National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

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

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



Case Details

This is page 151 out of 172

Result pages: prev   52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 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   next


VAERS ID: 1575495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-30
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Test Result: Positive ; Comments: Variant PCR based B.1.1.7; N501Y positive.
CDC Split Type: ATPFIZER INC202101016183

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician and concerns downloaded from the WEB AT-BASGAGES-2021-39224. A 93-year-old female patient received the second and first dose of BNT162B2 (COMIRNATY), second dose on 11Feb2021 (Lot Number: EJ6134; Expiration Date: 30Apr2021), first dose on 21Jan2021 (Lot Number: EL1491; Expiration Date: 30Apr2021), both via an unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 30Mar2021, the patient experienced SARS-CoV-2 infection death. The patient performed PCR, Variant PCR based B.1.1.7; N501Y positive. The cause of death was unknown. Autopsy was not reported. The outcome of events was fatal. For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5616433 (see File attachment in this investigation record) The complaint for LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. 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. It concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. It 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. For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5686343 (see File attachment in this investigation record) The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. 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 EJ6134. 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. It concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. It 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. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575496 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-24
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Name: SARS-cov-2 test; Test Result: Positive ; Comments: Variant: B.1.1.7 ; N501Y positive
CDC Split Type: ATPFIZER INC202101016111

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 93-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on an 05Mar2021 (Batch/Lot number EP2163, Batch expiry date: 31May2021) as single dose, dose 2 via an unspecified route of administration on an 26Mar2021 (Batch/Lot number ET7205, Batch expiry date: 31Jul2021) as single dose, for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 24Apr2021 the patient experienced Vaccination failure, SARS-CoV-2 infection. Variant Sequenced B.1.1.7; N501Y positive. The patient''s outcome was fatal for SARS-CoV-2 infection. Product complaint investigation 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 ET7205. 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. PGS Puurs 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. 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 EP2163. 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. PGS Puurs 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. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1575497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-07-18
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Variant PCR based B.1.617.2; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016119

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39259. A 52-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EW2239; Expiration Date: 31Jul2021) at single dose, and the first dose via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: ET1831; Expiration Date: 30Jun2021) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure, and sars-cov-2 infection on 18Jul2021. The patient underwent lab tests and procedures which included variant PCR based B.1.617.2: Positive (N501Y) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. 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 lots EW2239 and ET1831. 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. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1575498 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None.
Allergies:
Diagnostic Lab Data: Test Name: SARS-COV-2; Result Unstructured Data: Test Result: Variant PCR based: B.1.1.7; N501Y positive.
CDC Split Type: ATPFIZER INC202101016125

Write-up: SARS-CoV-2 infection; Vaccination failure; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39260. A 62-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on an 17Mar2021 (Batch/Lot number ET1831, Batch expiry date: 30Jun2021) as single dose, dose 2 via an unspecified route of administration on an 03Apr2021 at patient age of 62-year-old (Batch/Lot number EW2239, Batch expiry date: 31Jul2021) as single dose, for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 24Apr2021 the patient experienced Vaccination failure, SARS-CoV-2 infection. Variant PCR based: B.1.1.7; N501Y positive. The patient''s outcome was fatal for SARS-CoV-2 infection. Product complaint investigation 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 of the reported lot EW2239. 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 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. 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 of the reported lot ET1831. 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 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. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1575499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Headache, Malaise, Pneumonia, Unresponsive to stimuli, Vascular dementia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202100999557

Write-up: Pneumonia; Unresponsive to stimuli; Vascular dementia; Contusion; Headache; Malaise; This is a spontaneous report from a contactable other health professional received from the Regulatory Authority; the Regulatory Authority report number is 595495. An 83-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 immunization. The patient''s medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced pneumonia, unresponsive to stimuli, vascular dementia, contusion, headache, and malaise, all with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Contusion; Headache; Malaise; Pneumonia; Unresponsive to stimuli; Vascular dementia


VAERS ID: 1575536 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute psychosis, Completed suicide, Euphoric mood
SMQs:, Suicide/self-injury (narrow), Systemic lupus erythematosus (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: MADOPAR
Current Illness: Disease Parkinson''s
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202100997423

Write-up: He wrote a farewell note, probably installed the rope in the garage, then swallowed about 2 packages of sleeping pills and hanged himself; With the first vaccination we already noticed mood swings, after the second vaccination he had a brief, extremely euphoric phase and then shortly afterwards a psychic breakdown; With the first vaccination we already noticed mood swings, after the second vaccination he had a brief, extremely euphoric phase and then shortly afterwards a psychic breakdown; This is a spontaneous report received from a contactable consumer via Regulatory Authority. Regulatory authority report number CH-SM-2021-18663. A 76-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 29May2021 at 76-years-old (Batch/Lot Number: EW6126) as dose 2, single for covid-19 immunisation. Medical history included Parkinson''s disease (Disease Parkinson''s) diagnosed 5 years ago (2016 and ongoing) and being treated with Madopar. Following the diagnosis he initially experienced a depressive phase, but then resolved (not known if treated pharmacologically). The disease is stable with ongoing therapy. Not known if there are other co-morbidities or allergies / intolerances. Concomitant medication included benserazide hydrochloride, levodopa (MADOPAR) taken for Disease Parkinson''s. The patient received both doses of Comirnaty: first dose on 08May2021 (at 76-years-old, single, intramuscular, Lot number EX2405) and second dose on 29May2021. Already after the first dose (latency unknown) family members noticed mood swings. After the second dose, on 29May2021, after about 2 hours, the patient shows a brief euphoric phase followed immediately after by a psychic breakdown. The same symptomatology is reported at the same time on Sunday 30May2021 and also on the afternoon of Monday 31May2021. On Tuesday 01Jun2021 his wife contacted him by phone at 12:00 pm where he did not have any signs of depression and was carrying out his usual activities ("I phoned him at 12:00pm, no signs of depression, he was happy that I wanted to go home earlier. He ate breakfast at 09:00am and the prepared lunch at 01:30pm as always"). At about 03:15pm his son contacted him by telephone and reports that he found him a little down but without worrying signals ("When he phoned with his son at 03:15pm, he was a bit down, but made no hints, on the contrary, he said that he was happy to see him soon). He took his own life (Accomplished suicide) when he was home alone at 04:00pm. He wrote a farewell note, probably installed a rope in the garage and then swallowed about 2 packages of sleeping pills (drug name unknown) and hanged himself. Autopsy pending, probably not ready for inspection until October. It is not known where the event happened. The patient outcome of the event after the second vaccination he had a brief, extremely euphoric phase and then shortly afterwards a psychic breakdown was not recovered. The patient died on 01Jun2021. It was not reported if an autopsy was performed. Event occurred in a country different from that of the reporter. A causal relationship between Comirnaty and events was assessed as unlikely. Regulatory Authority assessed this case as serious with fatal outcome. Sender''s comment: Suicide occurred 3 days after the second dose of Comirnaty in an elderly patient known for Parkinson''s disease and with a history of depression. Psychiatric symptoms manifested with mood swings after the first dose (latency unknown) and then with alternating phases of euphoria and collapse 2h after the second dose. Vaccination and likely death occurred. From the information sent by the reporter, an autopsy is planned, but it is not known when the report will be available. Psychiatric symptom and suicide are not known adverse events for Comirnaty in both the Regulatory Authority monograph and FDA data sheets. In Reports they report no psychiatric symptoms and suicide deaths in adverse events to covid-19mRNA vaccines. Cases of onset of psychotic symptoms in COVID-19 positive patients without prior psychiatric pathology, with resolution of symptoms after recovery from COVID-19, are described in the literature [1]. However, to date, there are no data in the literature on possible psychiatric exacerbations and deaths by suicide following COVID-19 vaccinations. In the database [2], out of a total of 529,095 reports on Comirnaty, 11 cases of completed suicide (PT) are counted. In light of the data at our disposal, given the absence of data in the literature, in a patient known for a previous depressive episode, despite the restricted timing, the causal link between psychiatric symptom and accomplished suicide is judged unlikely. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Summary of Reporter Comment: Suicide occurred 3 days after the second dose of Comirnaty in an elderly patient known for Parkinson''s disease and with a history of depression. Psychiatric symptoms manifested with mood swings after the first dose (latency unknown) and then with alternating phases of euphoria and collapse 2h after the second dose. Vaccination and likely death occurred. From the information sent by the reporter, an autopsy is planned, not known when report is available.; Sender''s Comments: Based on the reported information and possible contributory effects from patient''s medical history of Parkinson''s disease and depression, a causal association between the reported events of complete suicide, acute psychosis and suspect drug bnt162b2 was assessed as unrelated.; Reported Cause(s) of Death: He wrote a farewell note, probably installed the rope in the garage, then swallowed about 2 packages of sleeping pills and hanged himself


VAERS ID: 1575582 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cardiac discomfort; Stomach discomfort
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987771

Write-up: Sudden cardiac death; This is a spontaneous report from a physician downloaded from the WEB, company number DE-PEI-202100133877. A 74-year-old female patient received bnt162b2 (COMIRNATY) at the age of 74-years-old, via an unspecified route of administration on 23Jun2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. Medical history included stomach discomfort, cardiac discomfort and arterial hypertension from unknown dates. The patient''s concomitant medications were not reported. The patient experienced sudden cardiac death on 24Jun2021. The patient died on 24Jun2021. An autopsy was performed and results were not provided. Pathological-anatomical not unequivocally ascertainable, most likely sudden cardiac death in cardiac hypertrophy, 2-vessel CHD; no meaningful connection between vaccination and onset of death. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1575588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic stenosis, Aortic valve incompetence, Cardiogenic shock, Dyspnoea, International normalised ratio, International normalised ratio increased, Platelet count, Platelet count decreased, Thrombosis
SMQs:, Cardiac failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   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: Aortic valve replacement (mechanical)
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: INR; Result Unstructured Data: Test Result:over 7; Test Date: 20210408; Test Name: platelets; Result Unstructured Data: Test Result:low
CDC Split Type: DEPFIZER INC202100987709

Write-up: INR over 7; Aortic stenosis; Aortic insufficiency; Shock/cardiogenic shock; Dyspnoea; Low platelets; Thrombosis; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number is DE-PEI-202100145039. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Apr2021 (lot number and expiry date: unknown) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history mechanical aortic valve replacement. Concomitant medications were not reported. On 08Apr2021, the patient experienced aortic stenosis, aortic insufficiency shock (cardiogenic shock), dyspnoea, low platelets, and thrombosis. On 11Apr2021, the patient showed International normalised ratio (INR) over 7. The patient underwent lab tests and procedures which included platelets: low on 08Apr2021; and international normalised ratio (INR): 7 on 11Apr2021. The patient died on an 12Apr2021 due to the events. It was unknown if an autopsy was performed. The health authority (PEI) assessed the event as B. intermediate. Sender''s comment: Hospital referral 5 days after vaccination, chemical laboratory INR over 7, fault with mechanical aortic valve with aortic stenosis and aortic insufficiency, consequently progressing cardiogenic shock and exitus letalis 6 days after the vaccination. Basic illness: mechanical aortic valve replacement, year of birth given only. No follow-up attempts are possible, information on lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: aortic insufficiency; Aortic stenosis; Dyspnoea; Low platelets; Thrombosis; shock/cardiogenic shock; exitus letalis; INR over 7


VAERS ID: 1575589 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autoimmune haemolytic anaemia, Cardiac arrest, Diastolic dysfunction, Haemolysis, Hyperkalaemia, Hypoxia, Lactic acidosis, Pulmonary embolism, Renal failure, Right ventricular failure, Septic shock
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987590

Write-up: cardiovascular arrest; Pulmonary embolism; Autoimmune haemolytic anaemia; acute right heart failure; other microembolic hypoxaemia; Haemolytic crisis; Severe lactic acidosis; hyperkalaemia; kidney failure; septic shock; Diastolic Dysfunction; This is a spontaneous report from a non-contactable physician downloaded from the WEB, regulatory authority number DE-PEI-202100146481. A 68-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26May2021 at 68-years-old (Batch/Lot Number: 1D012A) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took first dose of bnt162b2 (COMIRNATY, strength 0.3 ml), on 27Apr2021 at 68-years-old for covid-19 immunisation. The patient experienced pulmonary embolism (death) on 15Jun2021, autoimmune haemolytic anaemia (death) on 15Jun2021, cardiovascular arrest in 22Jun2021 with outcome of unknown, acute right heart failure in 2021 with outcome of unknown, other microembolic hypoxaemia in 2021 with outcome of unknown, haemolytic crisis in 2021 with outcome of unknown, severe lactic acidosis in 2021 with outcome of unknown, hyperkalaemia in 2021 with outcome of unknown, kidney failure in 2021 with outcome of unknown, diastolic dysfunction in 2021 with outcome of unknown, septic shock in 2021 with outcome of unknown. The patient died on 23Jun2021. An autopsy was performed and results were not provided. This report is serious due to death. Comirnaty/ all events/ Unclassifiable. Reporter''s comment: Diagnosis/ies: The lethal outcome on 09Apr2021. Sudden intrahospital cardiovascular arrest on 22Jun2021 a. e. as a result of acute right heart failure with microembolic. Pulmonary artery embolism V. a. other microembolic hypoxaemia in severe autoimmune haemolytic anaemia with V. a. Haemolytic crisis. Severe lactic acidosis, hyperkalaemia, kidney failure. Diastolic Dysfunction, septic shock. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Diagnosis/ies: The lethal outcome on 09Apr2021. Sudden intrahospital cardiovascular arrest on 22Jun2021 a. e. as a result of acute right heart failure with microembolic. Pulmonary artery embolism V. a. other microembolic hypoxaemia in severe autoimmune haemolytic anaemia with V. a. Haemolytic crisis. Severe lactic acidosis, hyperkalaemia, kidney failure. Diastolic Dysfunction, septic shock.; Reported Cause(s) of Death: Autoimmune haemolytic anaemia; Pulmonary embolism


VAERS ID: 1575590 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Echocardiogram, Ejection fraction, Epistaxis, Fall, Physical examination, Platelet count, Thrombocytopenia, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 38
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: Adiposis; Angioplasty; Aortic sclerosis; Aortic valve stenosis (High grade; mean graded atrioventricular=34 mmHg); Arterial stenosis; Atrial fibrillation (Persistent atrial fibrillation, CHA2DS2VASc score 5, HAS-BLED score 2); Cardiac catheterization (Non-ST-Elevation Myocardial Infarction: Balloon angioplasty and stenting of the main trunk...); Coronary heart disease (Coronary three-vessel disease); Hyperlipidemia; Hypertensive heart disease; Ischemic cardiomyopathy; Nicotine abuse; Non ST segment elevation myocardial infarction; Obesity; Obstructive sleep apnoea syndrome; Peripheral arterial occlusive disease (Peripheral Arterial Oclusive Disease stage lla of the pelvic/thigh type); Pulmonary hypertension (World Health Organization group II); Renal insufficiency (Chronic renal failure st. 5, current glomerular filtration rate 14.8 ml/min.); Stenosis (High-grade stenosis of the brachiocephalic trunk); Stenosis; Type II diabetes mellitus (newly diagnosed, Hb1AC currently 6.2 %)
Allergies:
Diagnostic Lab Data: Test Name: ejection fraction; Test Result: 30 %; Test Name: Clinical examination; Result Unstructured Data: Test Result:Clinically, laboratory serochemically and radiogra; Comments: ..radiographically, we were able to confirm the picture in the context of decompensated heart failure with known Ischemic Cardiomyopathy and high-grade aortic valve stenosis. We started i.v. diuretic therapy with furesis. Furthermore, the renal retention parameters deteriorated.; Test Date: 20210416; Test Name: Platelets; Result Unstructured Data: Test Result:30,000; Test Name: echocardiographically; Result Unstructured Data: Test Result:detectable cardiac arrest
CDC Split Type: DEPFIZER INC202100987578

Write-up: Thrombocytopenia; Decompensated heart failure; Epistaxis; ventricular fibrillation; Fell in the bathroom adn had to be resuscitated; This is a spontaneous report from a non-contactable physician downloaded from the WEB, regulatory authority number DE-PEI-202100146577. An 84-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ET3674) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. Medical history included arterial stenosis, atrial fibrillation (Persistent atrial fibrillation, CHA2DS2VASc score 5, HAS-BLED score 2), coronary heart disease (Coronary three-vessel disease), aortic sclerosis, type 2 diabetes mellitus (newly diagnosed, Hb1AC currently 6.2 %), renal insufficiency (Chronic renal failure st. 5, current glomerular filtration rate 14.8 ml/min), obesity, pulmonary hypertension (World Health Organization group II), hyperlipidemia, nicotine abuse, cardiac catheterization from 23May2019 (at Non-ST-Elevation Myocardial Infarction: Balloon angioplasty and stenting of the main trunk towards the Ramus Circumflexus and provisional stenting of the Ramus Inter Ventricularis Anterior ostium. Very good long-term result after Root cause analysis intervention 2017. Balloon angioplasty of the right iliac artery for severe stenosis), aortic valve stenosis from 08Jun2020 (High grade aortic valve stenosis in invasive measurement from 08Jun2020 mean graded atrioventricular=34 mmHg), stenosis in the Ramus Inter Ventricularis Anterior from 08Jun2020 (High Care Unit of 08Jun2020: In-stent restenosis of the main stem, significant stenosis in the Ramus Inter Ventricularis Anterior), stenosis of the left subclavian artery with subclavian steal phenomenon from 12Jun2020, Hypertensive heart disease, Peripheral Arterial Oclusive Disease (Peripheral Arterial Oclusive Disease stage lla of the pelvic/thigh type), Adiposis, Obstructive sleep apnoea syndrome, and stenosis of the brachiocephalic trunk. The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY) on 03Mar2021 for covid-19 immunisation. On 30Mar2021, the patient experienced epistaxis. On 05Apr2021, the patient experienced decompensated heart failure. On 16Apr2021, the patient experienced thrombocytopenia. The events caused hospitalization on an unspecified date. It was also reported that the patient had decompensated heart failure with highly reduced Left ventricular ejection fraction (30%). On admission, the patient was in a clearly reduced general condition. Clinically, laboratory serochemically and radiographically, the physicians were able to confirm the picture in the context of decompensated heart failure with known ischemic cardiomyopathy and high-grade aortic valve stenosis. They started intravenous (IV) diuretic therapy with furesis. Furthermore, the renal retention parameters deteriorated. On 07May2021, the patient fell in the bathroom and had to be resuscitated. Resuscitation measures were started immediately. Emergency intubation followed. After a total of 2 mg of adrenaline, they observed ventricular fibrillation. Resuscitation measures were continued including one-time defibrillatiory and further adrenaline administration, but showed no effect. In case of degeneration into persistent asystole and echocardiographically detectable cardiac arrest, resuscitation measures had to be discontinued without success. The patient died on 07May2021 at 21.38 hrs. The patient underwent lab tests and procedures which included clinical examination: clinically, laboratory serochemically and radiographically, we were able to confirm the picture in the context of decompensated heart failure with known Ischemic Cardiomyopathy and high-grade aortic valve stenosis. They started intravenous (IV) diuretic therapy with furesis. Furthermore, the renal retention parameters deteriorated on an unspecified date; and platelet count: 30,000 on 16Apr2021. Therapeutic measures were taken as a result of decompensated heart failure and epistaxis. The events decompensated heart failure and epistaxis resulted to fatal outcome. The outcome of events thrombocytopenia, fall, and ventricular fibrillation were unknown at the time of death. The patient died on 07May2021 at 21:38 hours. It was not reported if an autopsy was performed. Reporter''s Comment: Platelets on 16Apr2021 33,000 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Platelets on 16Apr2021 33,000; Reported Cause(s) of Death: Decompensated heart failure; Epistaxis


VAERS ID: 1575596 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diagnostic procedure
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   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: Coronary heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack; Infarct myocardial (10 years ago); Non-smoker; Stent insertion NOS
Allergies:
Diagnostic Lab Data: Test Name: diagnostics; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DEPFIZER INC202100996218

