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 121 out of 172

Result pages: prev   22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 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: 1364445 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   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:
Current Illness: Lymphoma; Squamous cell carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Death NOS; Diarrhoa; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death NOS) in an 80-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lymphoma and Squamous cell carcinoma. On 14-Apr-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced DIARRHOEA (Diarrhoa). On 15-Apr-2021, DIARRHOEA (Diarrhoa) outcome was unknown. The patient died on 15-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DIARRHOEA (Diarrhoa) to be possibly related and DEATH (Death NOS) to be unlikely related. Concomitant product use was not provided. Treatment information was not provided. Company comment: Based on reporter''s causality of unlikely and the patient''s advanced age and underlying medical conditions, the event of Death is assessed as unlikely related to mRNA-1273. Concerning the event of Diarrhoea, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on reporter''s causality of unlikely and the patient''s advanced age and underlying medical conditions, the event of Death is assessed as unlikely related to mRNA-1273. Concerning the event of Diarrhoea, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1364540 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Pulmonary embolism
SMQs:, Dementia (broad), Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced FEELING ABNORMAL . On 28-Apr-2021, the patient experienced PULMONARY EMBOLISM (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was lung embolism and organs failure. An autopsy was performed, but no results were provided. At the time of death, FEELING ABNORMAL had not resolved. Concomitant medications were not provided. Treatment information was not provided. Company comment: This regulatory report case concerns a 64-year-old male subject who experienced the unexpected events of pulmonary embolism and feeling abnormal and died on 28-APR-2021. The event of pulmonary embolism occurred 5 days after receiving the first vaccine dose, the reported cause of death was lung embolism and organs failure. Causality is confounded by the subject''s age. Very limited information regarding this event has been provided at this time. No further information is expected.; Sender''s Comments: This regulatory report case concerns a 64-year-old male subject who experienced the unexpected events of pulmonary embolism and feeling abnormal and died on 28-APR-2021. The event of pulmonary embolism occurred 5 days after receiving the first vaccine dose, the reported cause of death was lung embolism and organs failure. Causality is confounded by the subject''s age. Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Lung embolism and organs failure


VAERS ID: 1364572 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-14
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210557499

Write-up: FLU-LIKE SYMPTOMS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, DE-PEI-202100077678] concerned a 79 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: unknown) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the patient experienced flu-like symptoms. On an unspecified date, the patient died from flu-like symptoms. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0; 20210557499-COVID-19 VACCINE AD26.COV2.S-Flu-like symptoms. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FLU-LIKE SYMPTOMS


VAERS ID: 1365588 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, 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: COVID-19 test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021502425

Write-up: Patient passed away; COVID-19; COVID-19; The initial case was missing the following minimum criteria: no first-hand knowledge. Upon receipt of follow-up information on 25May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and from the nursing management of the retirement home. Initial information was received by Pfizer from Biontech, manufacturer control number: 50316, license party for COMIRNATY. An elderly patient (age reported as between 93-97 years, 10 Decade) of an unspecified gender received two doses of BNT162B2 (COMIRNATY), the first dose on 10Jan2021 (Lot. EM0477) and the second dose on 31Jan2021 (Lot. EK9788), both at single dose, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. Post the vaccinations, the patient has been tested for COVID-19 and resulted positive on an unspecified date. The patient passed away on an unspecified date. It was unknown if autopsy was done. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: The limited information provided in this report precludes a full assessment of the case. This case will be reassessed when 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: Patient passed away; COVID-19; COVID-19


VAERS ID: 1365605 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021604793

Write-up: Patient passed away; COVID-19; COVID-19; The initial case was missing the following minimum criteria: no first-hand knowledge. Upon receipt of follow-up information on 25May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and from the nursing management of the retirement home. Initial information was received by Pfizer from Biontech, manufacturer control number: 50316, license party for COMIRNATY. An elderly patient (age reported as between 93-97 years, 10 Decade) of an unspecified gender received two doses of BNT162B2 (COMIRNATY), the first dose on 10Jan2021 (Lot. EM0477) and the second dose on 31Jan2021 (Lot. EK9788), both at single dose, for COVID-19 immunization. Relevant medical history and concomitant medications were unknown. Post the vaccinations, the patient has been tested for COVID-19 and resulted positive on an unspecified date. The patient passed away on an unspecified date. It was unknown if autopsy was done. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Patient passed away; COVID-19; COVID-19


VAERS ID: 1365610 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001654 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had previously been healthy and well. The patient''s medical history was not reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Found dead; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Found dead) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001654) for COVID-19 vaccination. The patient had previously been healthy and well. The patient''s medical history was not reported. On 30-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 04-May-2021 The patient died on 04-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The patient''s concomitant medication was not reported. No treatment information was provided. This is a case of death in a 73-year-old female subject with unknown medical history, who died 4 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 73-year-old female subject with unknown medical history, who died 4 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1365611 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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: SULFAMETHIZOL; DIPROSALIC; ANTABUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abnormal behavior (Changes in behavior that could indicate dementia); Alcohol problem; Aneurysm cerebral; Cystitis; Skin disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Found death.; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Found death.) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. The patient''s past medical history included Aneurysm cerebral in 1982. Concurrent medical conditions included Abnormal behavior (Changes in behavior that could indicate dementia) in 2020, Cystitis on 12-Apr-2021, Skin disorder on 27-Jan-2021 and Alcohol problem on 13-Mar-2021. Concomitant products included DISULFIRAM (ANTABUS) from 13-Mar-2012 to 23-Apr-2021 for Alcohol problem, SULFAMETHIZOL from 12-Apr-2021 to 23-Apr-2021 for Cystitis, BETAMETHASONE DIPROPIONATE, SALICYLIC ACID (DIPROSALIC) from 27-Jan-2017 to 23-Apr-2021 for Skin disorder. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on 23-Apr-2021 The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter considered DEATH (Found death.) to be not related. No treatment medication information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant medication Diprosalic was used in strength 0.5+20 milligram per gram in 2 dosage form. Based on reporter''s causality and past medical history of aneurism and other central nervous system affections, the event is assessed as unlikely related to mRNA-1273.; Sender''s Comments: Based on reporter''s causality and past medical history of aneurism and other central nervous system affections, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: death from natural causes


VAERS ID: 1365613 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, C-reactive protein, Death, Electrocardiogram, Haemoglobin, Heart rate, Neutrophil count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN "KRKA"; ALLOPURINOL; TOSTRAN; ANCOZAN
Current Illness: Atherosclerosis (Severe atherosclerotic changes from previous cardiac thrombosis found on autopsy); Atrial fibrillation (Suspected AFLI due to auscultation 13mar2021 (pulse irregular and fast).); Dyspnoea (Consultation 13mar2021 due to increasing breathing difficulty and dyspnoea post activities. The dyspnoea was recovering around christmas, but then worsening.); Shooting pain (beneath last rib. no radiation.)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (No alcohol in a year.); Cardiac thrombosis (Previous cardiac thrombosis found on autopsy); COVID-19 (Close to hospitalisation due to affeced general condition.); Comments: The dyspnoea was recovering around christmas, but then worsening.
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Blood test; Result Unstructured Data: Nothing abnormal except hem, CRP and neu. above; Test Date: 20210409; Test Name: C-reactive protein; Result Unstructured Data: 18 (slightly increased) Units not specified; Test Date: 20210409; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: See sender''s comments.; Test Date: 20210509; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: Sinus tachycardia. Incomplete left sided bundle branch block. Suspected leftsided ventricular hypertrophy with repolarising chenges in all leads.; Test Date: 20210409; Test Name: Hemoglobin; Result Unstructured Data: 7.9 (slight hypohaemoglobinaemia) Units not specified; Test Date: 20210409; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 117 heart beats per minute; Test Date: 20210409; Test Name: Blood neutrophils; Result Unstructured Data: 7.5 (slightly increased) Units not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: death 1.5 days after vaccination.; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death 1.5 days after vaccination.) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. The dyspnoea was recovering around christmas, but then worsening. The patient''s past medical history included COVID-19 (Close to hospitalisation due to affeced general condition.) in November 2020, Alcohol abuse (No alcohol in a year.) in 2020, Atherosclerosis (Severe atherosclerotic changes from previous cardiac thrombosis found on autopsy) since an unknown date and Cardiac thrombosis (Previous cardiac thrombosis found on autopsy). Concurrent medical conditions included Dyspnoea (Consultation 13mar2021 due to increasing breathing difficulty and dyspnoea post activities. The dyspnoea was recovering around christmas, but then worsening.) since November 2020, Shooting pain (beneath last rib. no radiation.) since December 2020 and Atrial fibrillation (Suspected AFLI due to auscultation 13mar2021 (pulse irregular and fast).). Concomitant products included SIMVASTATIN (SIMVASTATIN "KRKA") from 17-Dec-2019 to an unknown date for Blood cholesterol increased, LOSARTAN POTASSIUM (ANCOZAN) from 07-Jan-2015 to an unknown date for Blood pressure high, ALLOPURINOL from 01-Feb-2013 to an unknown date for Gout, TESTOSTERONE (TOSTRAN) from 06-Mar-2019 to an unknown date for Testosterone low. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 10-Apr-2021 The patient died on 10-Apr-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood test: normal (normal) Nothing abnormal except hem, CRP and neu. above. On 09-Apr-2021, C-reactive protein: 18 (High) 18 (slightly increased) Units not specified. On 09-Apr-2021, Electrocardiogram: sinus tachycardia. incomplete left sided bundle br (Inconclusive) See sender''s comments.. On 09-Apr-2021, Haemoglobin: 7.9 (abnormal) 7.9 (slight hypohaemoglobinaemia) Units not specified. On 09-Apr-2021, Heart rate: 117 (Inconclusive) 117 heart beats per minute and 117 heart beats per minute. On 09-Apr-2021, Neutrophil count: 7.5 (High) 7.5 (slightly increased) Units not specified. On 09-May-2021, Electrocardiogram: sinus tachycardia. Sinus tachycardia. Incomplete left sided bundle branch block. Suspected leftsided ventricular hypertrophy with repolarising chenges in all leads.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. This is a case of death in a 70-year-old male subject with unknown medical history of HTN, A fib, Alcohol abuse, gout, high cholesterol and recent Covid-19 infection, who died 2 days after receiving the first dose of vaccine. No significant information was provided with the last follow up. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Senders comments confirmed date of death confirmed and lab data updated. On 20-May-2021: Significant FU; Sender''s Comments: This is a case of death in a 70-year-old male subject with unknown medical history of HTN, A fib, Alcohol abuse, gout, high cholesterol and recent Covid-19 infection, who died 2 days after receiving the first dose of vaccine. No significant information was provided with the last follow up; Reported Cause(s) of Death: unknown cause of death; Death


VAERS ID: 1365765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Fatigue, Infarction, Loss of consciousness, Loss of personal independence in daily activities
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021597443

Write-up: Cardiac arrest; great fatigue; loss of autonomy; shortness of breath; loss of consciousness; suspects an infarction; This is a spontaneous report from a contactable consumer downloaded from the, regulatory authority number FR-AFSSAPS-2021055401. A 67-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FA5831), intramuscular, administered in Arm Left on 06May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included diabetes and leg bypass surgery from an unknown date. No medical history of heart or cardiovascular disease. The patient''s concomitant medications were not reported. On 07May2021, 1 day after vaccination, the patient had an onset of great fatigue, loss of autonomy, shortness of breath, and loss of consciousness then had a cardiac arrest at 8:00 pm (20:00) and was taken to the hospital. The patient died in the intensive care during the night on 07May2021. The doctor suspects an infarction. The symptoms started on Friday morning on 07May2021. The patient died from cardiac arrest and suspected infarction in the night of 07May2021. It was not reported if an autopsy was performed. The outcome of the events great fatigue, loss of autonomy, shortness of breath, loss of consciousness was unknown.; Reported Cause(s) of Death: suspects an infarction; Cardiac arrest


VAERS ID: 1365766 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021591093

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [Regulatory Authority report number FR-AFSSAPS-2021055571]. A 72-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular in arm left, on 10May2021 (Lot Number: FA5831), at 0.3 ml single (1st dose, 0.3 ml single), for COVID-19 immunisation. Medical history and concomitant medications were none. On 15May2021 the patient was seen in good shape without signs of illness or fatigue. He lived alone at his home. On 16May2021, around 3:30 AM, the patient called his sister and leaved her a message stating that he did not feel well and that he had trouble breathing. At 8:00 AM his sister went to his home and found him unconscious. The patient experienced sudden death (death) on 16May2021. Therapeutic measures were taken as a result of sudden death and included gestures of resuscitation performed by the emergency services. The patient died on 16May2021. An autopsy was not performed. According to the first-aid doctor, the death dated back several hours before their arrival (very cold limbs), probably during the night. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1366057 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-30
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 29
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: Coronary artery disease; Insufficiency coronary artery; Stent placement (could not access one artery to place a stent to another)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021624977

Write-up: cardiac arrest; This is a spontaneous report from a contactable consumer (family friend). A 67-years-old female patient received BNT162b2 (COMIRNATY), dose 2 intramuscularly in the deltoid on 12May2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Relevant medical history included coronary artery disease from an unknown date and cardiac surgery/stent placement in April2020; however, they could not access one artery to place a stent to another, so there was insufficiency to one artery. The patient''s concomitant medications were not reported. On 30May2021 she had a cardiac arrest. She was transferred to a hospital and there were attempts for her resuscitation. The outcome of the cardiac arrest was fatal. The patient died on an unspecified day in May2021. An autopsy will be performed on "Thursday" and the reporter will provide results.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1366058 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (under treatment NOS)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021629439

Write-up: sudden death; This is a spontaneous report from a non-contactable consumer or other non hcp. A 62-year-old male patient received BNT162B2 (COMIRNATY) (Batch/Lot number was not reported), dose 1, via an unspecified route of administration on 27May2021 as 1st DOSE, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing (under treatment NOS). Concomitant medication included an unspecified hypertension medication. The patient experienced sudden death on 28May2021. The patient received the first dose and stayed at the vaccination center for 20 minutes after the vaccine was given, without any anaphylactic reaction. He left for home, where he lived alone. According to the official signal of the Police, around 1:15 in the morning, he contacted a relative and complained that he was not feeling well. His relative went home and stayed with him until 4:30. Yesterday morning (28May2021), around 9:05, the 62-year-old talked to his cousin again, but it was going to be the last time. About half an hour later his relative found him dead on the bed. The patient died on 28May2021. An autopsy was scheduled for a later date. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1366059 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-09
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypothermia, Organ failure, Oxygen saturation, Oxygen saturation decreased, Pneumonia bacterial, Pyrexia, SARS-CoV-2 test, Septic shock
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Accidents and injuries (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 10
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: GLUCOPHAGE [METFORMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus (under Glucophage treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210509; Test Name: oxygen saturation; Result Unstructured Data: Test Result:reduced; Test Date: 202105; Test Name: Sars-Cov-2 PCR; Result Unstructured Data: Test Result:negative; Test Date: 202105; Test Name: Sars-Cov-2 rapid test; Result Unstructured Data: Test Result:negative
CDC Split Type: GRPFIZER INC2021629830

Write-up: fever; O2 saturation reduced; hypothermia; Septic shock; febrile microbial/bacterial pneumonia; organ failure; This is a spontaneous report from a contactable consumer (son of the patient). A 71-year-old male patient received BNT162B2 (COMIRNATY, Lot unknown, second dose) solution for injection intramuscular on 27Apr2021 (at the age of 71-years-old) as single dose for COVID-19 vaccination. Medical history included type 2 diabetes mellitus, under GLUCOPHAGE treatment. Concomitant medication included metformin (GLUCOPHAGE) for type 2 diabetes mellitus. Historical vaccine included BNT162B2 (COMIRNATY, first dose) for COVID-19 vaccination on 05Apr2021. On 09May2021 the patient experienced fever, his O2 saturation was reduced, then 6 hours later he developed hypothermia. An ambulance was called and he was admitted on 09May2021. The patient was later intubated and transferred. The patient underwent 5 COVID-19 tests, rapid and PCR (molecular) and they were all negative in May2021. The patient died on 19May2021. The cause of death was determined as febrile microbial/bacterial pneumonia, septic shock, organ failure. The outcome of the events fever, O2 saturation reduced, hypothermia was unknown. It was not reported if an autopsy was performed. Follow-up activities not initiated. Information about lot/batch number cannot be obtained. Possibly legal case.; Reported Cause(s) of Death: organ failure; septic shock; febrile microbial/bacterial pneumonia


VAERS ID: 1366089 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-28
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Renal failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (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), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VALSARTAN; MILURIT; AMLODIPINE
Current Illness: Hypertension; Uraemia of renal origin
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 rapid POC test; Result Unstructured Data: Negative
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: diarrhoea; renal insufficiency; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DIARRHOEA (diarrhoea) and RENAL FAILURE (renal insufficiency) in a 76-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. Concurrent medical conditions included Uraemia of renal origin and Hypertension. Concomitant products included VALSARTAN, ALLOPURINOL (MILURIT) and AMLODIPINE for an unknown indication. On 02-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 28-Apr-2021, the patient experienced DIARRHOEA (diarrhoea) (seriousness criterion death) and RENAL FAILURE (renal insufficiency) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Diarrhoea and Renal insufficiency. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DIARRHOEA (diarrhoea) and RENAL FAILURE (renal insufficiency) to be unlikely related. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was Not Applicable Company comment: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reporter''s Comments: Sender Comment: Diarrhoea and renal insufficiency is not expected and not listed adverse events in the Product Information of COVID-19 VACCINE MODERNA. TTO is 27 days. Based on the patient''s medical history, the causal relationship is unlikely between the suspected drug and the adverse events. The case is serious due to fatal outcome.; 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: diarrhoea; renal insufficiency


VAERS ID: 1366092 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 6
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: HUMULIN R; XETER; EDNYT; MILURIT; DOXAZOSIN; ACETYLSALICYLIC ACID; PREDNISOLON RICHTER; ADVAGRAF; HUMULIN N; CONTROLOC; FUROSEMIDE; BETALOC ZOK; KALDYUM; MYFORTIC
Current Illness: Allergy to antibiotic; ARDS; Insulin therapy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; COVID-19 pneumonia; Diabetes mellitus; Kidney failure chronic; Kidney transplant
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: POSITIVE
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: COVID-19 pneumonia; Vaccination failure; COVID-19; This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia), VACCINATION FAILURE (Vaccination failure) and COVID-19 (COVID-19) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included COVID-19, COVID-19 pneumonia, Kidney failure chronic and Kidney transplant in June 2015. Concurrent medical conditions included Insulin therapy, ARDS, Allergy to antibiotic and Diabetes mellitus. Concomitant products included INSULIN HUMAN (HUMULIN R), ROSUVASTATIN CALCIUM (XETER), ENALAPRIL MALEATE (EDNYT), ALLOPURINOL (MILURIT), DOXAZOSIN, ACETYLSALICYLIC ACID, PREDNISOLONE (PREDNISOLON RICHTER), TACROLIMUS (ADVAGRAF), INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N), PANTOPRAZOLE SODIUM SESQUIHYDRATE (CONTROLOC), FUROSEMIDE, METOPROLOL SUCCINATE (BETALOC ZOK), POTASSIUM CHLORIDE (KALDYUM) and MYCOPHENOLATE SODIUM (MYFORTIC) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 16-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced COVID-19 (COVID-19) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria death, hospitalization and medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criteria death and hospitalization). The patient died on 22-Apr-2021. The reported cause of death was COVID-19 pneumonia, Vaccination failure and covid-19. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VACCINATION FAILURE (Vaccination failure) to be possibly related. No further causality assessments were provided for COVID-19 PNEUMONIA (COVID-19 pneumonia) and COVID-19 (COVID-19). Treatment medicines were not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: Very limited information regarding this events has been provided at this time.; Sender''s Comments: Very limited information regarding this events has been provided at this time.; Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure; COVID-19


VAERS ID: 1366093 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-29
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular examination, Dyspnoea, Emergency care examination, Hypertension, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: examined by cardiology; Result Unstructured Data: Test Result:no cardiological reason; Comments: was detected underlying his complaints.; Test Date: 20210317; Test Name: examined on emergency care unit; Result Unstructured Data: Test Result:left on his own responsibility
CDC Split Type: HUPFIZER INC2021599188

