiency; Diabetes mellitus; Hypertension; Liver abscess; Renal insufficiency; Right bundle branch block
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: abdominal CT; Result Unstructured Data: Test Result:multiple hepatic lesions, pericardial liquid; Comments: multiple hepatic lesions, pericardial liquid, renal cysts on the right side and renal mass on the left side; Test Date: 20210215; Test Name: Chest CT; Result Unstructured Data: Test Result:multiple hepatic lesions, pericardial liquid; Comments: multiple hepatic lesions, pericardial liquid, renal cysts on the right side and renal mass on the left side; Test Date: 20210215; Test Name: Hepatic function; Result Unstructured Data: Test Result:abnormal; Test Date: 20210215; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:high; Test Date: 20210215; Test Name: pancreatic enzymes; Result Unstructured Data: Test Result:elevated; Test Date: 20210215; Test Name: procalcitonin; Result Unstructured Data: Test Result:high
CDC Split Type: HUPFIZER INC202101158512

Write-up: sepsis; renal mass on the left side; multi organ failure; multiple hepatic lesions; renal cysts on the right side; pericardial liquid; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number HU-OGYI-729321. On 12/02/2021 at 13:41, the 81 years old male patient received the first dose of COMIRNATY (concentrate for dispersion injection; active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine; lot number: EL0725, expiry date: 31/03/2021, MAH: BioNTech Manufacturing GmbH) intramuscularly to the left upper arm for COVID-19 immunisation. On 15/02/2021, the patient was submitted to hospital because of abdominal pain. He was disoriented. Upon examination, his procalcitonin and inflammatory parameters were high. Hepatic function was abnormal, pancreatic enzymes were elevated. Chest and abdominal CT has found multiple hepatic lesions, pericardial liquid, renal cysts on the right side and renal mass on the left side. The patient''s condition was worsening, therefore he was submitted to ICU from gastroenterology. Sepsis and multi organ failure has occurred and he died on 20/02/2021. The outcome of sepsis and Renal mass were fatal and for other events are unknown. The patient''s medical history included hypertension, right bundle branch block, diabetes mellitus, renal insufficiency, hepatic abscess, and cardiac insufficiency.Concomitant medications included BETALOC (metoprolol), CARDURA (doxazosin), CAVINTON FORTE (vinpocetin), CO-VALSACOR (hydrochlorothiazide, valsartan), MEZITAN (trimetazidine) and TANYDON (telmisartan). The case was investigated by the national competent authority for vaccines. The investigator did not find any irregularities regarding the transportation and storage of the vaccine. No relationship was found between vaccination and death, it is contributed to the patient''s underlying diseases.; Sender''s Comments: Based on known temporal relationship the possibility of causal association between the reported events sepsis, renal mass, Renal cyst, hepatic lesion, pericardial effusion, multi organ failure, and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Sepsis; renal mass on the left side


VAERS ID: 1699466 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-10
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haematoma, Peripheral circulatory failure
SMQs:, Haemorrhage terms (excl laboratory terms) (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: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-775005) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL CIRCULATORY FAILURE in an 85-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced PERIPHERAL CIRCULATORY FAILURE (seriousness criterion death) and HAEMATOMA (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding these events have been provided at this time. No further follow up information is expected. Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up included no new information.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1699517 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-05-18
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: CSF test, Creutzfeldt-Jakob disease, Magnetic resonance imaging
SMQs:, Dementia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 86
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ISOPTINE; ACETYLSALICYLIC ACID; ATORVASTATIN; TIMOLOL; STILNOX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glaucoma; Non-Hodgkin''s lymphoma (large cell non-Hodgkin''s lymphoma, 8 cycles of CT, complete remission since 2004 (follow up annu); Paroxysmal supraventricular tachycardia (two remote episodes of paroxysmal supraventricular tachycardia); Radical prostatectomy (Robotic radical prostatectomy for carcinoma in 2016: T1 N0 Gleason 6. annual follow-up, always)
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: CSF; Result Unstructured Data: Test Result:Waiting for the results of the CSF tests; Test Date: 20210531; Test Name: MRI; Result Unstructured Data: Test Result:MRI abnormal; Comments: Signal changes in the right parietal cortex diffusion-weighted imaging / FLAIR of non-univocal iteration
CDC Split Type: ITPFIZER INC202101135850

Write-up: Jakob-Creutzfeldt disease; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number IT-MINISAL02-775458. A 79-years-old male patient received bnt162b2 (COMIRNATY,Formulation:Solution for injection,Batch/Lot Number: ET1831), via intramuscularly administered in Arm Left on 18Mar2021 as Dose 2, 0.3mL, Single for covid-19 immunization. Medical history included supraventricular tachycardia from an unknown date and unknown if ongoing, two remote episodes of paroxysmal supraventricular tachycardia, radical prostatectomy from 01Jan2016 to an unknown date Robotic radical prostatectomy for carcinoma in 2016, T1 N0 Gleason 6. annual follow-up, always, glaucoma from an unknown date and unknown if ongoing, non-hodgkin''s lymphoma from an unknown date and unknown if ongoing, large cell non-Hodgkin''s lymphoma, 8 cycles of CT, complete remission since 2004 (follow up annual). Historical vaccination included the patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6790) via unspecified route on 25Feb2021 as Dose 1, Single for covid-19 immunization.Concomitant medication(s) included verapamil hydrochloride (ISOPTINE) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ACETYLSALICYLIC ACID) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; timolol (TIMOLOL) taken for an unspecified indication, start and stop date were not reported; zolpidem tartrate (STILNOX) taken for an unspecified indication, start and stop date were not reported. The patient experienced jakob-creutzfeldt disease (creutzfeldt-jakob disease) (death, hospitalization) on 18May2021. The patient was hospitalized for jakob-creutzfeldt disease (creutzfeldt-jakob disease) from 03Jun2021 to 09Jun2021. The patient underwent lab tests and procedures which included CSF test: waiting for the results of the csf tests on 27Aug2021, magnetic resonance imaging: mri abnormal on 31May2021. Signal changes in the right parietal cortex diffusion-weighted imaging / FLAIR of non-univocal iteration. Therapeutic measures were taken as a result of jakob-creutzfeldt disease (creutzfeldt-jakob disease). The patient died on 12Aug2021. An autopsy was not performed. Reporter''s comment: probable Creutzfeldt Jakob disease detection from mRNA vaccines - Actions taken (hydration-morphine-anticholinergic-anticonvulsants) - Ethnic origin (PRIVACY) - COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (left shoulder) Booster dose number (2) second dose Pfizer 18Mar2021 (Lot ET1831) from April 2021. general malaise and dyspraxia, from May: ataxia. hallucinations. taste alterations, dysarthria, akinetic mutism, total dysphagia. First dose performed on 25Feb202 Sender''s comment: Regional Pharmacovigilance: Pending Lot Number. 25Aug2021 Regional Center for Pharmacovigilance : requests for follow-up information from the reporter regarding doc. medical case. 26Aug2021 hospital of PRIVACY: Pending final discharge letter, including the results of the CSF tests made 27Aug2021 Regional Center for Pharmacovigilance: the form is updated with the additional information provided by the reporter and the clinical report is attached. The autopsy was not done. LOT: ET1831 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: probable Creutzfeldt Jakob disease detection from mRNA vaccines - Actions taken (hydration-morphine-anticholinergic-anticonvulsants) - Ethnic origin (PRIVACY) - COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (left shoulder) Booster dose number (2) second dose Pfizer 18Mar2021 (Lot ET1831) from April 2021. general malaise and dyspraxia, from May: ataxia. hallucinations. taste alterations, dysarthria, akinetic mutism, total dysphagia. First dose performed on 25Feb202; Reported Cause(s) of Death: Jakob-Creutzfeldt disease


VAERS ID: 1699655 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-24
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Coma, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COUMADIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101135998

Write-up: Death; Coma; Cerebral haemorrhage; This is a spontaneous report from a contactable consumer or other non-HCP from the regulatory authority, regulatory authority number IT-MINISAL02-777111. A 54-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), intramuscular on an unspecified date as dose number unknwon single for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication included warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported. On 24Apr2021, the patient experienced death, coma, cerebral haemorrhage. The patient died on 24Apr2021. It was reported that the cause of death was coma, cerebral haemorrhage, death. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage; Coma; Death


VAERS ID: 1699661 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-05-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 74
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 (was naturally immunized in Jan2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101135900

Write-up: Dad was naturally immunized in Jan2021, he was given a double dose of PFIZER (Feb and Mar), and died on 14Jul2021; Bilateral pneumonia; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority. . An 86-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: ET7205, Expiration date not reported) via an unspecified route of administration on 31Mar2021 as single dose for COVID-19 immunisation. Medical history included COVID-19 from Jan2021 to an unknown date and was naturally immunized in Jan2021. The patient''s concomitant medications were not reported. Historical vaccine given to patient previously was first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date not reported) via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation. It was reported that reporter''s dad was naturally immunized in jan2021, he was given a double dose of Pfizer (In Feb2021 and Mar2021) on 01May2021, general physical health deterioration and experienced bilateral pneumonia, no swab and of course no correlation. The patient died on 14Jul2021. It was not reported if an autopsy was performed. Reporter''s comment: I am thrilled they authorize the use of this serum on kids over 12 years old, after a trial on 80 kids and I, nearby, know an 85-year-old diabetic who has been successfully cured twice by COVID, my father who was practically asymptomatic, had immunized in Jan2021, without problems, was then vaccinated in Feb2021 and Mar2021 with Pfizer, got progressively worse with hospitalization due to the absence of potassium (same symptom as another grandfather, who died this summer after. Sender''s comments: 23Aug2021 Local Centre of Pharmacovigilance contacted reporting after vaccination reports progressive deterioration of the state of health with the onset of pneumonia and death on 14Jul2021 requested clinical documentation. Waiting.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1699694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis bullous, Investigation, Limb injury, Septic shock, Skin lesion
SMQs:, Severe cutaneous adverse reactions (narrow), Toxic-septic shock conditions (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LASIX [FUROSEMIDE]; INHIXA; DIBASE; INSULIN LISPRO; LANSOPRAZOLE; TOUJEO; RAMIPRIL; DEXAMETHASONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain injury; Diabetes; Lung adenocarcinoma (undergoing atypical resection of the upper left lung lobe in lateral thoracotomy in Oct 2020); Thoracotomy
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:4/10
CDC Split Type: ITPFIZER INC202101155412

Write-up: lower limb injury; septic shock; fluid-filled blisters in the feet, from the knees down; fluid-filled blisters in the feet, from the knees down; This is a spontaneous report from a contactable consumer downloaded from the Agency. Regulatory authority number IT-MINISAL02-779310. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in right shoulder on 08Apr2021 (Lot Number: EW2246) as dose 1, 0.3 mL, single for covid-19 immunisation. Medical history included diabetes, lung adenocarcinoma (undergoing atypical resection of the upper left lung lobe in lateral thoracotomy in Oct 2020), single brain injury. Concomitant medications included furosemide (LASIX); enoxaparin sodium (INHIXA); colecalciferol (DIBASE); insulin lispro; lansoprazole; insulin glargine (TOUJEO); ramipril; dexamethasone. The patient experienced fluid-filled blisters in the feet, from the knees down, on 11Apr2021. On 18Apr2021, he had a septic shock, on 24Apr2021, he died. It was also reported that "Access to hospital for lower limb injury". Events resulted in "Physician Office Visit". The patient underwent lab tests and procedures which included Impact on quality of life (4/10). The outcome of event lower limb injury was unknown. The patient died from "fluid-filled blisters in the feet, from the knees down" and "septic shock" on 24Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dermatitis bullous; Skin lesion; septic shock


VAERS ID: 1699695 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Renal failure, Respiratory failure, Underdose, Vasculitis
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 (narrow), Guillain-Barre syndrome (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   Days after onset: 236
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: ITPFIZER INC202101155364

Write-up: initial asthenia and respiratory insufficiency; initial asthenia and respiratory insufficiency/vasculitis diagnosis; initial asthenia and respiratory insufficiency; renal and respiratory failure; as 0.03 mL, single dose; This is a spontaneous report from a contactable physician downloaded from the Agency. Regulatory authority number IT-MINISAL02-779342. A 48-years-old male patient received first dose of bnt162b2 (COMIRNATY), via intramuscular, administered in Arm Right on 04Jan2021 (Batch/Lot Number: EL1484; Expiration Date: 01Apr2021) as 0.03 mL, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced failure respiratory, vasculitis and asthenia, on 12Jul2021. Seriousness provided as death. It was reported patient experienced initial asthenia and respiratory insufficiency. Therapeutic measures were taken as a result of failure respiratory, vasculitis, Renal failure and asthenia. Patient was hospitalized at resuscitation from 23Jul2021 and immunoglobulins dialysis treatment plasma exchange were administered. The outcome of events was fatal. The patient died on 29Aug2021. It was not reported if an autopsy was performed. Reporter Comment: renal and respiratory failure, vasculitis diagnosis.; Reporter''s Comments: renal and respiratory failure, vasculitis diagnosis; Reported Cause(s) of Death: Unknown cause of death; initial asthenia and respiratory insufficiency; initial asthenia and respiratory insufficiency/vasculitis diagnosis; initial asthenia and respiratory insufficiency


VAERS ID: 1699696 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-28
Onset:2021-06-29
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral ischaemia, Renal failure, Respiratory failure, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101157985

Write-up: cerebral ischemia; Renal failure; Vasculitis; respiratory failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number IT-MINISAL02-779343. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 28Dec2020 (lot number: EJ6796; expiration date: 28Dec2020) as dose 1, 0.03 mL, single (pending confirmation) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced renal and respiratory failure vasculitis diagnosis, kidney and respiratory insufficiency cerebral ischemia on 29Jun2021. The patient died on 05Aug2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: cerebral ischemia; Renal failure; Vasculitis; respiratory failure


VAERS ID: 1699911 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101139112

Write-up: Adverse event following immunisation/Outcome: Fatal; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority (RA). Regulatory authority report number is 611939. A 49-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number unknown, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced an adverse event following immunisation/outcome: fatal on 07Aug2021. The patient died on an unspecified date. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation/Outcome: Fatal


VAERS ID: 1699912 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-09
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Concomitant disease aggravated, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139114

Write-up: Concomitant disease aggravated; Sepsis; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority (RA). The regulatory authority report number is 613030. A 67-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 09May2021, the patient experienced concomitant disease aggravated and sepsis. The patient died on an unspecified date due to concomitant disease aggravated and sepsis. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Concomitant disease aggravated; Sepsis


VAERS ID: 1699913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101139115

Write-up: Adverse event following immunisation; outcome: Fatal; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 610581. A 70-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Unknown if patient was pregnant at the time of vaccination. The patient experienced adverse event following immunisation; outcome: fatal on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation; outcome: Fatal


VAERS ID: 1700046 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169638

Write-up: Cardiac arrest; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 613371. A 44-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient received the first dose of bnt162b2 (COMIRNATY) on unknown date for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 04Aug2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1700047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169737

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable other health professional via the regulatory auhority. Regulatory authority report number is 613645. A 57-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 subarachnoid haemorrhage (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1700048 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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 INC202101169738

Write-up: Arthralgia; Headache; Vomiting; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 615012. A 54-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. The patient medical history and concomitant medications were not reported. The patient experienced arthralgia (death) on an unspecified date, headache (death) on an unspecified date, vomiting (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Arthralgia; Headache; Vomiting


VAERS ID: 1700049 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169739

Write-up: Cardiac arrest; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 617068. A 41-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiac arrest (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1700986 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169740

Write-up: Myocarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 615875. A 50-year-old male patient received unknown dose number of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1700987 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169741

Write-up: Adverse event following immunisation; Outcome - Fatal; Malaise; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 616124. A 17-years-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. The patient medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation; malaise on 01Sep2021. The outcome was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Adverse event following immunisation; Malaise


VAERS ID: 1700988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-28
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169742

Write-up: Headache; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 615803. A 43-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache on 28Aug2021. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Headache


VAERS ID: 1701080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Pericarditis, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 51
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gout; Hypertension; Insufficiency renal; Panic disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: CZPFIZER INC202101142485

Write-up: cardiac failure acute; pericarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB CZ-CZSUKL-21010315. A 55-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on 29Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunization. Medical history included hypertension, panic disorder, renal insufficiency and gout; all ongoing. Historical vaccine included BNT162B2 (COMIRNATY), on an unspecified date (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient experienced cardiac failure acute and pericarditis on Jun2021 which were fatal, life-threatening and disability. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 2021. The patient died on 22Jul2021. An autopsy was performed that revealed pericarditis. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardiac failure acute; with pericarditis; Autopsy-determined Cause(s) of Death: Pericarditis