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100152819. A 56-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 22Jul2021 as dose 2, single for covid-19 immunisation. The patient''s medical history included infarct myocardial from 2011 to an unknown date (reported as 10 years ago) which was as a single-vessel disease that has been treated with a stent on an unknown date, heart attack on an unknown date, and ongoing coronary heart disease. The patient has seen her cardiologist regularly. There the diagnostics indicated after infarction has been carried out regularly (dates unspecified; unknown results), the prescribed medication (according to guidelines) has been taken reliably, has been a non-smoker and has not had diabetes mellitus or other risk factors. She has not had uttered anginal complaints recently or after the heart attack. The patient''s concomitant medications were not reported. The patient received dose 1 of Comirnaty (strength: 0.3 ml) on 01Jul2021 for covid-19 immunisation. This report is serious - death. It was reported that 2 days after vaccination, on 24Jul2021, the patient experienced unknown cause of death. It was reported that patient had already entered rigor mortis. The woman had died in a semi-sloping prone position on the sofa, probably during the midday rest and was found by her husband. The husband reported seeing his wife last around 12:00 p.m., at which time she was symptom-free. The inquest did not reveal any evidence of an externally apparent cause of death. It was unknown if an autopsy was performed. In particular, the situation in which it was found (lying flat on the prone position, no leakage of pulmonary edema fluid or vomit) and the anamnestic information make death from the known Coronary heart disease appear relatively unlikely. Relatedness of drug to reaction/event as per source of assessment PEI was unclassifiable. Reporter''s Comments: It was a 56-year-old woman who had already entered rigor mortis. The woman had died in a semi-sloping prone position on the sofa, probably during the midday rest (?) And was found by her husband. The husband reported seeing his wife last around 12:00 p.m., at which time she was symptom-free. In medical history I was told of a stable Coronary heart disease, around 10 years earlier myocardial infarction as a single-vessel disease has been treated with a stent. The patient has seen her cardiologist regularly. There the diagnostics indicated after infarction has been carried out regularly, the prescribed medication (according to guidelines) has been taken reliably, has been a non-smoker and has not had diabetes mellitus or other risk factors. She has not have uttered anginal complaints recently or after the heart attack. The vaccination card presented to me for the deceased showed the entry of a BioNTech initial vaccination with the COMIRNATY vaccine on 01Jul2021, the 2nd vaccination with the same vaccine was carried out on 22Jul2021 approx. 48 hours before death. The inquest did not reveal any evidence of an externally apparent cause of death. In particular, the situation in which it was found (lying flat on the prone position, no leakage of pulmonary edema fluid or vomit) and the anamnestic information make death from the known Coronary heart disease appear relatively unlikely. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Summary of Reporter''s Comments: It was a 56-year-old woman who had already entered rigor mortis. The woman had died in a semi-sloping prone position on the sofa. The situation in which it was found (lying flat on the prone position, no leakage of pulmonary edema fluid or vomit) and the anamnestic information make death from the known Coronary heart disease appear relatively unlikely.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575599 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100996809

Write-up: Unknown cause of death; first dose of COMIRNATY (strength: 0.3 ml) on 07May2021 and the second dose on 16Jul2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100152920. A 74-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FF0900) as dose 2, 0.3 mL single (at the age of 74-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of COMIRNATY (strength: 0.3 ml) on 07May2021 and the second dose on 16Jul2021. 12 days after vaccination, on 28Jul2021, the patient experienced unknown cause of death. The event unknown cause of death was considered serious, fatal by the regulatory authority. It was unknown if an autopsy was performed. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575600 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-07-29
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Interchange of vaccine products
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MARCUMAR
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100155098

Write-up: This case was received via Regulatory Agency (Reference number: 202100155098) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH in a 74-year-old male patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) for Prophylactic vaccination. Concurrent medical conditions included Hypertension. Concomitant products included PHENPROCOUMON (MARCUMAR). On 26-Apr-2021, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (unknown route) 1 dosage form. On 19-Jul-2021, the patient received second dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product). The patient died on 29-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product) outcome was unknown. For mRNA-1273 (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Company comment: This case concerns an 74-year old male with medical history of Hypertension who died after receiving mRNA-1273. The cause of death was not reported. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information (translation) is expected. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Additional document attached on 9-AUG-2021.contain concomitant drug and medical history were added; Sender''s Comments: This case concerns an 74-year old male with medical history of Hypertension who died after receiving mRNA-1273. The cause of death was not reported. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information (translation) is expected. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1575603 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Gout; Heartburn
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016086

Write-up: Infarct myocardial; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is DE-PEI-202100157147. A 37 years old male patient received bnt162b2 (COMIRNATY, strength 0.3 ml), via an unspecified route of administration on 22Jun2021 (Batch/Lot number was not reported) (at the age of 36 years old) as single dose for covid-19 immunisation. Medical history included heartburn; gout; asthma and allergy; all from an unknown date and unknown if ongoing. Concomitant medication included omeprazole (OMEPRAZOL) taken for an unspecified indication, start and stop date were not reported. On 26Jun2021, the patient experienced Infarct myocardial, serious resulting in death. Diagnosis was confirmed by autopsy. The patient''s outcome was fatal for Infarct myocardial. The patient died on 26Jun2021. An autopsy was performed that revealed infarct myocardial. Relatedness of drug to reaction/event Infarct myocardial by Regulatory Authority was Unclassifiable. Sender Comment: Result of autopsy: fateful course, no connection to medication or vaccination. - Significant enlargement of the heart (550 g) - Atheroma plaques in all three main branches of the coronary artery - Pale heart muscle with streaky, reddish bleeding in places - Acute congestion of blood in the internal organs - pulmonary edema - Enlargement of the liver and fatty liver. The autopsy findings show a very recent heart attack. Despite only slight narrowing of the coronary arteries, a significant enlargement of the heart evidently led to an oxygen deficiency and thus to a heart attack. The autopsy - - did not reveal any evidence of a competing cause of death. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial; Autopsy-determined Cause(s) of Death: Infarct myocardial


VAERS ID: 1575607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Fibrin D dimer, Interchange of vaccine products, Off label use, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (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: Test Name: echo; Result Unstructured Data: Test Result:right heart strain; Test Name: D-dimer; Result Unstructured Data: Test Result:increased
CDC Split Type: DEPFIZER INC202101016081

Write-up: pulmonary artery embolism suspected; Interchange of vac patient receives one dose of Astra Zeneca and the patient receives the BNT162b2 vaccine as their second dose; Interchange of vac patient receives one dose of Astra Zeneca and the patient receives the BNT162b2 vaccine as their second dose; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100158187. A female patient of an unspecified age received BNT16B2 (COMIRNATY), 2nd dose via an unspecified route of administration on 16Jul2021 (Lot Number: FF0900, expiration date unknown) as a single dose (INITIAL PFIZER DOSE) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received VAXZEVRIA with 1st does (lot number and expiration date were unknown) on 04May2021 for covid-19 immunisation. The patient experienced pulmonary artery embolism suspected (death, hospitalization, life threatening) on an unspecified date. The patient underwent lab tests and procedures which included echocardiogram: right heart strain, D-dimer: increased, both on an unknown date. The patient died due to unknown cause of death and pulmonary artery embolism suspected on an unspecified date. It was not reported if an autopsy was performed. Relatedness of Comirnaty to Lung embolism: Result of Assessment: Unclassifiable from Regulatory Authority. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death; pulmonary artery embolism suspected


VAERS ID: 1575609 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101026276

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100159350. A 54-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 25Jun2021 (Batch/lot number: FD9234), at age 54 years old, as dose 1, 0.3 ml single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sudden cardiac death. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was done. The health authority assessed the relatedness of drug reaction to event as D: Unclassifiable (Source of assessment: Regulatory Authority). No follow-up attempts possible. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1575610 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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: COPD; Cor pulmonale; Coronary heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101026671

Write-up: Myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority: DE-PEI-202100159351. A 68-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Aug2021, at the age of 68-years-old, (Lot Number: FE9174) as dose 2, single for covid-19 immunisation. Medical history included ongoing Cor pulmonale, ongoing coronary heart disease, and ongoing chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. On 04Aug2021, 10 hours after vaccination, the patient experienced fatal Myocardial infarction. The patient died on 04Aug2021. It was not reported if an autopsy was performed. ; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1575668 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-26
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Labyrinthitis, Tonsillar inflammation, Wrong product administered
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diarrhea
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987599

Write-up: inner ear infection; Shortly after the vaccination, tonsillitis treated with antibiotics / Tonsillar inflammation; first vaccination was with VAXZEVRIA, then vaccinated the patient with COMIRNATY; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number DE-PEI-CADR2021124249. Additional case identifier: DE-PEI-202100120370. A 50-year-old male patient received BNT162B2 (COMIRNATY, solution for injection) dose 2 via an unspecified route of administration on 05Apr2021 (Lot number was not reported) as dose 2 (initial Pfizer dose), single for COVID-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration from an unspecified date (Lot number was not reported) to an unspecified date, at dose 1, single for an COVID-19 immunisation. Medical history included diarrhoea. Patient had no previous illnesses. The patient''s concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. The first vaccination was with VAXZEVRIA on an unspecified date. On 05Apr2021, the vaccination center vaccinated the patient with COMIRNATY according to the vaccination records found, because the deceased was under 60 years of age and the recommendation of the Standing Committee on Vaccination to restrict the AstraZeneca vaccination to the age group more than 60 years old was implemented at short notice by the vaccination center from 01Apr2021. On an unspecified date shortly after the vaccination, the patient had inner ear infection, where he was given antibiotics (it was not known at which doctor''s office). On an unspecified date, patient tonsillitis (tonsillar inflammation) treated with antibiotics. On 26Apr2021 10:40 am, patient died (unknown cause of death). Patient had no risk factor known, pre-existing conditions according to the treating physician on 18Mar2021, lastly at doctor office due to diarrhoea. o signs of illness/bleeding were found (the deceased was found lying in bed, box of paracetamol 500 mg and prednisolon acid 10 mg were found in a drawer at the location. The patient''s outcome was fatal for unknown cause of death, not recovered/not resolved for tonsillar inflammation, unknown for inner ear infection. The patient died on 26Apr2021. An autopsy was performed and results were not provided. The casual relationship of COMIRNATY and events were assessed as Unclassifiable. Reporter''s comment: clarification of vaccine situation, information about medical history Sender''s comment: Do you or the person concerned have any allergies? If so, which ones? Allergy against ibuprofen Information on risk factors or previous diseases no risk factor known, pre-existing conditions According to the treating physician on 18Mar2021, lastly at doctor office due to diarrhoea /. was found dead in his apartment on 26Apr2021 at 10.40 a.m., no autopsy carried out. No follow-up attempts are possible. Information on Batch/Lot numbers cannot be obtained. No further information is expected.; Reporter''s Comments: clarification of vaccine situation, information about medical history; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575670 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alveolitis, Autoimmune disorder, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 51
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Lung fibrosis (stabilised by medication); Rheumatic disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatological examination
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987700

Write-up: respiratory exhaustion; Alveolitis; Autoimmune disorder; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021134690. A 74-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Apr2021 (Batch/Lot Number: EX3599) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included Rheumatic disorder from 1990 and ongoing, Lung fibrosis from 2017 and ongoing (stabilised by medication), examination from 16Apr2021 11 am to an unknown date (Last examination with pulmonary fibrosis and rheumatism coordinating specialist: no significant change in the situation with rheumatism/pulmonary fibrosis, still stable. C vaccination recommendation maintained). Father was apparently not told anything about the mechanism of action or the associated waste products (peptides) and the resulting body''s own defense reactions. Patient still tried. Fear propaganda was stronger than reason, unfortunately. This is probably what happened to the vast majority of people who indulge in one-sided media insinuations. Just consider the very low percentage (%) of deaths among Covid-19(C)-sufferers. On16Apr2021, Covid-19 (C) vaccination recommendation. The patient''s concomitant medications were not reported. The patient experienced alveolitis (death, hospitalization) on 17Jun2021, autoimmune disorder (hospitalization) on 27Apr2021 with outcome of not recovered, respiratory exhaustion(hospitalization) on an unspecified date with outcome of unknown. The patient''s hospitalized and hospitalization was prolonged as a result of events, also reported as Hospital admission/Intense care unit (ICU), respiratory exhaustion, extracorporeal membrane oxygenation. The patient was hospitalized from 03Jun2021 to an unknown date. On 14Jun2021, treatment with particulate immune system blocker (without success). The patient died on 17Jun2021. An autopsy was not performed. Sender comment: Do you or the person concerned have any allergies? If so, which ones? None. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Alveolitis


VAERS ID: 1575671 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Breathing difficult; Heart attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987783

Write-up: Myocardial infarction old; Tachycardia; shortness of breath; chest pain; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number is DE-PEI-CADR2021134810. A 61-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 14May2021 at 12:50 (Batch/Lot Number: Unknown) (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing GOLD II chronic obstructive pulmonary disease (COPD), myocardial infarction/heart attack from 01Jan2021, severe back pain from 10May2021 to 14May2021 and feeling of not being able to breathe from 10May2021 to 14May2021. The patient''s concomitant medications were not reported. On 14May2021, patient experienced tachycardia, shortness of breath and chest pain. On 17May2021, patient experienced myocardial infarction old. The patient was hospitalized on an unspecified date due to the events. Therapeutic measures were taken as a result of myocardial infarction old. Outcome of myocardial infarction old was fatal, tachycardia was not recovered while rest of events was unknown. The patient died on 17May2021. An autopsy was not performed. Sender''s comment: My father was treated on 14May2021 at 12:50 by his general practitioner with BionTech vaccinated. He was suffering from stage GOLD II CHRONIC OBSTRUCTIVE PULMONARY DISEASE. In the week of 10May2021 to 14May2021 he had severe back pain and always the feeling of not being able to breathe. In retrospect, the doctors believe that he had already been suffering a heart attack. After the vaccination on 14May2021, he got severe shortness of breath again and chest pain. At around 9 p.m. (date unspecified), he was taken to the hospital by ambulance. The patient was taken to the emergency room of the university hospital and underwent emergency surgery. He died on 17May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: In retrospect, the doctors believe that he had already been suffering a heart attack. After the vaccination on 14May2021, he got severe shortness of breath again and chest pain. At around 9 p.m. (date unspecified), he was taken to the hospital by ambulance. The patient was taken to the emergency room of the university hospital and underwent emergency surgery. He died on 17May2021.; Reported Cause(s) of Death: Myocardial infarction old


VAERS ID: 1575672 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-07-16
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-17
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: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987988

Write-up: Death sudden; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number DE-PEI-CADR2021145491 with Safety Report Unique Identifier DE-PEI-202100145786. A 65-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Jun2021 (Batch/Lot Number: FC3095) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced ''death sudden'' on 16Jul2021. It was mentioned that patient fell dead off the bike while cycling without outside influence, resuscitation frustrated, patient was very sporty. The patient died on 16Jul2021. An autopsy was not performed. Event assessment : Comirnaty/ event/PEI /Result of Assessment: D. Unclassifiable. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no information on risk factors or previous illnesses none / fell dead off the bike while cycling without outside influence, resuscitation frustrated, patient was very sporty. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1575673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-09
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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: DEPFIZER INC202100987987

Write-up: Chronic obstructive pulmonary disease; Lung embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021145517. A 72-years-old male patient received bnt162b2 (COMIRNATY, lot ER7812), via an unspecified route of administration on 27Mar2021 at unknown dose, 0.3ml single for Covid-19 immunisation. The patient medical history was not reported. No concomitant medications reported. On 09Apr2021 the patient experienced Lung embolism; COPD (Chronic obstructive pulmonary disease) on unspecified date, both with fatal outcome. Therapeutic measures were taken as a result of the events. The patient died on 09Apr2021. It was not reported if an autopsy was performed. Sender comment: Information on risk factors or previous diseases not available. The patient tracheostomized in Chronic obstructive pulmonary disease, ventilated, suddenly massively increased ventilation pressure, immediate respiratory and circulatory arrest. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lung embolism; Chronic obstructive pulmonary disease


VAERS ID: 1575674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-03
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D018A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Gait disturbance, Headache, Pain, Pelvic pain, Pulmonary embolism, Renal pain, Venous thrombosis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis leg; Joint surgery (two)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987749

Write-up: Lung embolism/pulmonary embolism; venous thrombosis; Pain NOS; Headache; severe pain occurred in the kidney/pelvic area; severe pain occurred in the kidney/pelvic area; deep seated pain in the hip area; no longer ate much/loss of appetite; felt limp; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021147664. A 79-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 09Jun2021 (Lot Number: 1D018A) as dose number unknown, 0.3 mL single for COVID-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing, and two joint operations. The patient''s concomitant medications were not reported. On 03Jul2021, the patient experienced pain NOS and headache. On 05Jul2021, the patient experienced lung embolism. It was reported that since vaccination, the patient has felt limp and no longer ate much, she had loss of appetite on unspecified date in 2021. In the night of 03Jul2021 to 04Jul2021, severe pain occurred in the kidney/pelvic area and deep seated pain in the hip area and headaches. The intake of painkillers became necessary. In the evening of 05Jul2021, the person concerned passed away. A venous thrombosis was suspected, which was led to pulmonary embolism. The outcome of the event severe pain occurred in the kidney/pelvic area and deep seated pain in the hip area was recovered on 04Jul2021, the outcome of the event was not recovered for pain NOS and headache, the outcome of the event lung embolism/pulmonary embolism and venous thrombosis was fatal, while the outcome of the events was unknown. The patient died on 05Jul2021. It was not reported if an autopsy was performed. Sender comment: Do you or the person concerned have any allergies? If so, which ones? No. Information on risk factors or previous diseases After two joint operations, the Leg thromboses. The one surgery in a The other operation was in both legs / Since the second operation, the leg has been damaged. Vaccination, the person concerned has felt limp and no longer ate much Loss of appetite In the night of 03Jul2021 to 04Jul2021 severe pain occurred in the Kidney/pelvic area and deep seated Pain in the hip area and Headaches. The intake of Painkillers became necessary. In the evening of 05Jul2021, the person concerned passed away. A venous thrombosis is suspected, which is led to pulmonary embolism. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lung embolism/pulmonary embolism; venous thrombosis


VAERS ID: 1575675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100996096

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority. The Regulatory Authority Number is DE-PEI-CADR2021150610, and the Sender''s (Case) Safety Report Unique Identifier is DE-PEI-202100151101. A 47-year-old male patient received the first dose of BNT162B2 (COMIRNATY; strength: 0.3 ml; lot number: unknown), via an unspecified route of administration on 29Jun2021 (at an unspecified age) at dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jul2021, the patient experienced infarct myocardial. The patient died on an unspecified date in 2021. It was unknown if autopsy was done. Outcome of the event was fatal. Relatedness of BNT162B2 (COMIRNATY) to the event was D. unclassifiable (source of assessment: Regulatory Authority). No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial.