Write-up: dyspnoea; hypertension; sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-340221. A 65-year-old male patient received first dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 15Apr2021 at 08:00 (Batch/Lot Number: EW4815) as 0.3 mL single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 29Apr2021 the patient was transported to hospital by the ambulance due to dyspnoea and hypertension. He was treated on cardiology and died on 01May2021. Between vaccination and submission to hospital, he has not visited his physician. On 17Mar2021, he was examined on emergency care unit, but left on his own responsibility. On 25Mar2021, he was examined by cardiology, but no cardiological reason was detected underlying his complaints. An autopsy was performed, results were not provided. The patient outcome of the events dyspnoea and hypertension was unknown. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1366094 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-21
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   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: CURIDOL [PARACETAMOL;TRAMADOL HYDROCHLORIDE]; FRONTIN; AMLODIPIN TEVA; RISPERDAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Hypertension; Osteoporosis; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021599189

Write-up: Pneumonia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-342621. A 90-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm right on 31Jan2021 (Batch/Lot Number: EJ6134) as 0.3 mL single dose for COVID-19 immunisation. Medical history included pneumonia, hypertension, osteoporosis and arteriosclerosis all from an unknown date and unknown if ongoing. Concomitant medications included paracetamol/tramadol hydrochloride (CURIDOL, formulation: tablet, strength: 325 mg/37.5 mg) oral twice a day; alprazolam (FRONTIN, formulation: film-coated tablet) oral at 0.25 mg; amlodipine besilate (AMLODIPIN TEVA, formulation: tablet) oral at 5 mg daily and risperidone (RISPERDAL, formulation: oral solution) oral, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient experienced pneumonia on 21Feb2021 with fatal outcome. Therapeutic measures were taken as a result of pneumonia and included treatment with antibiotic therapy and antipyretics. The patient died on 22Feb2021 at 9:50. An autopsy was not performed. Sender Comment: as the reporter physician assessed the event as related to the patients primary diseases, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1366095 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-04-04
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Confusional state, Death, Fall, General physical health deterioration, Inflammation scan, Investigation, Rib fracture, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NITROMINT; RETAFYLLIN; SYMBICORT; VEROSPIRON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma bronchial; Cataract operation; Dementia vascular; Osteoporosis; Pyelonephritis chronic; Reflux esophagitis; Urinary infection
Allergies:
Diagnostic Lab Data: Test Name: inflammatory parameters; Result Unstructured Data: Test Result:elevated; Comments: Laboratory results showed elevated inflammatory parameters; Test Name: Laboratory results; Result Unstructured Data: Test Result:implied urinary infection; Test Date: 20210322; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210322; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021599191

Write-up: fell; rib fracture; weak state; confused state; condition deteriorated; Death; This is a spontaneous report from a contactable other health professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-345221. An 86-year-old female patient received second dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 10Mar2021 (Batch/Lot Number: EP2166) as 0.3 mL single dose for COVID-19 immunisation. Medical history included cataract operation, vascular dementia, urinary infection, osteoporosis, reflux esophagitis, asthma bronchial and pyelonephritis chronic, all from an unknown date and unknown if ongoing. Concomitant medications included glyceryl trinitrate (NITROMINT, formulation: transdermal patch) transdermal; theophylline (RETAFYLLIN); budesonide/formoterol fumarate (SYMBICORT) and spironolactone (VEROSPIRON) oral daily, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), intramuscular on 17Feb2021 (Batch/Lot Number: EL0725) as 0.3 mL single dose for COVID-19 immunisation. On 23Mar2021 the patient was hospitalized after she was found lying on the ground in her home. The old patient possibly fell because she had a rib fracture. The patient was in a weak, confused state the whole time. Despite the therapy (which also included parenteral antibiotics), the patient''s condition deteriorated and passed away on 04Apr2021. The patient underwent lab tests and procedures which included inflammatory parameters: laboratory results showed elevated inflammatory parameters and implied urinary infection, COVID-19 antigen test and COVID-19 PCR test: both negative on 22Mar2021. The patient died on 04Apr2021. The patient outcome of the events was unknown. An autopsy was not performed. Sender Comment: the reporter assessed the events 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. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1366096 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-08
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; COVID-19 pneumonia; Hypertension; Lymphoma (non-Hodgkin''s) (low-grade B cell lymphoma progressed); Tonsillectomy; Varicosity
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: Chest X-ray; Result Unstructured Data: Test Result:bilateral pneumonia; Test Date: 20210316; Test Name: Chest X-ray; Test Result: Positive ; Comments: confirmed pneumonia; Test Date: 20210308; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021599187

Write-up: COVID-19 pneumonia; COVID positive; COVID-19 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-345321. A 68-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: EP2166), intramuscular, administered in arm left on 24Feb2021 as 1st dose, 0.3 ml single for COVID-19 immunisation. Medical history included COVID-19 pneumonia, varicosity, tonsillectomy, COVID-19, lymphoma (non-Hodgkin''s) from 2020 (low-grade B cell lymphoma progressed) and hypertension. The patient''s concomitant medications were not reported. On 08Mar2021 thee patient experienced COVID-19 pneumonia , COVID positive and COVID-19 infection. It was reported that on 08Mar2021 COVID-19 infection was confirmed and the patient was hospitalized. Chest X-ray also showed bilateral pneumonia. The patient received COVID therapy but his condition did not get better and passed away on 24Mar2021 at 07:00. The patient was diagnosed with incurable low-grade B cell lymphoma in 2020 which progressed, therefore the patient''s general condition was not adequate enough to recover from the COVID-19 infection. The patient underwent lab tests and procedures which included chest x-ray: bilateral pneumonia on 08Mar2021, chest x-ray: positive (confirmed pneumonia) on 16Mar2021, COVID-19 antigen test: positive on 08Mar2021. The patient died on 24Mar2021 due to COVID-19. An autopsy was not performed. Sender comments: As the patient got infected with COVID-19 after the first dose, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1366106 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Drug ineffective, Fatigue, Malaise, Pneumonia, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 60
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; FUROSEMIDE; MIRAMEL; NUPRIN [ACETYLSALICYLIC ACID]; GABAPENTIN; ATORVASTATIN; MONTELUKAST; OMEPRAZOLE; AZITHROMYCIN; BETMIGA; DELTACORTRIL [PREDNISOLONE ACETATE]; GALFER; SERTRALINE [SERTRALINE HYDROCHLORIDE]; KALCIPOS; AMLOD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back injury NOS; COPD (hx well controlled COPD); Coronary bypass; Polymyalgia
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: CT scan; Result Unstructured Data: Test Result:descriptor included possible COVID-19.
CDC Split Type: IEPFIZER INC2021609241

Write-up: Malaise; FATIGUE; RIGHT SIDED PNEUMONIA; drug ineffective; Suspected COVID-19; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from a regulatory authority-WEB IE-HPRA-2021-073341. This case was split to capture events after second dose. This is first of two reports - for the first dose. Initial report was received by a regulatory authority on 10May2021 from a member of the public. An 86-year-old male patient received (COMIRNATY, Solution for injection, Lot number- EP2163, Expiration Date- Jun2021) via an unspecified route of administration on 24Feb2021 as 1st dose single and received (COMIRNATY, Solution for injection, Lot number- EW2243, Expiration Date-Jul2021) via an unspecified route of administration on 07Apr2021 as 2nd dose single for COVID-19 immunization. It was noted that the second dose was deferred to an earlier date, from 24Apr2021 to 07Apr2021. Patient medical history included previous coronary artery bypass, back injury in /Feb2021, polymyalgia and chronic obstructive pulmonary disease. The concomitant medications included amitriptyline, strength 10 mg and at a dose of 25 mg, 2 at night; furosemide, strength 20 mg and at a dose of 40 mg, once daily; pramipexole dihydrochloride monohydrate (MIRAMEL) strength 0.7 mg and at a dose of 0.18 mg, twice daily; acetyl salicylic acid (NUPRIN [ACETYLSALICYLIC ACID]) strength 75 mg and at a dose of 75 m, once daily; gabapentin at a dose of 100 mg twice daily; atorvastatin, strength 20 mg and at a dose of 20 mg one at night; montelukast, strength 4 mg and at a dose of 10mg, once daily; omeprazole, strength 10 mg and at a dose of 40 mg, once daily, azithromycin, strength 250 mg and at a dose of 250 mg three times a week (total of 750 mg dose); mirabegron (BETMIGA) strength 25 mg and at a dose of 25 mg once daily; prednisolone acetate (DELTACORTRIL [PREDNISOLONE ACETATE]) at a dose of 5 mg two daily; ferrous fumarate (GALFER) strength 305 mg and at a dose of 305 mg once daily; sertraline hydrochloride (SERTRALINE [SERTRALINE HYDROCHLORIDE]) at a dose of 50 mg once daily; calcium carbonate (KALCIPOS) at a dose of 500 mg once daily; amlodipine besilate (AMLODIPINE TEVA) strength 5 mg and at a dose of 5 mg once daily. Additional information on drug provided in product notes included time to onset reported as 12 days /10 days.On 08Mar2021, 12 days post-vaccination, the patient experienced malaise and fatigue. On 12Mar2021, the patient was admitted to hospital. It was reported that the patient was treated for pneumonia. CT scan was performed, the descriptor included possible COVID-19. In April, on an unknown date, following the second dose, the patient experienced increasing shortness of breath and significant reduced in mobility. On 11Apr2021, the patient''s chest was examined by his General Practitioner, and further investigation was arranged to be performed in hospital. On 17Apr2021, the patient was transferred to another hospital and was treated for ongoing and adaptive pneumonia. The patient required high flow oxygen therapy in special care unit after one week of increasing oxygen therapy. On 18April2021, X-rays and sputum investigations were performed. On 01May2021, the patient''s condition deteriorated and the patient passed away. The reporter stated the patient was very well prior to the vaccine with no respiratory complaints in the past couple of years. The outcome of the events inappropriate schedule of vaccine administered and off label use was unknown while for the other events was fatal. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : IE-PFIZER INC-2021616129 same patient, different vaccine doses; Reported Cause(s) of Death: malaise; fatigue; pneumonia; suspected COVID-19; drug ineffective


VAERS ID: 1366173 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH in a 97-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. The patient died on 30-Apr-2021. The reported cause of death was Sudden death. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication were reported by the reporter.Treatment medications for these events were not reported by the reporter. Action taken with mRNA-1273 in response to the events was not applicable. Very limited information regarding the event has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24 May 2021 has no new information.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1366178 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiogenic shock, Dyspnoea, Fatigue, Ventricular arrhythmia, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CARDIOGENIC SHOCK, VENTRICULAR TACHYCARDIA, FATIGUE, DYSPNOEA and VENTRICULAR ARRHYTHMIA in a 42-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 24-Apr-2021, the patient experienced CARDIOGENIC SHOCK (seriousness criteria death and medically significant), VENTRICULAR TACHYCARDIA (seriousness criteria death and medically significant), FATIGUE (seriousness criterion death), DYSPNOEA (seriousness criterion death) and VENTRICULAR ARRHYTHMIA (seriousness criteria death and medically significant). The reported cause of death was Cardiogenic shock, Ventricular tachycardia, Breath shortness and Arrhythmic storm. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The treatment information was not provided. Company Comment: This is a case of death in a 42 -year-old male subject with unknown medical hx who died 03 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Sender''s Comments: This is a case of death in a 42 -year-old male subject with unknown medical hx who died 03 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Cardiogenic shock; Ventricular tachycardia; Breath shortness; Arrhythmic storm


VAERS ID: 1366245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEXOTAN; PANTORC; PLAVIX; CONGESCOR
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery repair; Coronary arterial stent insertion (with application of four stents)
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: Covid-19 rapid test; Test Result: Negative
CDC Split Type: ITPFIZER INC2021604167

Write-up: Haemorrhagic stroke; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, Regulatory authority report number IT-MINISAL02-733413. An 85-year-old male patient received BNT162B2 (COMIRNATY), intramuscular in left arm on 13Feb2021 (Lot Number: EL0725, unknown expiration) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing hypertension, coronary arterial stent insertion (with application of four stents) in 2018, and he was operated on the left carotid. Concomitant medications included bromazepam (LEXOTAN); pantoprazole sodium sesquihydrate (PANTORC); clopidogrel bisulfate (PLAVIX) as thrombosis prophylaxis; and bisoprolol fumarate (CONGESCOR). The patient experienced haemorrhagic stroke on 15Feb2021. The patient referred to administering Clexane at home on medical indication and urgent hospitalization. The patient was hospitalized following haemorrhagic stroke from 15Feb2021 to 17Feb2021. Impact on quality of life (10/10). Therapeutic measures were taken as a result of haemorrhagic stroke. The patient underwent lab tests and procedures which included COVID-19 rapid test: negative on 15Feb2021. The patient died on 17Feb2021 due to haemorrhagic stroke. It was unknown if an autopsy was performed. Sender''s Comment: Regulatory Authority 22May2021 request for first aid clinical documentation / report, instrumental and laboratory test reports performed. Reporter''s comment: Patient with hypertension, operated on the left carotid, coronary intervention in 2018 with the application of four stents. No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1366497 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-20
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death, Malaise, Pneumonia, SARS-CoV-2 test, Syncope, Urinary tract infection bacterial
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 4
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: Dialysis; Lung cancer; Thymoma
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: COVID PCR (Nasal Swab); Result Unstructured Data: Test Result:Negative
CDC Split Type: JPPFIZER INC2021601276

Write-up: Cardio-respiratory arrest; Unknown cause of death; Pneumonia; The patient collapsed; Urinary tract infection; General malaise; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was an 85-year-old male. The patient received a vaccine (unknown product name) within 4 weeks prior to the BNT162B2 (COMIRNATY). The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies. Other medical history included thymoma, lung cancer and, artificial dialysis. On 11May2021 (the day of vaccination), the patient received the unspecified single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number/Expiration date unknown) (at 85-years-old) via an unspecified route of administration for COVID-19 immunization. On 24May2021 at 17:00 (13 days after the vaccination), the patient experienced Cardio-respiratory arrest and, which resulted in death. Clinical course of the event was reported as follows: On 11May2021, patient received the vaccine. On 20May2021 (9 days after the vaccination), General malaise noted. On 24May2021 (13 days after the vaccination), the patient visited a department of general internal medicine. The patient was diagnosed with urinary tract infection and pneumonia and, levofloxacin was given. The patient went home. The patient collapsed (CPA: Cardio-respiratory arrest) on his way home and, was resuscitated by physician of passer-by. Thereafter, the patient died. Coronary artery catheter revealed that there is no narrowing. An autopsy was not performed and, Cause of death was unknown. The PCR test with nasal swab was performed on 24May2021, which showed negative results. The reporting physician assessed the event as serious and, seriousness criteria-Results in death. The outcome of cardio-respiratory arrest and unknown cause of death was fatal while unknown for the other events.; Sender''s Comments: Based on the information provided, outcome of cardio-respiratory arrest and unknown cause of death was fatal while unknown for the other events.The impact of this report on the benefit/risk profile of the Pfizer drug 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: Cardio-respiratory arrest; Unknown cause of death


VAERS ID: 1366498 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Body temperature, Coagulopathy, Conjunctival haemorrhage, Intra-abdominal haemorrhage, Polymerase chain reaction, Prothrombin level, Small intestinal haemorrhage, Subarachnoid haemorrhage, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal haemorrhage (narrow), Accidents and injuries (broad), Conjunctival disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 6
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: APTT; Result Unstructured Data: Test Result:more than 250 seconds; Test Date: 20210514; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Name: PCR; Test Result: Negative ; Test Name: PT activity; Result Unstructured Data: Test Result:less than 5 %
CDC Split Type: JPPFIZER INC2021601520

Write-up: significant blood coagulation disorder; small intestinal haemorrhage; intra-abdominal haemorrhage; acute subdural haematoma; subarachnoid haemorrhage; conjunctival haemorrhage; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21109038. The patient was a 78-year-old female. Body temperature before vaccination was 36.5 degrees centigrade. The patient had no particular family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 14May2021 at 12:02 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021), at the age of 78 years, via an unspecified route of administration as a single dose for COVID-19 immunization. On 17May2021 (3 days after the vaccination), the patient experienced significant blood coagulation disorder, small intestinal haemorrhage, intra-abdominal haemorrhage, acute subdural haematoma, subarachnoid haemorrhage, and conjunctival haemorrhage. On 19May2021 (5 days after the vaccination), the patient was admitted to the hospital. On 23May2021 (9 days after the vaccination), the patient died. The course of the event was as follows: On 17May2021 (3 days after the vaccination), abdominal pain and bloody stool developed. On 19May2021 (5 days after the vaccination), the patient was admitted to the hospital. On 20May2021 at 06:15 (6 days after the vaccination), the patient was found to collapse. At 07:45, the patient had cardio-respiratory arrest. Resuscitation was obtained. On 23May2021 at 12:47 (9 days after the vaccination), the patient died. The blood examination showed significant coagulation function decreased (PT activity less than 5%, APTT 250 seconds or higher) on unspecified date. The imaging findings and autopsy findings showed acute subdural haematoma, subarachnoid haemorrhage, cerebral haemorrhage, pulmonary haemorrhage, small intestinal haemorrhage, and intra-abdominal haemorrhage. The result of PCR was negative. The reporting physician classified the events as serious (death) and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was some kind of acquired blood coagulation disorder. The reporting physician commented as follows: Three days after the vaccination, the patient without predisposition of haemorrhage experienced significant blood coagulation disorder. She had conjunctival haemorrhage, small intestinal haemorrhage, and intra-abdominal haemorrhage at first, and then had intracranial haemorrhage, and died. It could not help but be suspected that the event was caused by the vaccination. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: small intestinal haemorrhage; intra-abdominal haemorrhage; acute subdural haematoma; subarachnoid haemorrhage; conjunctival haemorrhage; significant blood coagulation disorder; Autopsy-determined Cause(s) of Death: acute subdural haematoma; subarachnoid haemorrhage; cerebral haemorrhage; pulmonary haemorrhage; small intestinal haemorrhage; intra-abdominal haemorrhage


VAERS ID: 1366500 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Emphysema; Heart disease, unspecified; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210525; Test Name: vital signs; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC2021604642

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable other health professional (chief clerk) received from the Agency Regulatory Authority. Regulatory authority report number is v21109407. A 91-year and 6-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection, lot number: EX3617 and expiration date: 31Aug2021), via an unspecified route of administration on 25May2021 14:30 (the day of vaccination, also reported at the age of 91-years-old) as second dose, single for COVID-19 immunization. Medical history included heart disease, dementia Alzheimer''s type, hypertension and emphysema. No information on concomitant medications or family history was provided. The patient previously received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. On 25May2021 (before the vaccination), the patient seemed to be fine as usual. Body temperature before vaccination was 36.5 degrees Centigrade. On 25May2021 at 14:30, the patient received the second dose of the vaccination. At 16:30, no abnormalities were noted in her vital signs. She consumed all of her dinner by herself. At around 20:00, the patient went to bed. At 23:00, while going the round, she was sleeping well. On 26May2021 at 02:10 (11 hours and 40 minutes after the vaccination), during the round, the patient was found in cardio-respiratory arrest, and she was transferred to a hospital by an ambulance. On 26May2021 at 03:05 (12 hours and 35 minutes after the vaccination), although cardiac massage was attempted, the patient''s death was confirmed by the physician. The patient died of cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting non-health professional (chief clerk) classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was other possible cause of the event such as any other diseases. The non-health professional (chief clerk) commented as follows: The cause of death was uncertain at present. The causal relationship with BNT162b2 was unassessable.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1366501 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021607214

Write-up: Cardiac failure; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 79-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 18May2021 (Batch/Lot number was not reported) as UNKNOWN, 0.3ML SINGLE for COVID-19 immunization. Medical history included cardiac failure from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient had taken diuretics. In the afternoon of 18May2021, the patient visited the reporting clinic and said that he received BNT162B2. At that time, the patient seemed to be the same as usual. On 22May2021, the patient''s family found him lying down at home and the patient was taken to another hospital by ambulance. On the same date 22May2021, patient''s death was confirmed. On 24May2021, the family contacted the reporting physician and seemed convinced of the death. The hospital personnel (details unknown) at the destination judged that there was no causal relationship between death and BNT162B2. Since there were no strokes, aneurysms or blood clots, the cause of death might be cardiac failure. The patient died on 22May2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: The underlying cardiac failure have been assessed to have played a contributory role towards the event and deemed unrelated to 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1366627 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-12
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   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: NLPFIZER INC2021598049

Write-up: top basilar artery thrombosis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [NL-LRB-00549207]. A 72-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, on 01May2021, as single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced top basilar artery thrombosis (death) on 12May2021. Therapeutic measures were taken as a result of the event and included treatment with intravenous and intraarterial thrombolysis. The patient died on 13May2021 due to top basilar artery thrombosis. It was not reported if an autopsy was performed. Reporter comment: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Basilar artery thrombosis. Additional information ADR: 12 days after vaccination top basilar thrombosis. With no chance of recovery neurology; decided to discontinue supportive therapy in Intensive Care Unit; patient has died. BSN available: yes. COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: No additional research performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Additional information ADR: 12 days after vaccination top basilar thrombosis. With no chance of recovery neurology; decided to discontinue supportive therapy in Intensive Care Unit; patient has died.; Reported Cause(s) of Death: top basilar artery thrombosis


