National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

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

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

Government Disclaimer on use of this data



Case Details

This is page 157 out of 193

Result pages: prev   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 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193   next


VAERS ID: 1519203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Suspected COVID-19, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210763420

Write-up: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a representative from a concerned a 78-year-old male. Initial information was processed along with the additional information received on 30-JUL-2021 The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 in total administered on 04-JUN-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 an unspecified date, the patient deceased with COVID diagnosis (suspected covid-19 infection) one month after vaccination (suspected clinical vaccination failure). The patient was hospitalized. Number of days of hospitalization were not reported. The action taken with covid-19 vaccine was not applicable. The patient died of suspected covid-19 infection on an unspecified date in 2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210764741. Sender''s Comments: V0:20210763420 JANSSEN COVID-19 VACCINE. Suspected covid19 infection with fatal outcome. 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). V0:20210763420 JANSSEN COVID-19 VACCINE. Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID DIAGNOSIS


VAERS ID: 1519235 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   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: PHJNJFOC20210764217

Write-up: CHEST PAIN; This spontaneous report received from a health care professional via a representative concerned a 50 years above old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total administered on 28-JUL-2021 for prophylactic vaccination at half past 09.00 (09:30). The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUL-2021, the patient complained of chest pain shortly. He was given Epinephrine within 15 mins. Patient was brought to hospital where he died within 30 mins from chest pains. The action taken with covid-19 vaccine was not applicable. This report was serious (Death). Sender''s Comments: V0:20210764217-Covid-19 vaccine. Chest pain. 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: CHEST PAINS


VAERS ID: 1519432 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-05-26
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: COVID-19 infectie na vaccinatie; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 infectie na vaccinatie) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced COVID-19 (COVID-19 infectie na vaccinatie) (seriousness criteria death and hospitalization). The patient died on 25-Jun-2021. The reported cause of death was covid-19 infectie na vaccinatie. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication information was not reported. Treatment medication was not reported. Company comment: Based on biological implausibility, a causal relationship between the reported serious unexpected event COVID-19 developed 1 month 17 days after the administration of mRNA-1273 is assessed as unlikely. The event was more consistent with the increased risk of environmentally mediated COVID-19 infections (including fatal infections) due to ongoing COVID-19 pandemic. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Additional information included patient''s death details, updated laboratory data, updated dosing details and updated event details.; Sender''s Comments: Based on biological implausibility, a causal relationship between the reported serious unexpected event COVID-19 developed 1 month 17 days after the administration of mRNA-1273 is assessed as unlikely. The event was more consistent with the increased risk of environmentally mediated COVID-19 infections (including fatal infections) due to ongoing COVID-19 pandemic.; Reported Cause(s) of Death: COVID-19 infectie na vaccinatie


VAERS ID: 1519774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic asthma; Left bundle branch block
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Septic shock; This regulatory authority case was reported by a physician and describes the occurrence of SEPTIC SHOCK (Septic shock) in a 70-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Allergic asthma and Left bundle branch block in April 2019. On 02-Jun-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced SEPTIC SHOCK (Septic shock) (seriousness criteria death, hospitalization and medically significant). The patient died on 05-Jun-2021. The reported cause of death was Septic shock. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected. ; Reported Cause(s) of Death: Septic shock


VAERS ID: 1520533 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-11
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; ENALAPRIL PENSA; SIMVASTATIN; CONDROSAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100920659

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB ES-AEMPS-945848. A 56-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number- FD8274) via intramuscularly on 26Jun2021 as dose 2 single for COVID-19 immunization. Medical history was not reported. Concomitant medications included oral paracetamol at 1000 mg from 21Jan2020 to an unknown date for traumatic arthropathy, oral enalapril maleate (ENALAPRIL PENSA) at 5 mg for hypertension from 22Jan2020 to an unknown date, oral simvastatina for hyperlipidaemia at 10 mg from 17Mar2017 to an unknown date, chondroitin sulfate (CONDROSAN) at 800 mg for Traumatic arthropathy from 10Jun2016 to an unknown date. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- FA5833) via an unspecified route of administration on 05Jun2021 as dose 1 single for COVID-19 immunization. It was reported that the second dose of Comirnaty had been administered 15 days before. It was reported that on 11Jul2021, the patient without serious illnesses is found death in cardiorespiratory arrest by his wife. The patient died on 11Jul2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1520688 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   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: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: post-mortem clinical examination; Result Unstructured Data: Test Result:Nothing particular
CDC Split Type: FRPFIZER INC202100948864

Write-up: Death sudden; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PO20213715, Safety Report Unique Identifier FR-AFSSAPS-2021096363. A 54-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), dose 2 intramuscular on 01Jul2021 as 0.3 ml, single dose for covid-19 immunisation. Medical history included smoker. The patient''s concomitant medications were not reported. The patient experienced death sudden on 18Jul2021. The patient died on 18Jul2021. An autopsy was not performed. Case Summary and Reporter''s Comments: 01Jul2021: Second IM injection of Comirnaty (batch unknown). The 18Jul2021: Sudden death of the patient who is found in his bed. Nothing particular to the post-mortem clinical examination. No autopsy performed. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: 01Jul2021: Second IM injection of Comirnaty (batch unknown). The 18Jul2021: Sudden death of the patient who is found in his bed. Nothing particular to the post-mortem clinical examination. No autopsy performed.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1520797 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-06-26
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Endocarditis noninfective, Heart injury, Intracardiac thrombus, Myocarditis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Antiphospholipid syndrome; Systemic sclerosis (Clinically stable prior to the vaccination with improvement of her systemic sclerosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100922986