VAERS ID: 1701164 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D020A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Deep vein thrombosis, Fibrin D dimer, Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Intervertebral disc prolapse
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: 37.9; Result Unstructured Data: Test Result:37.9; Test Date: 20210809; Test Name: D-dimer; Result Unstructured Data: Test Result:10.97 mg/l; Test Date: 20210809; Test Name: COVID-19 PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC202101142659

Write-up: Deep venous thrombosis groin; Pulmonary embolism; Vaccination failure; COVID-19 PCR positive; body temperature: 37.9; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100179157. A 70-year-old female patient received the second dose of BNT162B2 (COMIRNATY) at 70-year-old, via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: 1D020A) at single dose, and the first dose via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included intervertebral disc prolapse from Jun2021. The patient''s concomitant medications were not reported. The patient experienced deep venous thrombosis groin on an unspecified date, pulmonary embolism on 09Aug2021, vaccination failure on 09Aug2021, COVID-19 PCR positive on 09Aug2021, and body temperature: 37.9 on 09Aug2021. Patient notes: Alternative hypothesis on the pathogenesis of intervertebral disc protrusion and reduced mobility as well as possible lack of anticoagulation. DVT possibly already present before the second COVID-19 vaccination. This report was serious - death. The patient underwent lab tests and procedures which included body temperature: 37.9 on 09Aug2021, fibrin D dimer: 10.97 mg/l on 09Aug2021, COVID-19 PCR: Positive on 09Aug2021. Outcome of events vaccination failure, COVID-19 PCR positive, and body temperature: 37.9 was unknown. The patient died on 09Aug2021. It was not reported if an autopsy was performed. For events: Deep venous thrombosis groin and Pulmonary embolism: Relatedness of drug to reaction(s)/event(s): Source of assessment: RA; Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Deep venous thrombosis groin; Pulmonary embolism


VAERS ID: 1701170 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: MARCUMAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (treatment with Marcumar); Cardiac insufficiency; Pulmonary embolism; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142588

Write-up: Embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100179187. A 74-year-old female patient received BNT162B2 (COMIRNATY, lot number EW8904) at single dose via an unknown route on 09Apr2021 at 74-year-old for COVID-19 immunisation. Medical history included cardiac insufficiency, pulmonary embolism, type II diabetes mellitus, atrial fibrillation (treatment with phenprocoumon (MARCUMAR). Concomitant drugs included phenprocoumon for atrial fibrillation. On 12Apr2021 the patient experienced embolism. Outcome of embolism was fatal. It was unknown if autopsy was performed. Result of assessment (source: RA) was unclassifiable. This report was serious with seriousness of death. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Embolism


VAERS ID: 1701175 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / -

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: 2021-06-20
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142598

Write-up: Death sudden; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100179218. A 78-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: FC3095) as single dose for covid-19 immunisation. Historical vaccine included 1st dose of BNT162B2 on 12May2021 (Strength: 0.3 ml) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death sudden on 20Jun2021. It was not reported if an autopsy was performed. The RA assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1701191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-08-18
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9324 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adipositas per magna; Hypertension; Hypertensive heart disease; Lymphoedema
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:53
CDC Split Type: DEPFIZER INC202101142606

Write-up: Cardiac death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021170039, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100177053. A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: FD9324) at single dose for COVID-19 immunisation. Medical history included adipositas per magna, hypertension, lymphoedema, hypertensive heart disease. The patient''s concomitant medications were not reported. Patient previously received the first dose of BNT162B2 for COVID-19 immunisation. The patient experienced cardiac death on 18Aug2021. Sudden death, resuscitation unsuccessful. This report is serious - death. The patient''s outcome was fatal for cardiac death. Information on risk factors or previous illnesses: Obesity permagna (BMI 53), hypertension, lymphedema, hypertensive heart disease/no more patient contact after the second vaccination on 17Jun2021. The patient died on 18Aug2021. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s) assessed by RA as D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1701192 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-08-09
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Attention deficit hyperactivity disorder; Hypertension; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142620

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority [DE-PEI-CADR2021170054], Safety Report Unique Identifier is DE-PEI-202100177058. A 50-year-old male patient received the second dose of BNT162B2 (COMIRNATY, strength: 0.3 mL, Lot#: FD9234) at single dose on 17Jun2021 for COVID-19 immunisation. Ongoing medical history included obesity; asthma; attention deficit hyperactivity disorder; hypertension. Concomitant medication was not reported. On 09Aug2021, the patient experienced unknown cause of death. The autopsy was not performed. The outcome of event was fatal. This report was serious - death. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses: obesity, hypertension, asthma, ADHD. Found dead in the apartment on 09Aug2021. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701193 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Atrial fibrillation, Blood sodium, Cardiac arrest, Fatigue, Malaise, Multiple organ dysfunction syndrome, Transient ischaemic attack
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 67
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: Hypertrophy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Sodium; Result Unstructured Data: Test Result:Drop
CDC Split Type: DEPFIZER INC202101143191

Write-up: Atrial fibrillation; Multiple organ failure; cardiac arrest; Transient ischemic attack; Malaise; Fatigue; Weakness; This is as spontaneous report received from a non contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021170609, Safety report unique identifier DE-PEI-202100178090. A 81-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 19May2021 (Lot Number: 1C006A) as DOSE 2, SINGLE for covid-19 immunisation . Medical history included ongoing hypertrophy. The patient''s concomitant medications were not reported. The patient experienced multiple organ failure on 27Jul2021 , atrial fibrillation on an unspecified date with outcome of unknown , transient ischemic attack, malaise, fatigue , weakness on 21May2021 with outcome of unknown. The patient died on 27Jul2021. It was not reported if an autopsy was performed. In mid-July, taken to hospital by ambulance (suspected of having a transitory ischaemic attack). inpatient for 4 days, then ever greater weakness, sodium drop. 21Jul2021 hospital again with suspected epileptic seizure (tongue bite). In hospital, multiple organ failure: Pleural effusion, ascitis, liver congestion, subileus, diabetes, heart failure, atrial fibrillation. In the night of 27Jul2021, after resuscitation, died of cardiac arrest. The outcome of event multiple organ failure, cardiac arrest was fatal. Seriousness criteria reported as hospitalization for multiple organ failure, atrial fibrillation, transient ischemic attack. Relatedness Assessment: Weakness: D. Unclassifiable. Multiple organ failure: D. Unclassifiable Atrial fibrillation: D. Unclassifiable Malaise: Transient ischemic attack: D. Unclassifiable Fatigue: D. Unclassifiable Source of assessment: RA No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1701194 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRM8 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-27
   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: Sarcoidosis
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101143192

Write-up: On the morning of 27Aug2021, the husband found her dead.; A few hours after the injection, the patient reported that she was unwell.; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021170614, Safety Report Unique Identifier DE-PEI-202100177600. A 74-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: SCRM8) via an unspecified route of administration on 26Aug2021 at age of 74-year-old at single dose for COVID-19 immunisation. Medical history included rheumatism without drug therapy and ongoing sarcoidosis. The patient''s concomitant medications were not reported. A few hours after the injection on 26Aug2021, the patient reported that she was unwell. Put to sleep in the evening, found dead by the husband in the morning of 27Aug2021. The outcome of event "a few hours after the injection, the patient reported that she was unwell" was not recovered, the outcome of event "on the morning of 27Aug2021, the husband found her dead" was fatal. The patient died on 27Aug2021. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s) was Indeterminate for Malaise, and Unclassifiable for Unknown cause of death per RA. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: On the morning of 27Aug2021, the husband found her dead.


VAERS ID: 1701195 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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: Bronchitis; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142493

Write-up: Person found dead at home approx. 2 weeks after 2nd dose of Comirnaty; This is a spontaneous report from a consumer or other non hcp downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021170666 Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100177688 . A 77-year-old female patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included ongoing bronchitis, ongoing tobacco user. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) for covid-19 immunization. The patient experienced person found dead at home approx. 2 weeks after 2nd dose of comirnaty on 01Jul2021. The patient died on 01Jul2021. The patient''s outcome was fatal. An autopsy was not performed. This report is serious - death. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No information Information on risk factors or previous illnesses According to police report, bronchitis and heavy nicotine consumption known / No information. Causal relationship between the event/s and the administration of CORMINATY was assessed as "Unclassifiable (D)" by the RA. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701196 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142625

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the regulatory authority received from a non-contactable consumer. Regulatory Authority Report Number: DE-PEI-CADR2021170782. Other case identifier number DE-PEI-202100177998. An unknown age Male patient received 2nd dose of BNT162B2 (COMIRNATY, mRNA TOZINAMERAN), on 22Aug2021 at single dose for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. The reporter is the sister of the male vaccine, who died post vaccination, but no further information regarding medical validation of the outcome is currently available. The reporter has been contacted to provide further information on the circumstances of the fatal outcome. On 24Aug2021 the patient experienced Unknown cause of death. No autopsy was done. The patient''s outcome was fatal. This report is serious - death. Relatedness of drug to reaction(s)/event(s): event Unknown cause of death, Source of assessment PEI, Result of Assessment: D. Unclassifiable. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701197 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-06-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain death, Cardiac arrest, Fatigue
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: 2021-07-25
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart valve calcification
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101142613

Write-up: Brain death; cardiac arrest; Fatigue/exhaustion; This is a spontaneous report from a non-contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021170878, Safety Report Unique Identifier DE-PEI-202100177729. A 76-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via unspecified route of administration on 21May2021 (Batch/Lot Number: 1C006A) as single dose for COVID-19 immunisation. The patient medical history included slight calcification of the heart valve, but always assessed by cardiologists as not serious. The patient had none known allergy. No concomitant medication reported. On 01Jun2021 the patient experienced fatigue. On an unspecified date, the patient had inconspicuous visit to cardiologist (routine) 2 weeks before cardiac arrest / already after the 2nd vaccination, state of exhaustion in hitherto outstandingly good physical condition. On 16Jul2021, the patient collapsed during sport with cardiac arrest, resuscitation by wife. After switching off the equipment due to brain death, he was released on 25Jul2021. It was reported death from cardiac arrest. Autopsy was not performed. The outcome of the event fatigue was not recovered before death. The outcome of the other events was fatal. RA assessed the relatedness of drug to the event was D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death from cardiac arrest


VAERS ID: 1701198 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-31
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   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:
CDC Split Type: DEPFIZER INC202101142622

Write-up: Lung embolism; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021170993. Safety Report Unique Identifier: DE-PEI-202100178342. A 76 Years old male patient received BNT162B2 (COMIRNATY, Lot number unknown) at single dose for COVID-19 immunisation on 18Jun2021. The patient''s medical history and concurrent conditions were unknown. On 31Jul2021 the patient experienced Lung embolism. The patient''s outcome was fatal for Lung embolism. This report was serious - death. No autopsy was performed. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No / Deceased Relatedness: Comirnaty/Lung embolism/RA/D. Unclassifiable No follow-up attempts possible. No further information expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1701201 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arrhythmia, Body temperature, Breast pain, Computerised tomogram, Death, Decreased appetite, Dry mouth, Electrocardiogram, Fatigue, Lung disorder, Nausea, Pain, Pneumonia, Pyrexia, SARS-CoV-2 test negative
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Lipodystrophy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hay fever
Allergies:
Diagnostic Lab Data: Test Name: Suddenly fever appeared (38.6); Result Unstructured Data: Test Result:38.6; Test Name: Computerised tomogram; Result Unstructured Data: Test Result:milky white spots on the lungs; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed irregularities/interruptions; Test Name: PCR; Test Result: Negative
CDC Split Type: DEPFIZER INC202101149632

Write-up: Unknown cause of death; cardiac arrhythmia; milky spots on the lungs; Lung infection NOS; stomach pain/Acute gastric pain; Breast pain; Fatigue/Tiredness; loss of appetite; constant nausea; Dry mouth; pain in the upper body; Suddenly fever appeared (38.6); This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021172075, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100179922. A 74-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included asthma caused by hay fever from unknown date and unknown if ongoing, hay fever, ongoing hypertension and ongoing overweight. The patient''s concomitant medications were not reported. On 26Jul2021, the patient experienced arrhythmia, acute gastric pain, tiredness, breast pain, lung infection NOS, fatigue, stomach pain, chest pain, cardiac arrhythmia, milky spots on the lungs according to CT. 14 days after second vaccination on 24Jul2021, constant tiredness appeared. After about a week, there was a loss of appetite and constant nausea, dry mouth and pain in the upper body. On 15Aug2021, 112 was called. Electrocardiogram showed irregularities/interruptions. The patient was admitted to hospital. Computerised tomogram showed milky white spots on the lungs. PCR was negative (tested 2 days apart). Treatment with antibiotics for the events. After about 3 days there was an improvement. Suddenly fever appeared (38.6) and condition worsened. The patient died after 7 days in hospital. Result of Assessment: Comirnaty/ event(s): Arrhythmia, Lung infection NOS, Acute gastric pain, Tiredness Breast pain, Unknown cause of death/ RA: D. Unclassifiable. On 21Aug2021, the patient experienced unknown cause of death. It was unknown if an autopsy was performed. The outcome of loss of appetite, nausea, dry mouth, pain in the upper body and fever was unknown. The outcome of the rest of events was not recovered. Sender''s comments: Do you or the person concerned have any known allergies? If yes, which ones? Hay fever, asthma caused by hay fever. No follow-up attempts possible. No further information expected. Information about LOT/Batch number can not be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral ischaemia, Cerebral venous sinus thrombosis, Immune thrombocytopenia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210919864

Write-up: IMMUNE THROMBOCYTOPENIA; CEREBRAL ISCHEMIA; THROMBOSIS OF VENOUS SINUSES; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021174694) on 09-SEP-2021 concerned a 50 year old female. The patient''s weight was 65 kilograms, and height was 170 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 was not reported) dose was not reported, administered on 12-AUG-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 24-AUG-2021, the patient experienced immune thrombocytopenia, cerebral ischemia, thrombosis of venous sinuses. On 02-SEP-2021, the patient died from thrombosis of venous sinuses. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of immune thrombocytopenia and cerebral ischemia on 02-SEP-2021. This report was serious (Death).; Reported Cause(s) of Death: THROMBOSIS OF VENOUS SINUSES


VAERS ID: 1701227 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Electrocardiogram, Office visit, Pain in extremity
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications: CORODIL [ENALAPRIL MALEATE]
Current Illness: Hypercholesterolaemia (well regulated by medical check in feb2021); Hypertension (well regulated by medical check in feb2021)
Preexisting Conditions: Comments: The patient does not have any other health problems. He was a very active pensioner who had just finished 6 hour guard. The day before he won a hill sprint with the gymnastics team, and 3 weeks before he finished renovating the utility room. He did gymnastics and yoga and lived healthy. He had recently been to a major annual medical check-up, with no signs of worry - everything was normal. No previous blood clots (reported by the GP)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 202102; Test Name: office visit; Result Unstructured Data: Test Result:with no signs of worry - everything was normal; Comments: He had recently been to a major annual medical check-up, with no signs of worry - everything was normal.
CDC Split Type: DKPFIZER INC202101149865

Write-up: Cerebral thrombosis. Suddenly had a died without warning 3 weeks after 2nd vaccine; Pain in arm after both vaccinations; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0081966. This is the first of two reports. A 74-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EW6126; Expiration Date: 31Jul2021), via an unspecified route of administration on 03May2021 as dose 2, single for COVID-19 immunization. The patient medical history included ongoing hypercholesterolaemia (well regulated by medical check in feb2021), ongoing hypertension (well regulated by medical check in feb2021). The patient concomitant medications included enalapril maleate (CORODIL [ENALAPRIL MALEATE]) was taken for hypertension from 08May2014 to an unspecified stop date. Historical vaccine included first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunization. The patient experienced cerebral thrombosis. suddenly had a died without warning 3 weeks after 2nd vaccine on 20May2021 and pain in arm after both vaccinations on May2021. The reporter stated that patient does not have any other health problems. He was a very active pensioner who had just finished 6 hour guard. The day before he won a hill sprint with the gymnastics team, and 3 weeks before he finished renovating the utility room. He did gymnastics and yoga and lived healthy. He had recently been to a major annual medical check-up, with no signs of worry - everything was normal. No previous blood clots (reported by the GP). Causality was the GP considers the death to be surprising, however, there has been no suspicion of causality between the deaths and Comirnaty, and there still is not. The GP believes the death may be due to a blood clot in the brain, but this is not a confirmed diagnosis, but her best assessment, as the deceased was suddenly found dead at his volunteer work, and is found dead on arrival at the hospital. In addition, the Police reports state that relatives have stated that the deceased has not experienced any ADRs other than pain in the arm after neither the 1st nor the 2nd vaccination with Comirnaty. Therefore, the forensic pathologist has no suspicion of the vaccine, and no indication for autopsy. The case is not medically confirmed. The patient underwent lab tests and procedures which included electrocardiogram was normal on unspecified date Feb2021, office visit was with no signs of worry - everything was normal (He had recently been to a major annual medical check-up, with no signs of worry - everything was normal) on unspecified date Feb2021. Cause of Death was cerebral thrombosis. An autopsy was not performed. The outcome of the events was cerebral thrombosis. suddenly had a died without warning 3 weeks after 2nd vaccine was death on 20May2021 and pain in arm after both vaccinations was recovered on an unspecified date 2021. No follow up attempts possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101159351 Same patient/ vaccine, different dose/ events; Reported Cause(s) of Death: Cerebral thrombosis