VAERS ID: 1366666 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Embolism, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 42
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: 20210326; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210331; Test Name: saturation; Result Unstructured Data: Test Result:Normal; Comments: The vital parameters were normal, including saturation.; Test Date: 20210402; Test Name: saturation; Result Unstructured Data: Test Result:80; Comments: Saturation was measured twice, it was very low 80.; Test Date: 202103; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: PLPFIZER INC2021604335

Write-up: Embolism; Saturation low; COVID-19; COVID-19; This is a spontaneous report from contactable consumer. This consumer reported for two patients (parents). This is the first of two reports. A male patient of an unspecified age received BNT162B2 (COMIRNATY) at single dose, on 10Mar2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 26Mar2021 (Friday), the patient began to feel bad, the temperature was 38.3 degrees Celsius. On 27Mar2021 (Saturday) and on 28Mar2021 (Sunday) his health did not improve, he still had a temperature, dry cough and malaise. Patient called the clinic and reported his symptoms. The physician ordered to perform test in towards COVID-19. The test was positive on an unspecified date, in Mar2021. The patient received drugs and stayed in home isolation. On 31Mar2021, an ambulance was called, which concluded that the vital parameters were normal, including saturation. On 02Apr2021, the patient felt very bad. He didn''t have the strength to get out of bed. Saturation was measured twice, it was very low 80. General physician called an ambulance. In the hospital, it turned out that the patient was occupied with the disease 80% spit. Doctors gave him large amounts of oxygen. Unfortunately, the disease progressed as well. On 04Apr2021, 90% of the lungs were affected and there was an embolism. In the evening, patient was put into a pharmacological coma and put on a respirator. Patient died on 13Apr2021. The information on the lot number has been requested.; Reported Cause(s) of Death: Drug ineffective; COVID-19; Arterial oxygen saturation decreased; Embolism


VAERS ID: 1366669 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-03
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Body temperature increased, COVID-19, Gastritis, Parkinsonism, Pneumonia, Pyrexia, SARS-CoV-2 antibody test negative, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (narrow), Gastrointestinal nonspecific inflammation (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210303; Test Name: Body temperature increased; Result Unstructured Data: Test Result:40-40.4 Centigrade; Test Date: 20210303; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result:negative; Comments: antigen test; Test Date: 20210303; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: PLPFIZER INC2021591137

Write-up: Pneumonia; Anaemia; COVID-19 PCR test positive; Parkinson''s syndrome; Gastritis; Fever 40-40.4 degree Celsius up to 24 hours; Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB PL-URPL-3-633-2021t An 88-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 18Feb2021 15:18 (Batch/Lot Number: EP9598; Expiration Date: 30Jun2021) as 0.3ml single at the age of 88-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received bnt162b2 (COMIRNATY), dose 1 on an unknown date for COVID-19 immunisation. On 03Mar2021 the patient experienced pneumonia, anaemia, COVID-19 PCR test positive, Parkinson''s syndrome, gastritis, fever 40-40.4 degree celsius up to 24 hours, vaccination failure, COVID-19. The patient underwent lab tests and procedures which included: body temperature increased: 40-40.4 centigrade on 03Mar2021, Sars-cov-2 antibody test: negative on 03Mar2021, Sars-cov-2 test: positive on 03Mar2021. The patient died on 04Mar2021. It was not reported if an autopsy was performed. The course of events was as follows: Description of the reaction: on 03Mar2021 a patient was admitted to Hospital in a serious condition with diagnosed pneumonia. On admission, an antigen test for COVID-19 (-) and a PCR test for Covid-19 (+) were performed. On 04Mar2021, at approximately 14 hour, the patient died. Additional information: Emergency department diagnosis: COVID 19 virus identified, pneumonia, anemia, gastritis, parkinsonian syndrome, cause of death has not been clearly defined. Sender Comments: Pyrexia is an expected adverse drug reaction as described in a publication, after Comirnaty administration. Pneumonia and a positive covid-19 PCR test result are unexpected symptoms, but reported in a database (pneumonia, SARS-Cov-19 test positive). There is a time relationship between the second dose of the vaccine and the occurrence of side effects. Parkinson''s syndrome (so-called parkinsonism) is an unexpected adverse drug reaction for Comirnaty vaccine. Parkinsonism is most often caused by other virals or it occurs in inflammatory and neurodegenerative diseases. Anemia is most likely a symptom of inflammation in the lining of the stomach. A regulatory authority considers that these adverse drug reactions (parkinsonian syndrome, anemia, gastritis) coincided with vaccination. The reporting person qualified NOP as heavy. A regulatory authority assessed the NOP as heavy. The notification concerns the medicinal product Comirnaty, with regard to the lack of protective efficacy of the vaccine and the severe course of COVID-19 after vaccination (VAED - vaccine associated enhanced disease), therefore the reporting person was provided with a form on 13May2021 in order to obtain additional data, in accordance with Corminaty RMP. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1369908 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-05-13
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   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: Blindness; Chronic ischaemic heart disease, unspecified; Chronic migraine; Hypertension arterial; Prethrombosis retinal
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DIARRHOEA and VOMITING in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001946 and 3001442) for COVID-19 vaccination. Previously administered products included for an unreported indication: OMEPRAZEN [OMEPRAZOLE], CARDIOASPIRIN, NORVASC and SAFLUTAN. Concurrent medical conditions included Hypertension arterial, Chronic ischaemic heart disease, unspecified, Prethrombosis retinal, Chronic migraine and Blindness. On 13-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced DIARRHOEA (seriousness criterion death) and VOMITING (seriousness criterion death). The patient died on 13-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. This report refers to a case of an 85-year-old male patient with medical history of hypertension arterial, chronic ischaemic heart disease, prethrombosis retinal, chronic migraine and blindness who developed Diarrhoea and Vomiting and died. Very limited information regarding these events has been provided at this time. It is unknown whether an autopsy was done. No further information is expected.; Sender''s Comments: This report refers to a case of an 85-year-old male patient with medical history of hypertension arterial, chronic ischaemic heart disease, prethrombosis retinal, chronic migraine and blindness who developed Diarrhoea and Vomiting and died. Very limited information regarding these events has been provided at this time. It is unknown whether an autopsy was done. No further information is expected.; Reported Cause(s) of Death: cause of death unknown


VAERS ID: 1369918 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-22
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bronchitis, Cardiac failure, Death, Dyspnoea, Haemoglobin, Polycythaemia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   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: MADOPAR DISPERSIBL; CARDICOR; DIBASE; ACTONEL; LANSOX; SERTRALINE; COUMADIN
Current Illness: Atrial fibrillation; Hypokinetic-rigid syndrome; Ischaemic heart disease; Parkinsonism; Vascular encephalopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral ischemia
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: Hemoglobin; Result Unstructured Data: increased
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), CARDIAC FAILURE, BRONCHITIS, POLYCYTHAEMIA and DYSPNOEA in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cerebral ischemia. Concurrent medical conditions included Hypokinetic-rigid syndrome, Parkinsonism, Atrial fibrillation, Vascular encephalopathy and Ischaemic heart disease. Concomitant products included BENSERAZIDE HYDROCHLORIDE, LEVODOPA (MADOPAR DISPERSIBL), BISOPROLOL FUMARATE (CARDICOR), COLECALCIFEROL (DIBASE), RISEDRONATE SODIUM (ACTONEL), LANSOPRAZOLE (LANSOX), SERTRALINE and WARFARIN SODIUM (COUMADIN) for an unknown indication. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 22-Apr-2021, the patient experienced CARDIAC FAILURE (seriousness criterion life threatening), BRONCHITIS (seriousness criterion medically significant), POLYCYTHAEMIA (seriousness criterion medically significant) and DYSPNOEA (seriousness criterion medically significant). On 08-May-2021, CARDIAC FAILURE, BRONCHITIS, POLYCYTHAEMIA and DYSPNOEA outcome was unknown. The patient died on 08-May-2021. The reported cause of death was Cardiac failure. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Haemoglobin: high increased. This is a case of death in a 82-year-old male subject with hx of Cerebral Ischemia, Pakinsonism, Atrial Fibrillation and Ischemic Heart Disease , who died 23 days after receiving the first dose of the vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 82-year-old male subject with hx of Cerebral Ischemia, Pakinsonism, Atrial Fibrillation and Ischemic Heart Disease , who died 23 days after receiving the first dose of the vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1369919 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-16
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: VENITRIN 5 MG/24 HOUR TRANSDERMAL PATCH; CONGESCOR 1.25 MG, FILM COATED TABLETS; UROREC 8 MG HARD CAPSULES; LASIX 25 MG TABLET; BREVA? DOSED AEROSOL; MINIAS 2,5 MG/ML ORAL DROPS, SOLUTION; OMEPRAZOLE; COUMADIN 5 MG TABLET; FINASTERIDE
Current Illness: AFib; COPD; Ischemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Basedow''s disease; Cholecystectomy; Hernia inguinal
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210546385

Write-up: DEATH SUDDEN; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-730740] concerned an 89 year old male of unspecified ethnicity. The patient''s weight was 75 kilograms, and height was 165 centimeters. The patient''s past medical history included hernia inguinal surgery in 1970, Basedow''s disease, and cholecystectomy was performed in 1981, and concurrent conditions included atrial fibrillation (AFib), Ischemic heart disease (IHD) and chronic obstructive pulmonary disease (COPD). The patient was previously treated with tapazole for Basedow''s disease from 2015 to August 2020. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: unknown) 1 dosage forms was administered on 13-MAY-2021 for COVID-19 vaccination. Concomitant medications included Venitrin (glyceryl trinitrate) transdermal patch, Congescor (bisoprolol fumarate) film coated tablet, Urorec (silodosin) hard capsules, Lasix (furosemide) tablet, Breva (ipratropium bromide/salbutamol) aerosol, Minias (lormetazepam) oral drops solution, omeprazole, Coumadin (warfarin sodium) tablet and finasteride used for unknown indication. On 15-May-2021, the patient had accidental fall on the landing of his home. The patient called the emergency helpline number and no fractures were reported and the patient refused to visit a hospital. The next day, on 16-MAY-2021, the patient died from unknown cause of death and his body was found. A request for clinical report from the attending physician was made on 18-MAY-2021. It was unknown whether autopsy performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). Sender''s Comments: V0: 20210546385-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1369924 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: MORTE; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (MORTE) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 17-Apr-2021 The patient died on 17-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Very limited information regarding this event/s has been provided at this time. Since it is a RA report follow up is not required.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Since it is a RA report follow up is not required.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1370125 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021614455

Write-up: Death; This is a spontaneous report from a contactable physician via a Pfizer sales representative. It was uncertain if the patient had a medical history. Concomitant drugs and family history were not reported. On 27May2021, the patient of unspecified age and gender received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization at a different medical facility from the reporter''s. On 28May2021, the patient was transferred to the emergency room of the reporter''s hospital and died. It was not reported if an autopsy was performed. The reporting physician received the information from the chief of the pharmacy department. The reporting physician classified the event as serious. The assessment of causality between the event and BNT162b2 was not provided. It was confirmed that autopsy was planned.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported fatality and the use of the vaccine cannot be fully excluded. There is very limited information to make any further assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1370126 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Nausea, Oxygen saturation, Pneumonia
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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: BAYASPIRIN; LANSOPRAZOLE; BELSOMRA; ROZEREM; MAGNESIUM OXIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210527; Test Name: Body temperature; Result Unstructured Data: Test Result:over 39 Centigrade; Comments: at noon; Test Date: 20210527; Test Name: SpO2; Test Result: 60 %; Comments: at around 20:00; Test Date: 20210527; Test Name: SpO2; Test Result: 80 %; Comments: at 22:30
CDC Split Type: JPPFIZER INC2021616794

Write-up: Pneumonia; Queasy; This is a spontaneous report from a contactable pharmacist received from the Agency Regulatory Authority. Regulatory authority report number is v21109931. The patient was a 72-year and 11-month-old male. Body temperature before vaccination was 36.8 degrees centigrade. Family history was not reported. Concomitant medication included acetylsalicylic acid (BAYASPIRIN) 100 mg tablet 1 tablet taken orally once daily after breakfast, lansoprazole (LANSOPRAZOLE, Manufacturer: TOWA) 15 mg OD tablet 1 tablet taken orally once daily after breakfast, suvorexant (BELSOMRA) 15 mg tablet 1 tablet taken orally once daily before bedtime, ramelteon (ROZEREM) 8 mg tablet 1 tablet taken orally once daily after supper, and magnesium oxide (MAGNESIUM OXIDE, Manufacturer: Kene) 330 mg tablet 6 tablets taken orally 3 times daily after meals for unspecified indications, start dates were not reported and ongoing. On 26May2021 at 13:50 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as 1ST DOSE, SINGLE for COVID-19 immunization. On 27May2021 (1 day after the vaccination), the patient experienced pneumonia. On 27May2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26May2021, the patient received the first dose of COMIRNATY injection for coronavirus. From 26May2021, the patient had queasy. On 27May2021 at noon, the patient had pyrexia of over 39 degrees centigrade. At around 20:00, the patient had peripheral hypoperfusion and respiratory distress. SpO2 temporarily decreased to 60%. At 22:30, SpO2 increased to only 80% with 10 L of oxygen. The patient was transferred to another hospital. At the emergency hospital, the patient was diagnosed with pneumonia and death was confirmed. Outcome of the event queasy was unknown, while outcome of the event pneumonia was fatal. The patient died on 27May2021. It was not reported if an autopsy was performed. The reporting pharmacist 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 reporting pharmacist commented as follows: Although causal relationship was unknown, the case was reported because the event occurred after the vaccination. ; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1370163 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001530 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Blood pressure measurement, Heart rate
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BURINEX; LANOXIN; ISOPTIN RETARD; XARELTO
Current Illness: Atrial fibrillation; Heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: Blood pressure; Result Unstructured Data: Low; Test Date: 20210402; Test Name: Pulse rate; Result Unstructured Data: Low
CDC Split Type: NOMODERNATX, INC.MOD20211

Write-up: ACUTE RENAL FAILURE; This regulatory authority case was reported by a physician and describes the occurrence of ACUTE KIDNEY INJURY (ACUTE RENAL FAILURE) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001530) for COVID-19 vaccination. Concurrent medical conditions included Heart failure and Atrial fibrillation. Concomitant products included DIGOXIN (LANOXIN) from 02-May-2014 to 02-Apr-2021, VERAPAMIL HYDROCHLORIDE (ISOPTIN RETARD) from 04-May-2014 to 02-Apr-2021 and RIVAROXABAN (XARELTO) from 01-May-2014 to 02-Apr-2021 for Atrial fibrillation, BUMETANIDE (BURINEX) from 10-Nov-2020 to 02-Apr-2021 for Heart failure. On 31-Mar-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (ACUTE RENAL FAILURE) (seriousness criteria death and medically significant). The patient died on 04-Apr-2021. The reported cause of death was Acute renal failure, Drop in blood pressure and Pulse rate decrease. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: low (Low) Low. On 02-Apr-2021, Heart rate: low (Low) Low. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ACUTE KIDNEY INJURY (ACUTE RENAL FAILURE) to be possibly related. Treatment information was not provided. This case concerns an 83-year-old female patient with medical history of heart failure and atrial fibrillation who developed acute kidney injury with associated drop in blood pressure and pulse rate decreased and died. Very limited information regarding this event has been provided at this time. It is unknown if autopsy was performed. No further information is expected.; Sender''s Comments: This case concerns an 83-year-old female patient with medical history of heart failure and atrial fibrillation who developed acute kidney injury with associated drop in blood pressure and pulse rate decreased and died. Very limited information regarding this event has been provided at this time. It is unknown if autopsy was performed. No further information is expected.; Reported Cause(s) of Death: ACUTE RENAL FAILURE; DROP IN BLOOD PRESSURE; PULSE RATE DECREASE


VAERS ID: 1370852 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021601015

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable health care professional received from the Regulatory Authority. Regulatory authority report number is 557017. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Adverse event following immunisation (death) on an unspecified date. The outcome was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1370933 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-08
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Blood creatinine, Blood fibrinogen, Blood glucose, Blood potassium, Blood pressure measurement, Blood urea, C-reactive protein, Culture throat, Glomerular filtration rate, Heart rate, International normalised ratio, Oxygen saturation, Platelet count, Pneumonia, Prothrombin time, Prothrombin time ratio, Thrombin time, Ventilation/perfusion scan
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 4
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Furon; Pradaxa; DETRALEX; Lusopres 1/2; Gopten 2 mg; Letrox 100; Verospiron 25; ALOPURINOL
Current Illness: Aortic stenosis (gradient maximally 42 mm Hg, progressing); Chronic venous insufficiency (CEAP classification 6); Dyslipidemia (on diet); Extrasystoles ventricular (Pradaxa anticoagulation); Fasting hyperglycemia (dispensarised to internist); Hypertension (compensated); Hyperuricemia; Ischaemic heart disease (of dysrythmic type with atrial fibriloflutter); Lower limb ischemia (lower limbs - differentiated atherosclerotic changes from groin, bilateral occlusions of peripheral arteries according to angiologic examination); Monoparesis (central, left arm)
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchopneumonia; Infection urinary tract (Escherichia coli); Lung embolism (pulmonary embolism with vena saphena magna lateris dextri and vena saphena parva lateris sinistri thrombosis); Meningoencephalitis (when 28-year-old with following central monoparesis of left upper limb - permanent); Strumectomy (strumectomy total subtotal due to struma nodosa); Thrombophlebitis (repeatedly deep and superficial thromboflebitis on the right side with repeated ulcerations)
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: activated partial thromboplastin time; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Activated partial thromboplastin time ratio; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Fibrinogen; Result Unstructured Data: abnormal; Test Date: 20210409; Test Name: Glucose; Result Unstructured Data: abnormal; Test Date: 20210409; Test Name: Potassium; Result Unstructured Data: abnormal; Test Date: 202104; Test Name: Blood pressure; Result Unstructured Data: 90/60 mmHg; Test Date: 20210409; Test Name: Urea; Result Unstructured Data: abnormal; Test Date: 20210409; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 202104; Test Name: Throat swab; Result Unstructured Data: abnormal; Test Date: 20210409; Test Name: Glomerular filtration rate; Test Result: Inconclusive ; Result Unstructured Data: CKD-EPI; Test Date: 202104; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: International normalised ratio; Result Unstructured Data: abnormal; Test Date: 202104; Test Name: Oxygen saturation; Result Unstructured Data: Result: 90%; Test Date: 20210409; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Prothrombin test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Prothrombin time ratio; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210409; Test Name: Thrombin time; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 202104; Test Name: Lung scan; Result Unstructured Data: on the right perihiliously, in all fields and in the lower lung field on the right on the periphery there are flowing areas of the character of post-inflammatory residues or incipient inflammatory changes
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of PNEUMONIA in a 90-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. The patient''s past medical history included Lung embolism (pulmonary embolism with vena saphena magna lateris dextri and vena saphena parva lateris sinistri thrombosis) in 1996, Bronchopneumonia (lateris dextri, etiologically Proteus) in January 2019, Infection urinary tract (Escherichia coli), Thrombophlebitis (repeatedly deep and superficial thromboflebitis on the right side with repeated ulcerations) in December 2008, Meningoencephalitis (when 28-year-old with following central monoparesis of left upper limb - permanent) and Strumectomy (strumectomy total subtotal due to struma nodosa). Concurrent medical conditions included Ischaemic heart disease (of dysrythmic type with atrial fibriloflutter), Lower limb ischemia (lower limbs - differentiated atherosclerotic changes from groin, bilateral occlusions of peripheral arteries according to angiologic examination) since 2009, Hyperuricemia, Aortic stenosis (gradient maximally 42 mm Hg, progressing) since 2016, Chronic venous insufficiency (CEAP classification 6), Monoparesis (central, left arm) since 1958, Extrasystoles ventricular (Pradaxa anticoagulation), Hypertension (compensated), Fasting hyperglycemia (dispensarised to internist) and Dyslipidemia (on diet). Concomitant products included FUROSEMIDE (Furon), DABIGATRAN ETEXILATE (Pradaxa), DIOSMIN, HESPERIDIN (DETRALEX), NITRENDIPINE (Lusopres 1/2), TRANDOLAPRIL (Gopten 2 mg), LEVOTHYROXINE SODIUM (Letrox 100), SPIRONOLACTONE (Verospiron 25) and ALLOPURINOL (ALOPURINOL) for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 08-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PNEUMONIA (seriousness criteria death, hospitalization, disability, medically significant and life threatening). The patient was hospitalized from 08-Apr-2021 to 12-Apr-2021 due to PNEUMONIA. The patient died on 12-Apr-2021. The reported cause of death was terminal bronchopneumonia. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Activated partial thromboplastin time: 142 (Inconclusive) Inconclusive. On 09-Apr-2021, Activated partial thromboplastin time ratio: 2.57 (Inconclusive) Inconclusive. On 09-Apr-2021, Blood creatinine: 211 (Inconclusive) Inconclusive. On 09-Apr-2021, Blood fibrinogen: 5.18 (abnormal) abnormal. On 09-Apr-2021, Blood glucose: 6 (abnormal) abnormal. On 09-Apr-2021, Blood potassium: 5.7 (abnormal) abnormal. On 09-Apr-2021, Blood urea: 27.1 (abnormal) abnormal. On 09-Apr-2021, C-reactive protein: 164.4 mg/l (Inconclusive) Inconclusive. On 09-Apr-2021, Glomerular filtration rate: 0,29 ml/s/1,73m2 (Inconclusive) CKD-EPI. On 09-Apr-2021, International normalised ratio: 2.79 (abnormal) abnormal. On 09-Apr-2021, Platelet count: 198 (Inconclusive) Inconclusive. On 09-Apr-2021, Prothrombin time: 0.25 (Inconclusive) Inconclusive. On 09-Apr-2021, Prothrombin time ratio: 2,57 (Inconclusive) Inconclusive. On 09-Apr-2021, Thrombin time: $g60 (Inconclusive) Inconclusive. In April 2021, Blood pressure measurement: other (abnormal) 90/60 mmHg. In April 2021, Culture throat: klebsiella pneumoniae (abnormal) abnormal. In April 2021, Heart rate: 50-60 (Inconclusive) Inconclusive. In April 2021, Oxygen saturation: 90% (abnormal) Result: 90%. In April 2021, Ventilation/perfusion scan: other (abnormal) on the right perihiliously, in all fields and in the lower lung field on the right on the periphery there are flowing areas of the character of post-inflammatory residues or incipient inflammatory changes. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment details provided. This regulatory authority case was received from Czech Republic CZ-CZSUKL-21005385. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Translated source document included no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: terminal bronchopneumonia