VAERS ID: 1575679 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-22
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Ascites; Hepatic cirrhosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016091

Write-up: deceased; thrombus in the abdominal area; This is a spontaneous report received from a non-contactable Consumer downloaded from the Medicines Agency (MA) WEB number DE-PEI-CADR2021151187, Safety Report Unique Identifier DE-PEI-202100151072. An 82-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 31Mar2021 (lot number: unknown) via unknown route of administration at 0.3ml single dose for COVID-19 immunisation. Medical histories included Hepatic cirrhosis from unknown date and ongoing; Ascites from unknown date and ongoing. Concomitant medications were not reported. On 22Apr2021 the patient experienced thrombus in the abdominal area (hospitalization). On 27Apr2021 the patient experienced deceased. The patient''s outcome was not recovered for Thrombosis, fatal for Unknown cause of death. It was not reported if an autopsy was performed. The event assessment for all events to the suspect drug was reported as Unclassifiable. Sender Comment: Information on risk factors or previous illnesses liver cirrhosis, ascites / The patient was in inpatient treatment. Diagnoses: cirrhosis of the liver, ascites. No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Reported Cause(s) of Death: deceased


VAERS ID: 1575681 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-04
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal gland cancer; Cancer; Nephrectomy (one kidney removed in 1986)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016087

Write-up: Died; Weakness/feeling weak until completely powerless; Cough; Dyspnoea/shortness of breath; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021152779, Safety Report Unique Identifier: DE-PEI-202100153668. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 20May2021 (Lot Number: 1C006A) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included adrenal gland cancer from 1986 to an unknown date, ongoing Chronic renal insufficiency, Information on risk factors or previous illnesses included renal insufficiency; one kidney removed in 1986 due to cancer. The patient''s concomitant medications were not reported. The patient experienced died on 14Jun2021, cough on 05Jun2021, dyspnoea/shortness of breath on 04Jun2021, weakness/feeling weak until completely powerless on 11Jun2021. Two weeks after 2nd vaccination shortness of breath, then cough, then feeling weak until completely powerless; died three and a half weeks after 2nd vaccination. The outcome of the event died was fatal. The patient died on 14Jun2021. An autopsy was not performed. The outcome of the other events was not recovered. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575682 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-24
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematocrit, Haemoglobin, Nausea, Palpitations, Pneumonia viral, Pulmonary embolism, Thrombocytopenia, Thrombophlebitis superficial, Thrombosis, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pleuropneumonia; Polyglobulia
Allergies:
Diagnostic Lab Data: Test Name: Hct; Result Unstructured Data: Test Result:greater than 51 V% %; Test Name: Hct; Result Unstructured Data: Test Result:48 V% %; Test Name: Hb; Result Unstructured Data: Test Result:17.7 g/dl; Test Name: Hb; Result Unstructured Data: Test Result:17.6 g/dl; Test Name: thrombopenia; Result Unstructured Data: Test Result:95/nl
CDC Split Type: DEPFIZER INC202101016089

Write-up: palpitations; thrombosis right/suspected Right thrombosis femoral; nausea; vomiting; viral pneumonia; Thrombophlebitis of superficial arm veins; fulminant pulmonary embolism/ Lung embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority. Report number: DE-PEI-CADR2021154121. Sender''s (Case) Safety Report Unique Identifier: DE-PEI-202100155749. A 16-year-old male patient received second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 01Jul2021 at single dose for covid-19 immunisation. Medical history included polyglobulia, pleuropneumonia from Mar2021 to an unknown date. The patient''s concomitant medications were not reported. On 25Jul2021, the patient experienced fulminant pulmonary embolism/Lung embolism, thrombosis right. The patient recently in hospital stays due to palpitations - dyspnea extr. Performance kink - no cause found. The patient experienced thrombophlebitis of superficial arm veins. Mainly viral pneumonia, the patient was again hospitalization from 11Jul2021 to 14Jul2021 and received antibiotic infusion. Here already polyglobules Hb 17.7 g / dl, Hct greater than 51V%. On 24Jul2021, admission due to collapse nausea, vomiting. On 25Jul2021, resuscitation. The patient experienced LAE (laparoscopic appendectomy)/suspected Right thrombosis femoral. Noticeable volume depletion when admitted with polyglobules Hb 17.6 g / dl, At admission. Hct 48 V%, thrombopenia 95 / nl. Therapeutic measures were taken as a result of fulminant pulmonary embolism/ lung embolism, thrombosis right/suspected right thrombosis femoral, viral pneumonia. The outcome of event fulminant pulmonary embolism/ Lung embolism was fatal and other events was unknown. The patient died on 27Jul2021. It was not reported if an autopsy was performed. This report was reported as serious as death. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? none Relatedness of drug to reaction(s)/event(s) (for every event) Source of assessment: Regulatory Authority Result of Assessment: D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: fulminant pulmonary embolism/ Lung embolism


VAERS ID: 1575683 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-06-25
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Meningoencephalitis herpetic
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 8
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: Adenocarcinoma of prostate
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic regurgitation (grade 2); Arterial hypertension; Cerebral disorder; Cerebrovascular insufficiency; Computerized tomogram head; Epileptic seizure; Herpes simplex type I (in the lumbar puncture); Hyperlipoproteinemia; Prostate cancer (state after Prostate cancer); Pulmonary valve insufficiency (grade 2); Transient ischemic attack; Tricuspid regurgitation (grade 2); Unsteady gait; Vigilance decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016082

Write-up: Epileptic fit; Encephalitis herpes; This is a spontaneous report from a non-contactable consumer downloaded from the WEB DE-PEI-CADR2021154535. Sender''s (Case) Safety Report Unique Identifier: DE-PEI-202100155666. An 87-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 20Mar2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3ML SINGLE for covid-19 immunisation. Medical history included Adenocarcinoma of prostate; Aortic regurgitation grade 2, pulmonary valve insufficiency grade 2, Tricuspid regurgitation grade 2, arterial hypertension, HLP (Hyperlipoproteinemia), TIA(Transient ischemic attack), cerebrovascular insufficiency, Z.n. (State after) Prostate cancer / acute change of character with unsteady gait, strongly fluctuating vigilance, epileptic. Seizures, cerebral opacity, evidence of HSV (Herpes simplex viruses) 1 in the lumbar puncture, cCT (Cranial computed tomography) dtl. No known of any allergies. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) strength 0.3 ml, dose 1 on 27Feb2021 for COVID-19 immunization with no adverse reaction. This report was serious for death. On 25Jun2021 the patient experienced Encephalitis herpes (fatal), Epileptic fit (hospitalized). The patient had Exitus letalis on 03Jul2021, 21st after herpes encephalitis HSV1 with epilept. Seizures, onset acutely; Herpes virus reactivation possible after vaccination (unclear)? Patient Previously completely symptom-free in this regard. The patient''s outcome was fatal for Encephalitis herpes, not recovered/not resolved for Epileptic fit. The patient died on 03Jul2021. It was not reported if an autopsy was performed. Sender Comment: Information on risk factors or previous illnesses: AI II (Aortic regurgitation grade 2), PI II (pulmonary valve insufficiency grade 2), TI I (Tricuspid regurgitation grade 2) (I08.2 + G), arterial hypertension, HLP (Hyperlipoproteinemia), TIA(Transient ischemic attack) 8/08 in (G45.92 + G) CVI [cerebrovascular insufficiency] (I67.88 + G), Z.n. (State after) Prostate cancer / acute change of character with unsteady gait, strongly fluctuating vigilance, epileptic. Seizures, cerebral opacity, evidence of HSV(Herpes simplex viruses) 1 in the lumbar puncture, cCT (Cranial computed tomography) dtl. Medullary edema increasing in the course, exit from lethal. Relatedness of drug to reaction(s)/event(s) (for every event) per PEI was D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Encephalitis herpes


VAERS ID: 1575684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-22
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016080

Write-up: stroke/Accident cerebrovascular; High blood pressure after the 3rd day. 3 weeks later stroke, coma, death; High blood pressure after the 3rd day. 3 weeks later stroke, coma, death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority number DE-PEI-CADR2021154709. Sender''s Safety Report Unique Identifier: DE-PEI-202100155598. A 70-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (reported as 18Jul2021, pending clarify) (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. No known of any allergies. Never had anything for 70 years. The patient medical history and concomitant medications were not reported. On 22Jun2021 the patient experienced Hypertension. On 08Jul2021 the patient experienced Accident cerebrovascular. High blood pressure from the 3rd day. 3 weeks later stroke, coma, death. All on the same day. The patient died on 08Jul2021. An autopsy was not performed. The patient''s outcome was not recovered/not resolved for hypertension, fatal for accident cerebrovascular, unknown for other event. Result of assessment (source: PEI) unclassifiable. No follow-up activities possible. No further information expected. Batch/LOT number cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1575685 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-07-17
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Fatigue, Headache, Pneumonia, Pyrexia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic 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), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Disease Parkinson''s
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016100

Write-up: kidney failure; fatigue; Headache; Pyrexia; Pneumonia; Stroke; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021155137], Safety Report Unique Identifier [DE-PEI-202100156608]. A male patient of unknown age received the second dose of bnt162b2 (COMIRNATY) on 29May2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history included Disease Parkinson''s from unknown date and ongoing. Concomitant medications were not reported. On 17Jul2021 the patient experienced Pneumonia, Pyrexia, Headache, stroke. Patient experienced kidney failure, fatigue on unknown date. Therapeutic treatment was received for events Pneumonia; Stroke; Headache; Pyrexia. The patient''s outcome was fatal for Pneumonia, unknown for events kidney failure; fatigue and not recovered for other events. The patient died on 01Aug2021, due to Pneumonia. It was not reported if an autopsy was performed. Event assessment between the events with the suspect drug was reported as Unclassifiable. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? : no. Information about risk factors or previous illnesses: Parkinson''s disease / fatigue, fever, headache, intensive care with pneumonia, stroke, kidney failure. Treatment with various antibiotics, painkillers$g no success. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1575686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Death, Malaise, Nausea, Peripheral vascular disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016062

Write-up: Arrhythmia; Circulatory disorder peripheral; Nausea; Vomiting; Malaise; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021155166, Safety Report Unique Identifier DE-PEI-202100156711. A 67-year-old male patient received bnt162b2 (COMIRNATY, mRNA), via an unspecified route of administration on 29Jul2021 (Lot Number: FF0900) as dose number unknown, single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 30Jul2021 the patient experienced vomiting, nausea, circulatory disorder peripheral. On 31Jul 2021 the patient experienced Unknown cause of death. The patient also experienced arrhythmia, malaise. The seriousness of arrhythmia, vomiting, nausea, circulatory disorder peripheral was hospitalized. The patient died on 31Jul2021. It was unknown if an autopsy was performed. The outcome of unknown cause of death was fatal. The outcome of other events was not recovered. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575687 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Dyspnoea (dyspnoea during exercise); Palpitation; Tachycardia
Preexisting Conditions: Medical History/Concurrent Conditions: Pressure chest
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016057

Write-up: Myocarditis determined during the autopsy, which, when viewed together, suggests a causal myocarditis related to the vaccination against SARS-CoV2.; conspicuous cardiac arrhythmia; This is a spontaneous report received from a non-contactable consumer downloaded from the WEB. The regulatory authority report number is DE-PEI-CADR2021155185, Safety report unique identifier DE-PEI-202100156753. A 61-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Apr2021 (at unknown age) as single dose for COVID-19 immunisation. The patient''s medical history included: Tachycardia, Palpitation, Dyspnoea (dyspnoea during exercise), all above ongoing, and feeling of pressure on the heart. The patient''s concomitant medications were not reported. Myocarditis determined during the autopsy, which, when viewed together, suggests a causal myocarditis related to the vaccination against SARS-CoV2. The patient''s outcome was fatal for Myocarditis. This report is serious-death. The patient died on an unspecified date. Relatedness of drug to reactions/events. Source of assessment. Result of Assessment was D. Unclassifiable. Sender Comment: Information on risk factors or previous illnesses: Palpitations, dyspnoea during exercise + feeling of pressure on the heart/no known immediate reaction, during an inpatient stay conspicuous cardiac arrhythmia with subsequent resuscitation 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: Myocarditis; conspicuous cardiac arrhythmia; Autopsy-determined Cause(s) of Death: Myocarditis


VAERS ID: 1575688 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-20
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: House dust mite allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016072

Write-up: Stroke died/accident cerebrovascular; Stroke died; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021155544. An 81-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 ml, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on 29Apr2021 as single dose for covid-19 immunisation. Medical history included House dust mite allergy. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for prophylactic vaccination. The patient experienced stroke died on an unspecified date. The patient experienced also accident cerebrovascular on an unspecified date, aneurysm on 20May2021. Time Interval between beginning of drug administration and start of reaction / event was 3 weeks. The outcome of events was fatal. The patient died on 23May2021. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events. Source of assessment: Regulatory Authority. Result of Assessment: D. Unclassifiable Sender Comment: Are you or the person concerned known of any allergies? If yes, which? House dust mite allergy / no serious side effects for the time being. On 20May2021, aneurysm died 3 days later. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular; Aneurysm


VAERS ID: 1575698 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Cough, Death, Dyspnoea, Immune system disorder, Influenza like illness, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 123
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101028277

Write-up: Immune System Breakdown; pneumonia; Influenza like illness; fever; apathy; shortness of breath; cough; Unknown cause of death; This is a spontaneous report from a non-contactable consumer. This is the second of two reports. The first report is a report from the Medicines Agency (MA) WEB [DE-PEI-CADR2021034283]. A 95-year-old male patient received the 2nd dose of BNT162B2 (COMIRNATY) intramuscular on 29Jan2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had no allergies. The patient previously received the 1st dose of BNT162B2 (COMIRNATY) intramuscular on 08Jan2021 for COVID-19 immunisation, experienced throat tightness, immune system disorder (NOS), shingles, pneumonia on 26Jan2021; fever, apathy, struggling in sleep, severely weakened immune system on 27Jan2021 visit to the doctor. On 31Jan2021 the patient experienced immune system breakdown and Influenza like illness. Before: good general condition without serious pre-existing illnesses. On 29Jan2021, the patient had the 2nd corona vaccination (DESPITE CLEAR IMMUNE WEAKNESS). On 31Jan2021, the patient experienced fever, apathy, struggling, shortness of breath, cough, onset of pneumonia. On 02Feb2021, the patient was transferred to hospital, pneumonia, collapse of the immune system, life-threatening condition. On 12Feb2021, the patient was transferred back to the retirement home. Since then, bedridden, care level 5. This report is serious - hospitalization. The patient was died with unknown cause of death on 04Jun2021. No autopsy was performed. Outcome of the events immune system breakdown and Influenza like illness was recovered/resolved with sequelae, of the event Unknown cause of death was fatal, of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202100996489 same patient, first/second dose; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575708 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EW4815 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioimmunoblastic T-cell lymphoma recurrent, Condition aggravated, Death, Tubulointerstitial nephritis
SMQs:, Acute renal failure (broad), Chronic kidney disease (broad), Malignant lymphomas (narrow), Tubulointerstitial diseases (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 54
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: Chronic kidney disease; Dermatomyositis; Leucocytoclastic vasculitis; Mesangiocapillary glomerulonephritis; Prostate adenoma
Preexisting Conditions: Medical History/Concurrent Conditions: Angioimmunoblastic T-cell lymphoma; Cardiac failure congestive
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Nephritis interstitial acute; Condition aggravated; This case was received via Regulatory Authority (Reference number: ES-AEMPS-961434) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of TUBULOINTERSTITIAL NEPHRITIS, ANGIOIMMUNOBLASTIC T-CELL and CONDITION AGGRAVATED in a 78-year-old male patient who received mRNA-1273 (Spikevax) (batch no. EW4815) for COVID-19 vaccination. The patient''s past medical history included Angioimmunoblastic T-cell lymphoma in September 2020 and Cardiac failure congestive. Concurrent medical conditions included Leukocytoclastic vasculitis, Dermatomyositis, Chronic kidney disease, Mesangiocapillary glomerulonephritis and Prostate adenoma. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced TUBULOINTERSTITIAL (seriousness criteria death, hospitalization and medically significant), ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (seriousness criteria death, hospitalization and medically significant) and CONDITION (seriousness criteria death and hospitalization). The patient died on 14-Jun-2021. The reported cause of death was Nephritis interstitial acute and Condition aggravated. It is unknown if an autopsy was performed. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 15-Apr-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was given. No treatment medication was given Company comment- Very limited information regarding these events has been provided at this time. No further follow up information is expected. Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow up information is expected.


VAERS ID: 1575717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Asthenia, Inappropriate schedule of product administration, Pneumonia, Seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINEMET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101016150

Write-up: Inappropriate schedule of vaccine administered; aspirated the vomit; Asthenia; Pneumonia; vomited; SEIZURE; This is a spontaneous report received from a contactable consumer downloaded from the Agency WEB. The regulatory authority report number is FI-FIMEA-20213823. A 61-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 19Jul2021 (Lot Number: unknown) as single dose for COVID-19 immunization. Medical history included parkinson''s disease. Concomitant medication included carbidopa monohydrate, levodopa (SINEMET) taken for parkinson''s disease. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 26Apr2021 as single dose for COVID-19 immunization. On 20Jul2021, the second day really bad and at night, the patient experienced seizure and vomited, asthenia, aspirated the vomit and got pneumonia which led to Death. The cause of death was aspiration pneumonia. Autopsy was unknown. The outcome of Inappropriate schedule of vaccine administered was unknown. The outcome of other events was fatal. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Aspiration pneumonia


VAERS ID: 1575739 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Bacterial test, Death, Fatigue, SARS-CoV-2 test, Urine analysis
SMQs:, Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENOLOL; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; SERETIDE; MONURIL; SERTRALINE HYDROCHLORIDE; AVODART; DAFALGAN; TAMSULOSINE [TAMSULOSIN HYDROCHLORIDE]; DEPAKOTE; CLOZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic schizophrenia; COPD; COVID-19; Obesity
Allergies:
Diagnostic Lab Data: Test Name: Cytobacterioligical urine exam; Result Unstructured Data: Test Result:leukocytes +++; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: Urine stip test; Result Unstructured Data: Test Result:leukocytes +++
CDC Split Type: FRPFIZER INC202101016142

Write-up: Fatigue; Anxiety; Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-LM20212076. A 74-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 27Jul2021 (Lot Number: FF0680) as Dose 1, single for COVID-19 immunisation. Medical history included COVID-19, Arterial hypertension, Chronic schizophrenia, severe obesity, and chronic obstructive pulmonary disease (COPD). Concomitant medications included atenolol; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); fluticasone propionate, salmeterol xinafoate (SERETIDE); fosfomycin trometamol (MONURIL); sertraline hydrochloride; dutasteride (AVODART); paracetamol (DAFALGAN); tamsulosin hydrochloride (TAMSULOSINE); valproate semisodium (DEPAKOTE); and clozapine. The patient experienced death unexplained on 01Aug2021, fatigue and anxiety on an unspecified date. Information sought by the Regulatory Authority: Urinary gene reported by the patient the day before vaccination with pain when urinating. (Prescription of MONURIL present in the long-term drug history). Hyperthermia in the afternoon of 26Jul2021 (38.1 ? C) treated with paracetamol. Cytobacterioligical urine exam and Urine test strip carried out the next day 27Jul2021: leukocytes +++ Monuril in the morning of 29Jul2021. Vaccination on 27Jul2021 D1. Unusual anxiety and fatigue reported by the patient following vaccination; Found dead in his bed on 01Aug2021 (D + 6). no autopsy. Comments: Approximate period of onset of the adverse reaction: If the side effect is immediate, delay: Hospitalization service: Specify:. The outcome of the events fatigue and anxiety was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575742 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101016226

Write-up: Sudden death; Fever; This is a spontaneous report received from a contactable Physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MA20212995. A 39-years-old male patient received second dose of bnt162b2 (COMIRNATY), at the age of 39-years-old intramuscular on 01Jul2021 17:00 (Lot Number: FA7082) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previous received first dose of bnt162b2 (COMIRNATY) (lot EX7823) at the age of 39-years-old on 10Jun2021 13:30 as single dose for covid-19 immunisation. The patient experienced fever (medically significant) on 02Jul2021 morning, sudden death on 03Jul2021. Treatment was received for fever including intervention of the urgent medical aid service during the night of 02Jul2021 to 03Jul2021. The outcome of fever was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: sudden death


VAERS ID: 1575749 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Headache, Malaise, Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Discomfort; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101016213

Write-up: heart attack; Death NOS/sudden death; Headache; Feeling sick; Discomfort; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-NT20213103. A 70-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 11May2021 (at the age of 70 years old) (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included Smoker and discomfort while walking. The patient''s concomitant medications were not reported. The patient experienced death NOS on 07Jun2021, headache on 11May2021, feeling sick on 11May2021. It was reported that: Malaise and headache on the evening of the injection, then sudden death occurring on the night of 07Jun2021. According to the urgent medical aid service doctor, heart attack. Information obtained after contact with the declarant: the patient was not being followed up and had no attending physician. He smoked a lot. In March, he complained of discomfort while walking without further details. Evolution: Death on 07Jun2021. No autopsy. Discomfort and headache occurred on the evening of the first injection (11May2021). 2nd dose not carried out because initially planned on 19Jun2021. The outcome of Headache and Feeling sick was recovered on an unspecified date, of Death NOS/sudden death was fatal, of the other event was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Death NOS/sudden death


VAERS ID: 1575758 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-07-19
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood bicarbonate, Blood count, Blood pressure measurement, Body temperature, C-reactive protein, COVID-19, Computerised tomogram, Computerised tomogram thorax, Drug ineffective, Fibrin D dimer, Heart rate, Investigation, Lymphocyte count, Oxygen saturation, PCO2, PO2, Platelet count, Respiratory rate, SARS-CoV-2 test, Urine analysis, White blood cell count, pH body fluid
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: 2021-08-03
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Anaemia; Arterial hypertension; Beta thalassemia minor (diagnosed in 2018); Cancer of prostate (treated with laser, hormone therapy); Cardiac failure; Cholecystectomy; Chronic renal insufficiency (stage 3); Haemorrhage of digestive tract; Ketosis-prone diabetes mellitus; Lumbar spinal stenosis; Proctitis NOS.
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result: diffuse crackles; Test Date: 20210731; Test Name: bicarbonates; Result Unstructured Data: Test Result:23.4 mmol/L; Test Name: blood count; Result Unstructured Data: Test Result:8.3 g/dl; Comments: microcytic anemia at 8.3 g / dL; Test Name: Blood pressure; Result Unstructured Data: Test Result:135/82 mmHg; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210731; Test Name: CT; Result Unstructured Data: Test Result: CT which does not find pulmonary...; Comments: embolism but an increase in parenchymal attacks of severe pneumopathy type Covid-19. CT pulmonary arterial hypertension. Cardiomegaly.; Test Name: Un-injected pulmonary CT; Result Unstructured Data: Test Result:Covid-19 type pneumonia with severe...; Comments: ...involvement (50-75%) of the abnormalities. High blood pressure CT scans with pulmonary artery trunk measured at 33mm; Test Name: CRP; Result Unstructured Data: Test Result:146 mg/l; Test Name: D-dimer; Result Unstructured Data: Test Result:660 ng/ml; Test Name: Heart rate; Result Unstructured Data: Test Result:86; Comments: /min; Test Name: clinical examination; Result Unstructured Data: Test Result: fatty cough, a bilateral and symmetrical; Comments: vesicular murmur with diffuse, non-spastic crackles. No sign of failure; Test Name: lymphopenia; Result Unstructured Data: Test Result:0.2 x10 9/l; Comments: lymphopenia; Test Name: Saturation; Test Result: 88 %; Test Date: 20210731; Test Name: Saturation; Test Result: 96 %; Test Date: 20210801; Test Name: Saturation; Test Result: 90 %; Test Date: 20210731; Test Name: pCO2; Result Unstructured Data: Test Result:33 mmHg; Test Date: 20210731; Test Name: ph; Result Unstructured Data: Test Result:7.47; Test Name: platelet; Result Unstructured Data: Test Result:193 x10 9/l; Test Date: 20210731; Test Name: pO2; Result Unstructured Data: Test Result:62 mmHg; Test Date: 20210802; Test Name: respiratory rate; Result Unstructured Data: Test Result:22/min; Test Date: 20210719; Test Name: RT-PCR Sars-Cov-2 positive; Test Result: Positive; Comments: nasal aspiration sample; Test Name: Screening RT-PCR; Result Unstructured Data: Test Result: positive for the L452R mutation; Test Name: cytobacterioligical urine exam with leukocyturia; Result Unstructured Data: Test Result: cytobacterioligical urine exam with leukocyturia a; Comments: cytobacterioligical urine exam with leukocyturia at 37 / mm3.; Test Name: leukocytosis; Result Unstructured Data: Test Result:5.8 x10 9/l; Comments: leukocytosis.
CDC Split Type: FRPFIZER INC202101016225