VAERS ID: 1701244 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm, Blood pressure measurement, Cardio-respiratory arrest, Cerebrovascular accident, Coma scale, Computerised tomogram, Depressed level of consciousness, Headache, Hypertensive crisis, Malaise, Pyrexia, Subarachnoid haemorrhage, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Cataract (left); Cervical pain (worsening in the last week); COVID-19 (admission in Feb2021); Hospitalisation; Lumbar spondylosis; Scoliosis
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: CT scan; Result Unstructured Data: Test Result:subarachnoid hemorrhage; Comments: showing subarachnoid hemorrhage and saccular aneurysm of 3 mm in the anterior communicant.; Test Date: 20210424; Test Name: Blood pressure; Result Unstructured Data: Test Result:186/97 mmHg; Test Date: 20210417; Test Name: BP; Result Unstructured Data: Test Result:elevated; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Test Name: CT scan; Result Unstructured Data: Test Result:more cerebral edema; Comments: showing more cerebral edema and the rest without significant changes.; Test Name: CT scan; Result Unstructured Data: Test Result:subarachnoid hemorrhage in the cisterns; Comments: showing subarachnoid hemorrhage in the cisterns of the base, right sylvian and with interhemispheric component, without ventricular dilatation.
CDC Split Type: ESPFIZER INC202101174662

Write-up: Aneurysm; subarachnoid hemorrhage in the cisterns of the base; cardiorespiratory arrest; low level of consciousness; stroke; Frontal headache/Headache; General malaise; vomiting; Fever; Crisis hypertensive/elevated BP/blood pressure of 186/97 mmHg; This is a spontaneous report received from a contactable pharmacist downloaded from the regulatory authority. The regulatory authority report number is ES-AEMPS-973523. A non-pregnant 77-year-old female patient received 1st dose of BNT162B2 (COMIRNATY, Lot Number: EW9127), via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included Lumbar spondylosis, patient had passed COVID-19 and admission in Feb2021, anxiety, Cataract (left), scoliosis, cervical pain (worsening in the last week). Concomitant medications were not reported. The patient previously took omeprazol (2141A) and pontalsic. Patient complained of frontal headache since this morning (17Apr2021) and cervical pain for several months, worsening in the last week (since Apr2021). Three days ago she received her first dose of Pfizer vaccine. This morning she was seen in the PAC for general malaise and headache, with elevated BP, two vomiting this morning, fever on arrival at the ER, discharge after treatment. FOLLOW-UP: Telephone call for patient evaluation from the Neurosurgery Department. The patient presented with low level of consciousness, activating the stroke code. A cranial CT scan was performed showing subarachnoid hemorrhage in the cisterns of the base, right sylvian and with interhemispheric component, without ventricular dilatation. Midline not displaced. According to what we were told, the patient presented GCS of 7-8p so we proceeded to IOT in the hospital. Transfer was accepted, contacting the ICU, which accepted the patient''s admission. FOLLOW-UP: Patient vaccinated 10 days ago with Covid with Pfizer who has been presenting headaches and cervical pain since that time. She went to her physician''s office on 24Apr2021 in the early hours of the morning and was found to have blood pressure of 186/97 mmHg and was transferred to the Hospital for code Ictus. In the emergency room comatose state with medium pupils with little reactivity and deviation of the gaze to the right. Urgent cranial CT was performed showing subarachnoid hemorrhage and saccular aneurysm of 3 mm in the anterior communicant. The rest of the patient had no significant findings. In the emergency room she suffered cardiorespiratory arrest and was resuscitated for 10 min, recovering heart rate. She was transferred to the hospital by helicopter and pupillary arreativity was referred by the transfer team. On admission to our unit, the patient was intubated with bilateral mydriasis arrecativa and no corneal reflexes. Glasgow 3 p. Repeat CT scan of the skull showing more cerebral edema and the rest without significant changes. The patient was admitted with GCS 3p with mydriatic mydriatic pupils arreactivas, being the first record of BIS 11 with TS 71. Subsequent evolution to encephalic death, confirmed by clinical examination and transcranial Doppler. A subarachnoid hemorrhage Anterior communicating saccular aneurysm. Encephalic death. The outcome of the event cardiorespiratory arrest was recovering, of other events depressed level of consciousness, stroke, headache, general malaise, vomiting and Fever were not recovered. The patient died on an unspecified date due to Crisis hypertensive, Aneurysm ad subarachnoid hemorrhage in the cisterns of the base. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Crisis hypertensive; Aneurysm; subarachnoid hemorrhage in the cisterns of the base


VAERS ID: 1701267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-20
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101142875

Write-up: Sudden death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority FI-FIMEA-20214257. A 36-year-old male patient received BNT162B2 (COMIRNATY) at single dose via an unknown route on 21Jul2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. Serious event was reported as sudden death with onset date of 20Aug2021. The patient died suddenly while sitting on the living room couch during the day at 2 p.m. The first aid which came after 10 minutes could not do anything. The situation came as a complete surprise. It was also reported as "24Aug2021 initial consumer: Death". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1701271 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-06-04
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiomyopathy, Pulmonary embolism, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow), Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antibiotic therapy (In March, he contracted a shingles infection, which led him to use an antibiotic for a long time.); Overweight; Shingles (In March, he contracted a shingles infection, which led him to use an antibiotic for a long time.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101149856

Write-up: Pulmonary embolism; Cardiomyopathy; venous thrombosis of the left calf; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB-regulatory authority number FI-FIMEA-20214308. A 32-year-old male patient received unspecified dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an intramuscular route of administration on 03May2021 as dose number unknown, single for COVID-19 immunisation. Medical history included overweight from an unknown date and unknown if ongoing, the patient was otherwise of good health and did not have any known underlying diseases. In March, he contracted a shingles infection of his lower limb, which led him to use an antibiotic for a long time. The patient''s concomitant medications were not reported. On 04Jun2021 patient celebrated his engagement. In the evening began to breathe heavily and experienced malaise. His bride called the emergency centre. During the call, he lost consciousness. Upon the arrival of first aid, he went lifeless. Immediate resuscitation was ineffective. He died suddenly. An autopsy revealed abundant pulmonary embolism, venous thrombosis of the left calf, and cardiovascular disease. On 27Aug2021 follow-up doctor: death certificate Immediate cause of death Embolia pulmonis Pulmonary embolism basic cause of death cardiomyopathy causing heart dilatation. According to the information from the police investigation report (5530 / S / 5365/21) and the patient records of the health centre and the hospital. Outcome of the events were fatal. No follow-up attempts are possible. No further information is expected. Batch/Lot number cannot be obtained. ; Reported Cause(s) of Death: Cardiomyopathy; venous thrombosis of the left calf; Pulmonary embolism


VAERS ID: 1701291 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cholangiosarcoma, Drug ineffective, Oxygen saturation, Oxygen saturation decreased, Respiratory disorder
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Biliary malignant tumours (narrow), Liver malignant tumours (narrow), Respiratory failure (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 181
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: 20210208; Test Name: oxygen; Test Result: 85 %
CDC Split Type: FRPFIZER INC202101149744

Write-up: cholangiosarcoma; drug ineffective; Coronavirus infection; Oxygen saturation decreased; acute respiratory syndrome; This is a spontaneous report from a contactable physician downloaded from the regulatory authority , regulatory authority number FR-AFSSAPS-MA20213309. An 89-year-old female patient received bnt162b2 (COMIRNATY), first single dose intramuscularly on 19Jan2021 (Batch/Lot Number: EM0477) for covid-19 immunisation at age of 89-year-old. The patient''s medical history and concomitant medications were not reported. The patient experienced severe acute respiratory syndrome coronavirus 2 (Sars-Cov-2) infection desaturation in Oxygen (85%) (Oxygen saturation decreased) on 08Feb2021, 20 days after the first injection of COMIRNATY vaccine. The Sars-Cov-2 infection was resolved, but patient died later on 09Aug2021 of a cholangiosarcoma. It was unknown if autopsy was performed. Outcome of the event cholangiosarcoma was fatal, while of other events was recovered. No follow-up attempts are possible. No further information expected. ; Reported Cause(s) of Death: cholangiosarcoma


VAERS ID: 1701360 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-08-11
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (Advanced, bedridden); Chronic atrial fibrillation; COVID-19; Dependence (total dependence (GIR1)); Femoral neck fracture; Prostate adenoma
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: saturation; Test Result: 88 %; Comments: desaturation; Test Date: 20210820; Test Name: respiratory rate; Result Unstructured Data: Test Result:increase; Test Date: 20210811; Test Name: COVID-19 PCR; Test Result: Positive ; Comments: Search for variant: Delta variant
CDC Split Type: FRPFIZER INC202101166350

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20213971. A 92-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EJ6789) dose 2 via an Intramuscular route of administration, administered in Arm Left on 09Feb2021 as dose 2, single and bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EM0477) dose 1 via an Intramuscular route of administration, administered in Arm Left on 13Jan2021 as dose 1, single for covid-19 immunisation. Medical history included advanced Alzheimer''s disease bedridden, total dependence (GIR1), chronic atrial fibrillation and prostate adenoma from an unknown date and unknown if ongoing. On Mar2018 femoral neck fracture to an unknown date and covid-19 from 11Aug2021 to an unknown date. The patient''s concomitant medications were not reported. On 11Aug2021 the patient presented respiratory symptoms such as bronchitis and experienced vaccination failure and covid-19. on 11Aug2021 sars-cov-2 test with positive result Search for variant: Delta variant. On 20Aug2021 the patient underwent lab tests and procedures which included oxygen saturation: 88 % desaturation, respiratory rate: increase. Therapeutic measures were taken as a result of covid-19 (covid-19). subcutaneous perfusion, Lovenox 4000, ceftriaxone 1g, oxygen therapy was given to patient. On 20Aug2021 deterioration of the patient''s condition in the afternoon, supra-clavicular draught, the patient was apyretic. Decision not to hospitalize after calling for help. Oxygen therapy 5 L/min and scopolamine and Anticoagulant. On 21Aug2021 patient was stable. The patient died on 22Aug2021 11 days after confirmation of COVID-19 infection. It was not reported if an autopsy was performed. death from confirmed COVID-19 vaccine failure that occurred 6 months after completion of the vaccine regimen. The outcome of the event was fatal. The RA notes: Imputability score(s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Died 11 days after confirmation of COVID-19 infection


VAERS ID: 1701374 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-09-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal obstruction
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101181560

Write-up: intestinal obstruction; This is a spontaneous report received from a contactable consumer (patient''s friend) via Medical Information. An 88-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Aug2021 as dose number unknown, single for COVID-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing, stroke from Feb2021 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced intestinal obstruction in Sep2021. It was given that she was a cardiac person (she had a stroke in Feb2021), the physicians only investigated if this problem could have a cardiac etiology and did not find the intestinal obstruction right away. Her pain appeared in early Sep2021. The patient died from an intestinal obstruction on 05Sep2021. It was not reported if an autopsy was performed. The lot number for bnt162b2, was not provided and will be requested during follow up. ; Reported Cause(s) of Death: intestinal obstruction


VAERS ID: 1701375 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Karyotype analysis, Maternal exposure timing unspecified
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   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: LEVOTHYROX; UVEDOSE; SPASFON [PHLOROGLUCINOL]; PARACETAMOL; HYDROCORTISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Foetal macrosomia
Allergies:
Diagnostic Lab Data: Test Name: Cord blood sampling for foetal karyotype; Result Unstructured Data: Test Result:No results provided
CDC Split Type: FRPFIZER INC202101183106

Write-up: Maternal drug exposure during pregnancy; Foetal death in utero; This is a spontaneous report from a contactable physician downloaded . This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-SE20212241. A fetus patient received bnt162b2 (COMIRNATY), dose 2 transplacental on 10Aug2021 (Batch/Lot Number: FE7051) as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications for the fetus were none. On 17Aug2021. the patient experienced foetal death in utero maternal drug exposure during pregnancy. with outcome of recovered with sequelae. This mother reported her last menstrual period was on 04Dec2020. The mother reported she became pregnant while taking bnt162b2. The mother was 36 Weeks pregnant at the onset of the event. On 17Aug2021 (Day 7 of the 2nd dose of COMIRNATY), the patient, at week 35 of amenorrhea + 5 days, consulted the Gynaecological Emergency Room for absence of active foetal movements for 3 days. On monitoring: no audible heart sounds. On ultrasound monitoring: No cardiac activity, no fetal movement, oligohydramnios, high anterior placenta, no image of haematoma. Labour induced on 20Aug2021. On 21Aug2021: A stillborn male child was delivered by vaginal delivery at 9:18 am. as due to deliver on 10Sep2021. The mother delivered the pregnancy on 21Aug2021 via vaginal delivery. The pregnancy resulted in still birth. The fetal outcome is intrauterine death. The patient underwent lab tests and procedures which included karyotype analysis: no results provided on unspecified date. The patient died on 17Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101131236 same reporter, different patient( mother); Reported Cause(s) of Death: Foetal death in utero


VAERS ID: 1701380 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101153260

Write-up: Death unexplained; Tiredness; Dose 1 on Nov2020 and Dose 2 on Feb2021; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25887681. Safety Report Unique Identifier GB-MHRA-ADR 25887681. A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (at the age of 91-year-old) as dose 2, single for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 in Nov2020 for COVID-19 vaccination. The patient experienced tiredness in Feb2021 and death unexplained on an unspecified date. Clinical course was reported as follows: patient had the jab in Nov2020, she has no reaction to the jab and was as health as normal, 12 weeks later she got a call from her general practitioner (GP) saying it was time for the second dose, she went to the have the second jab and 2 days later her son noticed she was tired and called her GP for advice the GP said not to take her to hospital but to make her comfortable because she did not have long left and 4 days later patient passed away. Patient''s son is currently struggling with the loss of his mother and was looking for closure and wanted to know if there have been reports of deaths by the Pfizer vaccine and what background information is out there regarding deaths and Pfizer jab. The patient has not recovered from the event fatigue. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1701381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101176114

Write-up: Acute pancreatitis; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25901059. Safety Report Unique Identifier GB-MHRA-ADR 25901059. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 Immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced acute pancreatitis (death, hospitalization, life threatening) on an unspecified date. It was reported that: The patient had second dose Pfizer jab and immediately fell ill. Within 2 days he had severe acute Pancreatitis with complications which led to his death. He signed a waiver whilst in ITU for test to see if there was a conbection. The patient maintained the vaccine was cause. He was a very fit man who had never had a cold or illness previously. He worked up to his death. The patient died on an unspecified date. An autopsy was not performed. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Acute pancreatitis