VAERS ID: 1370934 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   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: Breathlessness; Cardiovascular disease, unspecified; Obesity; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021639129

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB regulatory authority number CZ-CZSUKL-21005900. A 65-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown), at the age of 65 years old, intramuscularly on 13May2021 07:20 at single dose for covid-19 immunisation. Medical history included ongoing breathless, ongoing cardiovascular disease, unspecified, ongoing obesity and ongoing smoker. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) on 01Apr2021 at single dose for covid-19 immunisation. The patient experienced unknown cause of death on 13May2021 22:00. The patient was found in an advanced stage of decay in an armchair at home after the second dose of BNT162B2 vaccination on 13May2021. According to a corner the patient died on 13May2021 22:00. An autopsy was performed and the results unavailable. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1370962 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary artery thrombosis, Right ventricular failure, Vaccination complication
SMQs:, Cardiac failure (narrow), Embolic and thrombotic events, arterial (narrow), Pulmonary hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021619437

Write-up: Acute right heart failure; Fulminant thrombosis of the pulmonary artery circulation; Fatal complication with the vaccination was probable and plausible; This is a spontaneous report based on information received by Pfizer from Biontech, manufacturer control number: 58694, license party for COMIRNATY. A contactable consumer (son of the patient) reported that a 75 years old female patient received BNT162B2 (COMIRNATY) at single dose, on 19Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 20Feb2021, one day after the vaccination, the patient died of acute right heart failure with fulminant thrombosis of the pulmonary artery circulation. The autopsy reported to the conclusion that a fatal complication with the vaccination was probable and plausible. The information on the lot number has been requested.; Reported Cause(s) of Death: Acute right heart failure; Fulminant thrombosis of the pulmonary artery circulation; Fatal complication with the vaccination was probable and plausible


VAERS ID: 1370970 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-04-27
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8725 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC2021610039

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable nurse downloaded from the Agency Regulatory Authority-WEB [Regulatory Authority number EE-SAM-377521051426]. A 97-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 16Jan2021 (Lot Number: EL1491) as 0.3 ml single, dose 2 intramuscular on 06Feb2021 (Lot Number: EL8725) as 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced COVID-19 (medically significant, death) on 27Apr2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 27Apr2021. On 28April 2021 morning the patient was in coma. On 29April2021 there was fever. The patient died on 02May2021. It was unknown if an autopsy was performed. Per doctors assessment, death was not due to COVID-19. Sender Comment: Serious vaccine ineffectiveness report but death is not related to COVID-19 infection, fever might have accelerated it. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19


VAERS ID: 1370971 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-04-27
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Dyspnoea, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SANORAL HCT; FLOSIN [FLURBIPROFEN]
Current Illness: Atrial fibrillation; Diabetes mellitus non-insulin-dependent; Heart failure; Hypertensive heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial flutter
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Test Date: 20210427; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC2021609967

Write-up: shortness of breath; COVID-19; Vaccination failure; fever 38,9 degree; This is a spontaneous report from a contactable other health professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number EE-SAM-377721051428. A 90-year-old male patient received BNT162B2 (COMIRNATY), dose 2 on 06Feb2021 (Batch/Lot Number: EL8723) and dose 1 on 16Jan2021 (Batch/Lot Number: EL1491), both intramuscular as 0.3 mL single dose for COVID-19 immunisation. Medical history included ongoing heart failure, ongoing atrial fibrillation, atrial flutter from an unknown date and unknown if ongoing, ongoing hypertensive heart disease, ongoing diabetes mellitus non-insulin dependent. Concomitant medications included amlodipine besilate/hydrochlorothiazide/olmesartan medoxomil (SANORAL HCT, formulation: coated tablet, strength: 5mg/12.5 mg, 40 mg) oral and flurbiprofen (FLOSIN, formulation: capsule hard, strength: 0.4 mg) oral, both concomitants were taken for an unspecified indication, start and stop date were not reported. The patient experienced SARS-CoV-2 (PCR) test positive on 27 April 2021. On 27Apr2021, fever of 38.9 degree occurred. On 10May2021, the patient died on the background of fever and shortness of breath. It was not reported if an autopsy was performed. Doctor''s assessment: death is not due to COVID, but due to comorbidities. Sender Comment: Serious vaccine ineffectiveness report but death is not related to COVID-infection. Fever and shortness of breath might have accelerated it but death due to comorbidities. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: covid-19; fever; shortness of breath


VAERS ID: 1371203 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Behcet''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021618630

Write-up: Severe dyspnea; Cardiac insufficiency; This is a spontaneous report from a contactable consumer (patient''s daughter). A 93-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration, on an unspecified date, in Apr2021, at single dose, for COVID-19 immunisation. Relevant medical history included Behcet''s disease from an unspecified date. Concomitant medications were unknown. On an unspecified date, in Apr2021, the next day after the vaccination, the patient experienced severe dyspnea and cardiac insufficiency. The patient''s condition rapidly deteriorated and she died on 22Apr2021 and this was due to the vaccine. It was not reported if an autopsy was performed. The information on the lot number has been requested.; Sender''s Comments: Linked Report(s) : FI-PFIZER INC-2021618317 Same reporter, same SD, different patient, different events; Reported Cause(s) of Death: Severe dyspnea; Cardiac insufficiency


VAERS ID: 1372183 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-26
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30001653 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-alcohol user; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Sudden death; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 30001653) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial and Ex-alcohol user. On 09-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 26-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Company Comment: This regulatory report case concerns a 83-year-old male subject who experienced the unexpected event of sudden death. The event occurred 18 days after receiving the first vaccine dose, the cause of death was unknown. Causality is confounded by the subject''s advanced age. Very limited information regarding this event has been provided at this time. No further information is expected. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021051536; Sender''s Comments: This regulatory report case concerns a 83-year-old male subject who experienced the unexpected event of sudden death. The event occurred 18 days after receiving the first vaccine dose, the cause of death was unknown. Causality is confounded by the subject''s advanced age. Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1372276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Myocardial ischaemia, Urinary retention, Urinary tract infection
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 31
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: ALFACALCIDOL; ATORVASTATIN; CITALOPRAM; LEVOTHYROXINE; HYDROXOCOBALAMIN
Current Illness: Chronic kidney disease; Hypertension; Lung fibrosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021617774

Write-up: Urinary tract infection; urinary retention; Ischaemic heart disease; Cardiac failure; This is a spontaneous report received from a contactable Physician by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 25354592. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included ongoing pulmonary fibrosis, ongoing chronic kidney disease, ongoing hypertension. Concomitant medications included alfacalcidol (ALFACALCIDOL) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hydroxocobalamin (HYDROXOCOBALAMIN) taken for an unspecified indication from an unspecified start date to 03Jun2020. The patient experienced urinary tract infection (UTI) on 05Jan2021, given amoxicillin then on 13Jan2021 nitrofurantoin and was admitted 24Jan2021 with urinary retention. "Unsure of reaction but was serious sequelae of vaccine but (?) timeline" as reported. The patient died in Feb2021 due to cardiac failure and ischaemic heart disease; It was not reported if an autopsy was performed. Outcome of the other events at the time of death was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ischaemic heart disease; Cardiac failure


VAERS ID: 1372465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute left ventricular failure, Blood thyroid stimulating hormone, Hyperthyroidism, SARS-CoV-2 test, Thyroxine, Tri-iodothyronine
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Hyperthyroidism (narrow), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARBIMAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperthyroidism (very well controlled)
Allergies:
Diagnostic Lab Data: Test Name: TSH <0.01; Result Unstructured Data: Test Result:<0.01; Test Date: 20210430; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: FT4: $g100; Result Unstructured Data: Test Result:$g100; Test Name: FT3: 48.1; Result Unstructured Data: Test Result:48.1
CDC Split Type: GBPFIZER INC2021575626

Write-up: acute left ventricular failure; Thyrotoxicosis; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202105191408373820-6KCH7. Safety Report Unique Identifier GB-MHRA-ADR 25321871. A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hyperthyroidism (very well controlled). Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included carbimazole taken for hyperthyroidism. The patient experienced thyrotoxicosis on an unspecified date. The patient presented to the hospital with fast AF and was found to have TSH <0.01, and Free T4 of $g100, FT3 of around 48. She was given rate controlled medications but unfortunately she arrested and passed away due to acute left ventricular failure on an unspecified date. The event "thyrotoxicosis" was assessed as serious (medically significant). Other lab data includes COVID-19 virus test: No - Negative COVID-19 test on 30Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event acute left ventricular failure was fata, while unknown for the event thyrotoxicosis. No follow-up attempts are possible, information about the batch number cannot be obtained.; Reported Cause(s) of Death: acute left ventricular failure


VAERS ID: 1372652 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Microscopy, Pulmonary embolism, Pulmonary infarction, Pulseless electrical activity
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Microscopy; Result Unstructured Data: Test Result:blood clots; Comments: blood clot (thrombus) forming inside the pulmonary arteries or blood clot forming in deep veins elsewhere in the body and then travelling via the heart to the pulmonary arteries. Microscopic examination has confirmed that the changes seen with the naked eye are the result of blood clots rather than tumour. The clots themselves are in various stages of organisation (healing) indicating that at least some of them are likely to be several days old (although it should be appreciated that very precise dating is not possible). There are also areas in which the lung tissue has been damaged by the arterial blockages (pulmonary infarcts).
CDC Split Type: GBPFIZER INC2021599623

Write-up: cardiac arrest; pulmonary thromboembolism; pulmonary infarcts; Difficulty breathing; Pulseless electrical activity; This is a spontaneous report received from a contactable Other Health Professional from a regulatory authority. The regulatory authority report number is (GB-MHRA-WEBCOVID-202105211141350840-TJM4R), Safety Report Unique Identifier GB-MHRA-ADR 25336216. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Feb2021, patient died. Causes of death reported are fatal cardiac arrest, pulmonary thromboembolism, pulmonary infarcts, difficulty breathing , pulseless electrical activity. The autopsy in this case has been supplemented with histology in order to determine the cause of death. The findings are detailed above. At autopsy, there were somewhat unusual changes in the lungs that could have been the result of tumour, blood clot (thrombus) forming inside the pulmonary arteries or blood clot forming in deep veins elsewhere in the body and then travelling via the heart to the pulmonary arteries. Microscopic examination has confirmed that the changes seen with the naked eye are the result of blood clots rather than tumour. The clots themselves are in various stages of organisation (healing) indicating that at least some of them are likely to be several days old (although it should be appreciated that very precise dating is not possible). There are also areas in which the lung tissue has been damaged by the arterial blockages (pulmonary infarcts). It would seem reasonable to suggest that these blood clots account for her clinical symptoms and the form of cardiac arrest described (PEA Pulseless Electrical Activity) is typical of an acute obstruction of the pulmonary arteries. I note the history of her having received her COVID vaccination some 12 days prior to her death. There have been well-publicised concerns raised over possible links between this vaccine and the development of blood clots. It should, however, be appreciated that pulmonary thromboembolism has always been a significant cause of sudden death, even in patients without an obvious underlying risk factor such as trauma, cancer, etc. The risk of the condition increases with increasing age. Therefore, and given the controversy surrounding any link with the vaccine, it is not possible pathologically to be sure that the two events are linked in this particular case. Should further consideration of this point be required then I would defer to the opinion of a suitably qualified clinician. Coroner may feel that completion of a so-called Yellow Card (to register a possible link between a medicine and an adverse effect) in this case is appropriate. There were no pathologically suspicious features. Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible, information on batch number and expiry date cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest; pulmonary thromboembolism; pulmonary infarcts; Difficulty breathing; Pulseless electrical activity


VAERS ID: 1372695 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Chest pain, Hypoaesthesia, Intracardiac thrombus, Radioisotope scan
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness: Hypercholesterolemia (treated with atorvastatin 10 mg oral); Hypothyroidism (controlled with treatment NOS)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Thallium cardiac scintigraphy; Result Unstructured Data: Test Result:normal
CDC Split Type: GRPFIZER INC2021648288

Write-up: cardiac thrombosis; increased blood pressure; arm numbness; precordial pain; This is a spontaneous report from a contactable physician via a sales representative. A 58-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 12May2021 (Batch/Lot number was not reported) at 0.3 ml single for COVID-19 immunisation. Medical history included ongoing hypercholesterolaemia treated with atorvastatin 10 mg oral and ongoing hypothyroidism controlled with unspecified treatment. It was unknown if the patient was pregnant. Concomitant medication included atorvastatin taken for hypercholesterolaemia, start and stop date were not reported and unspecified medication for hypothyroidism. On an unknown date in May2021 the patient experienced increased blood pressure, arm numbness, and precordial pain. On 30May2021 the patient experienced cardiac thrombosis. The clinical course is as follows: The patient experienced increased blood pressure, arm numbness and precordial pain 2-3 days after the 1st dose (May2021). She went to the hospital (not hospitalized) and to cardiologists who did not find anything abnormal. She underwent a Thallium cardiac scintigraphy which was normal. On Sunday, 30May2021 the patient died. An autopsy was performed, and the cause of death was reported as cardiac thrombosis. The patient underwent lab tests and procedures which Thallium cardiac scintigraphy: normal in May2021. The clinical outcome of the events increased blood pressure, arm numbness and precordial pain was unknown. The clinical outcome of the event cardiac thrombosis was fatal. The patient died on 30May2021. An autopsy was performed. It was unknown if autopsy results were available. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender''s Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (COMIRNATY) vaccine cannot be completely excluded. The case will be reevaluated should additional information become 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: cardiac thrombosis


VAERS ID: 1372721 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac failure, Dyspnoea
SMQs:, Cardiac failure (narrow), 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: 2021-04-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breathlessness; Diabetes mellitus; Lung disease; Peripheral vascular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021609237

Write-up: Weakness; Severe breathlessness; Severe heart failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [Regulatory Authority number IE-HPRA-2021-072182]. An 80-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, on 10Apr2021 (Batch/Lot Number: ER9480), as 0.3 ml single, for COVID-19 immunisation. Medical history included diabetes mellitus, peripheral vascular disorder, lung disorder, dyspnoea. Concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (COMIRNATY) on 13Mar2021 for COVID-19 immunisation. The patient experienced weakness (death, caused hospitalization) on 11Apr2021 with fatal outcome on 15Apr2021, severe heart failure (death, caused hospitalization) in Apr2021 with fatal outcome on 15Apr2021, severe breathlessness (death, caused hospitalization) on 11Apr2021 with fatal outcome on 15Apr2021. It was reported that on 11Apr2021 the patient experienced severe breathlessness, weakness, and was transfer to hospital by ambulance. The reporter stated that the patient developed severe heart failure in the days soon after the vaccine, which they may have had cardiac events contributing to the heart failure. The patient subsequently died in hospital on 15Apr2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Severe breathlessness; Weakness; Severe heart failure


VAERS ID: 1372723 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-23
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Pneumonia aspiration, Suprapubic pain, Urosepsis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   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: Acute kidney injury; CABG (x 26 yrs ago); Hypertension; Total hip replacement; Urinary catheter insertion (post acute urinary retention and AKI 2020); Urinary retention; Vestibular function disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021609246

Write-up: Shortness of breath; ASPIRATION PNEUMONIA; UROSEPSIS; SUPRAPUBIC PAIN; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB IE-HPRA-2021-072962. A 91-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot Number: EJ6789) as 0.3 ml single at the age of 91-year-old for COVID-19 immunisation. Medical history included bladder catheterisation from 2020 to an unknown date (post acute urinary retention and AKI 2020), vestibular disorder, total hip replacement, hypertension, urinary retention, coronary artery bypass (CABG) 26 years ago, acute kidney injury from 2020 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced shortness of breath, aspiration pneumonia, urosepsis and suprapubic pain on 23Feb2021. The patient died on 27Feb2021. The course of events was as follows: On 23Feb2021, the patient had his indwelling urinary catheter changed at home by the hospital team. Subsequently, the patient developed suprapubic pain and shortness of breath. On 25Feb2021, the patient was admitted to hospital with urosepsis and aspiration pneumonia. Aervo ventilator support and antibiotics were required. It was reported that the patient''s health deteriorated. On 27Feb2021, the patient died. It is unknown if autopsy was done. The events were serious as per hospitalization and death. The outcome of events was fatal. No follow-up attempts possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: Shortness of breath; Aspiration pneumonia; Urosepsis; Suprapubic pain


VAERS ID: 1372724 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Investigation, Mobility decreased, Sputum test, X-ray
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 30
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; FUROSEMIDE; MIRAMEL; NUPRIN [ACETYLSALICYLIC ACID]; GABAPENTIN; ATORVASTATIN; MONTELUKAST; OMEPRAZOLE; AZITHROMYCIN; BETMIGA; DELTACORTRIL [PREDNISOLONE ACETATE]; GALFER; SERTRALINE; KALCIPOS; AMLODIPINE TEVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back injury; COPD (hx well controlled COPD); Coronary bypass; Polymyalgia
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: chest examination; Result Unstructured Data: Test Result:unknown results; Comments: examined by his General Practitioner, and further investigation to be performed in hospital.; Test Date: 20210418; Test Name: Sputum test; Result Unstructured Data: Test Result:unknown results; Comments: Results not provided; Test Date: 20210418; Test Name: X-ray; Result Unstructured Data: Test Result:unknown results; Comments: Results not provided.
CDC Split Type: IEPFIZER INC2021616129