Write-up: Vaccination failure; symptomatic Covid-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PO20214066. A 82-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on May2021 (Batch/Lot Number: Unknown) as 0.3 mL, single dose for covid-19 immunisation. Medical history included lumbar spinal stenosis, cholecystectomy, Beta thalassemia minor diagnosed in 2018, AFib, ketosis-prone diabetes mellitus, Arterial hypertension, Proctitis NOS, Haemorrhage of digestive tract, Cancer of prostate treated with laser, hormone therapy, Chronic renal insufficiency stage 3, Cardiac failure and Anaemia. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and symptomatic covid-19 on 19Jul2021. The clinical course was as follows: 30Jul2021: The male patient is hospitalized for the management of a symptomatic Covid-19 with positive test on 19Jul2021 and asthenia, diarrhea, fluctuating fever and difficult alimentation / hydration since 22Jul2021. Suspected vaccine failure. It is put under 4L of O2 before a desaturation at 88%. Blood pressure 135 / 82mmHg, heart rate 86 / min. Clinical examination found a fatty cough, a bilateral and symmetrical vesicular murmur with diffuse, non-spastic crackles. No sign of failure. Biology: leukocytosis 5.8G / L, microcytic anemia at 8.3 g / dL, platelets at 193 G / L, lymphopenia at 0.2G / L, CRP at 146 mg / L, D-dimer at 660 ng / mL. cytobacterioligical urine exam with leukocyturia at 37 / mm3. RT-PCR Sars-Cov-2 positive (nasal aspiration sample). Screening RT-PCR (mutations of interest) positive for the L452R mutation. Increase in oxygen therapy to 8L / min due to desaturation under 4L. Un-injected pulmonary CT: Covid-19 type pneumonia with severe involvement (50-75%) of the abnormalities. High blood pressure CT scans with pulmonary artery trunk measured at 33mm. Initiation of treatment with amoxicillin / clavulanic acid, dexamethasone and anticoagulation with enoxaparin 4000IU. 31Jul2021: 38.7 C, polypneic 30 / min, SpO2 96% under 8L with a high concentration mask. The patient is asthenic, pulmonary auscultation with diffuse crackles. Blood gas: pH 7.47, pO2 62mmHg, pCO2 33mmHg, bicarbonates 23.4 mmol / L. CT which does not find pulmonary embolism but an increase in parenchymal attacks of severe pneumopathy type Covid-19. CT pulmonary arterial hypertension. Cardiomegaly. The patient went under 12L of o2 due to a new episode of desaturation under 8L. Increase in dexamethasone to 20mg / 24h. 01Aug2021: 90% desaturation under 12L of O2, increase to 14L with the mask. 02Aug2021: Clinical worsening: afebrile, multiple deep desaturations under 14L of O2, dyspneic with respiratory rate at 22 / min. Beginning of treatment with tocilizumab and 15L of O2 mask. 03Aug2021: Death of the patient. An autopsy was not performed. The outcome of the events vaccination failure and symptomatic covid-19 were 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: symptomatic Covid-19; Vaccination failure


VAERS ID: 1575765 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-07-14
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood bicarbonate, Blood creatinine, Blood fibrinogen, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood sodium, Body temperature, C-reactive protein, COVID-19, Coma scale, Fibrin D dimer, Heart rate, Oxygen saturation, PCO2, PO2, Physical examination, Prothrombin level, Respiratory disorder, Respiratory rate, SARS-CoV-2 test, Vaccination failure, White blood cell count, X-ray, pH body fluid
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 8
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: RAMIPRIL; TAMSULOSIN; HUMALOG; PARACETAMOL; MACROGOL; RIVAROXABAN; ASCORBIC ACID; COLECALCIFEROL; Comirnaty
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon (Adenocarcinoma of the right colon discovered on occlusive syndrome); Atrial fibrillation; Cataract; Diabetes mellitus insulin-dependent (insulin-requiring diabetes with neuropathy); Intellectual disability
Allergies:
Diagnostic Lab Data: Test Name: bicarbonate content; Result Unstructured Data: Test Result:23.3 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:326 umol/l; Test Date: 20210721; Test Name: fibrinogen; Result Unstructured Data: Test Result:5.18 g/l; Test Date: 20210721; Test Name: LDH; Result Unstructured Data: Test Result:564 IU/l; Test Name: lactate; Result Unstructured Data: Test Result:2.7 mmol/L; Test Name: K; Result Unstructured Data: Test Result:6 mmol/L; Test Name: Na; Result Unstructured Data: Test Result:158 mmol/L; Test Name: temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:6; Test Date: 20210720; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:7; Test Name: CRP; Result Unstructured Data: Test Result:47.5 mg/l; Test Date: 20210721; Test Name: Dimers; Result Unstructured Data: Test Result:3170 ng/ml; Test Name: Heart rate; Result Unstructured Data: Test Result:109; Comments: bpm; Test Name: SpO2; Test Result: 96 %; Comments: SpO2 96% under 15 L / min; Test Date: 20210720; Test Name: SpO2; Test Result: 97 %; Comments: SpO2 97% under 15 L; Test Name: pCO2; Result Unstructured Data: Test Result:35 mmHg; Test Name: pH; Result Unstructured Data: Test Result:7.4; Test Name: physical examination; Result Unstructured Data: Test Result:Irregular heart sounds, aortic hearth murmur; Comments: MV +/+, diffuse ronchi, thoraco-abdominal rocking, polypnea, painless supple depressible abdomen; Test Name: pO2; Result Unstructured Data: Test Result:110 mmHg; Test Date: 20210721; Test Name: prothrombin level; Test Result: 73 %; Test Name: Respiratory rate; Result Unstructured Data: Test Result:40; Comments: / min; Test Date: 20210714; Test Name: SARS CoV2 PCR; Result Unstructured Data: Test Result:SARS CoV2 delta variant infection; Test Name: polynuclear neutrophil; Result Unstructured Data: Test Result:11.12 g/l; Test Name: WB; Result Unstructured Data: Test Result:12.9 g/l; Test Name: pulmonary radiography; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC202101016234

Write-up: disturbances of consciousness; respiratory deterioration; diagnosis of SARS CoV2 delta variant infection/fever and dyspnea; diagnosis of SARS CoV2 delta variant infection/fever and dyspnea; This is a spontaneous report from a contactable physician downloaded from the Agency regulatory authority number FR-AFSSAPS-TS20213351. An 88-year-old male patient received BNT162B2 (COMIRNATY), second dose via intramuscular on 05Feb2021 as single dose, first dose via intramuscular on 18Jan2021 as single dose for covid-19 immunisation. Medical history included adenocarcinoma of colon from 2012 (Adenocarcinoma of the right colon discovered on occlusive syndrome), Diabetes mellitus insulin-dependent (insulin-requiring diabetes with neuropathy), complete arrhythmia by atrial fibrillation, intellectual disability, cataract. Concomitant medication included ramipril; tamsulosin; insulin lispro (HUMALOG); paracetamol; macrogol; rivaroxaban; ascorbic acid; colecalciferol. On 14Jul2021 (5 months from 2nd dose): fever and dyspnea. Consultation at the emergency reception service on 14Jul2021 with diagnosis of SARS CoV2 delta variant infection [polymerase chain reaction (PCR) of 14Jul2021]. Antibiotic therapy with Augmentin 3g/d for 8 days and Solupred 20 mg for 5 days. On 20Jul2021, readmitted to the emergency reception service via the urgent medical aid service for deterioration of his condition, with disturbances of consciousness and respiratory deterioration. Glasgow coma scale (GCS) 7, SpO2 97% under 15 L. At the emergency reception service: GCS 6, heart rate (HR) 109 bpm, temperature (T) 38.5 ?C, Respiratory rate (RR) 40/min, SpO2 96% under 15 L/min. Physical examination: irregular heart sounds, aortic hearth murmur, MV +/+, diffuse ronchi, thoraco-abdominal rocking, polypnea, painless supple depressible abdomen. Hydration, Augmentin, suspension of its usual treatment. Biology: White blood (WB) 12.9 G/L, including polynuclear neutrophil 11.12 G/L, Na 158 mmol/L, K 6 mmol/L, creatinine 326 umol/L, C-reactive protein (CRP) 47.5 mg/L. Blood gas under 15L: pH 7.40, pCO2 35 mmHg, pO2 110 mmHg, bicarbonate content: 23.3 mmol/L, lactate 2.7 mmol/L.. On 21Jul2021: Dimers 3170 ng/mL, fibrinogen 5.18 g/L, lactate dehydrogenase (LDH) 564 IU/L, prothrombin level 73%. On unspecified date, pulmonary radiography: unknown results. Implementation of oxygen therapy 3 L/min from 07/15. Death of the patient on the morning of 22Jul2021. In total, failure of the vaccination with delta-variant COVID-19 pneumonia, 5 months after the 2nd dose of Comirnaty, in a patient at risk of severe form, of unfavorable evolution. The outcome of the events was fatal. The patient died on 22Jul2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: diagnosis of SARS CoV2 delta variant infection/fever and dyspnea; diagnosis of SARS CoV2 delta variant infection/fever and dyspnea; disturbances of consciousness; respiratory deterioration


VAERS ID: 1575768 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal exposure during pregnancy, Foetal heart rate abnormal, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: ultrasound; Result Unstructured Data: Test Result: Nothing to report; Comments: ultrasound in 1st trimester; Test Date: 20210616; Test Name: ultrasound; Result Unstructured Data: Test Result: stop of foetal heart activity Intra uterine death; Comments: new ultrasound at 2.5 months of pregnancy.
CDC Split Type: FRPFIZER INC202101039993

Write-up: stop of foetal heart activity; fetus patient/was exposed to BNT162B2 (COMIRNATY), via transmammary; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BR20212888. A fetus patient of an unspecified gender was exposed to BNT162B2 (COMIRNATY), on 11Jun2021 (Lot Number: FD0168) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced stop of foetal heart activity in Jun2021. The patient underwent lab tests and procedures which included ultrasound scan: nothing to report on 10Jun2021 ultrasound in 1st trimester, ultrasound scan: stop of foetal heart activity intra uterine death on 16Jun2021 new ultrasound at 2.5 months of pregnancy. The outcome of the event stop of foetal heart activity was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100996798 Maternal case; Reported Cause(s) of Death: stop of foetal heart activity


VAERS ID: 1576141 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Barium meal, Computerised tomogram, Endoscopy, Leukopenia, Magnetic resonance imaging, SARS-CoV-2 test, Thrombosis, Vomiting, White blood cell count, X-ray
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 137
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: Anaemia; Bone cancer; Bone disorder
Allergies:
Diagnostic Lab Data: Test Name: Barium meal; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO; Test Name: CT scan; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO; Test Name: Endoscopy; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO; Test Name: MRI; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: white blood cell count; Result Unstructured Data: Test Result:seriously lowered; Test Name: white blood cell count; Result Unstructured Data: Test Result:never recovered; Test Name: X-ray; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO
CDC Split Type: GBPFIZER INC202100998323

Write-up: thrombosis arm; Vomiting; Leukopenia; 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-202108021624010440-ZUITU. Safety Report Unique Identifier is GB-MHRA-ADR 25742233. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 as dose 1, single for COVID-19 immunisation. Medical history included anaemia, bone cancer, and bone disorder from an unknown date and unknown if ongoing. Patient is not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. Concomitant medications included statins taken for an unspecified indication, chemotherapy pills for bone cancer, monthly bone strengthening injection to the pelvis for bone disorder, all start and stop dates were not reported. On 20Jan2021, the patient experienced leukopenia and vomiting. On an unspecified date, the patient experienced thrombosis arm. The patient was admitted to a hospital due to the events. The patient underwent lab tests and procedures which included barium meal, computerised tomogram (CT) scan, endoscopy, magnetic resonance imaging (MRI) scan, x-ray all with unknown results and no information available, Covid-19 virus test: No - Negative COVID-19 test, white blood cell count was seriously lowered and never recovered on unspecified dates. Outcome of the events of vomiting and thrombosis arm was not recovered. Leukopenia stop date was reported as 07Jun2021. The patient died on 07Jun2021. The cause of death was reported as leukopenia. It was not reported if an autopsy was performed. The clinical course was reported as follows: My mother was vulnerable because of on set of bone cancer. However a couple of hours after receiving the Pfizer shot she started vomiting. She was admitted to hospital A&E a couple of days later as it didn''t stop and was found to have a seriously lowered white blood cell count. She was told this was normal and it would pass in a week. A neighbour called an ambulance a couple of days later, told her that going into hospital was no a good idea because of the Variant and she should recover in 10 days or so. Her doctor repeated this, and said the shot was ''stirring up her meds''. She was eventually admitted to hospital where she vomited every day till her death. She was also found to have thrombosis in her arm, and her white blood cell count never recovered. Patient has not tested positive for COVID-19 since having the vaccine.Please provide details of any relevant investigations or tests conducted: "new, wider kidney stent. Endoscopy. Barium meal and scan. MRI scan. X ray. CT scan. Stomach stent. Total blood transfusion." I do not know the names of the medication, but my mother was taking statins. She had recently started chemotherapy pills and receiving a monthly bone strengthening injection to the pelvis. These medications were removed from her after a month or so in hospital. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Leukopenia


VAERS ID: 1576146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Not had a COVID-19 test)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992455

Write-up: Heart attack; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021910375450-WGDFM. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot number and Expiry date was unknown) via an unspecified route of administration on 02Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included symptoms associated with COVID-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. On 06Feb2021, the patient experienced heart attack. The patent died on 06Feb2021. 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 attack (death).


VAERS ID: 1576210 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-05-05
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100998354

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108031729017300-XSRUJ, Safety Report Unique Identifier GB-MHRA-ADR 25748658. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 04Mar2021 (also reported as 04Mar2020), (Lot number was not reported) as second dose, single for COVID-19 immunisation. Medical history included suspected covid-19 (unsure when symptoms started). The patient''s concomitant medications were not reported. The patient experienced death on 05May2021 (also reported as 03Feb2021). The patient underwent lab tests and procedures which included covid-19 virus test: Yes - Positive COVID-19 test on an unspecified date. The patient died on 05May2021. It was not reported whether an autopsy was performed. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1576277 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dehydration, Dermatitis exfoliative generalised, Psoriasis, Respiratory failure, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (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), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 4
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: FOLIC ACID; SERTRALINE; THIAMINE
Current Illness: Alcohol abuse; Alcoholism; Depression; Psoriasis (Chronic recurrent flares of psoriasis with hospital admissions).
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response).
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Psoriasis; Respiratory failure; Fluid loss; Erythroderma; This regulatory authority case was reported by a physician and describes the occurrence of DERMATITIS EXFOLIATIVE GENERALISED (Erythroderma), PSORIASIS (Psoriasis), RESPIRATORY FAILURE (Respiratory failure) and DEHYDRATION (Fluid loss) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response). Concurrent medical conditions included Alcoholism, Psoriasis (Chronic recurrent flares of psoriasis with hospital admissions.), Depression and Alcohol abuse. Concomitant products included FOLIC ACID from 20-Jul-2021 to an unknown date and THIAMINE from 20-Jul-2021 to an unknown date for Alcoholism, SERTRALINE from 18-Sep-2020 to an unknown date for Depression. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced DERMATITIS EXFOLIATIVE GENERALISED (Erythroderma) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced PSORIASIS (Psoriasis) (seriousness criteria death and hospitalization), RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria death, hospitalization and medically significant) and DEHYDRATION (Fluid loss) (seriousness criteria death and hospitalization). The patient was treated with BETAMETHASONE VALERATE (BETNOVATE) for Psoriasis, at an unspecified dose and frequency; CICLOSPORIN for Psoriasis, at an unspecified dose and frequency and Physical therapy (Resuscitation) for Respiratory failure. The patient died on 31-Jul-2021. The reported cause of death was Erythroderma. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was given fluids to correct the fluid loss as a treatment. It was reported that COVID vaccine was a potential trigger for the flares of psoriasis. On 31Jul 2021, patient deteriorated suddenly, with type 2 respiratory failure, and despite treatment and attempts at resuscitation, patient died. Reporter states that it was not clear whether patient died of pulmonary oedema/heart failure, pneumonia, PE, or ARDS associated with erythroderma. Patient''s death has been referred to the coroner and the post-mortem examination will be conducted. Patient was not enrolled in clinical trial Company Comment: Very limited information regarding this event/s has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Erythroderma


VAERS ID: 1576309 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Medication errors (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200707; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; inappropriate schedule of vaccine administered; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). The patient died on an unknown date. The cause of death was not reported. An autopsy was not performed. At the time of death, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2020, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medications were reported. No treatment information was provided. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. This is a case of sudden death in a 39-year-old male patient with no known past medical history, who died 30 days after receiving a dose of the vaccine. This report also refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown). Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 39-year-old male patient with no known past medical history, who died 30 days after receiving a dose of the vaccine. This report also refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown). Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576331 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Leukaemia
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012819

Write-up: Leukemia; This is a spontaneous report from a contactable consumer received from the Regulatory Authority report number is GB-MHRA-WEBCOVID-202108051321493730-MH2SX, Safety Report Unique Identifier GB-MHRA-ADR 25759327. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced leukemia on Apr2021. The patient died on 02Apr2021 due to Leukemia. It was not reported if an autopsy was performed. The outcome of Leukemia 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: Leukemia


VAERS ID: 1576344 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nipple pain, SARS-CoV-2 test
SMQs:, COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101012808

Write-up: Nipple pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051900058590-06OTW. Safety Report Unique Identifier GB-MHRA-ADR 25761414. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced nipple pain on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient died on 07May2021 due to Nipple pain. It was not reported if an autopsy was performed. The outcome of Nipple pain 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: Nipple pain


VAERS ID: 1576388 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; This case was received via Regeulatory Agency (Reference number: ADR 25765678) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 79-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 21-Mar-2021 The patient died on 21-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Company Comment :This is a case of sudden death in a 79-year-old male subject with no known medical history, who died 5 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 79-year-old male subject with no known medical history, who died 5 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1576472 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
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: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014749

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108080734040960-PKCKB, Safety Report Unique Identifier GB-MHRA-ADR 25771141. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient medical history and patient''s concomitant medications were not reported. The patient died on 03Aug2021. It was not reported if an autopsy was performed. Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1576503 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Small for dates baby
SMQs:, Neonatal disorders (narrow), 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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101047977

Write-up: This is a spontaneous report from a contactable consumer (patient''s mother). This is the second of two reports. The first report is a report downloaded from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301012054630-3YTOV. The reporter (mother) provided information both for herself and her baby. This is the baby report. A fetus patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via transplacental on 03Jul2021 (Lot Number: FA1027) as single dose for COVID-19 immunisation. The 30-year-old mother''s medical history was not reported. The mother''s concomitant medication included folic acid taken for folic acid supplementation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via transplacental on 06Mar2021 (lot number: ET8885) for COVID-19 immunisation. The scan on unspecified date in 2021 found a very small sac in the uterus, but much smaller than it should be for 5 weeks. The mother had another scan in 2 weeks. At this scan, on unspecified date in 2021, the sac had grown, but there was no sign of life inside (no foetal pole or yolk present). The outcome of the event was fatal on unspecified date in 2021. 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) : GB-PFIZER INC-202100977268 mother case;GB-MHRA-WEBCOVID-202107301012054630-3YTOV MHRA; Reported Cause(s) of Death: scan found a very small sac in the uterus. But much smaller than it should be for 5 weeks/At this scan, the sac had grown. But there was no sign of life inside/ no foetal pole or yolk present


VAERS ID: 1576529 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac arrest, Dyspnoea, Hypoxia, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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: 2021-07-24
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID-19 rapid POC test; Test Result: Positive
CDC Split Type: GRPFIZER INC202101016155