VAERS ID: 1701560 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ankle brachial index, Asthenia, Biopsy, Blindness cortical, Computerised tomogram, Death, Disease recurrence, Exercise tolerance decreased, Giant cell arteritis, Hypoperfusion, Interstitial lung disease, Investigation, Red blood cell sedimentation rate, SARS-CoV-2 test, Tenderness, Ultrasound scan, Vasculitis, Visual impairment
SMQs:, Interstitial lung disease (narrow), 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vasculitis (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Claudication; Cortical blindness (Admitted 14th August 2021); Dehydration; Giant cell arteritis; Headache; Hypertension; Hypoperfusion; Inflammatory arterial reaction; Interstitial lung disease; Leg pain (had seen vascular in 2017 for leg pain which was atypical for intermittent claudication); Non-smoker; Sciatica; Sexually transmitted infection; Stenosis; Tenderness; Vasculitis; Visual disturbance; Weakness
Allergies:
Diagnostic Lab Data: Test Name: Ankle brachial pressure index; Result Unstructured Data: Test Result:normal; Test Name: artery biopsy; Result Unstructured Data: Test Result:Unknown results; Comments: Pt was too unwell from admission for a temporal artery biopsy; Test Name: CT angiogram lower limb both; Result Unstructured Data: Test Result:imaging appearances are atypical; Comments: Clinical presentation and imaging appearances are atypical. There is diffuse circumferential vascular disease below the inguinal ligament with multifocal moderate to critical stenoses and short occlusions in both SFA, popliteal arteries and tibial vessels which raises the possibility of inflammatory pathology (medium sized vasculitis/Buerger''s disease; any history of smoking connective-tissue disease); Test Date: 202105; Test Name: investigation; Result Unstructured Data: Test Result:revealed bilateral inflammatory disease; Comments: investigation in May/June revealed bilateral inflammatory disease throughout his arterial extremities in lower limbs; Test Date: 202105; Test Name: ESR; Result Unstructured Data: Test Result:44; Test Date: 202105; Test Name: ESR; Result Unstructured Data: Test Result:37; Test Date: 20210329; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: temporal artery ultrasound; Result Unstructured Data: Test Result:giant cell arteritis; Comments: thickened temporal, frontal and axillary arteries in keeping with giant cell arteritis; Test Name: ultrasound; Result Unstructured Data: Test Result:suggestive for the presence of GCA; Comments: the common superficial temporal and frontal branch of the temporal artery exhibit positive halo and compression sign which would be suggestive for the presence of GCA. The parietal branch was unremarkable. The axillary artery was unremarkable at this time. Right Side The axillary artery exhibits evidence of wall thickening measuring 1.46mmAP which may indicate the presence of GCA in this vessel.
CDC Split Type: GBPFIZER INC202101174757

Write-up: cortical blindness; inflammatory disease; temporal tenderness; hypoperfusion; visual disturbance; weakness; giant cell arteritis; Vasculitis, Cortical blindness, hypoperfusion, visual disturbance, weakness and giant cell arteritis; symptoms persisted until his death; exercise tolerance; Vasculitis; This is a spontaneous report from two contactable physicians downloaded from the regulatory authority number GB-MHRA-WEBCOVID-202109021639158550-NTJET. Safety Report Unique Identifier GB-MHRA-ADR 25887817. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER- BIOTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included giant cell arteritis, stenosis, interstitial lung disease, tenderness, vasculitis, dehydration, headache, Cortical blindness (Admitted 14Aug2021), Sciatica, Hypoperfusion, Visual disturbance, Claudication, Weakness, Asthma and Hypertension. Non-smoker and not diabetic. Patient had seen vascular in 2017 for leg pain which was atypical for intermittent claudication and diagnosed as sciatica. Interestingly normal Ankle brachial pressure index then, so no evidence of peripheral vascular disease in 2017. Patient had not symptoms associated with COVID-19. Further investigation in May/June revealed bilateral inflammatory disease throughout his arterial extremities in lower limbs. He was referred to Rheumatology, but unfortunately developed and V&D illness. Concomitant medications included beclometasone dipropionate (CLENIL MODULITE) taken for asthma from 20Feb2020 to an unspecified stop date; ramipril taken for hypertension from 01Aug2018 to an unspecified stop date. The patient experienced exercise tolerance on an unspecified date; vasculitis NOS on Feb2021; cortical blindness, inflammatory disease, temporal tenderness, hypoperfusion, visual disturbance, weakness and symptoms persisted until his death all on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 29Mar2021. The outcome of event vasculitis was not recovered, while for remains events was unknown. The patient died on an unspecified date with unknown cause. It was not reported if an autopsy was performed. The clinical course was reported as follows: 2 weeks after 1st Pfizer vaccine developed symptoms of intermittent claudication and headaches, with no history of this before vaccine. Exercise tolerance was severely limited compared with christmas 2020. These symptoms persisted until his death. Further investigation in May/June revealed bilateral inflammatory disease throughout his arterial extremities in lower limbs. He was referred to Rheumatology, but unfortunately developed and V&D illness. Admitted on 14Aug2021 with cortical blindness, bilateral weakness and bilateral hemispheric MCA infarcts secondary to bilateral occluded internal carotid arteries. ESR in May was mildly elevated at 44 (37 when repeated). Described some temporal tenderness and visual disturbance around this time. Patent was too unwell from admission for a temporal artery biopsy, however temporal artery ultrasound revealed thickened temporal, frontal and axillary arteries in keeping with giant cell arteritis. Possible dehydration and prothrombotic state with D&V illness cause hypoperfusion and ICA occlusion on top of previous undiagnosed ICA stenosis, secondary to undiagnosed and untreated Vasculitis. Patient had no evidence of Atrial Fibrillation or Left ventricular thrombus and no known atherosclerotic disease previously. Any other relevant investigations or tests conducted: As above [US doppler temporal artery both] Bedside Assessment. Patient habitus prevented direct imaging of the right temporal arterial system. Left side On ultrasound the common superficial temporal and frontal branch of the temporal artery exhibit positive halo and compression sign which would be suggestive for the presence of GCA. The parietal branch was unremarkable. The axillary artery was unremarkable at this time. Right Side The axillary artery exhibits evidence of wall thickening measuring 1.46mmAP which may indicate the presence of GCA in this vessel. [CT angiogram lower limb both] Clinical presentation and imaging appearances are atypical. There is diffuse circumferential vascular disease below the inguinal ligament with multifocal moderate to critical stenoses and short occlusions in both SFA, popliteal arteries and tibial vessels which raises the possibility of inflammatory pathology (medium sized vasculitis/Buerger''s disease; any history of smoking connective-tissue disease). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: symptoms persisted until his death


VAERS ID: 1701584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   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: Anaemia; Cardiac failure chronic; Chronic kidney disease stage 3; Ischaemic heart disease; Pulmonary embolism; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: COVID-19 virus PCR test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101176175

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician.This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109061244084380-TUOOW, Safety Report Unique Identifier(GB-MHRA-ADR 25900260). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Apr2021 (Lot Number: EL0739, ER1749) as Single Dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing anaemia, immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...), ongoing type 2 diabetes mellitus (T2DM), ongoing Ischaemic heart disease (IHD), ongoing Chronic kidney disease stage 3 (CKD3), ongoing Cardiac failure chronic (CCF), ongoing Pulmonary embolism (PE). Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced SARS-CoV-2 infection on 16Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus PCR test: Yes - Positive COVID-19 test on 16Aug2021. The outcome of the event SARS-CoV-2 infection was fatal. The patient died on 02Sep2021. It was unknown if an autopsy was performed. The clinical course was reported as follows: Patient double vaccinated with Pfizer vaccine and caught covid four months second dose. Patient is not enrolled in clinical trial. Please provide details of any relevant investigations or tests conducted: "covid test PCR". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2 infection


VAERS ID: 1701610 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-02
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-04
   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: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC202101176137

Write-up: Vomiting; This is a spontaneous report from a contactable consumer received from the regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109071335437330-BLABO. Safety Report Unique Identifier GB-MHRA-ADR 25906658 A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included ongoing suspected covid-19 (Unsure when symptoms started). The patient''s concomitant medications were not reported. The patient previous took first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunization. The patient experienced vomiting on 02Sep2021, which was fatal. The patient underwent lab tests and procedures which included sars-cov-2 test: inconclusive test. The patient died on 04Sep2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: vomiting


VAERS ID: 1701645 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic thrombosis, Cardiac failure, Cardiogenic shock, Computerised tomogram, Death, Laboratory test, Monoplegia
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: BIOSONIDE; DEMOREN; SALOSPIR; BEROVENT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Surgery; Thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: CTA; Result Unstructured Data: Test Result:Eccentric mural thrombus; Comments: Eccentric mural thrombus at the level of origin of renal arteries; Test Date: 20210615; Test Name: laboratory examination; Result Unstructured Data: Test Result:thrombosis
CDC Split Type: GRPFIZER INC202101156067

Write-up: Heart failure; Cardiogenic shock; Death; Acute aortic thrombosis; Right leg paralysis; This is a spontaneous report from a contactable consumer downloaded from the, regulatory authority number GR-GREOF-20217057. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 26May2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, thrombosis, surgery. Concomitant medications included budesonide (BIOSONIDE); ipratropium bromide, salbutamol sulfate (DEMOREN); acetylsalicylic acid (SALOSPIR); ipratropium bromide, salbutamol (BEROVENT) all taken for an unspecified indication, start and stop date were not reported. The patient experienced death on 16Jun2021 with fatal outcome, heart failure on an unspecified date with fatal outcome, acute aortic thrombosis on 15Jun2021 with fatal outcome, right leg paralysis on 14Jun2021 with fatal outcome, cardiogenic shock on an unspecified date with fatal outcome. CTA performed on 15/06/2021 (the examination was performed before and after intravenous administration of contrast agent): Eccentric mural thrombus at the level of origin of renal arteries. The patient died on 16Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death; Right leg paralysis; Cardiogenic shock; Acute aortic thrombosis; Heart failure


VAERS ID: 1701651 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-08
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E027A / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Myocardial ischaemia
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101195743

Write-up: Unknown cause of death; Ischaemic heart disease; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (Regulatory authority report number: DH/21/5079), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003313), license party for bnt162b2 (COMIRNATY). This is 1 of 112 reports. A 63-year-old male patient received first dose of BNT162B2 (COMIRNATY/ Tozinameran, Solution for injection, Lot Number: 1E027A), via unspecified route of administration on 31Jul2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 08Aug2021, the patient experienced ischaemic heart disease and he passed away for an unknown reason on an unspecified date. The patient died on an unknown date. It was unknown whether an autopsy was performed. The death report did not have clinical evidence to support the event was caused by vaccine and the Expert Committee preliminary considered that the case had no causal relationship with vaccination. The reporter considered the event ischaemic heart disease as serious (medically significant). The outcome of event ischaemic heart disease was unknown. The primary reporter causality assessment between COMIRNATY and Ischaemic heart disease, Unknown cause of death was Possible whereas, per company (BioNTech SE), it was unlikely. Upon information received on 06Sep2021, from a non-contactable HCP received regulatory authority report number is not applicable. New information includes causality assessment from the Expert Committee. BioNTech SE Comment: Company Remarks: The medical review comments of PV Department on the reports of Death and myocardial ischaemia was as follows: The seriousness for myocardial ischaemia was serious (medically significant). Death and myocardial ischaemia are not common adverse events in the package insert of COMIRNATY, so its expectedness was: unexpected. Myocardial ischaemia was caused by coronary artery disease, according to currently known pathophysiological mechanisms, it was difficult to attribute the occurrence of myocardial ischaemia to vaccine, so the relationship between Death and myocardial ischaemia and COMIRNATY was considered as unlikely. Follow-up attempts closed. No further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101192625 same reporter/suspect drug and different patients;HK-PFIZER INC-202101192628 same reporter/suspect drug and different patients;HK-PFIZER INC-202101192632 same reporter/suspect drug and different patients;HK-PFIZER INC-202101189642 Same reporter, drug, different patient event.;HK-PFIZER INC-202101192623 Same reporter, drug, different patient event.;HK-PFIZER INC-202101193324 Same reporter, drug, different patient event.;HK-PFIZER INC-202101189652 Same reporter, drug, different patient and event.;HK-PFIZER INC-202101192629 same reporter/suspect drug and different patients;HK-PFIZER INC-202101195793 Same reporter/drug, different patients/events;HK-PFIZER INC-202101189651 Same reporter, drug, different patient, event.;HK-PFIZER INC-202101192626 same reporter/suspect drug and different patients;HK-PFIZER INC-202101192627 same reporter/suspect drug and different patients;HK-PFIZER INC-202101195791 Same reporter/drug, different patients/events;HK-PFIZER INC-202101192622 Same reporter, drug, different patient event.;HK-PFIZER INC-202101189647 Same reporter, drug, different patient, event.;HK-PFIZER INC-202101189649 Same reporter, drug, different patient, event.;HK-PFIZER INC-202101189645 Same reporter, drug, different patient event.;HK-PFIZER INC-202101192655 same reporter/suspect drug and different patients;HK-PFIZER INC-202101192631 same reporter/suspect drug and different patients;HK-PFIZER INC-202101189646 Same reporter, drug, different patient and event.;HK-PFIZER INC-202101193322 same reporter/suspect drug and different patients;HK-PFIZER INC-202101193265 same reporter/suspect drug and different patients;HK-PFIZER INC-202101189645 same reporter/suspect drug and different patients;HK-PFIZER INC-202101195802 same reporter/suspect drug and different patients;HK-PFIZER INC-202101195796 same reporter/suspect drug and different patients;HK-PFIZER INC-202101195797 same reporter/suspect drug and different patients;HK-PFIZER INC-202101204256 Same reporter/drug, different patients/events;HK-PFIZER INC-202101204283 Same reporter/drug, different patients/events;HK-PFIZER INC-202101204285 Same reporter/drug, different patients/events;HK-PFIZER INC-202101204273 Same reporter/drug, different patients/events;HK-PFIZER INC-202101204290 Same reporter/drug, different patients/events;HK-PFIZER INC-202101206653 same reporter/suspect drug and different patients;HK-PFIZER INC-202101206650 same reporter/suspect drug and different patients.;HK-PFIZER INC-202101206654 same reporter/suspect drug and different patients;HK-PFIZER INC-202101206657 same reporter/suspect drug and different patients;HK-PFIZER INC-202101204299 Same reporter/drug, different patients/events;HK-PFIZER INC-202101204294 Same reporter/drug, different patients/events;HK-PFIZER INC-202101206827 Same reporter/drug, different patients/events;HK-PFIZER INC-202101206656 same reporter/suspect drug and different patients;HK-PFIZER INC-202101206826 same reporter/suspect drug and different patients;HK-PFIZER INC-202101206830 Same reporter/drug, different patients/events;HK-PFIZER INC-202101206828 Same reporter/drug, different patients/events; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701652 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E027A / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101193324

Write-up: Unknown cause of death; Coronary artery disease; This is a spontaneous report from a non-contactable healthcare professional via Hong Kong department of health (Regulatory authority report number: DH/21/5229), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003323), license party for bnt162b2 (COMIRNATY). This is 1 of 112 reports. This is a spontaneous report received from a non-contactable HCP received via regulatory authority report number is DH/21/5229. On 09-Aug-2021, a 54-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1E027A) via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced coronary artery disease 4 days after vaccination (13-Aug-2021) and he passed away for an unknown reason on an unknwon date. The death report did not have clinical evidence to support the event was caused by vaccine and the Expert Committee preliminary considered that the case had no causal relationship with vaccination. Unknown cause of death met the seriousness criterion of death. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcome of the event ''coronary artery disease'' was unknown. The patient died on an unknown date. Whether an autopsy was performed was unknown and the reported cause of death was unknown. Initial report was received on 03-Sep-2021. Follow-up (06-Sep-2021): New information reported from a non-contactable HCP received via regulatory authority report number is not applicable. New information includes causality assessment from the Expert Committee. Follow-up closed, no further information is possible. Company Remarks: The medical review comments of PV Department on the reports of Death and coronary artery disease are as follows: The seriousness of Death is: serious. The seriousness of coronary artery disease is: unserious Death and coronary artery disease are not common adverse events in the package insert of COMIRNATY, so the expectedness is: unexpected. Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between Death and COMIRNATY is considered as possible. Based on currently known pathophysiological mechanisms, it is difficult to attribute coronary artery disease to vaccines, thus the relationships between coronary artery disease and COMIRNATY is considered as unlikely. Causality Assessment for COMIRNATY and Event Unknown cause of death as Per primary Reporter as Possible and as Per Company as possible. Causality Assessment for COMIRNATY and Event Coronary artery disease as Per primary Reporter as Possible and as Per Company as Unlikely.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The event Coronary artery disease is assessed as Unrelated. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review 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) : HK-PFIZER INC-202101195743 Same reporter, drug, different patient event.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1701653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E025A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101193322