Write-up: SIGNIFICANT REDUCED MOBILITY; INCREASING SHORTNESS OF BREATH; This is a spontaneous report from a contactable consumer. The first report was downloaded from the regulatory authority-WEB IE-HPRA-2021-073341. This is the second of two reports regarding second dose. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 07Apr2021 (Lot Number: EW2243; Expiration Date: Jul2021) as single dose for covid-19 immunisation. Previously the patient received 1st dose of COMIRNATY, batch/lot number: EP2163, expiration date: /Jun2021 on 24Feb2021 and experienced malaise, fatigue, pneumonia, suspected COVID-19. Medical history included polymyalgia, chronic obstructive pulmonary disease (COPD) (hx well controlled COPD), coronary artery bypass, all from an unknown date and unknown if ongoing, back injury from Feb2021 to an unknown date. Concomitant medications included amitriptyline; furosemide; pramipexole dihydrochloride monohydrate (MIRAMEL); acetylsalicylic acid (NUPRIN); gabapentin; atorvastatin; montelukast; omeprazole; azithromycin; mirabegron (BETMIGA); prednisolone acetate (DELTACORTRIL); ferrous fumarate (GALFER); sertraline; calcium carbonate (KALCIPOS); amlodipine besilate (AMLODIPINE TEVA), all taken for an unspecified indication, start and stop date were not reported. On Apr2021 the patient experienced significant reduced mobility and increasing shortness of breath. The events were serious for death, hospitalization, disability, medically significant, life threatening. The patient was hospitalized from 12Mar2021 to an unknown date. The patient''s hospitalization was prolonged as a result of the events. On 17Apr2021, the patient was transferred to another hospital and was treated for ongoing and adaptive pneumonia. The patient required high flow oxygen therapy in special care unit after one week of increasing oxygen therapy. The patient underwent lab tests and procedures which included sputum test: unknown results on 18Apr2021, x-ray: unknown results on 18Apr2021, chest examination: unknown results on 11Apr2021 (examined by his General Practitioner, and further investigation to be performed in hospital). Therapeutic measures were taken as a result of increasing shortness of breath. On 01May2021, the patient condition deteriorated and the patient passed away. The patient died on 01May2021. It was not reported if an autopsy was performed. The reporter stated the patient was very well prior to the vaccine with no respiratory complaints in the past couple of years. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : IE-PFIZER INC-2021609241 same patient, different vaccine doses; Reported Cause(s) of Death: Mobility decreased; Increased shortness of breath


VAERS ID: 1372728 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-23
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: It was not clear whether there was a previous disease or not.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210559467

Write-up: CORONARY THROMBOSIS; This spontaneous report received from a patient via a company representative concerned a 64-year-old male. Initial information was processed with additional information received on 30-MAY-2021 and 31-MAY-2021. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included it was not clear whether there was a previous disease or not. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 23-MAY-2021, the patient experienced a coronary thrombosis, and was hospitalized. The patient passed away shortly afterwards. The autopsy revealed that the cause of death was coronary thrombosis On 23-MAY-2021, the patient died from coronary thrombosis. An autopsy was performed on an unspecified date of MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report received from a patient via a company representative concerned a 64-year-old man who experienced fatal coronary thrombosis 1 day after vaccine. Past medical history was unknown. No concomitant medications were reported. One day after vaccine, the patient was hospitalized for a coronary thrombosis and died shortly after. The autopsy revealed that the cause of death was coronary thrombosis. There was no further available information on risk factors, clinical course, diagnostic or laboratory information. Information in this case is limited precluding a meaningful medical assessment. Additional information will be requested if contact information becomes available.; Reported Cause(s) of Death: CORONARY THROMBOSIS


VAERS ID: 1372732 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-22
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 antibody test, 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 Date: 20210222; Test Name: COVID-19 serology test; Result Unstructured Data: Test Result:positive; Test Date: 20210225; Test Name: COVID-19 serology test; Result Unstructured Data: Test Result:negative; Test Date: 20210222; Test Name: swab for coronavirus; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC2021260512

Write-up: positive swab for coronavirus; positive swab for coronavirus; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-688333. A 95-year-old female patient received bnt162b2 (COMIRNATY; Solution for injection; Batch/Lot Number: EJ6797), dose 2 intramuscular on 26Jan2021 as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of (COMIRNATY) (strength: 0.45 ML) on 05Jan2021, intramuscular. The patient experienced minimum seroconversion to anticovid vaccination with Comirnaty vaccine performed on 05Jan2021 and 26Jan2021; on 22Feb021 positive swab for coronavirus. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 22Feb2021, sars-cov-2 antibody test: negative on 25Feb2021. The outcome of the events was reported as not recovered. Sender''s comment: Spontaneous report form added in the regional vaccination registry received following access by the RLFV. 04Mar2021: additional info requested CRFV 05Mar2021 Following a comparison with AIFA we proceed with the removal of the ''therapeutic ineffectiveness'' PT and the ''non-serious'' restoration, as indicated in the form. 08Mar2021: patient domiciled in a nursing home; died, symptoms not strictly related to Covid-19.; Reported Cause(s) of Death: died, symptoms not strictly related to Covid-19; died, symptoms not strictly related to Covid-19


VAERS ID: 1372807 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021590905

Write-up: patient was admitted to the oncology department for exacerbation of known advanced cancer pathology, in a frail condition. On 11May2021 he received the second dose of vaccine and on 12May2021 he died.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-730585. An 83-year-old male patient received BNT162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 11May2021 as 2nd dose, single dose; and received BNT162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: ET7205, Expiration date: 31Jul2021), via intramuscular route of administration on 06Apr2021 at 15:05, as 1st dose, 0.3ml single dose in right arm, for COVID-19 immunization. The patient''s medical history included adenocarcinoma. The patient''s concomitant medications were not reported. On an unspecified date, the patient was admitted to the oncology department for exacerbation of known advanced cancer pathology, in a frail condition. On 11May2021, the patient received the second dose of vaccine and on 12May2021 he died. An autopsy was not performed for the reasons given in the clinical report. The clinical outcome was fatal. Reporter''s comments: The patient was admitted to the oncology department for exacerbation of known advanced cancer pathology, in a frail condition. On 11May2021 he received the second dose of vaccine and on 12May2021 he died. We report the case given the temporal link, although the general conditions of the patient were precarious and such as to make a causal link unlikely. Sender''s comments: 19May2021: clinical report attached. An autopsy was not ordered for the reasons given in the clinical report.; Reporter''s Comments: The patient was admitted to the oncology department for exacerbation of known advanced cancer pathology, in a frail condition. On 11May2021 he received the second dose of vaccine and on 12May2021 he died. We report the case given the temporal link, although the general conditions of the patient were precarious and such as to make a causal link unlikely. Sender''s comments: 19May2021: clinical report attached An autopsy was not ordered for the reasons given in the clinical report.; Reported Cause(s) of Death: patient was admitted to the oncology department for exacerbation of known advanced cancer pathology, in a frail condition. On 11May2021 he received the second dose of vaccine and on 12May2021 he died.


VAERS ID: 1372815 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-03
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: LUVION [CANRENOIC ACID]; COUMADIN; TORVAST; LANOXIN; CARAVEL; CARDIOASPIRIN; LASIX [FUROSEMIDE]; LUCEN [ESOMEPRAZOLE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cataract; Ischemic heart disease; Mitral insufficiency; Tricuspid insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021604135

Write-up: Ischemic brain stroke; This is a spontaneous report from contactable Physician downloaded from the Agency Regulatory Authority-WEB. Regulatory authority report number IT-MINISAL02-733414. A 75-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EX3599) via intramuscular route of administration in Arm on 22Apr2021 13:27 as 1st Dose, single dose 0.3 mL for COVID-19 immunization. Medical history included tricuspid insufficiency, ischemic heart disease, mitral insufficiency, atrial fibrillation and cataract. Concomitant medications included canrenoic acid (LUVION), warfarin sodium (COUMADIN), atorvastatin calcium (TORVAST), digoxin (LANOXIN), carvedilol (CARAVEL, Tablet, strength 6.25 mg), acetylsalicylic acid (CARDIOASPIRIN), furosemide (LASIX) and esomeprazole sodium (LUCEN). On 03May2021, the patient experienced ischemic brain stroke and died. A discharge letter was attached as a clinical report provided by the physician. The patient died of ischemic brain stroke on 03May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ischemic brain stroke


VAERS ID: 1372816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Cough, Dyspnoea, Haemorrhagic pneumonia, SARS-CoV-2 test negative
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic bronchitis; COPD; Gross obesity
Allergies:
Diagnostic Lab Data: Test Name: sars-cov-2 test negative; Test Result: Negative
CDC Split Type: ITPFIZER INC2021609244

Write-up: from the day 10May2021 cough and worsening dyspnea with death at 0.50 on 12May21. Autopsy: hemorrhagic pneumonia; acute pulmonary edema; cough; worsening dyspnea; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-733452. This is a spontaneous report from a contactable physician (patient) downloaded from a regulatory authority-WEB (regulatory authority number IT-MINISAL02-733452). A 49-year-old female patient received first dose of BNT162B2 (COMIRNATY (195FL 0.45ML), solution for injection; Lot number: EX7389, Expiration date: 31Aug2021), via an intramuscular route administered in the left arm on 01May2021 at 10:30, 195FL 0.45ML as a single dose for covid-19 immunization in full well-being. Medical history included chronic bronchitis in severe obesity and COPD. The patient concomitant medications were not reported. On 10May2021, patient experienced cough and worsening dyspnea with death at 00.50 on 12May2021. Autopsy report included bilateral haemorrhagic pneumonia and consequent acute pulmonary edema in a patient with a history of chronic bronchitis in severe obesity, the doubt emerged of a POSSIBLE correlation with vaccination as an event inducing pneumonia. Swab neg on the corpse. required dosing on autopsy lung tissue - Sent by Covid19-sheet. (covid neg swab - ineffective resuscitation). The clinical outcome of the events resulted in death. No follow up attempts needed; no further information is expected.; Reporter''s Comments: Reporters comment: considering the autopsy finding of bilateral haemorrhagic pneumonia and consequent acute pulmonary edema in a patient with a history of chronic bronchitis in severe obesity, the doubt emerged of a POSSIBLE correlation with vaccination as an event inducing pneumonia. Swab neg on the corpse. required dosing on autopsy lung tissue - Sent by VigiCovid19-sheet; Reported Cause(s) of Death: haemorrhagic pneumonia; acute pulmonary edema


VAERS ID: 1372817 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-08
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Blood pressure decreased, Blood pressure measurement, Chest pain, Dyspnoea, Headache
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LASITONE; COAPROVEL; PLAVIX; LACIREX; PANTORC; NITROGLICERINA DOC GENERICI
Current Illness: Angina unstable; Atrial fibrillation; Cardiac failure acute; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure/ Blood pressure drop arterial; Result Unstructured Data: Test Result:50/73 mmHg; Test Date: 20210508; Test Name: blood pressure/ Blood pressure drop arterial; Result Unstructured Data: Test Result:unknown result mmHg
CDC Split Type: ITPFIZER INC2021628330

Write-up: difficulty in breathing; aphasia; lowering of arterial P (minimum value detected: 50 / 73 mmHg); chest pain; excruciating headache/ Ice pick headache; This is a spontaneous report received from a contactable consumer (daughter of the patient who later died) downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-734538. This is the first of two reports. A 95-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiration date was not reported), intramuscularly on 28Apr2021 as 2nd dose single for COVID-19 immunisation. The patient medical history included ongoing atrial fibrillation, ongoing hypertension arterial, ongoing cardiac failure acute and ongoing angina unstable but in good general health. Concomitant medications included oral furosemide/ spironolactone (LASITONE; 75mg/37mg; Capsule, hard); hydrochlorothiazide/irbesartan (COAPROVEL; 12.5mg/300mg; Tablet), orally at 312.5mg; clopidogrel bisulfate (PLAVIX; 75 mg) orally at 75 mg; lacidipine (LACIREX; Film-coated tablet; 4 mg) orally at 4 mg; pantoprazole sodium sesquihydrate (PANTORC; 40mg), orally at 40 mg; glyceryl trinitrate (NITROGLICERINA DOC GENERICI; Transdermal patch) via transdermal at 10 mg/24 hours. The patient historical vaccine included first dose of BNT162B2 (COMIRNATY) on 20Mar2021 for COVID-19 immunisation and experienced breathing difficult and headache. It was reported that, the patient was in unspecified drug therapy for atrial fibrillation, arterial hypertension, cardiac failure acute and unstable angina but in good general health. On 20Mar2021, she received the first dose of COMIRNATY at home. In the following days she becomes unwell with episodes of headache and breathing difficulties. She goes to the emergency room of the PRIVATE hospital where she was discharged with the suggestion to carry out a cardiological examination; around 06Apr2021 the patient again reported headache and breathing difficulties. She was therefore taken to the PRIVATE where, following a cardiological visit, she was hospitalized for a few days, skipping the date of the second dose scheduled for 10Apr2021. She was discharged in clinical conditions in general improvement and on 28Apr2021, on the advice of the doctors, she receives the second dose of the vaccine at home. After 10 days, on 08May2021 the symptoms manifested following the 1st dose reappear in a much more intense and acute way, with excruciating headache and difficulty in breathing but also chest pain, lowering of arterial P (minimum value detected: 50 / 73 mmHg) and aphasia. She was hospitalized again at the PRIVATE where after 2 days the death was noted. Pressure value found at the first measurement after the onset of discomfort was 50/73 mmHg. The seriousness of the events was reported as serious (hospitalization and fatal). The patient was died on 10May2021. It was unknown whether the autopsy was performed or not. The outcome of the events was reported as fatal. Reporter''s comment: The administration of both doses of the vaccine was carried out at home by different operators. The batch or expiry date is not indicated on the vaccination sheet issued only for the second dose. The cardiologist who followed the patient recommended taking the second dose despite the symptoms that had already occurred following the I. After the access to the emergency room of PRIVATE around 24Mar2021 (after the 1st dose) she was discharged shortly after without any therapy; for the 2 days of hospitalization Sender''s comment: 21May2021: lots and expirations of both doses of vaccine administered are requested from the reporter; 24May2021: information on the patient''s clinical status and drug therapy is requested from the GP, who confirms the monthly prescribed therapies as reported and reports that he has never visited the patient lately, being treated by a cardiologist specialist. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: The administration of both doses of the vaccine was carried out at home by different operators. The batch or expiry date is not indicated on the vaccination sheet issued only for the second dose. The cardiologist who followed the patient recommended taking the second dose despite the symptoms that had already occurred following the I; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-2021632881 same patient, different events, same drug but first dose; Reported Cause(s) of Death: difficulty in breathing; aphasia; lowering of arterial P (minimum value detected: 50 / 73 mmHg); chest pain; excruciating headache/ Ice pick headache


VAERS ID: 1372994 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Atrial fibrillation, Blood pressure measurement, Body temperature, Cardiac arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: Abdominal aortic aneurysm; Atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: blood pressure; Result Unstructured Data: Test Result:120; Comments: at 05:00; Test Date: 20210521; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021595378

Write-up: acute cardiac arrest due to atrial fibrillation; acute cardiac arrest due to atrial fibrillation; she vomited something like saliva; abdominal pain; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21108760. An 85-year and 10-month old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration, on 21May2021 at 14:00 (at the age of 85-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation and ongoing abdominal aortic aneurysm. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. The patient experienced acute cardiac arrest due to atrial fibrillation on 23May2021 at 06:45 (1 day, 16 hours, and 45 minutes after the vaccination), which was reported as fatal. The patient also experienced vomited something like saliva and abdominal pain on 22May2021 at 09:50. The clinical course was reported as follows: On 21May2021 (the day of vaccination), at 14:00, the patient received the first dose of BNT162B2 vaccination; however, she had no pyrexia or others. The body temperature before vaccination was 36.5 degrees Centigrade on 21May2021. On 22May2021 (one day after vaccination), at 09:50 (19 hours and 50 minutes after vaccination), after the patient took a bath, she vomited something like saliva, and she complained of abdominal pain. The patient was examined; however, she had no signs of existing ruptured abdominal aortic aneurysm, and she was followed up with oral administration of hyoscine butylbromide (BUSCOPAN). On 23May2021 (2 days after vaccination), at 06:15 (one day, 16 hours, and 15 minutes after vaccination), when the nurse visited the patient''s room, s/he found the patient dead on the bed. On 23May2021 at 05:00 (one day and 15 hours after vaccination), one hour before the death, the blood pressure was 120. The reporter commented as follows: The patient had atrial fibrillation and abdominal aortic aneurysm for several years. It is considered that the patient had acute cardiac arrest due to atrial fibrillation. Therapeutic measures were taken as a result of abdominal pain as aforementioned. The patient died on 23May2021. The cause of death was reported as cardiac arrest and acute cardiac arrest due to atrial fibrillation. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the event and BNT162B2 as unassessable. There was other possible cause of the event, such as any other diseases, reported as atrial fibrillation.; Reported Cause(s) of Death: Cardiac arrest; acute cardiac arrest due to atrial fibrillation


VAERS ID: 1372995 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Aspiration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021596466

Write-up: asphyxia due to aspiration of jelly following pyrexia; asphyxia due to aspiration of jelly following pyrexia; asphyxia due to aspiration of jelly following pyrexia; This is a spontaneous report from a contactable pharmacist. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is v21108856. A 77-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 21May2021 (Batch/Lot number was not reported) at 77-years-old as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22May2021 at 17:30, the patient experienced: asphyxia due to aspiration of jelly following pyrexia (death, medically significant). The patient was a 77-year and 0-month-old male. Body temperature before vaccination was not reported. Family history and 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) were not reported. On 21May2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number, and Expiration date were not provided) via an unspecified route of administration as a single dose for COVID-19 immunization. On 22May2021 at 17:30 (1 day after the vaccination), the patient experienced asphyxia due to aspiration of jelly following pyrexia. The outcome of the event was fatal. Seriousness criteria, causality assessment, and other possible cause of the event such as any other diseases were not provided. The clinical outcome of the events was fatal. The patient died on an unspecified date due to asphyxia due to aspiration of jelly following pyrexia. It was unknown if an autopsy was performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Reported Cause(s) of Death: asphyxia due to aspiration of jelly following pyrexia; asphyxia due to aspiration of jelly following pyrexia; asphyxia due to aspiration of jelly following pyrexia


VAERS ID: 1372996 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021597022

Write-up: Cardio-respiratory arrest; Vomiting; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21108937. A 70-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 20May2021 at 11:00 at a single dose for covid-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. On 21May2021 at 4:41, the patient experienced cardio-respiratory arrest, which were serious for death. On 21May2021, the patient experienced vomiting, which were serious for death. The clinical course was as follows: on 20May2021 at 11:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 21May2021 at 04:41 (1 day after the vaccination), the patient experienced cardio-respiratory arrest and died. An autopsy was performed but the cause of death was uncertain. The event was further described as: On 21May2021 at around 03:50, the patient''s brother who lived together with the patient saw him frequently going to the bathroom. Then the patient did not return from the bathroom, so his brother wondered, and he went to the bathroom. The patient''s brother found the patient bent over vomiting in the bathroom and so he called an ambulance. The patient was transferred to a hospital in a state of cardiopulmonary arrest. Although cardiac massage in addition to trancheal intubation was performed, the patient''s death was confirmed at 05:08 on the same day. The patient underwent lab tests and procedures which included body temperature: 36.2 degrees Centigrade on 20May2021 before vaccination. Therapeutic measures were taken as a result of cardio-respiratory arrest and vomiting. The clinical outcome of the events, cardio-respiratory arrest and vomiting, was fatal. The patient died on 21May2021 due to cardio-respiratory arrest and vomiting. 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. REPORTER COMMENT: An autopsy was performed, but a definite cause of the death could not be determined and it was uncertain. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: vomiting; cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: unknown cause of death


VAERS ID: 1372997 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Dyspnoea, Fall, Hypophagia, Loss of consciousness, Malaise, Pneumonia, Pyrexia, Respiratory rate decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (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: 2021-05-24
   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: Brain disorder NOS (taking oral medications for prostate gland, hypertension, and brain); Hypertension (taking oral medications for prostate gland, hypertension, and brain); Prostatic disorder NOS (taking oral medications for prostate gland, hypertension, and brain)
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210522; Test Name: Body temperature; Result Unstructured Data: Test Result:pyrexia of 37.5 Centigrade; Test Date: 20210523; Test Name: Body temperature; Result Unstructured Data: Test Result:pyrexia of 39 Centigrade; Test Date: 202105; Test Name: CT; Result Unstructured Data: Test Result:performed after the death; Comments: revealing pneumonia in both lower lobes in the dorsal segment. Pneumonia was considered as the direct cause of the death.
CDC Split Type: JPPFIZER INC2021597030