Write-up: Cardiac arrest; SARS-CoV-2 test positive; fever; Hypoxaemia; ACUTE DYSPNEA; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB, regulatory authority number GR-GREOF-20216554. A 35-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 16Jul2021 as dose number unknown, single for covid-19 immunisation . Medical history included ongoing obesity. The patient''s concomitant medications were not reported. The patient experienced hypoxaemia, acute dyspnea, COVID-19 rapid POC test positive, fever on 18Jul2021, cardiac arrest on an unspecified date. Seriousness criteria reported as death and medically significant for events hypoxaemia, acute dyspnea, and cardiac arrest. The patient died on 24Jul2021. It was not reported if an autopsy was performed. The outcome of events hypoxaemia, acute dyspnea, and cardiac arrest was fatal; outcome of other events was unknown. No follow-up attempts possible. No further information expected. Batch/LOT number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest; Hypoxaemia; ACUTE DYSPNEA


VAERS ID: 1576553 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Decreased appetite, Dehydration, Drug ineffective, Multiple organ dysfunction syndrome, Systemic inflammatory response syndrome
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), Sepsis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension (arterial hypertension); Hyperlipoproteinemia (HLP); Unspecified cerebrovascular disease (cerebrovascular disease)
Preexisting Conditions: Medical History/Concurrent Conditions: Femoral hernia incarcerated; Gangrene intestine (Gangrene sg. intestinal tenuis); Incarcerated hernia repair (Op. plastic sec. Mc Vay); Intestinal anastomosis (Resection sg. intestinal tenuis cum anastomosis T-T); Intestinal resection (Resection sg. intestinal tenuis cum anastomosis T-T); Microcytic anemia; Sideropenia (Treated in 2011 for microcytic anemia, then sideropenia).
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC202100997898

Write-up: Systemic inflammatory response syndrome; multiorgan syndrome; COVID-19 pneumonia; Dehydration; stopped eating and drinking for 2 days; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HR-HALMED-300049886. An 81-year-old female patient received BNT162B2 (COMIRNATY) on 01Feb2021 (Batch/Lot Number: UNK) at the age of 81 years old as dose 2, 0.3 ml single, and on an unspecified date in 2021 (Batch/Lot Number: UNK) as dose 1, 0.3 ml single, intramuscular for COVID-19 immunisation. Medical history included treated in 2011 for microcytic anemia, then sideropenia; intestinal anastomosis and intestinal resection (resection sg. intestinal tenuis cum anastomosis t-t); ongoing unspecified cerebrovascular disease; ongoing arterial hypertension; femoral hernia incarcerated from 2013; incarcerated hernia repair (Op. plastic sec. Mc Vay); ongoing hyperlipoproteinemia (HLP); Gangrene intestine (Gangrene sg. intestinal tenuis. OP. Disincarceration). The patient''s concomitant medications were not reported. On 01Feb2021, the patient experienced vaccination failure. On 23Apr2021, stopped eating and drinking for 2 days (hospitalized from unknown date). Then on 24Apr2021, the patient experienced for COVID-19 pneumonia, systemic inflammatory response syndrome (SIRS), dehydration and multiorgan syndrome. Events were considered as life threatening. The patient was hospitalized for vaccination failure, covid-19 pneumonia, SIRS, dehydration and multiorgan syndrome from 24Apr2021 to an unknown date. Therapeutic measures were taken included hospitalization, rehydration, antimicrobial treatment, oxygen supplementation, NG probe. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Systemic inflammatory response syndrome; multiorgan syndrome; COVID-19 pneumonia; Vaccination failure; Dehydration; stopped eating and drinking for 2 days


VAERS ID: 1576556 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-09
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Fatigue, Heart rate, Heart rate decreased, Pain in extremity, Pulmonary oedema, Respiratory arrest, Suffocation feeling
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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: Lupus erythematosus systemic (Systemic lupus 34 years)
Preexisting Conditions: Medical History/Concurrent Conditions: Heart valve replacement (8 years ago she got an artificial valve and drank Martifarine)
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Heart rate; Result Unstructured Data: Test Result:39bpm
CDC Split Type: HRPFIZER INC202101018099

Write-up: water around her lungs and heart; she was suffocating; stopped breathing; coma; low heart rate; tiredness; arm pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. Report number HR-HALMED-300050040. A 53-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in 2021 as dose number unknown, 0.3ml single for COVID-19 immunisation. Medical history included ongoing Lupus erythematosus systemic (Systemic lupus 34 years), artificial valve from 2013 (8 years ago she got an artificial valve and drank Martifarine). The patient''s concomitant medications were not reported. The patient experienced low heart rate (death, hospitalization, medically significant, life threatening) on 09Jun2021, tiredness (death, hospitalization, medically significant, life threatening) on 09Jun2021, arm pain (death, hospitalization, medically significant, life threatening) on 09Jun2021. The patient was vaccinated a month ago pfizer. Although her former immunology had defended her flu vaccine all her life. 7 days later, a general doctor appeared and complained that it was not good for her to have a strong heartbeat. The doctor said that this was a side effect and how it will pass. After another 7 days she was taken away by an ambulance at 38 beats per minute and since then everyone has been shouting that it couldn''t be from the vaccine. After another 7 days in the hospital she died. On 15Jun2021, she was taken by ambulance with 38 beats per minute to hospital. 8 years ago she got an artificial valve and drank Martifarine. She was checked on hospital often in both immunology and cardiology. Last day hospital in 5 months. Condition great, of course with daily therapy (for lupus 34 years, for valvular 8). 15Jun,16Jun and 17Jun cannot operate on her (pacemaker) because pv in her blood was not suitable for surgery. 17Jun In the afternoon, her heart stops for the first time. They resuscitated her, intubate her and put her in a coma. 24Jun finally a doctor who said that she had water around her lungs and heart but within normal limits, that she had bacteria but they didn''t know which one yet, how she had a temperature (she was ok all those days, it got better as far as the heart was concerned) but she could not talk for long because she was suffocating, she could not breathe without oxygen, she was kept in an intensive care unit without air conditioning (lupus does not tolerate heat). They told the reporter they didn''t give her corticosteroids because they helped the bacteria grow faster, and she has been on them for 34 years. 24Jun2021 at 3.30pm they finished the correspondence, she said she was going to get some sleep. She stopped breathing, she was in a coma again and on a respirator, to call in 2.3 hours when the results will be ready. At 20 they said they were reviving her, at 21 others she said she died half an hour ago. The patient underwent lab tests and procedures which included heart rate (normal range 50-100): 39bpm on 15Jun2021. The outcome of events low heart rate, tiredness, arm pain was fatal, of other events was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: arm pain; tiredness; low heart rate


VAERS ID: 1576562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101020666

Write-up: Death; pulmonary embolism/breathing difficulties; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number HU-OGYI-661521. A 100-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Jun2021 (Batch/Lot Number: FD1921) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included bedridden. The patient''s concomitant medications were not reported. On 19May2021 the patient received the first dose (batch number: FA4598) and on 23Jun2021 received the second dose of 0.3 ml COMIRNATY to prevent Covid-19. 2 days after vaccination, the patient experienced breathing difficulties. When the physician arrived, the patient already passed away. Based on autopsy report, the cause of death was a recent pulmonary embolism. The patient was bedridden and occasionally took NSAID painkillers. The patient died on 25Jun2021. An autopsy was performed and results were not provided. Sender''s comment: Pulmonary embolism is not listed, but embolic events have been reported with the vaccine. Based on the above, the causal relationship is possible between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1576563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure (Hospitalized as treatment several times: three times in 2017, one time in 2019 and one time in 2020.); Type II diabetes mellitus.
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization; Ischaemic cardiomyopathy.
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: COVID-19 rapid POC test; Test Result: Negative.
CDC Split Type: HUPFIZER INC202101027715

Write-up: generalized oedema and dyspnoea at rest due to existing heart failure; death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-673721. A 67-years-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 16May2021 (Lot Number: FA4598) as DOSE 2, 0.3 ML SINGLE for covid-19 immunization. Medical history included ischaemic cardiomyopathy, ongoing type II diabetes mellitus and ongoing heart failure was hospitalized as treatment several times: three times in 2017, one time in 2019 and one time in 2020. The patient''s concomitant medications were not reported. The patient previously had COMIRNATY on 11-APR-2021, dose 1, 0.3 ml single (Lot number: EW2239) via intramuscular in the left arm for COVID-19 immunisation. The physician reported concerning the occurrence of death after the use of COMIRNATY of the patient on 21May2021. On 18May2021, the patient was hospitalized due to the progression of his heart disease. He experienced generalized oedema and dyspnoea at rest due to existing heart failure. The patients COVID-19 rapid POC test was negative on 18-MAY-2021. On 21May2021, the patient died. With regard to the patients severe heart failure existing for many years, no autopsy was initiated. The patient died on 21May2021. An autopsy was not performed. The outcome of events heart disease, generalized edema, dyspnea and "generalized oedema and dyspnoea at rest due to existing heart failure" was unknown. Senders comment: Death after vaccination with Comirnaty concentrate for dispersion for injection is not expected. TTO for hospitalization was 2 days until death was 5 days. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not related. The case is considered serious due to hospitalization and fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the available information reported event death most possibly related patient underlying medical history and the event cardiac failure aggravated cannot be totally 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 ac-tion in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Inves-tigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1576564 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pneumonia aspiration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis (severe atherosclerosis which caused severe narrowing of the arteries throughout the body)
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101020667

Write-up: aspiration pneumonia; Death; This is a spontaneous report from a contactable physician downloaded from the WEB. The regulatory authority report number HU-OGYI-674321. An 84-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 26Mar2021 (Batch/Lot Number: Unknown) as 0.3 ml single for covid-19 immunisation. Medical history included arteriosclerosis. The patient''s concomitant medications were not reported. The patient passed away on 15Apr2021. Based on the autopsy report, the patient had severe atherosclerosis which caused severe narrowing of the arteries throughout the body. The cause of death was determined to be aspiration pneumonia. The patient died on 15Apr2021. An autopsy was performed and results were not provided. Sender Comment: According to the autopsy, the pathologist assessed the case as not related to the suspected vaccine. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible, information on batch number cannot be obtained. No further information is expected ; Reported Cause(s) of Death: the patient had severe atherosclerosis which caused severe narrowing of the arteries throughout the body. The cause of death was determined to be aspiration pneumonia.


VAERS ID: 1576565 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Congestive heart failure; COPD; Hypertension; Ischemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101020669

Write-up: Death; cardiac insufficiency; This is a spontaneous report from a contactable other healthcare professional downloaded from the WEB HU-OGYI-674821. A 90-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 08Apr2021 (Batch/Lot Number: EW9127) as 0.3 ml single for covid-19 immunisation. Medical history included hypertension, cardiac failure congestive, chronic obstructive pulmonary disease, arteriosclerosis, Ischemic heart disease. The patient''s concomitant medications were not reported. On 04Mar2021 the patient received the first dose (batch number: EP2163) and on 08Apr2021 received the second dose of 0.3 ml COMIRNATY to prevent Covid-19. The patient went to the Emergency Room on 15Apr2021 because of cardiac decompensation. She was admitted in the hospital on 16Apr2021, but passed away 1 day later. Based on the autopsy report, the patient had atherosclerosis resulting in ischemic heart disease. The direct cause of death was cardiac insufficiency. The patient died on 17Apr2021. An autopsy was performed and results were not provided. The case was investigated, the investigator did not find any irregularities regarding the transportation and storage of the vaccine. The investigator assessed the event as not related to the vaccine. Sender Comment: The investigator assessed the causality between the suspected drug and the adverse event as unlikely. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible, information on batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac insufficiency


VAERS ID: 1576567 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-17
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Death, Respiratory failure, Weight
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MEDROL [METHYLPREDNISOLONE]; TREXAN [METHOTREXATE]; MELODYN [MELOXICAM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain; Hypertension; Rheumatoid arthritis (since 2005)
Allergies:
Diagnostic Lab Data: Test Name: weight; Result Unstructured Data: Test Result:lost 14 kg; Comments: 4 months before her passing
CDC Split Type: HUPFIZER INC202101020672

Write-up: cardiorespiratory insufficiency; cardiorespiratory insufficiency; Death; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number HU-OGYI-676121. A 67-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 25May2021 (Batch/Lot Number: FA4598) as 0.3 ml single for covid-19 immunisation. Medical history included rheumatoid arthritis from 2005, hypertension, pain. Concomitant medications included methylprednisolone (MEDROL) taken for rheumatoid arthritis; methotrexate (TREXAN) taken for rheumatoid arthritis; meloxicam (MELODYN) taken for rheumatoid arthritis. On 16Apr2021 the patient received the first dose (batch number: EW4815) and on 25May2021 received the second dose of 0.3 ml COMIRNATY to prevent Covid-19. The patient was sent to the ER because of weakness and severe pain causing her not being able to walk. The patient had known rheumatoid arthritis since 2005 and chronic pain syndrome. The patient passed away on 17Jun2021. 4 months before her passing, the patient has lost 14 kg-s. Based on the autopsy report, the cause of death was cardiorespiratory insufficiency. The patient died on 17Jun2021. An autopsy was performed. Sender Comment: The reporter physician assessed the case as related to the patient''s primary diseases, therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible, information on batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Respiratory insufficiency; Cardiac insufficiency


VAERS ID: 1576627 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-28
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 2 - / -

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: 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: ISTIN; ARICEPT; ATECOR; CALTRATE [CALCIUM CARBONATE;COLECALCIFEROL]; OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]; PROZAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Hypertension; Macular degeneration
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101016109

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory authority report number IE-HPRA-2021-079730 with Safety Report Unique Identifier IE-HPRA-CVARR2021071514089. An 81-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on Mar2021 (lot number: EW8904) at 0.3 ml single for COVID-19 immunisation. Medical history included macular degeneration, hypertension, and dementia. Concomitant medications included amlodipine besilate (ISTIN), donepezil hydrochloride (ARICEPT), atenolol (ATECOR), calcium carbonate, colecalciferol (CALTRATE), ascorbic acid, retinol, tocopherol (OCUVITE), and fluoxetine hydrochloride (PROZAC). On 28Apr2021 (as reported), the patient experienced pulmonary embolism 12 days post administration of 2nd Comirnaty vaccine. ?? (as reported) related to vaccine. Case narrative: Initial report received by the HPRA on 15Jul2021 from a healthcare professional. This report concerned an 81-year-old female who experienced pulmonary embolism following vaccination with Comirnaty for COVID-19 immunisation. The patient''s concomitant medication included Prozac, Caltrate, Atecor, Ocuvite, Aricept, and Istin. The patient''s medical history/concurrent conditions included dementia, hypertension, and macular degeneration. In Mar2021, the patient was vaccinated with the second dose of Comirnaty (batch number: EW8904), at a dose of 0.3 ml. On 28Apr2021, 12 days after the second dose, the patient experienced pulmonary embolism and was admitted to hospital. On an unknown date, the patient passed away in hospital. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1576646 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac arrest, Chest pain, Computerised tomogram, Culture, Echocardiogram, Hypotension, Oxygen saturation decreased, Pneumonia, Pulmonary embolism, Pyrexia, Sepsis, Tachycardia, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 81
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: Dilated cardiomyopathy; Heart failure
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown; Test Name: computerized tomography; Result Unstructured Data: Test Result:Unknown; Test Name: culture; Result Unstructured Data: Test Result:Unknown; Test Name: echocardiography; Result Unstructured Data: Test Result:Unknown; Test Name: radiograph; Result Unstructured Data: Test Result:Unknown
CDC Split Type: ISPFIZER INC202101010444

Write-up: Fever; Oxygen saturation low; Low BP; cardiac arrest; Chest pain; tachycardia; Thromboembolism in the left lung/pulmonary embolism; pneumonia; increase signs of infection in the blood in the uterus; This is a spontaneous report from a contactable physician downloaded from the WEB. This physician reported different events for both doses of Comirnaty for the same patient. This is the first of two reports for dose 2. The regulatory authority report number for the first, serious report is [IS-IMA-4078]. A 69-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 04May2021 (Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: Unknown), both as single dose for covid-19 immunisation. Medical history included dilated cardiomyopathy and heart failure. The patient''s concomitant medications were not reported. On 30Apr2021, 16 days after the first injection the patient''s heart failure gets worsened and was hospitalized. On 06May2021, 2 days after the second vaccination is diagnosed with thromboembolism in the left lung, new-onset pulmonary embolism. He was discharged on 07Jun2021 but was hospitalized again on 25Jun2021 because of chest pain and heart rate too high. He gets a fever and increase signs of infection in the blood in the uterus and was put on antibiotics for pneumonia. Has persistently low oxygen saturation and low blood pressure which got worse. Tried to improve blood flow around the body with Cordarone drip but went into cardiac arrest and died 26Jul2021. The outcome of increase signs of infection in the blood in the uterus and pneumonia was unknown, outcome of other events was fatal. The patient underwent lab tests and procedures which included blood test, computerised tomogram, culture, echocardiogram, x-ray with result of unknown on unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : IS-PFIZER INC-202101020610 the same patient, different doses and events; Reported Cause(s) of Death: Heart attack; Acute heart failure; Fever; Oxygen saturation low; Low BP; tachycardia; cardiac arrest; Chest pain; Thromboembolism in the left lung/pulmonary embolism


VAERS ID: 1576651 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW224G / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Cerebrovascular disorder; Cognitive impairment; Heart disorder; Senile dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100989581

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) WEB. The regulatory authority number is IT-MINISAL02-761888. An 86-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in left arm (also reported as left shoulder) on 15Apr2021 at 14:00 (Batch/Lot Number: EW224G) as dose 2, single for COVID-19 immunisation. Medical history included moderate cognitive impairment, senile involution syndrome, cerebrovascular disease, heart problems, and allergies. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: ET3620) as dose 1, single for COVID-19 immunisation. The patient was vaccinated with second dose of Pfizer on 15Apr2021 at 14:00 and was found dead on 16Apr2021 at 13:30. The emergency services physician said that she was dead since about an hour due to cardio-respiratory arrest. The patient died on 16Apr2021. It was reported that an autopsy was already requested. Reporter''s comments: moderate cognitive impairment in senile involution syndrome with associated cerebrovascular disease, heart problems and allergies; car-go cardio supplement effervescent sachets alternating with cycles. Sender''s comments: 26Jul2021: additional info and autopsy already requested. 28Jul2021: updated as far as available.; Reporter''s Comments: moderate cognitive impairment in senile involution syndrome with associated cerebrovascular disease, heart problems and allergies; car-go cardio supplement effervescent sachets alternating with cycles.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1576706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:10; Comments: 10/10
CDC Split Type: ITPFIZER INC202101026408

Write-up: Fever in the afternoon; This is a spontaneous report from a contactable consumer downloaded from the WEB. The regulatory authority number is IT-MINISAL02-767925. An 83-year-old female patient received the dose of BNT162B2 (COMIRNATY; lot number: unknown), via an unspecified route of administration on 28Jun2021 10:30 (at an unspecified age) at dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Jun2021, in the afternoon, the patient experienced fever. On 29Jun2021, in the morning, the patient was brought to the emergency room. Resignation in the early afternoon of the same day (as reported). On 29Jun2021 (also reported as 30Jun2021, pending clarification), in the night, the patient died. It was unknown of autopsy was done. The impact on quality of life on an unspecified date was 10/10. Outcome of the event was fatal. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Fever in the afternoon


VAERS ID: 1576708 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Investigation, Speech disorder
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), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: impact on quality of life; Result Unstructured Data: Test Result:10; Comments: 10/10
CDC Split Type: ITPFIZER INC202101026684

Write-up: stroke; slight speech difficulties; This is a spontaneous report from a contactable consumer downloaded from the WEB [IT-MINISAL02-768102]. A 90-year-old male patient received the second dose of BNT162B2 (COMIRNATY; lot number: unknown), via an unspecified route of administration on 14Mar2021 (at an unspecified age) at dose 2, single in the right arm for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Mar2021, the patient experienced slight speech difficulties. On 18Mar2021, the patient experienced stroke. The patient was hospitalized on an unspecified date in 2021 due to the events. The patient died on an unspecified date in 2021. It was unknown if autopsy was done. On 2021, the impact on quality of life was 10/10. Outcome of all the events was fatal. Sender''s comment: Card without information on date, time I and II vaccination, batch number, infusion arm. The reporter only provided e-mails to which, on the same date of 30Jul2021, I sent e-mails with a request for in-depth information to date with no response. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Stroke; slight speech difficulties


VAERS ID: 1576709 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101026398

Write-up: patient collapsed on the ground and died; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-768121. A 51-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Left Arm on 31Jul2021 (Lot Number: FF7481; Expiration Date: 30Nov2021) as DOSE 2, 0.3ML SINGLE for covid-19 immunisation. The patient''s medical history included trigeminal neuralgia, migraine and dental problems. Concomitant medications were not reported. Historical vaccine includes dose 1 of Comirnaty received on 16Jun2021 (lot: FC5435). The patient''s family members reported that the patient collapsed on the ground on 03Aug2021, so the 118 hotline was contacted, and they tried to resuscitate the patient. The patient died on 03Aug2021. 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: patient collapsed on the ground and died