Write-up: UNKNOWN CAUSE OF DEATH; CORONARY ARTERY DISEASE; This is a spontaneous report from a non-contactable healthcare professional via (Regulatory authority report number: DH/21/5400), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003324), license party for bnt162b2 (COMIRNATY). This is one of 112 reports. This is a spontaneous report received from a non-contactable HCP received via the regulatory authority report number is DH/21/5400. A 56-year-old male patient receive second dose of Tozinameran ((bnt162b2) COMIRNATY, Formulation: solution for injection) via unknown route of administration on 17Aug2021 (Lot Number: 1E025A), as single dose for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY; solution for injection), via an unspecified route of administration on unspecified date (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. The patient experienced coronary artery disease 1 day after vaccination on 18Aug2021 and he passed away for an unknown reason on an unknown date. The death report did not have clinical evidence to support the event was caused by vaccine and the Expert Committee preliminary considered that the case had no causal relationship with vaccination. Unknown cause of death met the seriousness criterion of death. The patient died on an unknown date. Whether an autopsy was performed was unknown and the reported cause of death was unknown. Initial report was received on 03Sep2021. Follow-up (06Sep2021): New information reported from a non-contactable HCP received via Hong Kong Department of Health. regulatory authority report number is not applicable. New information includes causality assessment from the Expert Committee. Causality assessment for the event coronary artery disease as per reporter was possible and as per company was unlikely, And the event unknown cause of death as per reporter and company was possible. At the time of the report, the outcome of the event coronary artery disease was unknown. No Follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101195743 same reporter/suspect drug and different patients; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1701654 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E025A / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101193265

Write-up: CORONARY ARTERY DISEASE; This is a spontaneous report from a non-contactable healthcare professional via (Regulatory authority report number: DH/21/5497), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003325), license party for bnt162b2 (COMIRNATY). This is one of 112 reports. This is a spontaneous report received from a non-contactable HCP received via the regulatory authority report number is DH/21/5497. On 19-Aug-2021, a 50-year-old male patient started to receive 2nd dose of Tozinameran (COMIRNATY) (batch number: 1E025A) via unknown route at unspecified dosing frequency for COVID-19 immunization. The 1st dose was received on an unknown date. Medical history, concomitant medication(s) and past product were not reported. The patient experienced coronary artery disease 3 days after vaccination (22-Aug-2021) and he passed away on an unknown date. The death report did not have clinical evidence to support the event was caused by vaccine and the Expert Committee preliminary considered that the case had no causal relationship with vaccination. Coronary artery disease met the seriousness criterion of death. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. The patient died on an unknown date. Whether an autopsy was performed was unknown and the reported cause of death was coronary artery disease. Initial report was received on 03-Sep-2021. Follow-up (06-Sep-2021): New information reported from a non-contactable HCP received via the regulatory authority . The regulatory authority report number is not applicable. New information includes: causality assessment from the Expert Committee. Causality Assessment for COMIRNATY and Event Coronary artery disease as Per Reporter as Possible and as Per Company as Unlikely. Follow-up closed, no further information is possible.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. 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) : HK-PFIZER INC-202101195743 same reporter/suspect drug and different patients; Reported Cause(s) of Death: CORONARY ARTERY DISEASE


VAERS ID: 1701787 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, General physical health deterioration, Mobility decreased, 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), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 86
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: BETMIGA; CITALOPRAM TEVA; COVERSYL AM; ISTIN; MADOPAR; MELATONIN; SINEMET PLUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Degenerative disc disease (in lumbar spine); Depression; Hypertension; Osteoarthritis; Overactive bladder; Parkinson''s disease (well compensated); Sleep disorder; Spondylosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101149923

Write-up: Loss of mobility; Multiple organ atrophy / no known cause; Sudden acute confusion; obvious general deterioration in condition from week to week after second vaccination; This is a spontaneous report from two contactable consumers. This is a report downloaded from the Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-082982, Safety Report Unique Identification Number: IE-HPRA-2021-082982. An 86-year-old male patient received second dose of BNT162B2 (COMIRNATY) (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Mar2021 (at age of 86-year-old, lot number: ER7812) for COVID-19 immunization. Medical history included osteoarthritis, sleep disorder, Overactive bladder, hypertension, Parkinson''s disease (well compensated), depression, Degenerative disc disease (in lumbar spine), Spondylosis. The patient was well prior to vaccine. No previous emergency hospital admissions. Mobile, aware and alert. Living at home with no services (e.g. home support). Very compliant with medications and did daily exercises to maintain good mobility. Concomitant medications included mirabegron (BETMIGA) taken for overactive bladder from 19Aug2018 to 05Jun2021; citalopram hydrobromide (CITALOPRAM TEVA) taken for depression from 19Aug2018 to 05Jun2021; amlodipine besilate, perindopril erbumine (COVERSYL AM) taken for hypertension from 19Aug1980 to 05Jun2021; amlodipine besilate (ISTIN) taken for hypertension from 19Aug1980 to 05Jun2021; benserazide hydrochloride, levodopa (MADOPAR) taken for parkinson''s disease from 19Aug2018 to 05Jun2021; melatonin to aid sleep cycle from 19Aug2018 to 05Jun2021; carbidopa monohydrate, levodopa (SINEMET PLUS) taken for parkinson''s disease from 19Aug2006 to 05Jun2021. Historical vaccine included first dose of BNT162B2 (COMIRNATY, lot number: ER0641) (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Feb2021 for COVID-19 Immunisation. The patient experienced loss of mobility (death, hospitalization) on 27Apr2021, multiple organ atrophy / no known cause (death) on 27Apr2021, obvious general deterioration in condition from week to week after second vaccination (death) on 17Mar2021, sudden acute confusion (death) on 27Apr2021. Therapeutic measures were taken as a result of loss of mobility. The patient died on 11Jun2021. It was not reported if an autopsy was performed. On 27Apr2021, the patient experienced sudden acute confusion and loss of mobility. The patient was admitted to hospital at end of April for two weeks and again 10 days later for two more weeks. He was treated with IV fluids, antibiotics and physiotherapy. His medication was also reviewed. The reporter outlined that the patient was excited to receive his COVID-19 vaccination. They were convinced that it caused an adverse reaction leading to his unexpected death. The patient''s confusion never resolved and his mobility never returned. The reporter also outlined that the patient had obvious general deterioration in his condition from week to week after his second dose of Comirnaty. The patient experienced multiple organ atrophy (no known cause) and passed away at home surrounded by his family. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Loss of mobility; Multiple organ atrophy / no known cause; obvious general deterioration in condition from week to week after second vaccination; Sudden acute confusion


VAERS ID: 1701804 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Extra dose administered, Off label use, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (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: ILPFIZER INC202101152874

Write-up: sudden death; third dose; third dose; This is a spontaneous report from a contactable consumer received via Regulatory Authority. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sudden death (death, medically significant) on an unspecified date. The clinical course was reported as follows: Adverse events following third dose. Repots of sudden death following vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event sudden death was fatal. The outcome of other events was unknown. Upon investigation no casual relationship can be made between receiving the vaccine and death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1701809 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Breath sounds abnormal, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACTAVISIO; LOSATRIX; PARATABS; HJARTAMAGNYL; SIMVASTATIN +PHARMA; ZALATINE; SOTALOL; BUPRENORPHINE; FURIX [CEFUROXIME]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (advanced alzheimer�s disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: Body temperature; Result Unstructured Data: 38.2 degree celcius; Test Name: Abnormal chest sound; Result Unstructured Data: abnormal
CDC Split Type: ISMODERNATX, INC.MOD20213

Write-up: Fever; This case was received via regulatory authority (Reference number: IS-IMA-4581) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA and PYREXIA (Fever) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 immunisation. The patient''s past medical history included Alzheimer''s disease (advanced alzheimer�s disease). Previously administered products included for an unreported indication: COMIRNATY. Concomitant products included FISH OIL, XANTOFYL, ZEAXANTHIN (ACTAVISIO), LOSARTAN POTASSIUM (LOSATRIX), PARACETAMOL (PARATABS), ACETYLSALICYLIC ACID (HJARTAMAGNYL), SIMVASTATIN (SIMVASTATIN +PHARMA), MEMANTINE HYDROCHLORIDE (ZALATINE), SOTALOL, BUPRENORPHINE and CEFUROXIME (FURIX [CEFUROXIME]) for an unknown indication. On 17-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced PNEUMONIA (Kl�n�sk merki um lugnab�lgu) (seriousness criteria death and medically significant). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion death). The patient died on 19-Aug-2021. The reported cause of death was most likely cause is bacterial pneumonia. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Body temperature: 38.2 (normal) 38.2 degree celcius. On an unknown date, Breath sounds abnormal: abnormal (abnormal) abnormal. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment medication provided. The case concerns a 79 -year-old male patient with past medical history of Alzheimer''s disease, presented with unexpected events of Pneumonia and pyrexia 1 day after booster dose of vaccine. Patient died 2 days after booster dose, cause of death was most likely Bacterial Pneumonia. The benefit risk relationship of vaccine is not affected by this report.; Sender''s Comments: The case concerns a 79 -year-old male patient with past medical history of Alzheimer''s disease, presented with unexpected events of Pneumonia and pyrexia 1 day after booster dose of vaccine. Patient died 2 days after booster dose, cause of death was most likely Bacterial Pneumonia. The benefit risk relationship of vaccine is not affected by this report; Reported Cause(s) of Death: Most likely cause is bacterial pneumonia


VAERS ID: 1701893 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Blood pressure measurement, Cerebrovascular accident, Computerised tomogram head, Dysarthria, Grip strength decreased, Laboratory test, Venous thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 9
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: LANSOX; RIOPAN [PIROXICAM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic cirrhosis of liver; Bleeding duodenal ulcer (bleeding bulbar ulcer treated surgically); Chronic alcoholism; Glucose tolerance decreased; Low back pain; Pathological dissection
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: blood pressure; Result Unstructured Data: Test Result:159/95 mmHg; Test Date: 20210521; Test Name: CT skull/brain; Result Unstructured Data: Test Result:unknown result; Test Date: 20210521; Test Name: laboratory tests; Result Unstructured Data: Test Result:unknown result
CDC Split Type: ITPFIZER INC202101149944

Write-up: Stroke, emergency admission to neurology with a diagnosis of venous thrombosis. Access to emergency room: dysarthria and right prehension deficit.; Stroke, emergency admission to neurology with a diagnosis of venous thrombosis. Access to emergency room: dysarthria and right prehension deficit.; Stroke, emergency admission to neurology with a diagnosis of venous thrombosis. Access to emergency room: dysarthria and right prehension deficit.; Stroke, emergency admission to neurology with a diagnosis of venous thrombosis. Access to emergency room: dysarthria and right prehension deficit.; appearance of aphasia and hyposthenia on the right side; appearance of aphasia and hyposthenia on the right side; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Agency-WEB. The regulatory authority report number is IT-MINISAL02-777910. A 65-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FA4597) dose 1 via intramuscular, administered in the right shoulder on 15May2021 as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included alcohol-related liver cirrhosis, chronic alcoholism, bleeding bulbar ulcer treated surgically, dissection of the esophago-gastric junction, reduced glucose tolerance, low back pain. Concomitant medication(s) included lansoprazole; piroxicam. On 21May2021 the patient experienced stroke, emergency admission to neurology with a diagnosis of venous thrombosis, access to emergency room: dysarthria and right prehension deficit, appearance of aphasia and hyposthenia on the right side. The patient underwent lab tests and procedures which included blood pressure measurement resulted 159/95 mmHg on 21May2021, computerised tomogram head resulted unknown on 21May2021, laboratory test resulted unknown on 21May2021. The events resulted in emergency room visit. Reporter reported that the impact on quality of life (10/10). The patient died on 30May2021. It was not reported if an autopsy was performed. Health Authority comments: Remote Pathological History: alcohol-related liver cirrhosis in a patient with chronic alcoholism, previous bleeding bulbar ulcer treated surgically (pyloroplasty according to Heineke-Mickulicz dissection of the esophago-gastric junction and section of the vagus nerve), reduced glucose tolerance, low back pain. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1701942 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Heart rate abnormal, Oxygen saturation, Oxygen saturation decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Unspecified circulatory system disorder (thinning abdominal aorta inoperable due to age and pathologies)
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: heart rate; Result Unstructured Data: Test Result:175; Comments: 175 beats; Test Date: 20210511; Test Name: heart rate; Result Unstructured Data: Test Result:40; Comments: collapse to 40 in a few seconds; Test Name: oxygen saturation; Result Unstructured Data: Test Result:from 95 to 82; Test Name: oxygen saturation; Result Unstructured Data: Test Result:72
CDC Split Type: ITPFIZER INC202101150041

Write-up: fainting; 175 beats and collapse to 40 in a few seconds; collapse of oxygenation in the blood, from 95 to 82 and in the following week to 72. From November to March, use of the oxygen cylinder once. From 25 March to 11 May use of the cylinder daily.; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority IT-MINISAL02-778178. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in right deltoid on 20Mar2021 (Batch/Lot Number: ET1831) as 0.3 ML single for covid-19 immunisation. The patient previously received first single dose of bnt162b2 on 27Feb2021 for COVID-19 vaccination in left deltoid (batch/lot number: EP9598). Medical history included stable pulmonary hypertension with circulatory problems thinning abdominal aorta inoperable due to age and pathologies. The patient''s concomitant medications were not reported. The patient experienced collapse of oxygenation in the blood on 25Mar2021, from 95 to 82 and in the following week to 72. From November to March, use of the oxygen cylinder once. From 25Mar2021 to 11May2021 use of the cylinder daily. The patient was followed by the pulmonology department, emergency hospitalization on 11May2021 for fainting with 175 beats and collapse to 40 in a few seconds) - Impact on quality of life (10/10). The patient died on an unspecified date since the event collapse of oxygenation. It was unknown if autopsy was performed. The outcome of the other events was unknown. No follow-up attempts were possible. No information was expected. ; Reporter''s Comments: stable pulmonary hypertension circulatory problems thinning abdominal aorta inoperable due to age and pathologies; Reported Cause(s) of Death: Oxygen saturation low


VAERS ID: 1701945 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebrovascular accident, Fatigue, Paralysis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:fever rises
CDC Split Type: ITPFIZER INC202101149957

Write-up: paralysis; 7 days after the second dose of the pfizer vaccine (21May) the mother began to have fever and after 15 days she was hospitalized where the following day she had a thrombosis-stroke with paralysis; her fever rises; tired; This is a spontaneous report from a contactable consumer(patient) downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-778264. A 85-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in Arm Left on 21May2021 (Lot Number: FA8016) (at the age of 85-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 28May2021 reported that the days following the 2nd dose the patient was more tired, after about a week her fever rises which even if treated with antibiotics does not go down. After 15 days from the vaccination she was hospitalized, the next day she suffers an extended cerebral stroke which leads to death after 4 days. Covid 19 comirnaty vaccine (Pfizer) 195FL 0.45ML: Administration site (left shoulder) Booster dose number (2) Reaction description (7 days after the second dose of the Pfizer vaccine (21May) the mother began to have fever and after 15 days she was hospitalized where the following day she had a thrombosis-stroke with paralysis and after 4 days on 19Jun2021 she died). The patient underwent lab tests and procedures which included body temperature. The patient died on 19Jun2021. It was not reported if an autopsy was performed. Sender''s comments: 30Aug2021 Regulatory Authority contacted reporter asked for Emergency Room minutes and concomitant therapy. Asked for a report from the medical department of the PRIVACY hospital where the patient was hospitalized, Pending. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reporter''s Comments: Concomitant conditions: pacemaker wearer - Sent by Prescribing antibiotics when fever started; Reported Cause(s) of Death: her fever rises; tired; paralysis; 7 days after the second dose of the pfizer vaccine (21May) the mother began to have fever and after 15 days she was hospitalized where the following day she had a thrombosis-stroke with paralysis


VAERS ID: 1701959 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agitation, Confusional state, Nervous system disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-778678) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER and CONFUSIONAL STATE in a 95-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 12-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced NERVOUS SYSTEM DISORDER (seriousness criterion death), AGITATION (seriousness criterion death) and CONFUSIONAL STATE. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant medication was not provided Treatment medication was not provided. 1st dose administered was the Moderna vaccine on Jun 12, 2021, by the physician. Onset of severe mental confusion, never manifested. Very severe agitation with obvious neurological impairment occurred. In response to the e-mail of Aug 26, 2021, with request for info regarding: -patient initials -lot and time of vaccine administration -specialist investigations, autopsy report, the reporter responds that they are not able to provide data before Sep 06, 2021 Company Comment : 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. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Translation document received on 09 Sep 2021 include no new information.; Reporter''s Comments: Aritmia; 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: Unknown cause of death