Write-up: Dyspnoea; Became unconscious and fell down; Became unconscious and fell down; respiration was also weak; Cardio-respiratory arrest; Pneumonia; Pyrexia of 37.5 degrees centigrade (and 37.5 degrees centigrade on 23May2021); General malaise; quantity of food intake decreased; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21108936. A 93-year and 3-month-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EY2173; Expiration Date: 31Aug2021), via an unspecified route of administration, on 21May2021 at 09:00 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate gland, hypertension, and brain (oral medications for prostate gland, hypertension, and brain). Concomitant medications included unspecified oral medications for prostate gland, hypertension, and brain. It was reported that no anticoagulant drugs were used. The patient experienced pneumonia, pyrexia of 37.5 degrees centigrade (and 37.5 degrees centigrade on 23May2021), and general malaise on 22May2021 at 09:00 and dyspneoa on 24May2021, which were reported as fatal. The patient also experienced quantity of food intake decreased on 22May2021 and became unconscious and fell down, respiration was also weak, and cardio-respiratory arrest on 24May2021. The clinical course was reported as follows: The body temperature before vaccination was 36.2 degrees Centigrade on 21May2021. On 22May2021 around 09:00 (1 day after the vaccination), the patient experienced pneumonia, pyrexia with body temperature of 37.5 degrees centigrade, and general malaise. The quantity of food intake decreased. On 23May2021 (2 days after the vaccination), the patient experienced pyrexia with a body temperature of 39 degrees centigrade, aggravation of malaise, and the patient could hardly eat. He was barely able to eat (oral nutritional supplement). On 24May2021 (3 days after the vaccination), the patient complained of dyspnoea in the morning. The patient raised his upper body to exchange his cloth and he became unconscious and fell down. His respiration was also weak. His family called ambulance. The patient was transported in a cardio-respiratory arrest. The reporting physician commented as follows: Computerized tomography (CT) was performed after the death in May2021, revealing pneumonia in both lower lobes in the dorsal segment. Pneumonia was considered as the direct cause of the death. The clinical outcome of pneumonia, pyrexia, general malaise, and dyspnoea was fatal and of quantity of food intake decreased, became unconscious and fell down, respiration was also weak, and cardio-respiratory arrest was unknown. The patient died on 24May2021. The causes of death were reported as pneumonia, pyrexia of 37.5 degrees centigrade (and 37.5 degrees centigrade on 23May2021), general malaise, and dyspnoea. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the events and BNT162B2 as unassessable. Other possible causes of the events, such as any other diseases, was pneumonia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: General malaise; Dyspnoea; Pneumonia; Pyrexia of 37.5 degrees centigrade (and 37.5 degrees centigrade on 23May2021)


VAERS ID: 1372998 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   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: DEPAKENE-R; URIEF; BELSOMRA; AMLODIN; MOBIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Encephalitis herpes; Hypertension; Mental disorder; Symptomatic epilepsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021602399

Write-up: Loss of consciousness; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received via a regulatory authority. The patient was an 88-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received valproate sodium (DEPAKENE-R) at 400 mg daily, silodosin (URIEF OD) at 8 mg daily, suvorexant (BELSOMRA) at 15 mg daily, amlodipine besilate (AMLODIN OD) at 5 mg daily, meloxicam (MOBIC) at 10 mg daily within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included sequelae of herpes encephalitis, organic mental disorder, symptomatic epilepsy and hypertension. On 17May2021 at 14:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 24May2021 around 09:45 (7 days after the vaccination), the patient experienced loss of consciousness and cardio-respiratory arrest. The clinical course was reported as follows: On 24May2021 around 09:45, the patient suddenly had a loss of consciousness in the toilet and suffered cardio-respiratory arrest. The patient was immediately transported by an ambulance to an emergency department at a hospital other than the reporter''s facility. On the same date at 10:53, the patient''s death was confirmed. The event resulted in emergency room/department or urgent care, and death. The cause of death was unknown. It was unknown if an autopsy was performed. The outcome of the events was fatal without treatment. Since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported fatal events loss of consciousness and cardio-respiratory arrest. 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: Loss of consciousness; Cardio-respiratory arrest


VAERS ID: 1372999 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Condition aggravated, Dyspnoea, Myocardial infarction, Myocardial ischaemia, Vomiting, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   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 (3 times a week); Renal failure chronic
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic gangrene; Diabetic nephropathy; Diabetic retinopathy; Ischaemic heart disease; Myocardial infarction; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021603101

Write-up: Cardiac arrest accompanying ischaemic heart disease and myocardial infarction; Cardiac arrest accompanying ischaemic heart disease and myocardial infarction; Cardiac arrest accompanying ischaemic heart disease and myocardial infarction; Cardiac arrest accompanying ischaemic heart disease and myocardial infarction; Dyspnoea; Wheezing; Vomiting; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21109169. A 71-year and 7-month-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), intramuscularly, on 21May2021 at 09:56 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic nephropathy, ongoing renal failure chronic with ongoing haemodialysis (3 times a week), ischaemic heart disease, non-ongoing myocardial infarction on an unspecified date, type 2 diabetes mellitus, non-ongoing diabetic gangrene of foot, and diabetic retinopathy. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 24May2021 at 02:48 and accompanying ischaemic heart disease and myocardial infarction on 24May2021 at 04:01, which were reported as fatal. The events were reported as: cardiac arrest accompanying ischaemic heart disease and myocardial infarction. The patient also experienced wheezing and vomiting on 24May2021 at 01:00 and dyspneoa on 24May2021 at 02:46. The clinical course was reported as follows: The body temperature before vaccination was 36.6 degrees centigrade on 21May2021. The patient was undergoing haemodialysis due to renal failure chronic caused by diabetic nephropathy 3 times a week. On 21May2021, the patient received the vaccination during haemodialysis. The patient developed no particular anaphylaxis or allergic reaction and haemodialysis was conducted as usual. On 24May2021 at around 01:00, the patient had wheezing and vomiting, for which the family member called an ambulance. At 02:46, when the ambulance arrived, the patient complained of dyspnoea. At 02:48, the patient experienced cardiac arrest. Resuscitation was initiated and the patient was transferred to an emergency center; however, the patient did not recover. At 04:01, death was confirmed. The reporting physician commented as follows: The physician who saw the patient at the emergency center where the patient was transferred and a contract physician of the police who did the inspection commented that the cause of death was probably cardiac arrest accompanying ischaemic heart disease and myocardial infarction. Therapeutic measures were taken as a result of cardiac arrest accompanying ischaemic heart disease and myocardial infarction as aforementioned and unspecified treatment for vomiting. The clinical outcome of cardiac arrest accompanying ischaemic heart disease and myocardial infarction was fatal and of wheezing, vomiting, and dyspneoa was unknown. The patient died on 24May2021 at 04:01 (2 days 18 hours 5 minutes after the vaccination). The cause of death was reported as cardiac arrest accompanying ischaemic heart disease and myocardial infarction. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the events and BNT162B2 as unassessable. Other possible causes of the event, such as any other diseases, were cardiac failure due to ischaemic heart disease and myocardial infarction.; Reported Cause(s) of Death: Cardiac arrest accompanying ischaemic heart disease and myocardial infarction; Cardiac arrest accompanying ischaemic heart disease and myocardial infarction; Cardiac arrest accompanying ischaemic heart disease and myocardial infarction; Cardiac arres


VAERS ID: 1373000 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   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: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021604798

Write-up: CPA; Loss of consciousness; Potential asphyxia due to aspiration; Potential asphyxia due to aspiration; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21109406. A 92-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration, on 21May2021 at 15:30 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient experienced cardio-pulmonary arrest (CPA), loss of consciousness, and potential asphyxia due to aspiration on 22May2021 at 07:35 (reported as: 1 day after the vaccination). The clinical course was reported as follows: The body temperature before vaccination was 36.4 degrees centigrade on 21May2021. On 22May2021 around 07:20 (1 day after the vaccination), the patient had breakfast (unassisted). On the same day around 07:35, the patient was found having loss of consciousness. With a suspicion of aspiration, Heimlich maneuver and suction were performed, and cardiopulmonary resuscitation (CPR) was started. An ambulance was called. At 07:49, the ambulance crews arrived. At 08:08, the patient arrived at the emergency department of another hospital. On arrival, because of CPA, CPR and bag-valve-mask ventilation were performed for 40 minutes but did not result in heartbeat return. At 08:46, the patient was confirmed dead. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 22May2021 at 08:46. The causes of death were reported as CPA, loss of consciousness, and potential asphyxia due to aspiration. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the event and BNT162B2 as unassessable and reported that as there was potential asphyxia due to aspiration, the causality with the vaccination was uncertain. There was no other possible cause of the event, such as any other diseases.; Reported Cause(s) of Death: loss of consciousness; Potential asphyxia due to aspiration; CPA; Potential asphyxia due to aspiration


VAERS ID: 1373002 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood lactic acid, Blood potassium, Blood uric acid, Body temperature, Cardiac failure acute, Cardio-respiratory arrest, Computerised tomogram, Fall, Fibrin D dimer, Investigation, Myocardial infarction, PCO2, Pericardial haemorrhage, Pleural effusion, SARS-CoV-2 test, Troponin T
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: GPT; Result Unstructured Data: Test Result:124; Test Date: 20210526; Test Name: GOT; Result Unstructured Data: Test Result:249; Test Date: 20210526; Test Name: CK; Result Unstructured Data: Test Result:1799; Test Date: 20210526; Test Name: CK-MB; Result Unstructured Data: Test Result:154; Test Date: 20210526; Test Name: cretinine; Result Unstructured Data: Test Result:1.45; Test Date: 20210526; Test Name: Lactate; Result Unstructured Data: Test Result:106; Test Date: 20210526; Test Name: K; Result Unstructured Data: Test Result:6.6; Test Date: 20210526; Test Name: UA; Result Unstructured Data: Test Result:9.3; Test Date: 20210525; Test Name: Body temperature; Result Unstructured Data: Test Result:35.3 Centigrade; Comments: before vaccination; Test Date: 20210526; Test Name: AI (postmortem CT); Result Unstructured Data: Test Result:revealed intrapericardial thrombosis; Test Date: 20210526; Test Name: D dimer; Result Unstructured Data: Test Result:67.52; Test Date: 20210526; Test Name: Investigation; Result Unstructured Data: Test Result:pH 7.098; Test Date: 20210526; Test Name: PCO2; Result Unstructured Data: Test Result:70.2; Test Date: 20210526; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210526; Test Name: Troponin T; Result Unstructured Data: Test Result:1.61
CDC Split Type: JPPFIZER INC2021608180

Write-up: haemopericardium; Bilateral pleural effusion; fell; Cardio-respiratory arrest; Cardiac failure acute; Suspected myocardial infarction; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21109505. An 85-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 25May2021 at 11:00 (Lot Number: EX3617; Expiration Date: 31Aug2021) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus (DM) and hypertension (HTN), both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 26May2021 at 11:50 (1 day after the vaccination), the patient experienced cardio-respiratory arrest, cardiac failure acute and suspected myocardial infarction. On an unspecified day, the patient experienced hemopericardium and bilateral pleural effusion. On 26May2021, the outcome of the event cardio-respiratory arrest, cardiac failure acute and suspected myocardial infarction was fatal, and the outcome of the other events was unknown. The course of the event was as follows: body temperature before vaccination was 35.3 degrees centigrade. At 11:30, the patient was last confirmed in a healthy state. A little past 11:50, the patient''s family member found the patient fell to a floor in a toilet and called an ambulance. At 12:10, an emergency medical service arrived. The patient was in a cardio-respiratory arrest (CPA) condition (asystole). The patient was transferred while undergoing cardiopulmonary resuscitation (CPR). During the transfer, laryngeal tube (LT) was used as a designated procedure. At 12:32, the patient arrived at hospital. The patient had pupils dilated. PH was 7.098, pCO2 was70.2, and lactate was 106. The patient was intubated and medication was administered. During this time, pulseless electrical activity (PEA) was observed; however, the patient was eventually in asystole and death was confirmed at 13:35. Blood collection revealed GOT 249, GPT 124, CK 1799, CK-MB 154, creatinine 1.45, uric acid 9.3, potassium 6.6, D dimer 67.52, and troponin T 1.61. SARS-CoV-2 PCR test was negative. Autopsy imaging (postmortem CT) revealed haemopericardium, with considering an influence of resuscitation. There was a possibility of focal dissociation of sinus of Valsalva, cardiac rupture, or coronary artery rupture. Differentiation was difficult whether it was postmortem change or a manifestation due to dissociation. There was also bilateral pleural effusion which was hemorrhagic. The reporting physician classified the event, cardio-respiratory arrest, cardiac failure acute and suspected myocardial infarction, as serious (death) and assessed that the causality between the event, cardio-respiratory arrest, cardiac failure acute and suspected myocardial infarction, and BNT162b2 as unassessable. The reporting physician did not provide seriousness or causality of the event haemopericardium and bilateral pleural effusion. The reporting physician commented as follows: causal relationship was unknown. The patient was not vaccinated at the reporting hospital, which was also not a primary care physician''s hospital; therefore, the situation of vaccination was also unknown. The event was reported because this was a death case occurred 1 day after the vaccination. According to inspection, external factor was unlikely. CT and blood collection revealed increase in cardiac enzymes and troponin T. Postmortem CT revealed haemopericardium and hemorrhagic bilateral pleural effusion. Although there was an influence of resuscitation, cause of death was presumably cardiac failure acute due to myocardial infarction. The patient died on 26May2021 at 13:35. Unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest; Cardiac failure acute; Myocardial infarction


VAERS ID: 1373003 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Computerised tomogram, Loss of consciousness, Pyrexia, Respiratory failure, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210523; Test Name: Blood pressure; Result Unstructured Data: Test Result:over 200; Test Date: 20210523; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 202105; Test Name: Head CT; Result Unstructured Data: Test Result:SAH (Subarachnoid haemorrhage)
CDC Split Type: JPPFIZER INC2021609417

Write-up: Loss of consciousness; Respiratory failure; Subarachnoid haemorrhage; Blood pressure increased; Slight fever; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21109823. A 90-year and 7-month old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the right arm on 23May2021 14:30 (at the age of 90-year-old) (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. Body temperature on 23May2021 before vaccination was 36.3 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 23May2021 at 18:00 (3 and half hours after the vaccination), slight fever and blood pressure increased (at over 200) were noted. The rest of the day passed without symptoms. However, on 26May2021 at 8:00, the patient was found unconscious at home and was in respiratory distress. The patient was rushed to hospital. A head CT scan showed subarachnoid haemorrhage, and respiratory management was required. Intubation was performed to treat the events. Subsequently, the blood pressure decreased. The patient was pronounced dead at 14:00 on 27May2021. Cause of death was subarachnoid haemorrhage. It was unknown if an autopsy was performed. The outcome of the events respiratory failure, blood pressure increased and fever was unknown; the outcome of loss of consciousness was not recovered; the outcome of subarachnoid haemorrhage was fatal. The reporting physician classified the event subarachnoid haemorrhage as serious (fatal, hospitalized from 26May2021 and life-threatening) 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 reporting physician commented as follows: it is unclear whether vaccination was the direct cause.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1373005 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure systolic, Cardio-respiratory arrest, Pneumonia, Subarachnoid haemorrhage, Subdural haematoma
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite impaired; COVID-19 pneumonia (hospitalized and received treatment); Fall; Haemodialysis; Renal disease
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:200 mmHg
CDC Split Type: JPPFIZER INC2021609974

Write-up: Subarachnoid haemorrhage; Acute subdural haematoma; Pneumonia; consciousness disturbed; cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21109573. An 84-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 21May2021 (Lot Number: EY4834; Expiration Date: 31Aug2021) (at the age of 84-year-old) as single dose for COVID-19 immunisation. Medical history included renal disease from an unknown date and unknown if ongoing, hemodialysis from 2013 to an unknown date, COVID-19 pneumonia (hospitalized and received treatment) from 10Mar2021 to 05Apr2021, fall on 12May2021 and decreased appetite from 12May2021 to an unknown date. The patient''s concomitant medications were not reported. On 23May2021 at 18:30, the patient experienced subarachnoid haemorrhage, acute subdural haematoma, pneumonia, consciousness disturbed and cardio-respiratory arrest. The patient underwent lab tests and procedures which included blood pressure systolic: 200 mmHg in May2021. The patient died on 23May2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Other possible causes of the event such as any other diseases were fall on 12May2021 and 23May2021 and blood pressure, which stayed at 200mmHg during dialysis before the vaccination. The course of the event was as follows: the patient was undergoing hemodialysis since 2013. From 10Mar2021 to 05Apr2021, the patient was hospitalized due to COVID-19 pneumonia and received treatment. The symptom improved and the patient was discharged from the hospital; however, the patient had decreased physical strength. On 12May2021, the patient experienced fall and appetite impaired thereafter. Blood pressure was 200 and stayed at high value. On 23May2021 at around 16:00, the patient experienced fall again and was taken to a hospital by ambulance. The patient had no haemorrhage intracranial and returned home. On the same day at around 18:30, the patient had consciousness disturbed and was taken to a hospital by ambulance. After the transfer, the patient had cardio-respiratory arrest. With do-not-resuscitate order, the patient died. The reporting physician commented as follows: direct relationship to the vaccine was not positively suggested; however, the case was reported because the event occurred 2 days after the vaccination.; Reported Cause(s) of Death: consciousness disturbed; Subarachnoid haemorrhage; Acute subdural haematoma; Pneumonia; cardio-respiratory arrest


VAERS ID: 1373006 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac tamponade, Cardio-respiratory arrest, Computerised tomogram
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: 2021-04-30
   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: ADALAT CR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 2021; Test Name: AI-CT scan; Result Unstructured Data: Test Result:pericardial effusion; Comments: after death
CDC Split Type: JPPFIZER INC2021609997

Write-up: Cardiac tamponade; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician via the regulatory authority. The Regulatory Authority report number is v21109634. An 87-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, on 27Apr2021 11:30 (Lot Number: ET3674; Expiration Date: 31Jul2021), as single dose, for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included nifedipine (ADALAT CR) for hypertension. The patient experienced cardiac tamponade (death) on 29Apr2021 23:40 with fatal outcome on 30Apr2021, cardio-respiratory arrest (death) on 29Apr2021 23:40 with fatal outcome on 30Apr2021. The patient underwent lab tests and procedures which included body temperature: 36.4 C on 27Apr2021 (before vaccination), computerised tomogram: pericardial effusion in 2021 (after death). The patient died on 30Apr2021. Clinical course: on 30Apr2021 at 00:12, the patient was taken to the reporting hospital by ambulance. Cardiopulmonary resuscitation was immediately conducted, which was continued after arriving at the hospital; however, no return of spontaneous circulation was observed. At 02:08, death was confirmed. After death, AI-CT scan (autopsy imaging CT scan) revealed pericardial effusion and diagnosis of cardiac tamponade was made. The reporting physician classified the event as serious (death) and assessed the causality between the event and Comirnaty as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting physician commented as follows: relationship to the vaccination was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Cardiac tamponade; Autopsy-determined Cause(s) of Death: pericardial effusion; Cardiac tamponade


VAERS ID: 1373008 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Bradycardia, Cardiac failure chronic, Chronic kidney disease, Chronic respiratory failure, Disease progression, Dyspnoea, Heart rate, Hypoxia, Oxygen therapy
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Respiratory failure (narrow), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   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: Oxygen therapy
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Chronic respiratory failure; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Blood pressure; Result Unstructured Data: Test Result:90-100/40; Test Date: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210525; Test Name: Heart rate; Result Unstructured Data: Test Result:40-50/min; Test Date: 20210525; Test Name: SpO2; Result Unstructured Data: Test Result:90 (O2 2L) %
CDC Split Type: JPPFIZER INC2021610292

Write-up: Aggravation of the underlying diseases (Renal failure); Aggravation of the underlying diseases (respiratory failure); Aggravation of the underlying diseases (respiratory failure); Aggravation of the underlying diseases (cardiac failure); Hypoxaemia; Dyspnoea; Blood pressure decreased; Bradycardia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21109650. A 100-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 21May2021 16:00 (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation . Medical history included chronic kidney disease, chronic respiratory failure, cardiac failure chronic, ongoing oxygen therapy. The patient''s concomitant medications were not reported. The patient experienced hypoxaemia on 25May2021 16:00 , dyspnoea on 25May2021 16:00 , blood pressure decreased on 25May2021 16:00 , bradycardia on 25May2021 , aggravation of the underlying diseases (renal failure) , aggravation of the underlying diseases (respiratory failure), aggravation of the underlying diseases (cardiac failure) on an unspecified date. The patient died from all the reported events on 26May2021. The patient underwent lab tests and procedures which included blood pressure measurement: 90-100/40 on 25May2021 , body temperature: 36.5 centigrade on 21May2021 before vaccination , heart rate: 40-50/min on 25May2021 , oxygen therapy: 90 (O2 2l) % on 25May2021 . It was not reported if an autopsy was performed. The course of the events was as follows: On 21May2021 in the late afternoon (the day of vaccination), the patient was vaccinated. No side effects were noted in particular. On 25May2021 (4 days after the vaccination), her condition had remained unchanged until noon. On the same day in the late afternoon, the patient began to complain of dyspnoea. On the same day at night, a medical house visit was made. The SpO2 was 90% (O2 2L), the blood pressure 90-100/40, and the heart rate 40-50/min. On the next day, the patient still had not achieved recovery; her death was confirmed on 26May2021 at 16:00 (5 days after the vaccination). The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was aggravation of the underlying diseases. The reporting physician commented as follows: Although the patient, who was very old and had several underlying diseases, experienced a sudden change on day 4 from the vaccination and died on day 5, the causal relationship was unknown. Follow up information has been requested.; Reported Cause(s) of Death: Aggravation of the underlying diseases; Aggravation of the underlying diseases; Aggravation of the underlying diseases; Bradycardia; Hypoxaemia; Dyspnoea; Blood pressure decreased; Aggravation of the underlying diseases