VAERS ID: 1576765 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer; Metastases to brain
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: pyrexia; Result Unstructured Data: Test Result: 38 Centigrade.
CDC Split Type: JPPFIZER INC202100986803

Write-up: Pyrexia of 38 degrees Celsius; Vomiting; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122114. The patient was a 71-year and 6-month-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 included lung cancer and metastases to brain. On unknown date in 2021, the patient previously received the first dose of COVID-19 vaccine (Lot# unknown, Expiration date unknown). On 15Jun2021 (the day of vaccination), the patient received the second dose of COVID-19 vaccine (Lot number unknown, Expiration date unknown) via an unspecified route of administration as dose 2, single (at the age of 71 years old) for COVID-19 immunization. On 16Jun2021 (one day after the vaccination), the patient experienced pyrexia of 38 degrees Celsius and vomiting. On 28Jun2021 (13 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Until 15Jun2021 (the day of vaccination), the patient had no pyrexia. The patient received the second dose of COVID-19 vaccine. On 16Jun2021 (one day after vaccination), in the morning, the patient experienced pyrexia of 38 degrees Celsius. At noon, when nutrition was administered via the gastrostomy tube, the patient experienced vomiting. The reporting physician classified the event as serious (death). The causality between the event and COVID-19 vaccine was not provided. Other possible causes of the event such as any other diseases were lung cancer and metastases to brain. The reporting physician commented as follows: Since the patient was bedridden for lung cancer and metastases to brain, it was considered unlikely that the patient died due to the vaccination. Although the pyrexia was improving during the hospital course, the pathological condition suddenly changed, and the patient died on 28Jun2021. It was unknown if autopsy was performed. Pfizer is a marketing authorization holder of COVID-19 vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events fever and vomiting (fatal) and suspect drug BNT162B2 cannot be established. 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: pyrexia of 38 degrees Celsius; vomiting


VAERS ID: 1576778 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Gaze palsy, Haematemesis, Muscle spasms, Pneumonia aspiration, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 4
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: Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 202107; Test Name: CT; Result Unstructured Data: Test Result:showed pneumonia in both lungs; Comments: performed as an autopsy imaging (AI)
CDC Split Type: JPPFIZER INC202100993495

Write-up: pale blooded watery vomit; cardio-respiratory arrest; Vomiting/large amount of vomiting; cramps of lower extremities; eyeballs raise upward; pneumonia in both lungs/pneumonia aspiration; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122209. A 92-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Jul2021 10:00 (Lot Number: EY0573; Expiration Date: 30Sep2021) as dose 1, single for COVID-19 immunization. Medical history included late effects of cerebral infarction on an unknown date. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.2 degrees centigrade. On 04Jul2021 at 23:00 (13 hours after the vaccination), the patient experienced vomiting. On 05Jul2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: on 04Jul2021 (the day of vaccination), at 10:00, the patient received the first dose of BNT162b2 vaccination. After the patient went home, he experienced vomiting at 23:00. On the same day, also at 23:00 (13 hours after vaccination), the patient had cramps of lower extremities and eyeballs raise upward. An ambulance was called. After the patient was admitted to the reporting hospital, he repeatedly had vomiting. On 05Jul2021, at 06:50 (20 hours and 50 minutes after vaccination), the patient had a large amount of vomiting (pale blooded watery vomit) and had cardio-respiratory arrest. Emergency resuscitation was performed. However, the patient was confirmed to die at 07:47 (21 hours and 47 minutes after vaccination). CT was performed as an autopsy imaging (AI) on Jul2021 and showed pneumonia in both lungs. 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 reported as unknown. The reporting physician commented as follows: After the patient received BNT162b2 vaccination, he repeatedly had vomiting, and he had pneumonia aspiration and died.; Reported Cause(s) of Death: pneumonia in both lungs/pneumonia aspiration; vomiting; cramps of lower extremities; eyeballs raise upward; pale blooded watery vomit; cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: pneumonia in both lungs/pneumonia aspiration


VAERS ID: 1576785 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-29
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONIEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Obesity (Body mass index (BMI): 38)
Allergies:
Diagnostic Lab Data: Test Name: Body mass index (BMI); Result Unstructured Data: Test Result:38; Test Date: 20210709; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100995347

Write-up: death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122323. A 59-years-old male patient received BNT162B2 (COMIRNATY) at the age of 59-years-old, via an unspecified route of administration on 09Jul2021 18:00 (Batch/Lot Number: FA5715; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunization. Medical history included hypertension and obesity (body mass index (BMI): 38). Concomitant medication included benidipine hydrochloride (CONIEL) taken for an unspecified indication from an unspecified start date and ongoing. The patient was a 59-year and 3-month-old male. Body temperature before vaccination was 36.6 degrees centigrade. The family history was not provided. The patient had medical history of hypertension and obesity. The patient was orally taking benidipine hydrochloride (CONIEL (4)) 2 tablets per day. On 09Jul2021 at 18:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5715, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 29Jul2021 (20 days after the vaccination), the patient experienced death. On 29Jul2021 (20 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: 20 days after vaccination, the patient was found dead at his home. An autopsy by the police was performed. The results of the autopsy were unknown. The patient lived alone, and he seemed to collapse while he was changing his clothes. The patient had obesity with the height of 172 cm, the body weight of 115 kg, and BMI of 38. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. There was other possible cause(s) of the event such as any other diseases, but detail was not provided. The reporting physician commented as follows: Since the patient had severe obesity, the event was unlikely to be related to BNT162b2 vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576786 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-08-02
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100995351

Write-up: Cardiac arrest; thoracic aortic aneurysm rupture; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority report number is v21122303. An 89-year-old (also reported as 89-year and 11-month-old) male patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 21Jun2021 (Bath/lot number not reported), as dose 2, single, for COVID-19 immunisation. Relevant medical history included thoracic aortic aneurysm from an unknown date, not reported if ongoing or not. Concomitant medication was reported as unknown. The family history was not provided. Historical vaccine included BNT162B2 (COMIRNATY Solution for injection) received on 31May2021 (Batch/lot number unknown), as dose 1, single, for COVID-19 immunisation. Body temperature before vaccination was unknown. On 02Aug2021 at 09:00 (one month/12 days/9 hours after the vaccination), the patient experienced thoracic aortic aneurysm rupture and cardiac arrest. The patient died on 02Aug2021. The course of the event was as follows: On 02Aug2021, at 09:00 (one month, 12 days, and 9 hours after vaccination), the patient who had medical history of thoracic aortic aneurysm experienced cardiac arrest. On 02Aug2021 (one month/12 days after the vaccination), the outcome of the event was fatal. It was unknown if autopsy was performed. The reporting physician classified the event 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 as follows: The patient had medical history of thoracic aortic aneurysm. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest; thoracic aortic aneurysm rupture


VAERS ID: 1576787 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Arteriosclerosis, Cardiac failure, Mitral valve incompetence, Ultrasound Doppler
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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: intravascular ultrasound; Result Unstructured Data: Test Result:arteriosclerotic lesion; Comments: the coronary artery lesion on the intravascular ultrasound was arteriosclerotic lesion which was usually observed.
CDC Split Type: JPPFIZER INC202100995707

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122367. A 71-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jun2021 15:00 (Lot Number: FA5765; Expiration Date: 30Sep2021), at the age of 71-year-old, as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: EY0779, Expiration date 31Aug2021) for COVID-19 immunisation. On 16Jun2021 at 15:00 (one day after the vaccination), the patient experienced acute myocardial infarction. On 08Jul2021 (23 days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 16Jun2021, at 15:00 (one day after the second dose of vaccination), the patient experienced acute myocardial infarction. Since the patient considered it as a side reaction to the vaccination, he did not visit the hospital until 2 days after the onset of the symptom on 17Jun2021 (2 days after vaccination). The patient visited the hospital after he had cardiac failure. Ischaemic mitral valve insufficiency was severe. Unfortunately, the outcome was death. Of note, the coronary artery lesion on the intravascular ultrasound was arteriosclerotic lesion which was usually observed. 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 arteriosclerosis. The reporting physician commented as follows: This case was reported at the family''s strong wish. The myocardial infarction seemed by the arteriosclerotic plaque rather than the thrombosis.; Reported Cause(s) of Death: Cardiac failure; Ischaemic mitral valve insufficiency; Arteriosclerosis; Acute myocardial infarction


VAERS ID: 1576788 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, CSF culture, Computerised tomogram head, Hypophagia, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: Head CT; Result Unstructured Data: Test Result:Performed; Comments: Subarachnoid haemorrhage and cerebral haemorrhage were denied.; Test Date: 20210708; Test Name: Spinal fluid; Result Unstructured Data: Test Result:Meningitis was denied.
CDC Split Type: JPPFIZER INC202100995725

Write-up: Consciousness disturbed; dietary intake declined; Pyrexia; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority report number is v21123133. A 83-year-old male patient received bnt162b2 (COMIRNATY), dose 2 at the age of 83-years-old via an unspecified route of administration on 28Jun2021 09:06 (Batch/Lot Number: EW0203; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Body temperature before vaccination was not reported. The patient''s family history was unknown. Medical history was not reported. The patient''s concomitant medications were not reported. On 08Jun2021 at 09:38, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY0779, Expiration date 31Aug2021) for covid-19 immunisation. On 08Jul2021 at 23:22 (10 days after the vaccination), the patient experienced consciousness disturbed. The course of the event was as follows: On 28Jun2021, the patient received the second dose of BNT162b2 and thereafter presented with pyrexia. He became less responsive and also became bedridden. From around 04Jul2021, dietary intake declined but was able to drink water. From 07Jul2021, the level of his consciousness lowered. On 08Jul2021, he was urgently transferred to the reporting hospital (on arrival at hospital, the consciousness disturbed was prolonged for more than 8 hours). Head computed tomography ruled out subarachnoid haemorrhage and cerebral haemorrhage, and spinal fluid analysis ruled out meningitis. Based on the suspicion of nonconvulsive epilepsy, electroencephalographic examination was scheduled on the following day. On 10Jul2021, the patient was discharged dead without recovery of the consciousness. The reporting pharmacist classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. The reporting pharmacist stated that the cause of the event was unknown for other possible cause of the event such as any other diseases. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included computerised tomogram head: performed on 08Jul2021; Subarachnoid haemorrhage and cerebral haemorrhage were denied and csf culture: meningitis was denied on 08Jul2021. On 10Jul2021 (12 days after the vaccination), the outcome of the event consciousness disturbed was fatal. The outcome of the other events was unknown. The reporting pharmacist commented as follows: Although the cause of the event was unknown, this case had been reported according to the patient''s family members'' strong request.; Reported Cause(s) of Death: Consciousness disturbed


VAERS ID: 1576789 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Delirium, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   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: LANSOPRAZOLE; QUETIAPINE; THEOPHYLLINE; FOLIAMIN [FOLIC ACID]; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Late effects of cerebral infarction; Oesophageal hiatal hernia; Oxygen therapy (1L/min); Pulmonary fibrosis (Home Oxygen Therapy(HOT)1L/min)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100995801

Write-up: This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 96-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 12Jul2021 13:30 (Batch/Lot Number: EW0203; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included dementia, pulmonary fibrosis, both from an unknown date if ongoing Home Oxygen Therapy(HOT)1L/min, Late effects of cerebral infarction, Oesophageal hiatal hernia,all from an unknown date. Patient had his first dose of COMIRNATY (Lot Number: EW0203; first dose; at 13:30 ) for COVID-19 immunisation on 21Jun2021. Concomitant medications included lansoprazole; quetiapine; theophylline; folic acid (FOLIAMIN); furosemide. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. On 14Jul2021 (2 days after the vaccination),the patient experienced delirium.On 15Jul2021 at 13:08 (3 days after the vaccination), the patient experienced cardio-respiratory arrest. On 15Jul2021 (3 days after the vaccination), the patient experienced ventricular fibrillation. The outcome of the event delirium was unknown, other events was fatal without treatment. The reporting physician assessed the event as serious (Death). Autopsy was not performed. Clinical course provided as follows: The patient, with dementia and pulmonary fibrosis, had been living in the nursing home. On 12Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2. On 14Jul2021 (2 days after the vaccination), the patient had delirium symptom, letting out his voice at night. On 15Jul2021 at 12:15 (3 days after the vaccination), the patient ate all of his lunch. At 12:55, it was confirmed that the patient was alive. At 13:08, the staff found at the dining room that the patient drooped his head sitting in the wheelchair. The patient was in cardio-respiratory arrest. As ''''Do Not Attempt Resuscitation (DNAR) '''' had been requested, the patient''s death was then confirmed.Since the vaccination, the patient has not been tested for COVID-19. Patient died on 15Jul2021. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events : Cardio-respiratory Arrest, ventricular fibrillation, delirium and the administration of the vaccine 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: Ventricular fibrillation; Cardio-respiratory arrest


VAERS ID: 1576790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-07-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction (acute myocardial infarction associated with smoking and dyslipidaemia); Dyslipidaemia (acute myocardial infarction associated with smoking and dyslipidaemia); Smoker (acute myocardial infarction associated with smoking and dyslipidaemia).
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100995965

Write-up: a possibility of idiopathic myocardial infarction; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122346. A 69-year-old (also reported as 69-year and 2-month-old) male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jun2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included acute myocardial infarction associated with smoking and dyslipidaemia. The family history was not reported. Information was not reported 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 not reported. On 05Jul2021 at 00:10, (8 days after the vaccination), the patient experienced a possibility of idiopathic myocardial infarction. The outcome of the event was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases was acute myocardial infarction associated with smoking and dyslipidaemia. The reporting physician commented as follows: The causality was difficult to assess. Considering primary disease and social history, there was a possibility of idiopathic myocardial infarction. The patient died on 05Jul2021. 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: a possibility of idiopathic myocardial infarction


VAERS ID: 1576794 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Subdural haematoma, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL SULFATE; AMLODIPINE BESILATE; LIMAPROST ALFADEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombotic cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100999664

Write-up: Thrombotic subdural haematoma; Thrombotic subdural haematoma; This is a spontaneous report from a contactable physician. This report was received via a sales representative. An 83-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 15Jul2021 as dose number unknown, single for covid-19 immunisation. Medical history included atherothrombotic cerebral infarction right (in Mar2021). Concomitant medications included oral clopidogrel sulfate, oral amlodipine besilate, and oral limaprost alfadex, all taken for an unspecified indication from an unspecified start date and ongoing. On 16Jul2021 (one day after the vaccination), the patient experienced thrombotic subdural haematoma. The course of the event was as follows: On 15Jul2021 (the day of vaccination), the patient received a dose of BNT162b2 vaccination. On 16Jul2021 (one day after vaccination), the patient was emergently transferred, and she died (the cause of death was thrombotic subdural haematoma). It was unknown if an autopsy was performed. The reporting physician stated that the event was unrelated to BNT162b2. The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 can be excluded for the reported event of Subdural hematoma and Thrombosis, as there is also possible contributory effects from patient''s medical history of atherothrombotic cerebral infarction right. 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: thrombotic subdural haematoma


VAERS ID: 1576798 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; Self injurious behaviour
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101008056

Write-up: Suicide; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122543. The 16-year and 5-month-old male patient received first dose of bnt162b2 (COMIRNATY) at 16-year-old on 15-JUL-2021 12:00 as dose 1, single (lot number: EY0583, expiration date: 31Oct2021) for COVID-19 immunisation. Body temperature before vaccination was 36.2 degrees Centigrade. Medical history included attention deficit hyperactivity disorder (ADHD) and Self injurious behaviour. Concomitant medications and family history were not provided. The course of the events was as follows: On 15Jul2021 at 12:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0583, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 23Jul2021 at 18:30 (8 days after the vaccination), the patient experienced suicide and died. The outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 23Jul2021, the patient jumped off the top floor of the apartment and died. It was assumed the he killed himself. The reporting physician classified the event as serious (fatal) and assessed that the event was not related to BNT162b2. Other possible cause of the event such as any other diseases was ADHD. The reporting physician commented as follows: The patient was prescribed oral medicines for ADHD at a psychiatry department, but recently he had stopped taking them, and self injurious behaviour had been noted.; Sender''s Comments: Event suicide represents an intercurrent medical condition and unrelated to bnt162b2 . The underlying history of attention deficit hyperactivity disorder (ADHD) and Self injurious behavior may play a explanation.; Reported Cause(s) of Death: Suicide


VAERS ID: 1576800 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dyspnoea, Myocardial infarction, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BETAMETHASONE; ROSUVASTATIN; CILOSTAZOL; BIFIDOBACTERIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Intrahepatic bile duct cancer; Polymyalgia rheumatica; Pulmonary embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101008452

Write-up: Dyspnoea; Subacute myocardial infarction; Chills; Vomiting; This is a spontaneous report from a contactable physician received via COVID-19 Self-Reporting. The patient was an 89-year-old male. Body temperature before vaccination was not reported. The patient''s family history was not reported. Medical history included cerebral haemorrhage, polymyalgia rheumatica, intrahepatic bile duct cancer, and pulmonary embolism. The patient had no known allergies. Concomitant medications taken within 2 weeks of vaccination included betamethasone, rosuvastatin, cilostazol, and bifidobacterium tablet. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jun2021 at 12:00, the patient aged 89 previously received the first single dose of BNT162b2 (COMIRNATY, Lot# EY0573, Expiration date 30Sep2021) in the left arm. On 29Jun2021 at 12:00 (the day of vaccination), the patient aged 89 received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscularly in the left arm for COVID-19 immunization. On 02Jul2021 at 01:30 (3 days after the vaccination), the patient experienced chills and vomiting. On 03Jul2021 at 11:30 (4 days after the vaccination), the patient experienced dyspnoea and was taken to a hospital. On 03Jul2021 (4 days after the vaccination), the patient passed away. The course of the event was as follows: On 02Jul2021 at 01:30, the patient presented with chills and vomiting. On 03Jul2021 at 11:30, the patient experienced dyspnoea and was transferred to a hospital. He died on the same day. The cause of death was subacute myocardial infarction. The outcome of other events was unknown. It was unknown if any treatment was given for the events. Autopsy was not performed. The adverse events resulted in emergency room/department or urgent care, hospitalisation, death. Since the vaccination, the patient had not been tested for COVID-19. Sender''s Comments: The event fatal myocardial infarction is considered not related to BNT162B2. The patient had underlying medical conditions including cerebral hemorrhage, which are considered as risk factors for the event. The event dyspnea is considered associated with myocardial infarction and also not related to BNT162B2. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: Subacute myocardial infarction.