VAERS ID: 1701962 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Blood test, Decreased appetite, Full blood count abnormal, Muscular weakness, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 72
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DELTACORTENE; LASIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Autoimmune thrombocytopenia (for 20 years. The only drug that could keep her platelets at an acceptable value was deltacortene.); Back pain; Coronavirus infection (contracted COVID); Esophageal reflux; Fluid imbalance (Lasix to dispose of fluids); Hypercholesterolaemia; Hypertension arterial (took tablets for the pressure that tended to be high); Hypothyroidism; Mitral valve replacement; Reactive depression; Thrombopenia
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Blood test; Result Unstructured Data: Test Result:very high; Comments: blood values ??were very high
CDC Split Type: ITPFIZER INC202101174870

Write-up: vomited; no longer had the strength to stand up and not even a good functioning of her arms; blood values were very high; lack of strength to stand up; Abdominal pain; Inappetence; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority. The regulatory authority report number is IT-MINISAL02-779538. A 71-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left, on 18May2021 (Batch/Lot Number: FA4597) as single dose, for covid-19 immunisation. Medical history included coronavirus infection from 01Dec2020 to 26Jan2021, Hypertension arterial from 01Jan2015, hypercholesterolaemia from 01Jan2015, Thrombopenia from 01Jan2015, Reactive depression from 01Jan2015, Esophageal reflux from 01Jan2016, mitral valve replacement in 2018, hypothyroidism from 01Jan2015, autoimmune thrombocytopenia (for 20 years), back pain and arthrosis, and had fluids. It was reported the patient had been living with an autoimmune thrombocytopenia for 20 years. The only drug that could keep her platelets at an acceptable value was prednisone (DELTACORTENE), which was periodically adjusted by her hematologist. She took tablets for the pressure that tended to be high, furosemide (LASIX) to dispose of fluids, she had back pain and arthrosis. These conditions she had been able to control for years and was used to living with them. Concomitant medications included prednisone (DELTACORTENE); furosemide (LASIX), and tablets for the pressure that tended to be high. The patient previously took first dose of BNT162B2 (COMIRNATY, lot number EW6327 and expiration date not provided), via an unspecified route of administration, on 27Apr2021, at single dose, for COVID-19 immunization. On 01Jun2021, the patient experienced asthenia, abdominal pain and inappetence. Since she had the vaccine, the situation deteriorated from day to day. Her blood values were very high, the cortisone could no longer maintain a correct platelet value, she had abdominal pain (so much that lately she didn''t eat anymore because otherwise she vomited), she no longer had the strength to stand up and not even a good functioning of her arms. All this slowly manifested itself after taking the two doses of the vaccine (the patient died following the second dose of vaccine that was administered in the wrong way because after having contracted COVID in Dec2020 and healed in Jan2021 she had to do a single dose of vaccine). The patient underwent lab tests and procedures which included blood values were very high on 30Jun2021. The outcome of events was fatal. The patient died on 12Aug2021. The autopsy was not performed. Sender''s comments: 27Aug2021 Regulatory Authority: follow up information requested from reporter regarding suspected adverse reaction, clinical history, eventual concomitant drugs, exact dates of ADR onset, death, lot number, medical documentation of the case. 01Sep2021 Regulatory Authority: reporter provided blood tests and patient clinical history (attached). The reporter was requested to find the lot number and exact dates. 02Sep2021 Regulatory Authority: the file is updated with lot number and date of death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Abdominal pain; lack of strength to stand up; blood values were very high; Vomited; Inappetence; no longer had the strength to stand up and not even a good functioning of her arms


VAERS ID: 1702004 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101135941

Write-up: Death; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21125479. A 74-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 06Aug2021 09:30 (Batch/Lot Number: FE8206; Expiration Date: 31Oct2021) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was 36.1 degrees centigrade. The patient had no medical history. There was no concomitant medication. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 06Aug2021 (the day of vaccination) at 09:30, the patient received the second dose of BNT162b2 (COMIRNATY). On 09Aug2021 (2 days/14 hours/30 minutes after the vaccination), the patient experienced death. On 09Aug2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 06Aug2021 (the day of vaccination), at 09:30, the patient received the second dose of BNT162b2 vaccination, and he went home. The patient lived alone. One the same day, a helper visited the patient''s home. It was considered that the patient went to sleep after supper. On 09Aug2021 (2 days, 14 hours, and 30 minutes after vaccination), the helper called the patient''s daughter who lived near the patient to say that no response was obtained, and things seemed strange. The patient was found dead beside the bed. An autopsy by the police was performed and results are not provided. On 01Sep2021 (25 days, 14 hours, and 30 minutes after vaccination), in the morning, the daughter called the reporting hospital. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Death


VAERS ID: 1702009 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute
SMQs:, Cardiac failure (narrow), 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: Test Date: 20210519; Test Name: Body temperature; Result Unstructured Data: Test Result:not provided; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101136192

Write-up: Acute cardiac insufficiency (assumed).; This is a spontaneous report from a contactable physician received from Regulatory Authority. Regulatory authority report number is v21125855. The patient was a 48-year-old male. Body temperature before vaccination was not provided. The family history was not provided. There were no 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). Medical history and concomitant medications were not reported. On 28Apr2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW4811, Expiration date 31Jul2021) for COVID-19 immunization. On 19May2021 at 12:55 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose at 48 years old (as reported) for COVID-19 immunization. On 23May2021 at around 00:30 (3 days/11 hours/35 minutes after the vaccination), the patient experienced acute cardiac insufficiency. The course of the event was as follows: An autopsy was performed, and the patient was diagnosed with acute cardiac insufficiency (assumed). The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. On 23May2021 (4 days after the vaccination), the outcome of the event was fatal.; Autopsy-determined Cause(s) of Death: Acute cardiac insufficiency (assumed).


VAERS ID: 1702032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101136890

Write-up: Death; This is a spontaneous report from a contactable pharmacist received via Medical information group. A 73-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 31Aug2021 (the day of vaccination), (Dose number, lot number, and expiration date were not reported) as a single dose for COVID-19 immunization. Family history and medical history were not reported. Concomitant medications were not reported. On 01Sep2021 (1 day after the vaccination), the patient experienced death. The course of the event was as follows: Almost twenty-four hours after the vaccination, the patient died. Whether the death was due to the vaccine could not be confirmed. The patient received the vaccine on previous day (on 31Aug2021) and was confirmed to be dead almost twenty-four hours later. At the time of this report, the cause was unknown. The reporting pharmacist assessed that the causality between the event and BNT162b2 as unknown. It was unknown if Autopsy Done. On 01Sep2021 (1 day after the vaccination), the outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: The paucity of clinical details precludes a full assessment and does not allow the company to completely exclude a reasonable possibility that the suspect vaccine BNT162b2 contributed to the patient''s demise. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. This case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1702043 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101139455

Write-up: Interstitial pneumonia; This is a spontaneous report from a contactable physician received via medical information group. This physician reported similar events for four patients. This is the first of four reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. On an unspecified date, the patient of unknown age and gender received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was not provided. One day after the second dose of the vaccination (date not provided), the patient experienced interstitial pneumonia and died. It was not reported if the patient received the treatment for the event. The patient died on an unspecified date. The cause of death was interstitial pneumonia. It was unknown if an autopsy was performed. The reporter commented as follows: This was suspected to be vaccine-related interstitial pneumonia which was occasionally seen in Japanese after receiving Flu vaccination or pneumococcal vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event (interstitial pneumonia) and the BNT162B2 cannot be excluded. "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate." ,Linked Report(s) : JP-PFIZER INC-202101142980 Same reporter, same drug, same event, different patient;JP-PFIZER INC-202101142981 Same reporter, same drug, same event, different patient;JP-PFIZER INC-202101142982 Same reporter, same drug, same event, different patient; Reported Cause(s) of Death: Interstitial pneumonia


VAERS ID: 1702088 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Circulatory collapse, Feeling abnormal
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), Dementia (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   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 Date: 20210827; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101142891

Write-up: Acute circulatory failure; feeling strange in his arm; This is a spontaneous report from a contactable physician (anatomist) received from the Regulatory Agency. Regulatory authority report number is v20106082. A 23-year and 9-month-old male patient (Body temperature before vaccination was 36.1 degrees centigrade) received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021), via an unspecified route of administration, on 27Aug2021, at the age of 23-year-old and 9 months, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient family history was unknown. There were no 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). The patient previously took first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on 06Aug2021, at single dose, for COVID-19 immunization. After the vaccination, pyrexia of 38.0-38.9 degrees centigrade and malaise persisted for 2 days, for which the patient orally took over-the-counter antipyretic medication. On 30Aug2021 (3 days after the vaccination), the patient experienced acute circulatory failure. The course of the event was as follows: On 27Aug2021 (the day of vaccination), the patient was inoculated with the second dose of BNT162b2. The patient told his family that he had feeling strange in his arm (details unknown). On 29Aug2021 (2 days after the vaccination) at night, the patient''s Line (a social networking service) was read (the last time that the patient was confirmed to be alive). On 30Aug2021 at noon (3 days after the vaccination), the patient was found dead in his room. The outcome of the event "Acute circulatory failure" was fatal, of "feeling strange in arm" was unknown. Patient died on 30Aug2021. The autopsy was performed, autopsy results was available. The cause of death and autopsy result were acute circulatory failure. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. As for other possible cause of the event such as any other diseases, the possibility of paroxysmal arrhythmia unrelated to the vaccine and or myocarditis could not be denied at the time of reporting. The reporting physician commented as follows: This was a case of a young adult man who was found dead at home the following day of the vaccination. An autopsy was performed; however, acute circulatory failure was the only findings confirmed at the time of reporting. As histological examinations would be conducted at a later date, causal relationship with the vaccination was unassessable.; Reported Cause(s) of Death: Acute circulatory failure; Autopsy-determined Cause(s) of Death: Acute circulatory failure


VAERS ID: 1702117 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-08-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Oxygen saturation, Pneumonia, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   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: Angina pectoris; Pyothorax; Stent placement; Swallowing difficult
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: blood pressure; Result Unstructured Data: Test Result:80s; Test Date: 20210831; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210831; Test Name: SpO2; Test Result: 84 %
CDC Split Type: JPPFIZER INC202101147330

Write-up: Pneumonia; The patient had shock vital with the blood pressure of 80s; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21125680. An 89-year and 6-month-old male patient received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 31Aug2021 15:05 (the day of the vaccination) (Batch/Lot Number: FF2782; Expiration Date: 30Nov2021) at the age of 89 years old as dose 2, single for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees centigrade. The family history was not provided. The patient had medical histories of severe swallowing dysfunction, pyothorax, angina pectoris, and after stent treatment for left cervical vessels. Concomitant medications were not reported. On unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 31Aug2021 at 22:00 (6 hours/55 minutes after the vaccination), the patient experienced pneumonia. On 01Sep2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was being admitted to the hospital for swallowing disorder. On 31Aug2021 (the day of vaccination) at 15:05, the patient received the second dose of BNT162b2 vaccination. At the time of a round by a nurse at 22:00, the patient complained of dyspnoea. Since the SpO2 was 84%, oxygen administration was initiated. Since the patient had sputum, it was sucked. The patient had shock vital with the blood pressure of 80s. A drip infusion, dopamine (DOA), and an antibiotic were administered. The patient died on 01Sep2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was pneumonia. The reporting physician commented as follows: The causality between the events and BNT162b2 vaccination was unassessable.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1702125 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery; Heart disorder; Rectal cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101153556

Write-up: pneumonia aspiration; a large volume of sputum; Sudden cardio-respiratory arrest; sudden death; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21125906. The patient was a 77-year and 1-month-old female (age at vaccination was 77-year and 1-month old). Body temperature before vaccination was 36.3 degrees centigrade. Family history was unknown. Medical history included heart disorder, surgery for rectal cancer. Concomitant medication were not reported. On 03Sep2021 at 14:27 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 03Sep2021 at 20:20 (5 hours 53 minutes after the vaccination), the patient experienced sudden cardio-respiratory arrest. On 03Sep2021 (on the same day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 03Sep2021 at 14:27, the patient received bnt162b2 vaccine. Fifteen minutes later, the patient had no particular problem. At 17:30, when round of visit was made, the patient was confirmed to have no particular change. At 20:20, when round of visit was made, the patient had respiratory arrest and monitor was placed. At 20:57, death was confirmed. The patient was diagnosed with pneumonia aspiration for the duration of about 13 days. The reporting physician classified the events as serious (death) and assessed that the causality between the events and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was a large volume of sputum. The reporting physician commented as follows: The patient did not develop anaphylaxis after the vaccination; however, the patient experienced sudden death on 03Sep2021. Causality between the event and bnt162b2 vaccine was unknown. The patient died on 03Sep2021. It was unknown if an autopsy was done. The outcome of events was fatal.; Reported Cause(s) of Death: Sudden cardio-respiratory arrest; sudden death; pneumonia aspiration; a large volume of sputum


VAERS ID: 1702126 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-08-17
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardio-respiratory arrest, Chest pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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 (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   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: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina unstable; Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101153559

Write-up: Acute myocardial infarction; chest pain; cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21125745. The patient was a 75-year and 4-month-old female. Body temperature before vaccination was not provided. The family history was not provided. Medical history included in 2015, 2 stents were placed through cardiac catheters for angina unstable. Thereafter, the patient had been orally taking acetylsalicylic acid (BAYASPIRIN) 150 mg. Concomitant medication included acetylsalicylic acid. On 08Jun2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021) via an unspecified route of administration for COVID-19 immunisation. On 29Jun2021 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose at the age of 75-year-old for COVID-19 immunisation. On 17Aug2021 at 09:36 (49 days after the vaccination), the patient experienced acute myocardial infarction. On 17Aug2021 (49 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: In 2015, 2 stents were placed through cardiac catheters for angina unstable. Thereafter, the patient had been orally taking acetylsalicylic acid (BAYASPIRIN) 150 mg once daily, and she did not complain of chest pain. On 08Jun2021 and on 29Jun2021 (the day of vaccination), the patient received bnt162b2 vaccination twice. On 17Aug2021 (49 days after vaccination), the patient had chest pain. The patient had cardio-respiratory arrest in an ambulance. On the same day, the patient died. The effect of bnt162b2 vaccination could not be ruled out. The reporting physician classified the event as serious (death). The causality between the event and bnt162b2 was not provided. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Since the patient had haematoma formation as a complication of coronavirus infection, the possibility of haematoma formation caused by bnt162b2 vaccination could not be ruled out. The patient died on 17Aug2021. It was not reported if an autopsy was done. The outcome of events was fatal.; Reported Cause(s) of Death: cardio-respiratory arrest; chest pain; Acute myocardial infarction


VAERS ID: 1702127 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-20
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ataxia, Body temperature, Cerebral arteriosclerosis, Cerebral infarction, Dyslalia, Dysphagia, Gait disturbance, Irregular breathing, Magnetic resonance imaging head, Respiratory arrest, Respiratory disorder, Thrombotic cerebral infarction
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 11
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: PIOGLITAZONE; REBAMIPIDE; EQUMET; NIFEDIPINE; TICLOPIDINE; GLIMEPIRIDE; PRAVASTATIN; LEVOCETIRIZINE; SILODOSIN; EPALRESTAT; REMINYL; YOKUKANSAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Diabetes mellitus; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210731; Test Name: Head MRI; Result Unstructured Data: Test Result:right medullary infarction and severe right verteb; Comments: right medullary infarction and severe right vertebral artery stenosis
CDC Split Type: JPPFIZER INC202101153570