VAERS ID: 1373009 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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; Cardiac failure; Hypertension; Prostate cancer; Pulmonary tuberculosis (when the patient was 30''s years-old)
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021613091

Write-up: Prostate cancer progression; Prostate cancer progression; abnormal death; asystole; Loss of consciousness; This is a spontaneous report from a contactable pharmacist received from the Agency Regulatory Authority. Regulatory authority report number is v21109574. A 89-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 24May2021 10:00 (Batch/Lot Number: EY4834; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation . Medical history included prostate cancer , hypertension , atrial fibrillation , cardiac failure , pulmonary tuberculosis when the patient was 30''s years-old. The patient''s concomitant medications were not reported. The patient experienced abnormal death on 25May2021 19:23 , loss of consciousness on 25May2021 17:30 , asystole on 25May2021 17:40 , prostate cancer progression on an unspecified date. All the reported events caused patient''s death. The patient underwent lab tests and procedures which included body temperature: 35.8 centigrade on 24May2021 Before vaccination. The patient died on 25May2021. It was not reported if an autopsy was performed. Course of the event The patient had been regularly visiting the urology department of the reporter''s hospital for the treatment of prostate cancer. On 24May2021, the patient received the vaccination. On 25May2021 in the morning, the patient had a fever. Until 17:20, he was able to have a conversation as usual. But as of 17:30, the patient had loss of consciousness. When an emergency team was handling the patient, he developed asystole. On 25May2021 at 18:02, the patient was emergently transferred to the reporter''s hospital by an ambulance because of CPA (cardiopulmonary arrest). On 25May2021 at 19:23, the patient''s death was confirmed. The reporting pharmacist classified the events as serious (Fatal outcome) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported if there was other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: At present, the causal relationship with BNT162b2 was unassessable. It was only informed that the patient received the vaccination at a nearby hospital on 24May2021. The hospital was closed on 26May2021, so information on the vaccination could not be obtained. Other possible cause of the event such as any other diseases includes prostate cancer. The reporting pharmacist commented as follows: The patient has a history of prostate cancer, but the attending urologist said that this was not the only explanation. The event was a day after the vaccination, but the causal relationship was unclear. Follow up information has been requested; Reported Cause(s) of Death: Unknown cause of death; Loss of consciousness; Cardiac arrest; Prostate cancer progression; Prostate cancer progression


VAERS ID: 1373010 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 1
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: Oedema peripheral
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210526; Test Name: Abdominal ultrasound; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: JPPFIZER INC2021613157

Write-up: Cardiac failure; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21109698. A 89-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 24May2021 (Batch/Lot Number: FA2453; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation . Medical history included oedema peripheral. The patient''s concomitant medications were not reported. The patient experienced cardiac failure on 25May2021 leading to patient''s death. The patient was hospitalized for cardiac failure from 25May2021 to an unknown date. The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade on 24May2021 before vaccination , ultrasound abdomen: unknown results on 26May2021 . The patient died on 26May2021. It was not reported if an autopsy was performed. Course of the event: From the beginning of May, the patient had lower leg oedema. On 25May2021, the patient had respiratory distress, for which ambulance was requested. The patient was transferred to the reporting hospital and was hospitalized due to cardiac failure. On 26May2021, the patient experienced depressed level of consciousness while undergoing abdominal ultrasound. Subsequently, the patient had cardiac arrest. On 26May2021 at around 13:00, death was confirmed. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was myocardial infarction. The reporting physician commented as follows: The event occurred on day 2 of the vaccination and there were two possibilities: 1) It was caused by the vaccine; and 2) myocardial infarction resulted in cardiac arrest. Follow up information has been requested.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1373011 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amylase, C-reactive protein, Computerised tomogram, Dyspnoea, Malaise, Nausea, Pancreatitis necrotising, Respiratory distress, Sepsis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: Amylase; Result Unstructured Data: Test Result:1910; Comments: after vaccination; Test Date: 20210521; Test Name: CT; Result Unstructured Data: Test Result:findings of pancreatitis necrotising; Test Date: 20210521; Test Name: CRP; Result Unstructured Data: Test Result:42.29; Comments: after vaccination
CDC Split Type: JPPFIZER INC2021618039

Write-up: vomiting; pancreatitis necrotising; respiratory distress; Sepsis; Dyspnoea; Queasy; malaise; This is a spontaneous report from a uncontactable physician. The patient was an 80-year-old female. On 17May2021 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration for COVID-19 immunization. On 20May2021 (3 days after the vaccination), the patient experienced vomiting, queasy, and malaise. On 21May2021, the patient experienced dyspnoea, pancreatitis necrotizing, and sepsis. Vomiting resulted in hospitalization. The course of the event was as follows: In the morning on 20May2021 (3 days after the vaccination), the patient had vomiting for 5-10 times and she was transported to the hospital of the primary care physician by ambulance. Although detailed examination was conducted, cause of the symptom could not be identified, and poor improvement was noted after intravenous administration of metoclopramide (PRIMPERAN). Therefore, she was emergently admitted to the hospital for observation. After admission, queasy and malaise persisted. In the morning on 21May2021 (4 days after the vaccination), no apparent physical findings were observed but malaise was still noted. At 10:20 on the same day, respiratory distress and dyspnoea were noted and oxygen administration was given. Blood examination showed amylase of 1910 and C-reactive protein of 42.29. Pancreatitis necrotising was suspected as her pathological condition also by CT findings. At 15:35 on the same day, the patient died from sepsis and discharged dead from hospital. The patient died on 21May2021. It was not reported if an autopsy was performed. Outcome of sepsis was fatal while all other events were unknown.; Sender''s Comments: Drug causality for suspect drug in the onset of some reported events cannot be completely excluded assuming a plausible temporal association, although pancreatitis necrotizing probably followed by sepsis seems to be a pre existing underlying conditions The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as seems to be part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1373022 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021600534

Write-up: aneurysm and died; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced aneurysm and 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: aneurysm and died


VAERS ID: 1373051 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Death, Dyspnoea, Malaise
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   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: Arachnoid cyst; Decubitus; Leg paresis (straight leg); Weight below normal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021597748

Write-up: patient died; on the day of death contact with the GP about malaise; slight dyspnoea; elevation; complaints related to the vaccination; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00549281. A 75-years-old female patient received second dose of BNT162B2 (COMIRNATY: Solution for injection; Batch/Lot number: unknown), dose 2 via an unspecified route of administration on 11May2021 (at the age of 75 years) as 2ND DOSE SINGLE DOSE for covid-19 immunisation. Medical history included arachnoid cyst, leg paresis, weight below normal, decubitus from an unknown date. The patient''s concomitant medications were not reported. Patient received first dose of BNT162B2 (covid-19 vaccine pfizer Injectable solution) with adverse reaction on 30Mar2021. On 13May2021 the patient experienced, on day of death contact with GP about malaise, mild dyspnoea, increase; complaints related to the vaccination. Confounding factors was arachnoid cyst, paresis of the leg, underweight, pressure ulcers. Not known previous COVID-19 infection. The patient died on 13May2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: unknown, not reported to GP Date: 30Mar2021 - patient died Additional information ADR: on day of death contact with GP about malaise, mild dyspnoea, increase; complaints related to the vaccination Citizen service number available: yes Confounding factors: arachnoid cyst, paresis of the leg, underweight, pressure ulcers COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: no; Reported Cause(s) of Death: patient found dead


VAERS ID: 1373052 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue
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: OXAZEPAM; PAROXETINE; METOPROLOL SUCCINATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Familial risk factor (father died of cardiac arrest at the age of 54.); Hypertension; Overweight; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021628353

Write-up: Fatigue; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00553010. A 56-years-old female patient received received bnt162b2 (COMIRNATY, Solution for injection, Lot/batch Number: FA7082) via an unspecified route of administration on 22May2021 as 1st dose, 0.3 ml single for COVID-19 Immunisation. Medical history included hypertension, smoker, overweight, familial risk factor for cardiac arrest (father died at the age of 54 years due to cardiac arrest). Concomitant medication included metoprolol modified-release tablet 100mg (METOPROLOL SUCCINATE), paroxetine (PAROXETINE) tablet 20mg, oxazepam (OXAZEPAM) tablet 10mg, taken for an unspecified indication from 2020 to an unspecified stop date. There was no previous COVID-19 infection. Obduction (including brain extraction) has been agreed upon and will be done in hospital. On 22May2021, the patient experienced fatigue (death) within 1 day following administration of covid-19 vaccine Pfizer injection fluid for covid 19 immunisation. This concerns sudden death during sleep less than 24 hours after vaccination. The clinical outcome of the event is fatal. The cause of death was unknown. The patient died on an unspecified date. An autopsy was performed, and results were not provided. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1373055 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH A4DEY4834 / EY4 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021613454

Write-up: 2 days after vaccination, patient was found dead in his residence.; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is PH-PHFDA-300075783. A 58-years-old male patient received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot Number: A4DEY4834 / EY4834) as UNKNOWN, SINGLE DOSE for covid-19 immunisation . The patient medical history and concomitant medications were not reported. Two days after vaccination, patient was found dead in his residence. 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: Unknown cause of death


VAERS ID: 1373056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-19
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Troponin I, Vaccination site pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: ECG; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Test Date: 20210519; Test Name: TROP-I; Test Result: Negative
CDC Split Type: PHPFIZER INC2021614085

Write-up: 3:42 PM - ARRIVED IN ER WITH COMPLAINT OF PAIN IN INJECTION SITE RADIATING TO CHEST;ECG DONE- TROP-I NEGATIVE; 3:42 PM - ARRIVED IN ER WITH COMPLAINT OF PAIN IN INJECTION SITE RADIATING TO CHEST;ECG DONE- TROP-I NEGATIVE; This is a spontaneous report from a contactable health care professional via the Regulatory Authority. Regulatory authority report number is PH-PHFDA-300075861. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot Number: EY4834) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 19May2021 at 15:42 the patient arrived in ER with complaint of pain in injection site radiating to chest. The events were serious as fatal. The patient underwent lab tests and procedures which included electrocardiogram: unknown results on 19May2021 and troponin I negative on 19May2021. 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: 3:42 PM - ARRIVED IN ER WITH COMPLAINT OF PAIN IN INJECTION SITE RADIATING TO CHEST;ECG DONE- TROP-I NEGATIVE; 3:42 PM - ARRIVED IN ER WITH COMPLAINT OF PAIN IN INJECTION SITE RADIATING TO CHEST;ECG DONE- TROP-I NEGATIVE


VAERS ID: 1373080 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021612809

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number RO-NMA-2021-SPCOV10419. A 84-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 05Apr2021 (Batch/Lot Number: EW2239) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced acute myocardial infarction on 06Apr2021 leading to patient death. The patient died on 06Apr2021. It was not reported if an autopsy was performed. Following investigation of the case by the regulatory authority, the conclusions were: coincidental. These are the only information provided from regulatory authority. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1373162 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, COVID-19, Drug ineffective, Renal failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia Alzheimer''s type; Hypertension; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: antibody titer; Result Unstructured Data: Test Result:low; Test Date: 202103; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021609371

Write-up: INFECTION GENOLET AFTER VACCINATION (POSSIBLE EFFECT); POSITIVT COVID-19 (TEST); Renal failure; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Agency Regulatory Authority-WEB (SE-MPA-2021-035694). An 81-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration in Feb2021 (Batch/Lot Number: EJ 6797) as single dose for COVID-19 immunisation. Relevant medical history included ongoing dementia Alzheimer''s type, ongoing hypertension and ongoing hypothyroidism. The patient''s concomitant medications were not reported. In Mar2021, the patient experienced "infection genolet after vaccination (possible effect)", positive COVID-19 (test) (both considered serious as involving hospitalization and fatal outcome) and died due to renal failure on an unspecified date in 2021; it was unknown if an autopsy was performed. The patient was vaccinated with dose two of COMIRNATY in early February. In connection with screening for cases of COVID-19 in the patient''s accommodation, it was found that the patient had COVID-19 at the beginning of March. He was then asymptomatic. He developed breathing problems and was admitted to hospital ten days later for oxygen treatment. Discharged to the accommodation and judged to be in his habitual condition again. Low antibody titer. Thereafter, relatively quickly became ill and the patient later died with symptom picture of kidney failure. The man died ten weeks after the vaccination (dose two) and about five weeks after the positive COVID test. The information on the batch number has been requested.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1373185 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood homocysteine, Blood lactate dehydrogenase, Computerised tomogram abdomen, Computerised tomogram head, Confusional state, Diarrhoea, General physical health deterioration, Haemoglobin, Heparin-induced thrombocytopenia test, Meningioma, Multiple organ dysfunction syndrome, Platelet count, Serum ferritin, Thrombocytopenia, Transferrin
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia; Radius fracture
Allergies:
Diagnostic Lab Data: Test Name: homocystein; Result Unstructured Data: Test Result:54; Test Name: LD; Result Unstructured Data: Test Result:22; Test Name: CT abdomen; Result Unstructured Data: Test Result:diffuse heterogeneous spleen; Test Name: CT brain; Result Unstructured Data: Test Result:newly discovered suspected meningioma; Test Name: HB; Result Unstructured Data: Test Result:105; Test Name: P-HIT Antibodies IgG Positive; Test Result: Positive ; Test Name: TPC; Result Unstructured Data: Test Result:29; Test Name: TPC; Result Unstructured Data: Test Result:255; Test Name: ferritin; Result Unstructured Data: Test Result:1877; Test Name: transferrin; Result Unstructured Data: Test Result:1
CDC Split Type: SEPFIZER INC2021609242

Write-up: impaired general condition; confusion; diarrhea; suspected meningioma; multi organ failure; THROMBOCYTOPENIA; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB SE-MPA-2021-041737. A 92-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Mar2021 (Batch/Lot Number: EP2166) as single dose at the age of 92-year-old for COVID-19 immunisation. Medical history included ongoing hypertension, pneumonia in Mar2021, radius fracture in 2012. The patient''s concomitant medications were not reported. The patient received bnt162b2 (COMIRNATY), dose 1 in Feb2021 (Batch/Lot Number: Ej6790) as single dose at the age of 92-year-old for COVID-19 immunisation. In Apr2021 7 weeks after 2nd vaccination, the patient experienced thrombocytopenia, impaired general condition, confusion, diarrhea, suspected meningioma and multi organ failure on Apr2021. The patient underwent lab tests and procedures which included. The patient died on an unspecified date. The outcome of the events was fatal. It was not reported if an autopsy was performed. The course of events was as follows: Reported suspect adverse event was thrombocytopenia with start date 7 weeks after vaccination with dose two. She was essentially a healthy woman with the exception of hypertension. Admitted to the hospital ward due to impaired general condition, confusion and diarrhea. TPC (platelet) 29. Also Hb (hemoglobin) 105, SR (Sedimentation rate) 42, LD (lactate dehydrogenase) 22, Ferritin 1877, Transferrin 1, Homocystein 54 and LPK (prealbumin) 3.9. The latest previous TPC value 19 days earlier was 255. CT (computed tomogram) abdomen with diffuse heterogeneous spleen, possibly artifact, was recommended by radiologist to order additional survey. CT brain with newly discovered suspected meningioma. Assessed in consultation with a haematologist as suspected haematological malignancy. Not considered treatable with regard to the patient''s age, status and suspected meningioma. Thus no further investigation. Transfers to palliative care and the patient later dies calmly and quietly. Sampling was taken before this in view of the sudden onset of thrombocytopenia and vaccination administration. The patient has not received Heparin, Fragmin or similar preparations according to the medical record. P-HIT Antibodies IgG Positive. HPF4 Antibodies IgG Negative. The reporting physician discussed the case with a hematologist consultant and coagulation consultant. In summary, this is interpreted as a primarily probable hematological malignancy. There is a low degree of suspected vaccine side effect. Cause of death stated in the report as multi organ failure. No follow-up attempts possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: Multi organ failure


VAERS ID: 1373957 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-25
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Acute myocardial infarction, Coronary artery embolism, Headache, Nausea, Troponin increased
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: DEJNJFOC20210601135

Write-up: ACUTE MYOCARDIAL INFARCTION, OF ANTERIOR WALL; EMBOLUS CORONARY ARTERY; CARDIAC TROPONIN INCREASED; ABDOMINAL PAIN UPPER; NAUSEA; HEADACHE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, DE-PEI-202100079089] concerned a 68 year old male, ethnicity unknown. 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 was not reported, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 25-MAY-2021, the patient experienced acute myocardial infarction, of anterior wall, nausea, headache, embolus coronary artery, cardiac troponin increased and abdominal pain upper. On an unspecified date, the patient died from acute myocardial infarction, of anterior wall. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of acute myocardial infarction, of anterior wall, nausea, headache, embolus coronary artery, cardiac troponin increased and abdominal pain upper on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210601135-covid-19 vaccine ad26.cov2.s- acute myocardial infarction, of anterior wall, embolus coronary artery, cardiac troponin increased, abdominal pain upper, nausea, headache. 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: ACUTE MYOCARDIAL INFARCTION, OF ANTERIOR WALL


VAERS ID: 1373959 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Metastases to peritoneum
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (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: ESMODERNATX, INC.MOD20211

Write-up: Carcinomatosis peritoneal; Dyspnoea; This regulatory authority case was reported by a physician and describes the occurrence of METASTASES TO PERITONEUM (Carcinomatosis peritoneal) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 14-Apr-2021, the patient experienced DYSPNOEA (Dyspnoea). On an unknown date, the patient experienced METASTASES TO PERITONEUM (Carcinomatosis peritoneal) (seriousness criterion death). The patient died in 2021. The reported cause of death was Peritoneal carcinomatosis. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (Dyspnoea) outcome was unknown. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on 14-Apr-2021. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-May-2021 was significant and included the event death, date of death reported as ??-???-2021, autopsy done was reported as unknown and cause of death as peritoneal carcinomatosis.; Sender''s Comments: This regulatory report case concerns a 70-year-old female patient who experienced the unexpected events of metastasis to peritoneum and dyspnoea. The patient died in 2021 and the reported cause of death was peritoneal carcinomatosis. Causality is confounded by the patient''s advanced age. Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Peritoneal carcinomatosis


VAERS ID: 1373981 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-04-01
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 626761A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: Alzheimer''s disease; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Blood test; Result Unstructured Data: inflammatory parameters indicating COVID-19, increased fibrin D dimer; Test Date: 20210413; Test Name: Chest X-ray; Result Unstructured Data: no alterations; Test Date: 20210413; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: vaccination failure; COVID-19 pneumonia; This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) and VACCINATION FAILURE (vaccination failure) in an 84-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 626761A and 626761A) for COVID-19 immunization. Concurrent medical conditions included Alzheimer''s disease and Dementia. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 09-Apr-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced VACCINATION FAILURE (vaccination failure) (seriousness criterion death). In April 2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion death). The patient died on 13-Apr-2021. The reported cause of death was COVID-19 pneumonia and Vaccination failure. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood test: abnormal (abnormal) inflammatory parameters indicating COVID-19, increased fibrin D dimer. On 13-Apr-2021, Chest X-ray: normal (normal) no alterations. On 13-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. No treatment information provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up report was received on 01-June-2021, and included lab dates and COVID pneumonia as event and COVID-19 positive as a lab test.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time; Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure


VAERS ID: 1374049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-17
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Dyspnoea, Embolism, Hypertension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MOXOGAMMA; AMLODIPINE;PERINDOPRIL
Current Illness: Allergic reaction to drug (Statins cause urticaria); Hypercholesterolaemia (Statins contraindicated - patient had urticaria when using them); Primary hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVJNJFOC20210606885

Write-up: THROMBOEMBOLISM; ACUTE MYOCARDIAL INFARCTION IN INFERIOR WALL OF LEFT VENTRICLE; HYPERTENSION; SHORTNESS OF BREATH; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, LV-SAM-2021055756] concerned an 86 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included primary hypertension, hypercholesterolaemia, and allergic reaction to drug (experienced urticaria with statins). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) 0.5 ml, 1 total, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included amlodipine/perindopril, and moxonidine. On 17-MAY-2021, the patient had thromboembolism, acute myocardial infarction in inferior wall of left ventricle, hypertension, and shortness of breath. The patient was hospitalized (dates and duration unspecified). On 19-MAY-2021, the patient died due to acute myocardial infarction, hypertension, and thromboembolism. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of acute myocardial infarction in inferior wall of left ventricle, thromboembolism and hypertension on 19-MAY-2021, and the outcome of shortness of breath was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210606885-COVID-19 VACCINE AD26.COV2.S-thromboembolism, acute myocardial infarction in inferior wall of left ventricle, shortness of breath. 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). 20210606885-COVID-19 VACCINE AD26.COV2.S-hypertension. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: ACUTE MYOCARDIAL INFARCTION; HYPERTENSION; THROMBOEMBOLISM