VAERS ID: 1576801 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Fibrin D dimer, Platelet count, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Haemodialysis; Peritoneal dialysis; Renal failure chronic (IgA nephropathy progression)
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic calcification (Mild aortic calcification was observed but dialysis complication was rarely noted.)
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Name: CT; Result Unstructured Data: Test Result:did not indicated any cause of the death; Comments: such as haemorrhage or others.; Test Name: D-dimer; Result Unstructured Data: Test Result:747; Comments: After death; Test Name: platelet; Result Unstructured Data: Test Result:77000; Comments: After death
CDC Split Type: JPPFIZER INC202101008470

Write-up: suspected thrombosis; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122611. The patient was a 70-year and 4-month-old female. Body temperature before vaccination was 36.4 degrees Centigrade. The patient family history was not reported. medical history included ongoing renal failure chronic (IgA nephropathy progression), peritoneal dialysis from 2012 and ongoing, haemodialysis from 2017 and ongoing, and mild aortic calcification (Mild aortic calcification was observed but dialysis complication was rarely noted). The patient had been treated with peritoneal dialysis and haemodialysis. On 10Jun2021 at 10:05 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose, at age of 70-year-old of vaccination, for COVID-19 immunization. On 11Jun2021 at approximately 17:00 (1 days after the vaccination), the patient suspected to had thrombosis. The patient was transported to another hospital. At 18:57, the patient died. The outcome of the event was fatal. The course of the event was as follows: Due to IgA nephropathy progression, the patient started peritoneal dialysis in 2012, and haemodialysis in 2017, which were under treatment. Mild aortic calcification was observed but dialysis complication was rarely noted. The patient had lived a stable life. On 10Jun2021 at 10:05 (the day of vaccination), the patient received the first dose of COVID-19 vaccination during dialysis. No adverse reaction was noted, and the patient returned home after dialysis. On 11Jun2021 at around 16:00 (1 days after the vaccination), the patient was taking a bath. Just after 17:00, the patient''s family member found the patient fall down on her face in the bath tab without response. An ambulance was requested, and she was transported to another hospital. At 18:11, on arrival, the patient was in cardio-respiratory arrest. There was no response to resuscitation. At 18:57, the patient was confirmed dead. It was unknown if autopsy was done. Computerised tomography (CT) did not indicated any cause of the death such as haemorrhage or others. Considering abnormal levels of D-dimer 747 and platelet 77000, there might have been some sort of thrombosis. 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 haemodialysis that was being conducted due to renal failure chronic. The reporting physician commented as follows: One day after the vaccination given during stable dialysis, the event occurred. A presence of thrombosis was suspected on examination after death; thus, even though causality was unknown, relationship with BNT162b2 was suggested. ; Reported Cause(s) of Death: Cardio-respiratory arrest; suspected thrombosis


VAERS ID: 1576802 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Geromarasmus; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101008473

Write-up: Hypoxia aggravated acute/the oxygenation was suddenly aggravated; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122569. A 96-year-old (reported as 96-year and 11-month-old) male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Aug2021 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as dose 1, single at the age of 96-year-old for covid-19 immunisation. The patient had medical histories of geromarasmus and pneumonia aspiration. The patient was using a beta blocker. The family history was not provided. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.9 degrees centigrade. On 04Aug2021 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Aug2021 (one day after the vaccination), the patient experienced hypoxia aggravated acute. On 05Aug2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was bedridden for geromarasmus, and the condition which required total assistance was continued. The patient repeatedly had pneumonia aspiration, and hypoxia was continued. During the last 2 weeks, the condition was stable, and the patient received the first dose of bnt162b2 vaccination. Approximately 12 hours later, the oxygenation was suddenly aggravated, and the patient died. The patient died on 05Aug2021. 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 geromarasmus.; Reported Cause(s) of Death: Hypoxia aggravated acute


VAERS ID: 1576803 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Physical deconditioning, Platelet count
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: platelets; Result Unstructured Data: Test Result:decreased; Test Date: 20210803; Test Name: platelets; Result Unstructured Data: Test Result:decreased to 4000
CDC Split Type: JPPFIZER INC202101008508

Write-up: Cerebral infarction; physical deconditioning; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122544. An 86-year-old female patient received the second dose of bnt162b2 (COMIRNATY) (lot number: unknown) on 24Jul2021 (at the age of 86-years-old) via unknown route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Body temperature before vaccination was not reported. It was unknown if the patient had relevant family history. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as the first single dose for COVID-19 immunization. On 24Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as the second single dose for COVID-19 immunization. After the second vaccination, the patient had physical deconditioning. On 28Jul2021 (4 days after the vaccination), the patient developed cerebral infarction (severe) and was hospitalized. Decreased platelets had been already noted, for which the patient was treated with heparin and ozagrel sodium (XANBON). The initial symptom was thrombotic thrombocytopenic purpura (TPP). On 03Aug2021 (10 days after the vaccination), the platelet decreased to 4000, and the impression was that it was likely to be heparin-induced thrombocytopenia (HITT). Heparin was discontinued. The only remedy for HITT, argatroban was initiated. On 04Aug2021 (11 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The outcome of the event physical deconditioning was unknown. The reporting physician classified the events as serious (fatal outcome) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported if there were other possible causes of the events such as any other diseases. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1576804 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Imaging procedure, Respiratory disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   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: Medical History/Concurrent Conditions: Atelectasis; Emphysema; Pneumonia (treated with antibiotics and tended to improve).
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: Test Result: decreased; Comments: at 16:50; Test Date: 20210729; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210729; Test Name: Imaging; Result Unstructured Data: Test Result: residual pleural effusion and atelectasis.
CDC Split Type: JPPFIZER INC202101008517

Write-up: respiratory status suddenly aggravated; blood pressure decreased; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122605. The patient was an 86-year and 8-month-old male. Body temperature before vaccination was 36.8 degrees centigrade. Family history was not reported. Medical history included emphysema, atelectasis, and pneumonia from 06Jul2021 which was treated with antibiotics and tended to improve. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) for COVID-19 immunisation. On 27Jul2021, the antibiotics for pneumonia was suspended. On 29Jul2021 at 15:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) via an unspecified route of administration as the second single dose for COVID-19 immunization. Imaging revealed residual pleural effusion and atelectasis on 29Jul2021, but vital signs were stable and consciousness level and complexion were good; thus, the patient received BNT162b2. On 31Jul2021 at 16:50 (2 days 1 hour and 20 minutes after the vaccination), the patient experienced respiratory status suddenly aggravated and blood pressure decreased. The condition did not improve, and the patient died on the same date (31Jul2021). It was not reported if an autopsy was performed. The reporting physician classified the events as serious (fatal) and assessed that the events were related to BNT162b2. Other possible causes of the event such as any other diseases were emphysema, pleural effusion, and atelectasis, which were observed. The reporting physician commented as follows: General condition before the vaccination was good and there was no particular change in condition immediately after the vaccination. Since there was no other pathological condition that resulted in sudden change, causality between the events and the vaccine could not be denied. ; Reported Cause(s) of Death: respiratory status suddenly aggravated; blood pressure decreased; emphysema; pleural effusion; atelectasis


VAERS ID: 1576805 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac dysfunction, Depressed level of consciousness, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: Medical History/Concurrent Conditions: Apnoea; Dementia; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result: 36.4 Centigrade; Comments: before vaccination; Test Date: 20210731; Test Name: oxygen saturation; Result Unstructured Data: Test Result:80s to the lower 90s%.
CDC Split Type: JPPFIZER INC202101009726

Write-up: Cardiac function decreased; function kidney decreased; suspected pneumonia; depressed level of consciousness; oxygen saturation 80s to the lower 90s %; This is a spontaneous report from a contactable other healthcare professional (HCP) received from the Regulatory Authority. The Regulatory authority report number is v21122573. An 81-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) on 27Jul2021 09:45 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade. Medical history included diabetes mellitus, hypertension, dementia, and apnoea. The patient''s family history was not reported. The patient''s concomitant medications were not reported. On an unspecified date, the patient previously received the first dose of BNT162B2 (Lot number unknown). On 27Jul2021 at 09:45 (the day of vaccination), the patient received the second dose of BNT162B2. On 30Jul2021 at 20:00 (three days after the vaccination), the patient developed adverse event, but any symptoms on that time were not reported. On 31Jul2021 (four days after the vaccination), the patient was admitted to another hospital. On 01Aug2021 (five days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 31Jul2021, after the breakfast, depressed level of consciousness and oxygen saturation 80s to the lower 90s%. The patient was urgently transported to hospital. Cardiac function decreased, function kidney decreased, and suspected pneumonia were noted. The patient died on 01Aug2021. It was not reported if an autopsy was performed. The reporting other HCP 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 apnoea. The outcome of the events cardiac function decreased, function kidney decreased, and suspected pneumonia was fatal. The outcome of the events depressed level of consciousness and oxygen saturation 80s to the lower 90s% was unknown. Reporter''s comment: Nothing in particular to comment. Reporter''s Comments: Nothing in particular to comment; Reported Cause(s) of Death: Cardiac function decreased; function kidney decreased; possible pneumonia.


VAERS ID: 1576806 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (primary disease); Cardiac failure congestive (primary disease); Late effects of cerebral infarction (primary disease); Orthostatic hypotension (primary disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202101009919

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122636. The patient was a 85-year and 10-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade. The patient family history was not reported. The patient had primary disease of late effects of cerebral infarction, atrial fibrillation, cardiac failure congestive, and orthostatic hypotension. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunization.On 31Jul2021 at 15:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Aug2021 at an unknown time (3 days after the vaccination), the patient experienced cardio-respiratory arrest. On 03Aug2021 at an unknown time (3 days after the vaccination), the patient died. The outcome of the event was fatal. The course of the event was as follows: The patient was found cardio-respiratory arrest at home and was transported to the emergency department of another hospital. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were primary diseases including late effects of cerebral infarction, atrial fibrillation, cardiac failure congestive, and orthostatic hypotension. The reporting physician commented as follows: The patient had primary diseases including late effects of cerebral infarction, atrial fibrillation, cardiac failure congestive, and orthostatic hypotension. There was a high possibility that these diseases were involved with the cause of the death.; Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 1576807 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Coma scale, Computerised tomogram, Death, Imaging procedure, Investigation, Magnetic resonance cholangiopancreatography, Movement disorder, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210802; Test Name: CS; Result Unstructured Data: Test Result:300; Test Date: 20210715; Test Name: CT; Result Unstructured Data: Test Result:suspected to have cancer at the lower end; Comments: suspected to have cancer at the lower end of the common bile; Test Name: AI; Result Unstructured Data: Test Result:the cause of death could not be identified; Test Date: 20210802; Test Name: pupils; Result Unstructured Data: Test Result:3 mm/3mm; Comments: no pupils dilated was noted; Test Date: 20210715; Test Name: MRCP; Result Unstructured Data: Test Result:suspected to have cancer at the lower end; Comments: suspected to have cancer at the lower end of the common bile
CDC Split Type: JPPFIZER INC202101009993

Write-up: Unknown cause of death; cardio-respiratory arrest; difficulty in body motion; queasy; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122553. An 86-year and 9-month-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021), at the age of 86 years and 9 months old, on 30Jul2021 at 13:30 at 0.3 ml single dose for COVID-19 immunization. In the vaccination coupons, age was also reported as 85 and 88. Body temperature before vaccination was 36.4 degrees centigrade. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire. In the vaccination coupons for the second dose of BNT162B2 vaccination, this was not the first time to receive Coronavirus Disease 2019 vaccine (first dose on 09Jul2021, this was second dose). The name of present local municipal government (who issues a Certificate of Residence for the patient) correctly printed on the coupon ticket. The patient had read ''''Coronavirus Disease 2019 Vaccination Guide'''' and understood its effect and potential side effects. The patient fell under any of the following priority vaccination groups (65-year-old or older). The patient was not currently treated (with medications, etc.) for any disease. The patient had not been sick or had no fever in the past month. The patient was not feeling sick on the day of vaccination. The patient had never had convulsions (seizures). The patient had never had severe allergic reactions (anaphylaxis, etc.) to a medication or food. The patient had never been sick after receiving vaccination. The patient was not possibly pregnant (e.g. late period) or she was not currently breast-feeding. The patient had not received any other vaccines in the past two weeks (BNT162b2 only). The patient did not have any questions about this vaccination. The patient''s concomitant medications were not reported. On 09Jul2021, the patient previously received the first dose of BNT162B2 (Lot number FC5974, Expiration date 30Sep2021) at 0.3 ml single dose for COVID-19 immunization and experienced feeling of hot flushes. On 30Jul2021 at 13:30 (the day of vaccination), the patient received the second dose of BNT162B2. On 02Aug2021 at 06:00 (2 days/16 hours/30 minutes after the vaccination, also reported as 05:00), the patient experienced unknown cause of death. On 02Aug2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jul2021, the patient received the second dose of BNT162B2 vaccination. On 01Aug2021 at 18:30, the patient went to sleep. Until then, no significant changes from usual were observed. On 02Aug2021 at 03:00, on awaking, the patient complained of queasy; however, she was confirmed to survive. At around 05:00, the patient was found to have difficulty in body motion by her family, and an ambulance was called. At 05:05, the ambulance service arrived on the site. The patient was judged to have cardio-respiratory arrest, and resuscitation and administration of adrenaline were performed. When the patient arrived at the reporting hospital, Coma Scale (CS) was 300, the pupils were 3 mm/3mm, no pupils dilated was noted, and light reflex was not observed. Since the pulse rate and the respiration did not return, the condition was explained to her husband, and the resuscitation was discontinued. At 06:00, the patient died. The cause of death was unknown. Although an autopsy imaging (AI) was performed, the cause of death could not be identified. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. The outcome of the event unknown cause of death was fatal. The outcome of other events was unknown. The patient died on 02Aug2021 at 06:00. An autopsy was performed and results were not provided. Reporter''s comment: On 15Jul2021, the patient had feeling of hot flushes, and she was examined at the gastroenterological medicine department. The patient was suspected to have cancer at the lower end of the common bile duct on the computerised tomogram (CT) and Magnetic resonance cholangiopancreatography (MRCP). Thereafter, an examination was to be performed, this result was not cause of death, and the cause of death was unknown.; Reporter''s Comments: On 15Jul2021, the patient had feeling of hot flushes, and she was examined at the gastroenterological medicine department. The patient was suspected to have cancer at the lower end of the common bile duct on the computerised tomogram (CT) and Magnetic resonance cholangiopancreatography (MRCP). Thereafter, an examination was to be performed, this result was not cause of death, and the cause of death was unknown.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576808 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
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: 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: Diabetes mellitus; Giddiness; Hypercholesterolaemia; Hypertension; Pericarditis; Pleurisy; Queasy; Reflux oesophagitis; Sjogren''s syndrome; Swaying feeling.
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result: 36.2 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202101010021

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician, the inoculator, received from the Regulatory Authority. Regulatory authority report number is v21122666. The patient was a 73-year-old female. Body temperature before vaccination was 36.2 degrees centigrade. The patient family history was not reported. Medical history was as follows: In Sep2007, the patient was admitted to another hospital for treatment of pleurisy, pericarditis and Sjogren''s syndrome. After that, the patient had received the treatment with steroids for about half year. Hypertension since 2012, hypercholesterolaemia since 2014, reflux oesophagitis since 2016, diabetes mellitus since 2019 and the patient regularly went to hospital. The patient had complained of giddiness and swaying since around Jun2021. Unspecified concomitant medications taken for giddiness and feeling queasy from 24Jul2021 prescribed by otologist. On 29Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 31Jul2021 at 15:37 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unknown date, the patient died of unknown cause. On 05Aug2021 (five days after the vaccination), the patient was confirmed dead by the local police. The course of the event was as follows: On 29Jun2021, the patient received the first dose of Comirnaty. On 31Jul2021, the patient received the second dose of Comirnaty. On 31Jul2021, the family of the patient contacted the patient. After that, the family could not get in touch with the patient and on 05Aug2021, the patient was confirmed dead by the police. The reporting physician classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as unassessable. There was/were unspecified other possible cause(s) of the event. The reporting physician did not provide any comment.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576809 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 4
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: Hyperlipidaemia; Hypertension; Large intestine carcinoma; Large intestine operation (Postoperative state of large intestine carcinoma)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101014173

Write-up: This is a spontaneous report from a contactable physician received via Regulatory Authority. A 53-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) on 14Jul2021 at 10:30 intramuscular in the left arm at single dose for COVID-19 immunization, at age of 53 years old of vaccination. 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. The patient had no allergies to medications, food, or other products. Medical history included postoperative state of large intestine carcinoma, hypertension and hyperlipidaemia. Concomitant drug was unknown. On 14Jul2021 at 10:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization, at age of 53 years old of vaccination. On 28Jul2021 (14 days after the vaccination), the patient experienced cerebellar infarction. On 30Jul2021 (16 days after the vaccination), the patient was hospitalized for cerebellar infarction. On 01Aug2021 (18 days after the vaccination), the patient died. The outcome of the event was fatal with antithrombotic treatment. The reporting physician assessed the event as serious (death). The cause of death was cerebellar infarction. Autopsy was not performed. It was unknown if the patient was tested for COVID-19 after the vaccination.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event fatal cerebral infarction 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: Cerebellar infarction


VAERS ID: 1576812 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-09
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram, Death, Pneumonia, SARS-CoV-2 test
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), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? Yes
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomegaly (received no medical intervention); Hypertension (received no medical intervention); Lipids abnormal (received no medical intervention)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Autopsy imaging (AI)-CT; Result Unstructured Data: Test Result:ground-glass shadows in the dorsal half of bilater; Comments: ground-glass shadows in the dorsal half of bilateral lungs; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: JPPFIZER INC202101021206

Write-up: death/Unknown (pneumonia); death/Unknown (pneumonia); respiratory arrest/Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received. A 64-years-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: unknown as inoculated at another institution) at the age of 64-years, via intramuscular route on 28Jul2021 at single dose for COVID-19 immunization. The patient previously received the first single dose of BNT162b2 (COMIRNATY, solution for injection, lot number: unknown as inoculated at another institution) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient was a 64-year-old male. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. It was unknown if the patient had allergies to medications, food, and other products. Other medical history included hypertension, cardiomegaly, and lipids abnormal. It was reported that these were pointed out at medical checkup, but the patient received no medical intervention. Relevant past drug history was unknown. The description of the events was reported as follows: On 09Aug2021 at 05:30 (12 days after the vaccination), the patient developed respiratory arrest at his home and was transported by ambulance. At 05:47, the patient arrived at the reporting hospital. At the time, the patient was in cardio-respiratory arrest (pulseless electrical activity (PEA)). Cardiopulmonary resuscitation was continued; however, the patient had no response, and the death was confirmed at 06:43. Autopsy imaging (AI)-CT showed ground-glass shadows in the dorsal half of bilateral lungs, but the physician could not conclude that it was the direct cause of death. The result of COVID-19 PCR test was negative. The patient died on 09Aug2021. It was reported that no autopsy was done. The cause of death was reported as "unknown (pneumonia)". The events resulted in emergency room/department or urgent care. The outcome of the events was fatal. The patient received no treatment. The reporting physician assessed the events as serious (death, life-threatening). It was reported as unknown whether the patient has been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events cardiorespiratory arrest, pneumonia, death and 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: respiratory arrest/Cardio-respiratory arrest; death/Unknown (pneumonia); death/Unknown (pneumonia)


VAERS ID: 1576813 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Internal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia with Lewy bodies; Edentulous
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202101023223

Write-up: This is a spontaneous report from a contactable nurse received from the Regulatory Authority. Regulatory authority report number is v21122753. The patient was a 94-year and 11-month-old female. Body temperature before vaccination on 29Jun2021 was 36.9 degrees centigrade. Family history and concomitant medication were not reported. Medical history included dementia with Lewy bodies, the patient had no teeth. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: not reported, Expiration date: not reported). On 29Jun2021 at 14:26 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EY5423, Expiration date: 31Aug2021) via an intramuscular route as a single dose for COVID-19 immunization at 94-year and 11-month-old. On 01Jul2021 at 23:00 (2 days after the vaccination), the patient experienced cardio-respiratory arrest. On 02Jul2021 (3 days after the vaccination), the outcome of the event cardio-respiratory arrest was fatal. The outcome of internal haemorrhage around the middle of the left tongue margin was unknown. It was unknown if autopsy was done. The course of the event was as follows: On 29Jun2021 at 14:26, the patient received the second dose of the COVID-19 vaccine. On 30Jun2021 at 09:00, internal haemorrhage around the middle of the left tongue margin was confirmed (the patient had no teeth). Internal haemorrhage did not appear to spread. On 01Jul2021 at 21:20, an aspiration was performed. On 01Jul2021 at 22:00, during a round, the patient''s condition was the same as usual. On 01Jul2021 at 23:00, during a round, the patient experienced pallor facial and respiratory arrest; thus, assistance was requested and the patient was taken to the emergency department. The reporting nurse classified the event cardio-respiratory arrest as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was geromarasmus. The reporting nurse commented as follows: No obvious symptoms of adverse reaction were observed. However, since the patient died after the second vaccination, this case was reported.; Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 1576814 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis (go to hospital regularly); Heart disorder; Renal disease; Renal failure (end-stage)
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101023224

Write-up: unknown death; This is a spontaneous report from a contactable primary physician (also reported as clerical staff) received from the Regulatory authority; report number is v21122776. The patient was a 63-year and 9-month-old male. Age at vaccination was 63-year and 9-month-old male. Body temperature before vaccination was 35.8 degrees centigrade on 03Aug2021. The patient family history was not reported. Medical history included cardiac disease and kidney disease (the patient regularly went to hospital for the blood dialysis treatment due to end-stage renal failure). Concomitant therapy included dialysis treatment and treatment or medication. On 13Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY0583, Expiration date 31Oct2021) at age of 63-year-old. On 03Aug2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 30Nov2021) via an unspecified route of administration at 0.3 ml, as a single dose for COVID-19 immunization. On unknown date in Aug2021 at unknown time (unknown days after the vaccination), the patient experienced unknown death. On 05Aug2021 (two days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 03Aug2021 from 13:31 to 17:31, the patient received the dialysis treatment and returned home without significant changes. On 05Aug2021 at around 11:30, the hospital shuttle went to the patient home to pick him up for the dialysis treatment, but nobody responded. The family of the patient called the patient mobile phone, but no response. The local police were called. After that, the patient was confirmed dead by the local police. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was not reported. The reporting physician did not provide any further comment. Additional information from Prevaccination Screening for COVID-19 vaccine answered on 03Aug2021 was as follows: The patient was currently suffering from cardiac disease and kidney disease and receiving treatment or medication. The patient had not have a fever or gotten sick in the last month. There were no parts of the body that were not feeling well on the day of vaccination. The patient had never have a convulsion (seizure). The patient had never experienced severe allergic symptoms (such as anaphylaxis) from medications or foods. The patient had never been sick after receiving a vaccine. The patient had not have any vaccines within the last two weeks. In light of the results of the screening and examination, the physician assessed vaccine on that day was possible. After receiving a medical examination and explanation from a doctor and understanding the effects and side effects of the vaccine, the patient wished to receive the vaccine.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1576815 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-06
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101023225