Write-up: Atherothrombotic cerebral infarction; Cerebral infarction; swallowing disorder; ataxia of the right upper and lower limbs; cerebral arteriosclerosis; respiratory disorder; respiratory arrest; ataxic breathing; gait disturbance; dyslalia; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21125775. The patient was an 81-year-old male (age at the time of vaccination). Body temperature before vaccination was 36.5 degrees centigrade. The patient had no family history. The patient had medical histories of diabetes mellitus, hypertension, dyslipidaemia, and cerebral infarction. The concomitant medications included pioglitazone (PIOGLITAZONE), rebamipide (REBAMIPIDE), vildagliptin, metformin hydrochloride (EQUMET), nifedipine (NIFEDIPINE CR), ticlopidine (TICLOPIDINE), glimepiride (GLIMEPIRIDE), pravastatin(PRAVASTATIN), levocetirizine (LEVOCETIRIZINE), silodosin (SILODOSIN), epalrestat (EPALRESTAT), galantamine hydrobromide (REMINYL), and angelica acutiloba root, atractylodes lancea rhizome, bupleurum falcatum root, cnidium officinale rhizome, glycyrrhiza spp. root, poria cocos sclerotium, uncaria spp. hook (YOKUKANSAN[TSUMURA]) (Route of administration of all drugs was oral). On 21Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FC3661, Expiration date 30Sep2021). On 11Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 20Jul2021 (9 days after the vaccination), the patient experienced cerebral infarction/ atherothrombotic cerebral infarction. On 20Jul2021 (9 days after the vaccination), the patient was admitted to the hospital and treated. On 31Jul2021 (20 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: On 20Jul2021 (9 days after the vaccination), in the morning, the patient had gait disturbance and dyslalia. On the same day, the patient visited the emergency room of the reporting hospital. The patient was diagnosed with cerebral infarction (right medullary infarction), and he was admitted to the reporting hospital. Drug therapy (a drip infusion and oral administration) was initiated. After the hospitalization, the dyslalia, swallowing disorder, ataxia of the right upper and lower limbs, and gait disturbance were aggravated. On 31Jul2021 (20 days after the vaccination), the patient had respiratory disorder. The patient had respiratory arrest due to ataxic breathing, and he died. Head MRI showed right medullary infarction and severe right vertebral artery stenosis. The patient was diagnosed with atherothrombotic cerebral infarction. Since the event occurred soon after the vaccination, the possibility could not be ruled out that the event was triggered by the vaccination. The reporting physician classified the events (atherothrombotic cerebral infarction, respiratory disorder, respiratory arrest, and ataxic breathing) as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was cerebral arteriosclerosis. The reporting physician commented as follows: The diagnosis of atherothrombotic cerebral infarction in the region of the medulla oblongata due to arteriosclerosis was definite. However, since there was a possibility that the vaccination was related to the trigger for the onset, this case was reported. Outcome of the events gait disturbance, dyslalia, swallowing disorder, ataxia of the right upper and lower limbs was not recovered, while for cerebral arteriosclerosis was unknown. The patient died on 31Jul2021 due to cerebral infarction, atherothrombotic cerebral infarction, respiratory disorder, respiratory arrest, and ataxic breathing. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: respiratory arrest; ataxic breathing; Atherothrombotic cerebral infarction; respiratory disorder; Cerebral infarction


VAERS ID: 1702130 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   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: Atrial fibrillation paroxysmal; Diabetes mellitus; Hypertension; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101153993

Write-up: dead; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21125913. A 50-year-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 27Aug2021 14:10 (Lot Number: FF3620; Expiration Date: 30Nov2021) as single dose for covid-19 immunisation. Medical history included sleep apnoea syndrome, hypertension, diabetes mellitus, and atrial fibrillation paroxysmal. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2, via an unspecified route of administration from an unspecified date a single dose for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees centigrade on 27Aug2021. On 30Aug2021 at 06:40 (2 days/16 hours/30 minutes after the vaccination), the patient experienced found dead. The course of the event was as follows: On 30Aug2021, at 06:40 (2 days/16 hours/30 minutes after vaccination), the police contacted the reporting clinic that the patient was found dead sitting on a sofa in his home by his mother. The symptoms which occurred from the vaccination to the death were not recognized by the reporting clinic. On 30Aug2021 (3 days after the vaccination), the outcome of the event was fatal. The patient died on 30Aug2021. An autopsy was not performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was unknown.; Reported Cause(s) of Death: dead


VAERS ID: 1702135 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Oxygen saturation, Polymerase chain reaction, Pyrexia, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dyslipidaemia
Allergies:
Diagnostic Lab Data: Test Name: SpO2; Test Result: 95 %; Comments: On hospitalization; Test Name: PCR; Test Result: Positive ; Comments: After vaccination
CDC Split Type: JPPFIZER INC202101162154

Write-up: Dyspnoea; Urinary tract infection; Pyrexia; PCR positive; PCR positive; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 72-year-old male patient received first dose of BNT162B2 (COMIRNATY) on unknown date at single dose for COVID-19 immunisation. The family history was not provided. The patient had medical histories of chronic obstructive pulmonary disease (COPD), for which an inhalant was used, and dyslipidaemia. Concomitant medications were not reported. On unknown date, after the patient received the first dose of BNT162b2 vaccination, PCR test was positive. Since the patient had pyrexia, he was admitted to another hospital. On hospitalization, the SpO2 was 95%. The symptom was aggravated, and the patient had dyspnoea and urinary tract infection, which led to death. The outcome of PCR test was positive and pyrexia was unknown. The outcome of dyspnoea and urinary tract infection was fatal. The causality between the event and BNT162b2 was not provided. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Dyspnoea; Urinary tract infection


VAERS ID: 1702136 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-06-05
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Body temperature
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Orthopaedic procedure
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101162195

Write-up: Abdominal aneurysm, ruptured; This is a spontaneous report from a contactable other healthcare professional received from the RA. Regulatory authority report number is v21125967. A 95-year-old male patient received first dose of BNT162B2 (COMIRNATY) Lot number EX3617, expiration date 31Aug2021, on 22May2021 14:16 at single dose (at the age of 95-year-old) for COVID-19 immunisation. Body temperature before vaccination was 36.3 degrees centigrade. The family history was not provided. Medical history included surgical orthopaedics. Concomitant medication was not reported. On 05Jun2021 (14 days after the vaccination), the patient experienced abdominal aneurysm, ruptured. On an unspecified date, the outcome of the event was fatal. The reporting other healthcare professional classified the event as serious (death). The causality between the event and BNT162b2 was not provided. Other possible cause of the event such as any other diseases was not reported. Reporter comments: The fact of death was reported by the vaccine recipient''s wife. Thus, the cause of death was confirmed on the death certificate, and this case was reported.; Reported Cause(s) of Death: Abdominal aneurysm, ruptured


VAERS ID: 1702141 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium increased, Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101162714

Write-up: Cardiac failure; potassium increased; This is a spontaneous report from a contactable physician via a Regulatory Authority. An 85-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included atrial fibrillation. The patient''s concomitant medications included apixaban (ELIQUIS) at 5mg (frequency not reported) from an unspecified date for atrial fibrillation and experienced haemorrhage, and then dose was reduced to 2.5mg (frequency not reported). On an unspecified date, the patient experienced cardiac failure. The patient died of cardiac failure in around Jun2021. Clinical course was as follows: On an unspecified date, the patient experienced Cardiac failure. Left atrial enlargement, potassium increased and stagnation in blood flow were noted as the symptoms. On around Jun2021, the patient died. Although the patient received the BNT162b2 on a few days before he died, physician assessed the causality between the event and BNT162B2 as unrelated. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event cardiac failure, blood potassium increased and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: potassium increased; Cardiac failure


VAERS ID: 1702148 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Arthralgia, Back pain, Blood pressure measurement, Cardiac tamponade, Chest pain, Craniocerebral injury, Drowning, Emphysema, Fall, False lumen dilatation of aortic dissection, Haemorrhage subcutaneous, Headache, Heart rate, Hypertrophy, Neck injury, Oxygen saturation, Pericardial haemorrhage, Pulmonary congestion, Respiratory rate, Skin laceration, Soft tissue haemorrhage
SMQs:, Cardiac failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Arthritis (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ABILIFY; LUNESTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Recurrent depressive disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: blood pressure; Result Unstructured Data: Test Result:164/96 mmHg; Test Date: 20210820; Test Name: pulse rate; Result Unstructured Data: Test Result:97; Comments: beats/minute; Test Date: 20210820; Test Name: SpO2; Test Result: 99 %; Comments: room air; Test Date: 20210820; Test Name: respiratory rate; Result Unstructured Data: Test Result:24; Comments: beats/minute
CDC Split Type: JPPFIZER INC202101170422

Write-up: Cardiac tamponade due to aortic dissection acute; Cardiac tamponade due to aortic dissection acute; An intima tear of 1.8 cm in length was observed in the proximal side of the aortic arch, from which to the ascending aorta, a false lumen was formed.; lungs were congestive hydrops; concentric hypertrophy (559 g) and the large volume of each organ such as the liver, kidney, and pancreas; pericardial haemorrhage; A total of 495 g of the haematoma and the blood were accumulated in the pericardium; fell; mild injury on the craniocervical part; mild injury on the craniocervical part; he died with his face drowning in the river; lungs were wet emphysema; subcutaneous haemorrhage in the left temporal region; Soft tissue haemorrhage; contused-lacerated wound in the anterior neck; Headache; Chest pain; Low back pain; Bilateral shoulder pain; This is a spontaneous report from a contactable physician received from the Regulatory Agency . Regulatory authority report number is v21127149. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot number and expiration date were not reported) at age of 55 years old as a single dose for covid-19 immunisation. Medical history included recurrent depressive disorder, hypertension. Concomitant medications included aripiprazole (ABILIFY) taken for Recurrent depressive disorde; eszopiclone (LUNESTA) taken for Recurrent depressive disorder. The patient previously received 1st dose of bnt162b2 (COMIRNATY) with an unknown date (lot number and experienced date unknown) for covid-19 immunisation. The patient experienced cardiac tamponade due to aortic dissection acute on 21Aug2021 (also reported 22Aug2021), lungs were congestive hydrops, concentric hypertrophy (559 g) and the large volume of each organ such as the liver, kidney, and pancreas, pericardial haemorrhage, fell, mild injury on the craniocervical part, lungs were wet emphysema, soft tissue haemorrhage, subcutaneous haemorrhage in the left temporal region, contused-lacerated wound in the anterior neck, all 21Aug2021, he died with his face drowning in the river on 21Aug2021, headache, chest pain, low back pain, bilateral shoulder pain, all on 31Jul2021. The patient underwent lab tests and procedures which included blood pressure measurement: 164/96 mmhg, heart rate: 97 beats/minute, oxygen saturation: 99 % room air, respiratory rate: 24 beats/minute, all on 20Aug2021. Therapeutic measures were taken as a result of headache, chest pain, low back pain, bilateral shoulder pain. The patient died on 21Aug2021 (also reported as 22Aug2021). An autopsy was performed that revealed cardiac tamponade due to aortic dissection acute, lungs were congestive hydrops, concentric hypertrophy (559 g) and the large volume of each organ such as the liver, kidney, and pancreas, pericardial haemorrhage, mild injury on the craniocervical part, lungs were wet emphysema, Haemorrhage subcutaneous. The outcome of events bilateral shoulder pain, low back pain, chest pain, and headache, contused-lacerated wound in the anterior neck, Soft tissue haemorrhage was unknown, the rest events was death. The course of the event was as follows: On 31Jul2021 (the day of vaccination), on the day of the second dose of BNT162b2 vaccination, the patient seemed to be aware of bilateral shoulder pain, low back pain, chest pain, and headache. The details of other side reactions were unknown. On 19Aug2021 (19 days after vaccination), when the patient was absent from work, he told his colleague that he was to visit the medical institution. On 20Aug2021 (20 days after vaccination), the patient visited his nearby hospital (he was not visiting the hospital regularly, and this was the first visit), the blood pressure was 164/96 mmHg, the pulse rate was 97 beats/minute, the respiratory rate was 24 beats/minute, and the SpO2 was 99% at room air. The patient was prescribed acetaminophen, and he went home. No information on the results of the tests which were performed was obtained. The last time when the patient was found to be alive was at around 19:00 on the same day by his family who lived with him. On 21Aug2021, at 14:50 (21 days, 14 hours, and 50 minutes after vaccination), the patient was found to collapse on his stomach in the river near his home by a person in his neighborhood. Although an ambulance was called, death spots and postmortem rigidity were found, and thus, the patient was not transferred. Since the death situation was unknown, a legal autopsy was determined to be performed. On 22Aug2021, at 14:15, a legal autopsy was performed at the Postmortem Investigation Support Center of the reporting hospital. A contused-lacerated wound in the anterior neck and subcutaneous haemorrhage in the left temporal region were observed; however, no intracranial injury was observed. An intima tear of 1.8 cm in length (it was accompanied with a calcified lesion of 1.2 cm in diameter in the end) was observed in the proximal side of the aortic arch, from which to the ascending aorta, a false lumen was formed. An outer membrane tear of 1.5 cm in length was observed at 1.5 cm above the aortic root, and a haematoma exposed. A total of 495 g of the haematoma and the blood were accumulated in the pericardium. No coronary artery compression due to a haematoma was observed. Considering of concentric hypertrophy (559 g) and the large volume of each organ such as the liver, kidney, and pancreas, comorbidity of hypertension was suspected. The lungs were congestive hydrops and wet emphysema, which suggested concomitance of near drawing. Soft tissue haemorrhage without fracture was observed around the left superior horn of the thyroid cartilage. No blood ethanol was detected. The destructive test detected diatom which was not inconsistent with the water of the river from lung and stomach contents. It was assumed that while the patient was walking on the riverside, he had pericardial haemorrhage caused by aortic dissection acute, and he had mild injury on the craniocervical part when he fell, and he died with his face drowning in the river. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was concomitance of untreated hypertension. The reporting physician commented as follows: It was highly likely that the bilateral shoulder pain, low back pain, chest pain, and headache which the patient had complained of from the day of the second dose of BNT162b2 vaccination (Pfizer product) were side reactions with relatively high frequency. These symptoms usually disappeared or were relieved in approximately one week; however, the details of the range and degree of the pain for the patient and the duration were unknown. The possibility was considerable that the headache which the patient mentioned 20 days after the vaccination (2 days before the death) was a symptom accompanied with hypertension rather than that the pain continued after the vaccination, considering of the findings at the time of the autopsy (enlargement of the heart and other organs). However, the possibility could not be ruled out that under the presence of untreated hypertension, the onset of pain which defied imagination for the patient after the vaccination became a stress, which encouraged further blood pressure increased, and these factors invited aortic dissection acute. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: lungs were congestive hydrops; concentric hypertrophy (559 g) and the large volume of each organ such as the liver, kidney, and pancreas; pericardial haemorrhage; fell; mild injury on the craniocervical part; mild injury on the craniocervical part; h; Autopsy-determined Cause(s) of Death: lungs were congestive hydrops; concentric hypertrophy (559 g) and the large volume of each organ such as the liver, kidney, and pancreas; pericardial haemorrhage; fell; mild injury on the craniocervical part; mild injury on the craniocervical part; h


VAERS ID: 1702150 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101183380

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received via a Pfizer employee. A 06-decade-old (in his 50s) male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration on 24Aug2021 (the day of vaccination), [06-decade-old (in his 50s)] as Dose 2, Single for COVID-19 immunization. The patient had medical history of schizophrenia. Concomitant drug was not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, Lot# FC5947, Expiration date 30Sep2021) via an unspecified route of administration on 03Aug2021 [06-decade-old (in his 50s)] as Dose 1, Single for COVID-19 immunisation. On unknown date in 2021, the patient experienced unknown cause of death. The course of the event was as follows: On 03Aug2021, after the patient received the first dose of BNT162B2 vaccination, he complained of no physical deconditioning, and he did not visit the outpatient department. On 24Aug2021 (the day of vaccination), at the time of the second dose of BNT162B2 vaccination, the patient was asked about his physical condition after the first dose of the vaccination, and he said that there were no abnormalities. After the second dose of the vaccination, the patient did not visit the outpatient department. On 03Sep2021, the police contacted the reporting physician that the patient died. The decay of the dead body processed, and no legal autopsy was performed. Thus, the police reported that the estimated date of death was unknown, and the cause of death was also unknown. On unknown date in 2021, the outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnaty in triggering the onset of fatal event unknown cause of death cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1702151 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENARMON [TESTOSTERONE ENANTHATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hormone therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101183845

Write-up: Died at home; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 32-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received testosterone enanthate (ENARMON DEPOT) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included male hormone therapy. On 04Sep2021 at 12:45 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD0349, Expiration date 31Oct2021) via intramuscular route of administration in the arm left for COVID-19 immunization at age of 32 years old. On 10Sep2021, the patient died at home. The event resulted in death. The outcome of the event was fatal. It was unknown if the patient received the treatment for the event. The reporting physician assessed the event as serious (death). Since the vaccination, it was unknown whether the patient has not been tested for COVID-19. The reported event was as follows: It was revealed that the patient was found dead at his home because the police asked the reporting hospital to provide the information. The cause of death was unknown. It was unknown if the autopsy was performed.; Reported Cause(s) of Death: Died at home


VAERS ID: 1702152 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest X-ray, Lung opacity, Pulmonary fibrosis
SMQs:, Interstitial lung disease (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210904; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pulmonary fibrosis; Comments: on admission
CDC Split Type: JPPFIZER INC202101183870