VAERS ID: 1374612 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: Unknown cause of death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Unknown cause of death) in an 80-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001651 and UNK) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment details were provided Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1375195 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-18
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021634808

Write-up: Aspiration; This is a spontaneous report from a contactable other healthcare professional received via the Regulatory Authority. Regulatory authority report number is 557542. A 91-year-old female patient received BNT162b2 (COMIRNATY), at unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced aspiration on 18May2021. The patient died on May2021 due to the event. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Aspiration


VAERS ID: 1375200 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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 INC2021616449

Write-up: Phlegmasia cerulea dolens; Pulmonary embolism; This is as spontaneous report from a non-contactable physician, downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100077673. An 83-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 06Apr2021 (Lot Number: EW8904), at the age of 83 years old, at 0.3 mL, single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced phlegmasia cerulea dolens and fulminant pulmonary embolism both on 08Apr2021, and both leading to death on 16Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Phlegmasia cerulea dolens; Fulminant pulmonary embolism


VAERS ID: 1375201 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021616452

Write-up: Unknown cause of death; This is as spontaneous report from a non contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100077675. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10May2021 at single dose for COVID-19 immunisation at the age of 68-year-old. Lot number was EX8679. Medical history and concomitant medications were unknown. Historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Apr2021 for COVID-19 immunisation. On 11May2021, the patient died due to an unknown cause of death. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1375202 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021616443

Write-up: Unknown cause of death; This is as spontaneous report from a non contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100077677. A 80-years-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Mar2021 (Batch/Lot Number: ER2659), age at vaccination of 80-years-old, as 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The received BNT162B2 (COMIRNATY), dose 1 on 21Feb2021 for covid-19 immunisation. The patient died on 26Mar2021;cause of death was unknown; an autopsy was not performed. Relatedness of drug to reaction(s)/event(s) Source of assessment: Regulatory Authority Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1375203 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
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 INC2021616457

Write-up: Cardiac arrhythmia NOS; Hypercalcaemia; This is a spontaneous report received from a non-contactable physician via regulatory authority (PEI) and downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100078499. A 71-year-old male patient received tozinameran (COMIRNATY, lot number EX8679) on 07May2021 (at the age of 71-year-old) as 2nd dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of COMIRNATY (lot number not reported) on 16Apr2021 (at the age of 71-year-old) for COVID-19 immunization. On unspecified date the patient experienced cardiac arrhythmia not otherwise specified (NOS) and hypercalcemia. The case was reported as serious with death criteria. Patient died on 08May2021. It was unknown if autopsy was performed. The outcome of the events was fatal. The regulatory authority (PEI) assessment of the causal relationship of the events with the suspect product COMIRNATY was reported as D. unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrhythmia (NOS); Hypercalcemia


VAERS ID: 1375208 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal ischaemia
SMQs:, Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REQUIP PROLIB; MADOPAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinsonism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021616453

Write-up: Mesenteric ischemia; This is as spontaneous report received from a contactable consumer (patient''s daughter) via regulatory authority and downloaded from a regulatory authority-WEB. The regulatory authority report number is ES-AEMPS-875732. A 73-year-old male patient received BNT162B2 (COMIRNATY, lot number unknown), via unspecified route of administration in right arm on 14May2021 as 2nd dose, single for COVID-19 immunisation. The patient''s medical history included parkinsonism. It was also reported that a family member suffered of AMR (as reported). The patient had not passed the COVID-19. The patient''s concomitant medications included ropinirole hydrochloride (REQUIP PROLIB) 8 mg and benserazide hydrochloride/levodopa (MADOPAR) 50 mg/200 mg, both from unspecified date. The patient previously received the first dose of COMIRNATY (lot number unknown), via unspecified route of administration in right arm on 23Apr2021 for COVID-19 immunisation. On unspecified date in May2021 the patient experienced mesenteric ischemia reported as serious with death criteria. The patient died on unspecified date in May2021. No autopsy was performed. It was reported that as the patient did not have a medical history in the public system, they had requested follow-up information and they were awaiting this information. They had spoken personally with the daughter and she informed them that the patient had not undergone a necropsy. The outcome of the event was fatal.; Reported Cause(s) of Death: Mesenteric ischemia


VAERS ID: 1375230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-24
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, International normalised ratio
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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: PANTOPRAZOL 1A PHARMA; RAWEL; KVENTIAX; ADIMET; MELOXEP; SYNCUMAR; GLICLADA; COVEREX KOMB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Decubitus; Gastroesophageal reflux; Hypertension; Incontinence; Multi-infarct dementia; Non-insulin-dependent diabetes mellitus; Polyarthritis; Psychosis
Allergies:
Diagnostic Lab Data: Test Date: 20210217; Test Name: INR; Result Unstructured Data: Test Result:11.1
CDC Split Type: HUPFIZER INC2021618065

Write-up: Death; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB HU-OGYI-343021. A 91-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 31Jan2021 (Batch/Lot Number: EJ6134) as 0.3 ml single dose for covid-19 immunisation. Previously the patient received the first dose of COMIRNATY, batch number: EL 1484, on 09Jan2021. Medical history included atrial fibrillation, type 2 diabetes mellitus, polyarthritis, psychosis, gastrooesophageal reflux disease, Multi-infarct dementia, incontinence, hypertension, decubitus. Concomitant medications included pantoprazole sodium sesquihydrate (PANTOPRAZOL 1A PHARMA); indapamide (RAWEL); quetiapine fumarate (KVENTIAX); metformin hydrochloride (ADIMET); meloxicam (MELOXEP); acenocoumarol (SYNCUMAR); gliclazide (GLICLADA); indapamide, perindopril erbumine (COVEREX KOMB): all taken for an unspecified indication, start and stop date were not reported. The patient experienced death on 24Feb2021. The patient underwent lab tests and procedures which included international normalised ratio: 11.1 on 17Feb2021 (her coumarin therapy was adjusted). Her condition gradually deteriorated, the patient died on 24Feb2021 at 16:30. The cause of death was attributed to the patient''s old age, autopsy was not requested. The patient died on 24Feb2021. An autopsy was not performed. Sender Comment: The 91-year-old patient died 24 days after Comirnaty vaccination. The cause of death was attributed to the patient''s old age, autopsy was not requested. The case is serious due to fatal outcome. ; Reported Cause(s) of Death: Death


VAERS ID: 1375231 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-29
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Atherosclerosis; Cardiomyopathy; COVID-19; COVID-19 pneumonia; Diabetic retinopathy; Hyperlipidaemia; Hypertension; Ischemic heart disease; NIDDM
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: Chest X-ray; Test Result: Positive ; Comments: confirmed pneumonia; Test Date: 20210329; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021618066

Write-up: COVID-19; COVID-19 pneumonia; COVID-19 PCR test positive; This is a spontaneous report received from a contactable physician via Regulatory Authority, downloaded from the regulatory authority-WEB (regulatory authority report number HU-OGYI-347021). A 77-year-old female patient received the first dose of BNT162B2 (COMIRNATY) intramuscular in the left arm on 22Mar2021 (Batch/Lot Number: ET3620) at 0.3 mL single dose for COVID-19 immunisation. Relevant medical history included angina pectoris, type 2 diabetes, hypertension, COVID-19, diabetic retinopathy, COVID-19 pneumonia, cardiomyopathy, myocardial ischaemia, hyperlipidaemia and arteriosclerosis, all from unknown dates and unknown if ongoing. The patient''s concomitant medications were not reported. On 29Mar2021, the patient experienced COVID-19, COVID-19 pneumonia and COVID-19 PCR test positive. On 29Mar2021, the patient was hospitalized because of breathing difficulties. PCR test was positive and chest X-ray confirmed COVID-19 pneumonia on 29Mar2021. The patient received COVID therapy and oxygen, but her general condition gradually deteriorated and passed away on 31Mar2021 at 7:20. The cause of death was reported as COVID-19. An autopsy was not performed. Sender Comment: The patient got infected with COVID-19 nine days after the first dose, therefore immunity may not have developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. Further information is not expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1375232 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-30
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Bedridden (And could not be mobilized.); COVID-19; Crossectomy; Hospitalization (Already hospitalized because of her dementia and general condition.); Hypertension; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021618067

Write-up: Death; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB [Regulatory Authority report number HU-OGYI-347821]. An 83-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular in arm left, on 06Apr2021 (Lot Number: EW2239; Expiration Date: 31Jul2021) as 0.3 ml single, for COVID-19 immunisation. Medical history included phlebectomy, dementia alzheimer''s type, covid-19 from Oct2020 to an unknown date, hypertension, hospitalisation from 17Sep2020 to an unknown date (already hospitalized because of her dementia and general condition), bedridden (and could not be mobilized), pneumonia from Mar2021 to an unknown date. Concomitant medications were not reported. The patient died on 30Apr2021 at 23:10. An autopsy was not performed. Sender Comment: As the patient''s general condition was already deteriorating because of her primary diseases even before vaccination, 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. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1375400 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: Dialysis; Renal failure chronic (blood dialysis at the outpatient department 3 times a week for renal failure chronic)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021597057

Write-up: Cardiac failure acute; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21108938. An 85-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EY2173; Expiration Date: 31Aug2021), via an unspecified route of administration on 24May2021 at 14:31 at a single dose for covid-19 immunisation. Medical history included ongoing renal failure chronic (blood dialysis at the outpatient department 3 times a week for renal failure chronic). The family history was not reported. The patient''s concomitant medications were not reported. On 25May2021 at 01:35, the patient experienced cardiac failure acute, which was serious for death. The clinical course was as follows: on 24May2021 at 14:31 (the day of vaccination), the patient received the first dose of BNT162b2. On 25May2021 at 01:35 (11 hours and 4 minutes after the vaccination), the patient experienced cardiac failure acute. This event was further described as: on 24May2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination while he was receiving blood dialysis at the outpatient department 3 times a week (Tuesday, Thursday, and Saturday) for chronic renal failure. On 25May2021 (one day after vaccination), at 01:35 (11 hours and 4 minutes after vaccination), it was reported that the patient had respiratory discomfort. On the same day, at 03:00 (12 hours and 29 minutes after vaccination), blood dialysis was initiated. However, the patient had respiratory arrest, and cardiopulmonary resuscitation was performed. However, at 04:02 (13 hours and 31 minutes after vaccination), the patient died. On 25May2021 (one day after the vaccination), the outcome of the event was fatal. The patient underwent lab tests and procedures which included body temperature: 36.7 degrees Centigrade on 24May2021 before vaccination. Therapeutic measures were taken as a result of cardiac failure acute. The clinical outcome of the event, cardiac failure acute, was fatal. The patient died on 25May2021 due to cardiac failure acute. It was not reported if an autopsy was performed. 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 chronic renal failure. REPORTER COMMENT: The patient died while he was receiving blood dialysis for chronic renal failure. Thus, it was considered that the event was unrelated to BNT162b2 vaccine. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of cardiac failure acute. The reported event likely represent intercurrent medical condition. As reported, the patient died while he was receiving blood dialysis for chronic renal failure. Thus, it appears that the patient''s death was associated with cardiac failure acute and history of chronic renal failure. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1375403 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Asphyxia, Body temperature, Pneumonia aspiration, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   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: PREDONINE [PREDNISOLONE]; REBAMIPIDE; SENNOSIDE [SENNOSIDE A+B CALCIUM]; MAGMITT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular disorder; Dementia; Diabetes mellitus; Heart disorder; Pemphigoid
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021603465

Write-up: Respiratory arrest; Consciousness disturbed; Vomiting; Asphyxia; Pneumonia aspiration; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21109380. An 88-year-old female patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration on 15May2021 at 14:30 at a single dose for covid-19 immunisation. Medical history included dementia, diabetes mellitus, pemphigoid, cerebrovascular disorder, and heart disorder. Family history was not reported. Concomitant medications included prednisolone (PREDONINE [PREDNISOLONE]); rebamipide (REBAMIPIDE); sennoside a+b calcium (SENNOSIDE [SENNOSIDE A+B CALCIUM]); magnesium oxide (MAGMITT). The patient previously received the first dose of the bnt162b2 for covid-19 immunization. In May2021, the patient experienced vomiting, asphyxia, and pneumonia aspiration. The patient experienced consciousness disturbed on 16May2021 at 10:00 and respiratory arrest on 17May2021 09:30. All events were serious for death. The clinical course was as follows: On 15May2021 at 14:30 (the day of vaccination), the patient received?the second dose of BNT162b2. The event was further described as follows: the patient had difficulty with verbal communication due to dementia but was capable of yes or no communication. On 16May2021, (the following morning of the vaccination), the patient ate breakfast as usual. At around 10:00, the patient suddenly had poor response and residue was suctioned from the mouth. Subsequently, consciousness disturbed continued. On 17May2021 at around 09:30, the patient had respiratory arrest. At 11:00, death was confirmed. The patient vomited a small amount; thus, it was considered asphyxia after vomiting. Clinically, pneumonia aspiration (for about 1 day) was described in death certificate. On 17May2021 at 11:00 (1 day 20 hours 30 minutes after the vaccination), the patient died. The patient underwent lab tests and procedures which included body temperature: 36.2 degrees Centigrade on 15May2021 before vaccination. Therapeutic measures were taken as a result of respiratory arrest, consciousness disturbed, vomiting, asphyxia, and pneumonia aspiration. The clinical outcome of the events was fatal. The patient died on 17May2021 due to respiratory arrest, consciousness disturbed, vomiting, asphyxia after vomiting, and pneumonia aspiration. An autopsy was not performed. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases included cerebrovascular disorder and heart disorder, but no examination was conducted. REPORTER COMMENT: Multiple cases of queasy after the vaccination have been reported; thus, it was surmised that the patient had asphyxia due to vomiting that was associated with the vaccination. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Respiratory arrest; Consciousness disturbed; Vomiting; Pneumonia aspiration; Asphyxia after vomiting


VAERS ID: 1375404 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   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: BROTIZOLAM; CARBOCISTEINE; MONTELUKAST SODIUM; ADOAIR
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021604878

Write-up: Cerebral haemorrhage left; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number is v21109403. A 75-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: FA2453; Expiration Date: 31Aug2021), via an unspecified route of administration on 24May2021 at 14:29 at a single dose for covid-19 immunisation. Medical history included ongoing asthma. The family history was not reported. Concomitant medications included brotizolam (MANUFACTURER UNKNOWN); carbocisteine (MANUFACTURER UNKNOWN); montelukast sodium (MANUFACTURER UNKNOWN); fluticasone propionate/salmeterol xinafoate (ADOAIR); "BUKUMONDO-TO". On 25May2021 at 08:00, the patient experienced cerebral haemorrhage left, which was serious for death. The clinical course was as follows: on 24May2021 at 14:29 (the day of vaccination), the patient received the first dose of BNT162b2. On 25May2021 at 08:00 (17 hours and 31 minutes after the vaccination), the patient experienced cerebral haemorrhage left. The event was further described as follows: the patient lived alone. On 24May2021 (the day of vaccination), at around 20:00 (5 hours and 31 minutes after vaccination), the final time when the patient was confirmed to be alive was when her daughter conversed on the telephone. On 25May2021, at around 16:00 (one day, one hour, and 31 minutes after vaccination), although the student, who went to the tutoring school which was run by the patient, visited the patient, no response was obtained. The parent of the student who got contacted reported to the police. The policeman found the patient collapsed at the undressing room. The postmortem phenomenon was found, and the patient was not emergently transferred. On 26May2021 (2 days after vaccination), an autopsy was performed at the hospital, and the patient was diagnosed with cerebral haemorrhage left. The patient underwent lab tests and procedures which included body temperature: 36.3 degrees Centigrade on 24May2021 before vaccination. The clinical outcome of the event was fatal. The patient died on 25May2021 due to cerebral haemorrhage left. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. REPORTER COMMENT: according to the postmortem phenomenon and the patient''s lifestyle habit which was heard by the policeman, it was assumed that the event occurred, and the patient died at around 08:00 on 25May2021 (17 hours and 31 minutes after vaccination).; Reported Cause(s) of Death: Cerebral haemorrhage left; Autopsy-determined Cause(s) of Death: Cerebral haemorrhage left


VAERS ID: 1375407 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cerebellar haemorrhage, Computerised tomogram, Fall
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: CT; Result Unstructured Data: Test Result:revealed cerebellar haemorrhage
CDC Split Type: JPPFIZER INC2021616781

Write-up: Cerebellar haemorrhage; Consciousness disturbed; Fell; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21109883. A 89-years-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 18May2021 (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 20May2021, the patient fell and had (illegible) and hyporesponsiveness. On the same day, the patient visited emergency department in a stuporous state. CT revealed cerebellar haemorrhage, for which the patient was emergently admitted to the hospital. On 20May2021 at 14:00 (2 days after the vaccination), the patient experienced cerebellar haemorrhage and consciousness disturbed. The patient was hospitalized for cerebellar haemorrhage and consciousness disturbed from 20May2021 to 21May2021. Clinical outcome of both events was fatal. Therapeutic measures were taken as a result of cerebellar haemorrhage (cerebellar haemorrhage), consciousness disturbed (altered state of consciousness), was conducted (administration of hemostatic drug, blood pressure decrease), however, on 21May2021 at 05:26, the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death and hospitalization) 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. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Cerebellar haemorrhage


VAERS ID: 1375408 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Oxygen saturation, Oxygen saturation decreased, Pneumonia aspiration, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNISOLONE
Current Illness: Polymyalgia rheumatica
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210516; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210415; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the first vaccination; Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before the second vaccination; Test Date: 20210511; Test Name: CT; Result Unstructured Data: Test Result:revealed bilateral pneumonia; Comments: revealed bilateral pneumonia, which was more predominant in the right lower lobe of the lung; these findings led to a suspicion of pneumonia aspiration; Test Date: 20210511; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 20210516; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 20210511; Test Name: Antigen test; Result Unstructured Data: Test Result:negative to SARS-CoV-2; Test Date: 20210511; Test Name: PCR test; Result Unstructured Data: Test Result:negative to SARS-CoV-2
CDC Split Type: JPPFIZER INC2021618366

Write-up: Pyrexia on the next day of the vaccination; Oxygen saturation decreased; suspicion of pneumonia aspiration; Cardio-respiratory arrest; Blood pressure decreased; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21109961. A 100-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 10May2021 at 11:00 (Lot Number: ER9480; Expiration Date: 31Jul2021) (at the age of 100-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing polymyalgia rheumatica. Concomitant medications included prednisolone oral at 3 mg taken for polymyalgia rheumatica, start and stop date were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Apr2021 (Lot Number: ER9480; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. On 11May2021 in late afternoon (1 day after the vaccination), pyrexia and oxygen saturation decreased developed; at 23:00, an ambulance was called, and the patient was admitted to the hospital. Antigen test and polymerase chain reaction (PCR) test were negative to SARS-CoV-2. Computerized tomography (CT) revealed bilateral pneumonia, which was more predominant in the right lower lobe of the lung; these findings led to a suspicion of pneumonia aspiration. Administration of an antibiotic drug was started. Blood pressure decreased was noted, and a vasopressor was used. On 16May2021 (6 days after the vaccination), the condition improved to the extent that the oxygen was reduced from 4L to 1L. However, on 16May2021 at 21:00 (6 days after the vaccination), the oxygen saturation and blood pressure decreased. At 23:30, the patient experienced cardio-respiratory arrest and died. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases was aspiration due to pyrexia. The reporting physician commented as follows: it seemed to be not a side effect of the vaccination, but the patient''s family strongly requested to report the event. The patient underwent lab tests and procedures which included blood pressure measurement: decreased on 11May2021 and decreased on 16May2021, body temperature: 36.5 centigrade on 15Apr2021 before the first vaccination and 36.7 centigrade on 10May2021 before the second vaccination, computerized tomogram (CT): revealed bilateral pneumonia, which was more predominant in the right lower lobe of the lung; these findings led to a suspicion of pneumonia aspiration on 11May2021, oxygen saturation: decreased on 11May2021 and decreased on 16May2021, SARS-COV-2 (PCR and antigen) tests: both negative on 11May2021. The outcome of cardio-respiratory arrest and pyrexia was fatal and unknown for the other events. It was unknown whether autopsy was done.; Reported Cause(s) of Death: Cardio-respiratory arrest; pyrexia


Result pages: prev   22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 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=121&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