Write-up: cardiopulmonary arrest; Shock; This is a spontaneous report from a contactable physician (Emergency department) received from the Regulatory authority report number is v21122723. The patient was an 84-year and 3-month-old male. Body temperature before vaccination was unknown. The patient family history was unknown. Information was unknown reported 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 medical history and concomitant medication was not provided. On an unknown date, the patient previously received the first dose of COVID-19 Vaccine (Manufacturer Unknown, Lot number and, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 11Jul2021 or 12Jul2021 at unknown time (the day of vaccination), the patient received the second dose of COVID-19 Vaccine (Manufacturer Unknown, Solution for injection, Lot number and Expiration date unknown) via an unspecified route of administration as a single dose, for COVID-19 immunisation, at age of 84 years old of vaccination. On 06Aug2021 at 09:02 (25 days or 26 days after the vaccination), the patient experienced shock. The patient was transported to the reporting physician''s hospital. On 06Aug2021 at 10:36 (25 days or 26 days after the vaccination), the patient died. The outcome of the event was fatal. The course of the event was as follows: On 06Aug2021 at 08:40 (25 days or 26 days after the vaccination), the patient left the living room after saying ''''I''m going to the bathroom.'''' Then, his wife found the patient fall down in the bathroom. Emergency medical services were requested, and the patient was to be brought by ambulance to the reporting physician''s hospital. When the emergency staff arrived at the patient''s home, the patient was in shock status. At 09:04, cardiopulmonary arrest (CPA) was confirmed, for which cardiopulmonary resuscitation (CPR) was initiated. Even after arrival at the reporting physician''s hospital, a full course of resuscitation efforts was attempted. However, heart rate was not resumed. At 10:36, the death was confirmed. 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. The outcome of all the events was fatal. Pfizer is the Marketing authorization holder of COVID-19 VACCINE in the country of incidence .This may be a duplicate report if another marketing authorization holder of COVID-19 VACCINE has submitted the same report to regulatory authorities. The lot number for the vaccine, COVID-19 Vaccine, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Shock; cardiopulmonary arrest


VAERS ID: 1576817 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardiac arrest, Chest pain, Computerised tomogram, Depressed level of consciousness, Scan myocardial perfusion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm (aneurysm of the ascending and descending aorta found on 28Jan2021); Angina pectoris; Chest pain (had become frequent in these days); Coronary artery bypass; Heart disorder; Ischaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210128; Test Name: CT; Result Unstructured Data: Test Result:aneurysm; Comments: in the ascending and descending aorta; Test Date: 20210806; Test Name: CT; Result Unstructured Data: Test Result:aortic dissection; Comments: ascending and descending aortic dissection; Test Name: myocardial scintigraphy; Result Unstructured Data: Test Result:aggravated ischaemia
CDC Split Type: JPPFIZER INC202101023236

Write-up: Acute aortic dissection; depressed level of consciousness; chest pain; asystole; This is a spontaneous report from a contactable physician (Emergency outpatient department) received from the Regulatory authority report number is v21122767. The patient was an 83-year-old female. Body temperature before vaccination was 36.3 degrees Centigrade on 05Aug2021. The patient family history was not reported. Medical history included cardiac disease (as reported), in 2008, the patient underwent coronary artery bypass surgery for angina pectoris. Chest pain attack had become frequent in these days, and findings of aggravated ischaemia were observed on myocardial scintigraphy. Treatment with oral medicines had been pushed to the limit. On 28Jan2021, computerised tomography (CT) revealed aneurysm in the ascending and descending aorta. The patient''s concomitant drug was not reported. On 05Aug2021 at 15:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization, at age of 83 years old of vaccination. On 06Aug2021 at around 01:00 (approximately 9 hours and 45 minutes after the vaccination), the patient experienced acute aortic dissection, chest pain and depressed level of consciousness. The patient was transported to the reporting physician''s hospital. On 06Aug2021 at an unknown time (unknown day or time after the vaccination), the patient died. The course of the event was as follows: In 2008, the patient underwent coronary artery bypass surgery for angina pectoris. Chest pain attack had become frequent in these days, and findings of aggravated ischaemia were observed on myocardial scintigraphy. Treatment with oral medicines had been pushed to the limit. On 28Jan2021, computerised tomography (CT) revealed aneurysm in the ascending and descending aorta. On 05Aug2021 (the day of vaccination), the patient received the vaccination. On 06Aug2021 past 01:00 (approximately 9 hours and 45 minutes after the vaccination), the patient experienced chest pain (illegible) and depressed level of consciousness. When emergency medical service staff arrived, asystole was confirmed. The patient was immediately transported to the reporting physician''s hospital. CT showed ascending and descending aortic dissection. The outcome of the events for acute aortic dissection was fatal, for other events was unknown. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was not reported. The reporting physician commented as follows: This situation would have occurred even if the patient had not been vaccinated; thus, the possibility of considered involvement of BNT162b2 was considered unknown (illegible) or unrelated.; Reported Cause(s) of Death: Acute aortic dissection


VAERS ID: 1576818 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-24
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood test, Echocardiogram, Myocarditis, Oxygen saturation
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: 2021-07-27
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DEXAMETHASONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple myeloma (DRd therapy had been initiated)
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Coronary angiography; Result Unstructured Data: Test Result:no significant stenosis in coronary artery; Test Date: 20210726; Test Name: Blood test; Result Unstructured Data: Test Result:increase in cardiac enzymes; Test Date: 20210726; Test Name: Echocardiography; Result Unstructured Data: Test Result:decrease in wall motion; Test Date: 20210726; Test Name: SpO2; Result Unstructured Data: Test Result:decrease; Comments: at 22:00
CDC Split Type: JPPFIZER INC202101023237

Write-up: fulminant myocarditis; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21122758. The patient was an 85-year and 5-month-old female (age at vaccination was 85-year and 5-month old). Body temperature before vaccination was not reported. On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were unknown) via an unspecified route of administration as a single dose for COVID-19 immunization, lenalidomide (REVLIMID), daratumumab, route of administration, start and stop date, batch/lot number and dose were not reported for multiple myeloma recurrent. The patient had no family history. Medical history included recurrent multiple myeloma. Concomitant medications included dexamethasone taken for multiple myeloma recurrent. On 08Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were unknown) for COVID-19 immunization. On 24Jul2021 at around 10:00 (25 days after the vaccination), the patient experienced fulminant myocarditis. On 24Jul2021, the patient developed pyrexia and chest discomfort, for which the patient was admitted to hospital and antibiotic was started. On 24Jul2021 (25 days after the vaccination), the patient was admitted to the hospital. On 26Jul2021 at 22:00, the patient experienced decrease in SpO2. Blood test revealed increase in cardiac enzymes and echocardiography revealed decrease in wall motion. Coronary angiography was performed but there was no significant stenosis in coronary artery. It was assessed as myocarditis and vasopressor was started for blood pressure decreased. The condition did not improve and on 27Jul2021 at 17:18, death was confirmed. The action taken in response to the events for lenalidomide and daratumumab was not applicable. On 27Jul2021 (28 days after the vaccination), the outcome of the event was fatal. The patient died on 27Jul2021. It was unknown 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 causes of the event such as any other diseases were REVLIMID and DARZQURO. The reporting physician commented as follows: Relationship between the vaccination and the event could not be denied. The lot number for the vaccine BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: fulminant myocarditis


VAERS ID: 1576819 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardio-respiratory arrest, Chest X-ray, Computerised tomogram thorax, Dyspnoea exertional, Echocardiogram, Interstitial lung disease, Oxygen saturation, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Interstitial lung disease (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TAGRISSO
Current Illness: Lung cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: blood pressure; Result Unstructured Data: Test Result:degreased; Test Date: 20210727; Test Name: chest X-ray; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210805; Test Name: chest X-ray; Result Unstructured Data: Test Result:No disease which might cause CRA; Comments: No disease which might cause cardio-respiratory arrest; Test Date: 20210802; Test Name: chest CT; Result Unstructured Data: Test Result:Ground-glass opacity in the left lower lobe; Test Date: 20210805; Test Name: echocardiogram; Result Unstructured Data: Test Result:R ventricular dilation/L ventricular collapse; Comments: right ventricular dilation and left ventricular collapse; Test Date: 20210727; Test Name: SpO2; Result Unstructured Data: Test Result:maintained %; Test Date: 20210802; Test Name: SpO2; Result Unstructured Data: Test Result:91 to 95 %; Test Date: 20210802; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210803; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: JPPFIZER INC202101023238

Write-up: drug-induced pneumonia/drug-induced interstitial pneumonia; pulmonary thromboembolism; Sudden cardio-respiratory arrest; dyspnoea exertional; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122724. The patient was a 71-year-old female. Body temperature before vaccination was not provided. The family history was not provided. The patient had medical history of lung cancer, for which she was orally taking osimertinib mesilate (TAGRISSO). On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 19Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization at age of 71 years old. On 05Aug2021 at 08:30 (17 days after the vaccination), the patient experienced sudden cardio-respiratory arrest. On 02Aug2021 (14 days after the vaccination), the patient was admitted to the hospital. On 05Aug2021 (17 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was orally taking osimertinib mesilate (TAGRISSO) for recurrence of lung cancer. On 19Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 21Jul2021 (2 days after vaccination), the patient had dyspnoea exertional. On 27Jul2021 (8 days after vaccination), at the regular hospital visit, SpO2 was maintained, and chest X-ray showed no abnormalities. Thereafter, the dyspnoea on exertion persisted. On 02Aug2021 (14 days after vaccination), the patient visited the outpatient department of the reporting hospital. The SpO2 was 91 to 95%, and chest CT showed ground-glass opacity in the left lower lobe. On the same day, the patient was admitted to the reporting hospital. The PCR for SARS-CoV-2 test was negative on 02Aug2021 (14 days after vaccination) and 03Aug2021 (15 days after vaccination). The patient was considered to have drug-induced pneumonia, and a drip infusion of a steroid was initiated. On 05Aug2021, at 08:00 (17 days and 8 hours after vaccination), the patient sent a line to her family, but she did not complain in particular. At 08:30 (17 days, 8 hours, and 30 minutes after vaccination), the patient complained of dyspnoa, and she put the nurse call button. The patient had orthopnea and rapid breathing. The blood pressure decreased, and the patient had cardio-respiratory arrest. The patient was transferred to the intensive care unit (ICU). The sternum was compressed, the trachea intubation was performed, an artificial ventilator was attached, and catecholamine was administered. Then, the pulse rate returned once; however, the patient had cardiac arrest again. At 11:21 (17 days, 11 hours, and 21 minutes after vaccination), the patient died. The echocardiogram when the pulse rate returned showed right ventricular dilation and left ventricular collapse. Chest X-ray showed no diseases which might cause cardio-respiratory arrest. 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 as follows: Almost no examination could be performed after a sudden change. Although there were many unclear points, pulmonary thromboembolism was most considerable. Others were deniable. The reporting physician commented as follows: At the time of the hospitalization, the cause of hypoxia was considered as drug-induced interstitial pneumonia. However, the range was not so large, and chest X-ray after a sudden change showed no expansion of the opacity. It was not considered that the sudden change occurred due to acute aggravation of interstitial pneumonia. It was most reasonable that the patient was complicated with pulmonary thromboembolism based on the clinical course; however, there was no direct evidence. If the patient would have thrombosis, the causality between the event and the vaccination was unknown. However, since the patient died, this case was reported. The outcome of events drug-induced pneumonia/ drug-induced interstitial pneumonia, pulmonary thromboembolism, dyspnoea exertional was not resolved. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Sudden cardio-respiratory arrest


VAERS ID: 1576820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-08-03
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101023245

Write-up: Suicide; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was an 80-year-old male. On 17Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as single dose for COVID-19 immunization. Relevant medical history was unknown. Concomitant medications were not reported. On 26Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunization. On 03Aug2021 (17 days after the vaccination), the patient experienced suicide at his home. The patient died on 03Aug2021. It was not reported whether an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2 vaccination. The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on known drug safety profile, there is less possibility of causal association between the event Suicide and the suspect drug BNT162B2. 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: Suicide


VAERS ID: 1576821 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101023253

Write-up: cerebral infarction; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 72-year-old female. Underlying disease included hypertension. Concomitant medications were not reported. On an unspecified date, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# and Expiration date were not reported) via an unspecified route of administration as dose 1, single for COVID-19 immunisation. On 24Jun2021 at unspecified time (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot# and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28Jun2021 (four days after the vaccination), the patient experienced cerebral infarction. The patient was admitted to hospital. On 01Jul2021 (seven days after the vaccination), the patient died. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the event and bnt162b2 as unknown. The outcome of the event was fatal. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on temporal association, the causal relationship between bnt162b2 and the event cerebral infarction cannot be excluded. The contributory role of the pre-existing hypertension in this elderly female cannot be ruled out as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: cerebral infarction


VAERS ID: 1576824 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-13
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Intellectual disability; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101023468

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory authority; report number is v21122809. A 35-years-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 02Jul2021 16:00 (Lot Number: FC3661; Expiration Date: 30Sep2021) as dose 2, single (at age of 35-years-old) for covid-19 immunisation. Medical history included intellectual disability and sleep apnoea syndrome. The patient had no relevant family history. The patient''s concomitant medications were not reported. Historical Vaccine included the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA2453, Expiration date: 31Aug2021) on 10Jun2021 as a single dose for COVID-19 immunization. On 13Jul2021 at 15:00 (11 days after the vaccination), the patient experienced subarachnoid haemorrhage. On 13Jul2021 at 16:39 (11 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 13Jul2021 at around 15:00, since the patient complained of headache, she took CALONAL 200 mg, 2 tablets, and then went to the restroom. When she returned from the restroom, she lost consciousness and collapsed. An ambulance was called, and she was transferred to a hospital where cardiopulmonary resuscitation was performed. However, at 16:39, the patient passed away. The patient underwent lab tests and procedures which included body temperature: 36.5 centigrade before vaccination on 02Jul2021. Outcome of the event was fatal. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The event occurred 11 days after the second dose of the vaccination, therefore it could not be said that there was no causal relationship.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1576840 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-31
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002337 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   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: Dilated cardiomyopathy (Idiopathic dilated cardiomyopathy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP069699

Write-up: This case was received via Regulatory Authority (Reference number: 2021TJP069699) on 03-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This case, reported by a physician, was via adverse reaction reporting site (TASK0020683). On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 02-Jul-2021, at 13:30, the patient received the 1st dose of the vaccine. On 30-Jul-2021, at 13:30, the patient received the 2nd dose of the vaccine. On 31-Jul-2021, low-grade fever and malaise developed, so the patient took a rest. At 12:00, the patient was confirmed as normal for the last time by the conversation with the patients wife. At 13:15, when the wife went to see the patient, there was no response, and the patient was transported by ambulance with asystole. At 13:24, the patient was in a state of asystole when the ambulance crew contacted with him. After transportaion to the hospital, CPR was continued, and 6A of adrenaline was administered in total, but the patient was in a state of asystole throughout the whole time. At 14:07, the patient was confirmed dead. AiCT: there were images of cardiomegaly and congestion in the lung field, no intracranial hemorrhage, no intrathoracic or intraperitoneal hemorrhage, and no images suggestive of aortic dissection or cardiac tamponade. The cause of death was confirmed as acute cardiac death (1 hour from onset to death) at autopsy. Lethal arrhythmia may be one of the other possible contributing factors. The outcome of low-grade fever, malaise, asystole, cardiomegaly, and image of congestion in the lung field was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Low grade fever; Malaise; Asystole; Cardiomegaly; Pulmonary congestion; Cardiac death


VAERS ID: 1576841 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anal incontinence, Body temperature, Cardiac arrest, Malaise, Pupillary reflex impaired, Pyrexia, Respiratory arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: 37.8 degrees Celsius; Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: 36 degrees Celsius, Body temperature slightly decreased
CDC Split Type: JPTAKEDA2021TJP069734

Write-up: Respiratory arrest; Cardiac arrest; Respiratory elimination; Loss of light reflex; Faecal incontinence; Vomiting; Malaise; Pyrexia; This case was received via Regulatory Authority (Reference number: 2021TJP069734) on 04-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. The license partner had received the report (Reference number: v21122358 ). This case, initially reported to the Regulatory Agency by a pharmacist, was received (Ref, v21122358). On an unknown date, body temperature before the vaccination: unknown. On an unknown date, the patient received the 1st dose of this vaccine. On 05-Jul-2021, the patient received the 2nd dose of this vaccine. On 06-Jul-2021, pyrexia of about 37.8 degrees Celsius developed. On 07-Jul-2021, body temperature was in the 36 degrees Celsius range. The patient had malaise but ate as usual. On 08-Jul-2021, around 18:30, the family member heard the patient''s sleep-breath. Around 19:30, the patient was in respiratory arrest, and an emergency call was made. At 19:33, the patient was raced to a hospital (using an automatic cardiac massage machine). CPR for asystole was performed, and oral vomit was aspirated. The patient had faecal incontinence. Route was secured, and adrenaline was administered intravenously 7 times. PAE occurred several times but returned to asystole. The patient''s family memeber did not request intubation or ventilator management. CPR was performed for about 1 hour, and its discontinuation was requested. Spontaneous circulation, spontaneous breathing, and loss of light reflex were noted. At 20:30, the patient was confirmed dead. The outcome of pyrexia, malaise, respiratory arrest, vomiting, faecal incontinence, cardiac arrest, respiratory elimination, and loss of light reflex was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Pyrexia; Malaise; Respiratory arrest; Vomiting; Faecal incontinence; Cardiac arrest; Respiratory arrest; Pupillary light reflex lost


VAERS ID: 1576842 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure congestive, Computerised tomogram, Cough, Decreased appetite, Diarrhoea, Dyspepsia, Dyspnoea, Gait inability, Lung neoplasm malignant, Malaise, Myalgia, Nausea, Orthopnoea, Pericardial effusion, Pneumonia, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Dermatitis atopic; Glucose tolerance impaired; Lung cancer (Postoperative lung cancer).
Preexisting Conditions: Medical History/Concurrent Conditions: Lung neoplasm surgery (Postoperative lung cancer).
Allergies:
Diagnostic Lab Data: Test Name: CT Scan; Result Unstructured Data: Diagnosed with pneumonia and pericardial effusion and further details were not specified.; Test Name: X-ray; Result Unstructured Data: Diagnosed with pneumonia and pericardial effusion and further details were not specified.
CDC Split Type: JPTAKEDA2021TJP069751

Write-up: Cardiac failure congestive; Lung cancer; Diarrhoea; Heartburn; Inappetence; The patient had orthopnea; Nausea; Pericardial effusion; Pneumonia; Patient was unable to walk properly even for about 5 minutes; Shortness of breath; Cough; Malaise; Myalgia in the arm; This case was received via the Regulatory Authority (Reference number: 2021TJP069751) on 03-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0020687). On an unknown date, body temperature before the vaccination: unknown. On 08-Jul-2021, the patient received the 1st dose of this vaccine. On 09-Jul-2021, the patient experienced myalgia in the arm and malaise. On 10-Jul-2021, short of breath and cough occurred. The symptom tended to get worse. On 19-Jul-2021, the patient was unable to walk properly even for about 5 minutes, and cough also persisted. The patient visited a primary care physician and underwent X-ray and CT, and the patient was seemed to be diagnosed with pneumonia and pericardial effusion (details unspecified). On 20-Jul-2021, the patient had nausea, diarrhoea, heartburn, and inappetence. The patient had orthopnea. On 24-Jul-2021, before dawn, the patient was confirmed dead. According to the postmortem report, the patient died due to cardiac failure congestive and lung cancer around 22-Jul-2021. The outcome of malaise, shortness of breath, cough, pneumonia, and pericardial effusion was fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 61 year-old male patient with a history of lung cancer, who died approximately 16 days after receiving the first dose of the mRNA-1273 vaccine. There is a discrepancy in source document regarding the date of death. For the event lung neoplasm malignant: based on information received and the natural history of lung cancer, the event is assessed as unlikely related to mRNA-1273. For the rest of the events, very limited information has been provided at this time. However, patient''s significant history of lung cancer could be a confounding factor that may play a possible contributory role, providing alternative explanation.; Reported Cause(s) of Death: Malaise; Shortness of breath; Cough; Pneumonia; Pericardial effusion; Cardiac failure congestive; Lung cancer


VAERS ID: 1576859 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse drug reaction
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRJNJFOC20210827798

Write-up: UNSPECIFIED ADVERSE REACTIONS; This spontaneous report received from a consumer concerned 7 patients. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified adverse reactions. On an unspecified date, the patient died from unspecified adverse reactions. It was unknown if the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210827798- covid-19 vaccine ad26.cov2.s -UNSPECIFIED ADVERSE REACTIONS . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNSPECIFIED ADVERSE REACTIONS


Result pages: prev   52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 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   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=151&PERPAGE=100&VAX=COVID19&DIED=Yes

Government Disclaimer on use of this data


Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166