Write-up: interstitial shadows were aggravated; Pulmonary fibrosis; This is a spontaneous report from a contactable physician (hospital director) received from the Regulatory Authority. Regulatory authority report number is v21126374. The patient was an 84-year and 7-month-old male. Body temperature before vaccination was 36.9 degrees Centigrade. The patient family history was not reported. Medical history was none. There were no 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). The patient concomitant drug was not reported. On 03Sep2021 at 13:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF4204, Expiration date 31Oct2021) via an unspecified route of administration as a single dose, at age of 84 years old, for COVID-19 immunization. On 04Sep2021 at 05:35 (16 hours and 5 minutes after the vaccination), the patient experienced pulmonary fibrosis. On an unknown date (unknown days after the vaccination), the patient was admitted to the hospital. On 05Sep2021 (2 days after the vaccination), the patient died. The outcome of the events was fatal. The course of the event was as follows: Chest X-ray on admission showed pulmonary fibrosis. At no interval in the course, interstitial shadows were aggravated before the death. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not reported. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Pulmonary fibrosis; aggravated interstitial shadows


VAERS ID: 1702154 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Body temperature, Cardiac arrest, Cardio-respiratory arrest, Computerised tomogram, Electrocardiogram, Intestinal ischaemia, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Ischaemic colitis (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210816; Test Name: blood test; Result Unstructured Data: Test Result:An obvious cause of cardiac arrest was unknown; Comments: An obvious cause of cardiac arrest was unknown; Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210816; Test Name: CT; Result Unstructured Data: Test Result:An obvious cause of cardiac arrest was unknown; Comments: An obvious cause of cardiac arrest was unknown; Test Date: 20210831; Test Name: CT; Result Unstructured Data: Test Result:NOMI(Non-occlusive mesenteric ischaemia); Test Date: 20210816; Test Name: electrocardiogram; Result Unstructured Data: Test Result:An obvious cause of cardiac arrest was unknown; Comments: An obvious cause of cardiac arrest was unknown
CDC Split Type: JPPFIZER INC202101184843

Write-up: Cardiac arrest; cardiopulmonary arrest; NOMI(Non-occlusive mesenteric ischaemia); ventricular fibrillation; This is a spontaneous report from a contactable physician received from the Reglatory Agency. Regulatory authority report number is v21126302. A 16-year-old (also reported as 16-year and 6-month-old) male patient received bnt162b2 (COMIRNATY, Lot Number: FF0843; Expiration Date: 31Oct2021), dose 1 via an unspecified route of administration on 10Aug2021 13:00 as single dose for covid-19 immunisation. Medical history was none. The patient had no family history. There were no 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). The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.2 degrees Centigrade. On 10Aug2021 at 13:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 16Aug2021 at 16:40 (6 days, 3 hours and 40 minutes after the vaccination), the patient experienced cardiac arrest. The patient was immediately transported and admitted to the reporting hospital. On 01Sep2021 (22 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16Aug2021 at 16:40 (6 days, 3 hours and 40 minutes after the vaccination), the patient was immediately transported the reporting hospital because of cardiopulmonary arrest (CPA). Before arrival to the hospital, automatic external defibrillator (AED) was conducted once. After the arrival, asystole, then VF(ventricular fibrillation) were noted. And return of spontaneous circulation (ROSC) was achieved after the one attempt of direct-current defibrillator (DC). The patient was hospitalized after resuscitated from the CPA. An obvious cause of cardiac arrest was unknown on computerised tomogram (CT), the blood test and electrocardiogram. The patient underwent tracheal intubation, and was managed by artificial respiration under hospitalization. Although targeted temperature management (TTM) was performed, there was no recovery of consciousness. On 31Aug2021 (21 days after the vaccination), blood pressure decreased. NOMI(Non-occlusive mesenteric ischaemia) was diagnosed through CT. On 01Sep2021 (22 days after the vaccination), the death was confirmed. The reporting physician classified the event as serious (Hospitalized) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not reported. The patient died on 01Sep2021. It was not reported if an autopsy was performed. The outcome of event ventricular fibrillation was recovered on 16Aug2021, the rest of events was fatal.; Reported Cause(s) of Death: Cardiac arrest; cardiopulmonary arrest; Non-occlusive mesenteric ischaemia


VAERS ID: 1702156 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE BESILATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Calculus urethral; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101189504

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution and from Pfizer sales representative. A 51-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF9944, Expiration date 30Nov2021), via an intramuscular route of administration, administered in left arm on 08Sep2021 16:00 (the day of vaccination, at the age of 51-year-old) as dose 1, single for COVID-19 immunisation. The patient other medical history included hypertension and ureteral calculus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine besilate at a dose of 10 mg, received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Sep2021 (2 days after the vaccination), the patient died. No treatment was given in response to the event. The reporting physician assessed the event as serious (death). It was not reported, if an autopsy was performed. No Follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of unknown cause of death cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1702157 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101190204

Write-up: Acute cardiac insufficiency; This is a spontaneous report from a non-contactable consumer received via COVID-19 Adverse Event Self-Reporting Solution. A 58-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm Left on 26Aug2021 16:00 (Lot Number: FF3620; Expiration Date: 30Nov2021) (at the age of 58-year-old) as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had no allergies to medications, food, or other products. The patient medical history was unremarkable. The patient medical history and concomitant medications were not reported. Since the vaccination, the patient has not been tested for COVID-19. On 05Aug2021 at 09:00 (at the age of 58-year-old), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FE8162, Expiration date 30Nov2021), via an unspecified route of administration in the left arm for COVID-19 immunization. On 26Aug2021 at 16:00 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY). On 31Aug2021 at 10:00 (4 days 18 hours after the vaccination), the patient experienced acute cardiac insufficiency. The patient died of acute cardiac insufficiency on 31Aug2021. The outcome of the event was fatal without treatment. Autopsy was performed, revealing the result of acute cardiac insufficiency.; Reported Cause(s) of Death: Acute cardiac insufficiency; Autopsy-determined Cause(s) of Death: Acute cardiac insufficiency


VAERS ID: 1702158 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Sleep apnoea syndrome; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: JPPFIZER INC202101192601

Write-up: Malaise; Myocardial infarction; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 56-year-old male patient received a single dose (dose number unknown) of BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Sep2021 for COVID-19 immunisation. The patient medical history included historical angina pectoris for which he underwent stent placement, historical sleep apnoea syndrome. The patient''s concomitant medications were not reported. On 04Sep2021 (2 days after the vaccination), the patient experienced malaise. On unspecified date in Sep2021, the patient experienced myocardial infarction. On 10Sep2021 (8 days after the vaccination), the patient died. The course of the event was as follows: The patient began to have malaise on around 04Sep2021(2 days after the vaccination). On 06Sep2021(4 days after the vaccination), the patient got off work because malaise persisted. The patient''s mother, who went to the patient''s room to see how the patient was feeling, found that the patient was dead on 10Sep2021 (8 days after the vaccination). His mother called the reporting pharmacist who was his mother''s relative. In the police, the attending physician considered no causality of Comirnaty. Given that the patient had historical angina pectoris having undergone stent placement, historical sleep apnoea syndrome, and increased troponin in this case, it was determined that there was no causality between Comirnaty and the cause of the death. The seriousness assessment was not reported. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: A contributory role of BNT162B2 to the event myocardial infarction cannot be fully excluded based on the temporal relationship. Angina pectoris in the past and history of sleep apnoea syndrome provide alternate explanation for the event. 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: Myocardial infarction


VAERS ID: 1702197 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-25
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003658 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Dyslipidaemia; Hyperlipidaemia; Hyperuricaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Sepsis; Sudden death; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP083555) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This case, reported by a physician, was received via Moderna''s adverse reaction reporting site (TASK0021405). The patient had regularly visited the primary care physician for dyslipidemia, diabetes mellitus, and hyperuricemia and was on medication to lower uric acid level. The patient was also on medication for hyperlipidemic tendency. On 15-Jul-2021, at 13:45, the patient received the 1st dose of this vaccine. On an unknown date, stomatitis developed before and after the vaccination. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 19-Aug-2021, at 13:45, the patient received the 2nd dose of this vaccine. After the vaccination, the patient experienced stomatitis and had difficulty eating due to it. On 23-Aug-2021, the patient visited a gastroenterology department and was diagnosed as having mold in the mouth. The patient was scheduled to be hospitalized for detailed investigation of the cause (scheduled for 27-Aug-2021). On 25-Aug-2021, 09:00, the patient requested porridge for breakfast. When the patient''s family member came back home after a brief outing, the patient was in cardiac arrest. Estimated time of death was 1 hour after the conversation with the family member. Sudden death due to sepsis occurred. The outcome of sepsis was reported as fatal. Follow-up investigation will be made. Company Comment: Although the events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), it is also considered that the events are due to effects from concomitant disease and patient background, etc.; Reporter''s Comments: It is presumed that the patient experienced sepsis when infection developed concurrently during an acute exacerbation of diabetes mellitus, but a possibility that immune abnormality was caused by this vaccine is suspected. Other factors may include diabetes mellitus and oral fungal infection.; Sender''s Comments: This is a case of sudden death in a 54-year-old male with underlying medical history of dyslipidemia, diabetes mellitus, and hyperuricemia, who died 7 days after receiving second dose of vaccine (Lot Number 3004733). Cause of death was unknown. Very limited information regarding these events, use of concomitant medication and autopsy report has been provided at this time. Further information was requested.; Reported Cause(s) of Death: Sepsis; Sudden death


VAERS ID: 1702205 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Arteriosclerosis coronary artery
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Coronary artery arteriosclerosis; Acute myocardial infarction; This case was received via Regulatory Authority (Reference number: 2021TJP083705) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This case, initially reported to the Pharmaceuticals and Regulatory Agency by a physician, was received via the Regulatory Authority (Ref, v21125403). On an unknown date, the patient received the 1st dose of this vaccine. On 16-Jul-2021, the patient received the 2nd dose of this vaccine. On 23-Jul-2021, acute myocardial infarction developed. On an unknown date, the patient was confirmed dead. The cause of death was acute myocardial infarction due to coronary artery arteriosclerosis. Main findings (1) Cardiac hypertrophy: 418 g. (2) Coronary artery arteriosclerosis: 75% or more of stenosis was observed in the left anterior descending coronary artery. (3) Histopathological examination revealed contraction band necrosis of myocardial cells (acute myocardial infarction). The outcome of acute myocardial infarction and coronary artery arteriosclerosis was reported as fatal. Follow-up investigation will be made. Company Comment: Event "Acute myocardial infarction" Although the event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), factors such as patient characteristics may have also had an influence. Event " Arteriosclerosis coronary artery" It is unlikely that COVID-19 vaccine mRNA (mRNA 1273) caused coronary artery stenosis of 75% or more in 7 days after the administration, and thus the event was not considered to be related to COVID-19 vaccine mRNA (mRNA 1273).; Reporter''s Comments: Event "Acute myocardial infarction" Although the event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), factors such as patient characteristics may have also had an influence. Event " Arteriosclerosis coronary artery" It is unlikely that COVID-19 vaccine mRNA (mRNA 1273) caused coronary artery stenosis of 75% or more in 7 days after the administration, and thus the event was not considered to be related to COVID-19 vaccine mRNA (mRNA 1273).; 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: Acute myocardial infarction; Arteriosclerosis coronary artery


VAERS ID: 1702207 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-20
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood creatine phosphokinase, Body temperature, Cardiac failure chronic, Catheterisation cardiac, Death, Electrocardiogram, Fibrin D dimer, Headache, Intracranial aneurysm, Low cardiac output syndrome, Malaise, Platelet count decreased, Respiratory distress, Seizure, Subarachnoid haemorrhage, Thrombosis
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Food allergy (Buckwheat)
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiopulmonary resuscitation; Device implant NOS (IABP insertion); Endotracheal intubation (endotracheal intubation was performed as the respiratory condition is not normal); Percutaneous coronary intervention
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: CPK; Result Unstructured Data: After surgery, CPK increased to 11059 and caused extensive myocardial damage; Test Name: body temperature; Result Unstructured Data: body temperature was 35 degrees; Test Date: 20210825; Test Name: cardiac catheterization; Result Unstructured Data: showed acute occlusion of 2 branches of the left anterior descending coronary artery and the right coronary artery; Test Date: 20210825; Test Name: electrocardiogram; Result Unstructured Data: suspected acute myocardial infarction; Test Date: 20210827; Test Name: D-dimer; Result Unstructured Data: 1422; Test Date: 20210827; Test Name: platelets; Result Unstructured Data: 1,30,000 cell per microliter, thrombocytopenia
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: low cardiac output syndrome; severe cardiac failure; death; Cerebral aneurysms were found in the left basilar artery and the bifurcation of superior cerebellar artery; Subarachnoid haemorrhage; convulsion; respiratory discomfort; Transient headache; Acute myocardial infarction; malaise; Thrombosis with thrombocytopenia, subarachnoid haemorrhage; This case was initially received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP083740) on 31-Aug-2021. The most recent information was received on 06-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This case was reported by a person in charge of occupational field vaccination via the Drug Information Center. On 06-Sep-2021, follow-up information was received from a healthcare professional (a physician in charge of administrative autopsy). On 08-Sep-2021, follow-up information, initially reported to the Regulatory Authority by a coroner, was received via the Regulatory Authority (Ref, v21126206). Precautions in Prevaccination Screening Questionnaire (underlying diseases, allergies, vaccinations or diseases within the last month, drugs being taken, past history of adverse reactions, condition of growing, etc.): Yes (Buckwheat allergy, complete right bundle branch block) On 14-Jul-2021, around 11:26, the patient received the 1st dose of this vaccine. On 11-Aug-2021, around 11:13, the patient received the 2nd dose of this vaccine. On 12-Aug-2021, in the morning, the patient was found dead by a family member and confirmed dead by the police. The patient was transported to the medical institution. AI diagnosis by postmortem CT revealed no cerebral haemorrhage or no finding of heart abnormality. On 13-Aug-2021, at 09:00, an administrative autopsy was performed. The cause of death was not identified only by the findings of autopsy (the causes of death were unknown). On 06-Sep-2021, in order to perform histopathological examination, histopathological specimens of various organs of the whole body were being prepared. On 08-Sep-2021, the cause of death was currently being investigated. The patient had no serious past medical history, and although complete right bundle branch block was found in the electrocardiogram during the medical examination, the patient had no symptom and was on follow-up. There was no obvious abnormality in the latest blood test. The patient did not smoke or drink alcohol excessively. Based on the findings of the corpse and the circumstances until the death, it was suspected that the patient died about 20 hours after the administration of this vaccine. The core body temperature was 35 degrees at about 8 hours after death, suggesting that the patient had hyperthermia at the time of death. At autopsy, there were no potentially fatal injuries to the body surface. In internal findings, significant petechiae which indicated sudden death, congestion of various organs, and dark red cardiac blood flow were found. The anatomical features of the corpse were ostium secundum type atrial septal defect and residual thymus. However, there was no obvious cardiac hypertrophy or ventricular dilation, and there were also no other conditions that could cause sudden death, such as intracranial hemorrhage, coronary thrombosis or sclerosis, aortic dissection, pulmonary embolism, or pharyngeal edema. No medicinal toxicant was detected in urine or heart blood tests. Based on the above, the cause of death of the patient could not be clarified only by body surface observation or findings on gross examination autopsy. The differential diagnosis included sudden cardiac death or inflammatory disease that was difficult to see macroscopically. Therefore, to estimate the cause of death more carefully, various organs of the whole body were being evaluated histologically. Findings in the postmortem inspection and autopsy It was estimated from the findings of the dead body that the patient died approximately 20 hours after the vaccination. There was no damage that could be a cause of death, except that the external findings suggested hyperthermia at the time of death. Visible findings of the autopsy suggested sudden death, but no apparent disease was identified that could cause sudden death. In addition, no substance was apparently detected by drug tests, etc. Follow-up investigation will be made. Follow-up received on 06-SEP-2021. Updated: Reporter Information, Product Information, Narrative Follow-up received on 06-SEP-2021 Updated: Event Death Details, Reporter Information, Narrative Follow-up received on 07-SEP-2021 Updated: Patient Information, Narrative Follow-up received on 08-SEP-2021 Updated: Reporter Information, Narrative, Reporter Comments Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The cause of death is currently under investigation, and the causal relationship between the vaccine and death cannot be assessed. Other possible factors include sudden cardiac death and febrile illness.; Sender''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be determined. Based on the follow-up reports and autopsy none of the events listed are invalid as the autopsy did not reveal any of them.; they were all mentioned in the report as ruled out. The only valid event is Death and no other cause, except possible Hyperthermia, is postulated.; Reported Cause(s) of Death: unknown cause of death; Autopsy-determined Cause(s) of Death: Death


Result pages: prev   86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=185&PERPAGE=100&VAX=COVID19&VAXTYPES=COVID-19&DIED=Yes


Copyright © 2022 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166