Write-up: Intracardiac thrombus, intra myocardial capillary thrombosis; breathless; mitral valve destruction; Nonbacterial thrombotic endocarditis; Acute myocarditis; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161405463720-Z3IZH. Safety Report Unique Identifier is GB-MHRA-ADR 25664073. A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Feb2021 as single dose for COVID-19 immunisation. The patient previously received the first dose on an unspecified date. Medical history included ongoing antiphospholipid syndrome and ongoing systemic scleroderma (clinically stable prior to the vaccination with improvement of her systemic sclerosis). She has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient''s concomitant medications included unspecified anticoagulant. The patient experienced nonbacterial thrombotic endocarditis and acute myocarditis on 26Jun2021, intracardiac thrombus and breathless on an unspecified date. Case narrative: Acute myocarditis, nonbacterial thrombotic endocarditis. This patient was a complex case. She had systemic sclerosis and antiphospholipid syndrome. She was on anticoagulants. She had been clinically stable prior to the vaccination with improvement of her systemic sclerosis. She became acutely breathless over 48 hours and was admitted but despite care in critical care unit (CCU) with inotropic support she passed away. She has subsequently had a post-mortem which was unable to exclude the vaccine as a cause for her death. The extent of her mitral valve destruction was noted as was intra myocardial capillary thrombosis. In physician''s opinion, the vaccine was a major contributory factor in her death. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unknown date. The patient died on 26Jun2021. Cause of death was nonbacterial thrombotic endocarditis. The outcome of acute myocarditis was not recovered, while outcome of other events was unknown. Case was reported as serious by health authority (resulted to death, hospitalization, and disability). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Nonbacterial thrombotic endocarditis


VAERS ID: 1521259 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Apnoea, Biopsy heart, Biopsy kidney, Biopsy liver, Biopsy lung, Cardiac arrest, Cyanosis, Death, Fatigue, Myalgia, Mydriasis, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD (Without medication); Hypercholesterolemia (Regulated with medication); Hypertension (Regulated with medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: Biopsy of heart; Result Unstructured Data: PULMONARY EMBOLISM; Comments: .; Test Date: 20210407; Test Name: Biopsy of kidney; Result Unstructured Data: PULMONARY EMBOLISM- histological part of kidney.; Test Date: 20210407; Test Name: Biopsy of liver; Result Unstructured Data: PULMONARY EMBOLISM- histological part of liver; Test Date: 20210407; Test Name: Biopsy of lung; Result Unstructured Data: PULMONARY EMBOLISM- histological part of lungs
CDC Split Type: GRMODERNATX, INC.MOD20212

Write-up: Death; Asystole; Cyanosis; Mydriasis in both eyes; Apnea; Fatigue; Pulmonary embolism; Intense muscle pain; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism), MYALGIA (Intense muscle pain), DEATH (Death), CARDIAC ARREST (Asystole), CYANOSIS (Cyanosis), MYDRIASIS (Mydriasis in both eyes), APNOEA (Apnea) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypercholesterolemia (Regulated with medication), Hypertension (Regulated with medication) and COPD (Without medication). On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant), MYALGIA (Intense muscle pain) (seriousness criteria death and medically significant) and FATIGUE (Fatigue) (seriousness criteria death and medically significant). On 05-Apr-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CARDIAC ARREST (Asystole) (seriousness criteria death and medically significant), CYANOSIS (Cyanosis) (seriousness criteria death and medically significant), MYDRIASIS (Mydriasis in both eyes) (seriousness criteria death and medically significant) and APNOEA (Apnea) (seriousness criteria death and medically significant). The patient died on 05-Apr-2021. The reported cause of death was Pulmonary embolism. An autopsy was performed. The autopsy-determined cause of death was Pulmonary embolism. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Biopsy heart: pulmonary embolism (abnormal) PULMONARY EMBOLISM. On 07-Apr-2021, Biopsy kidney: pulmonary embolism (abnormal) PULMONARY EMBOLISM- histological part of kidney.. On 07-Apr-2021, Biopsy liver: pulmonary embolism (abnormal) PULMONARY EMBOLISM- histological part of liver. On 07-Apr-2021, Biopsy lung: pulmonary embolism (abnormal) PULMONARY EMBOLISM- histological part of lungs. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. No Concomitant medication were provided by the reporter Company Comment: Very limited information regarding these events have been provided at this time. No further information is expected at this time.; Reporter''s Comments: .; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1521274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Pneumonia, Pulmonary embolism, Pulmonary infarction
SMQs:, Embolic and thrombotic events, venous (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: 2021-07-07
   Days after onset: 12
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: Asthma; Hypertension; Non-insulin-dependent diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cholelithiasis; COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT- angiography; Result Unstructured Data: Test Result:bilateral embolism of pulmonary arteries; Comments: bilateral embolism of pulmonary arteries and infarction with pneumonia. Slight cardiomegaly was detected
CDC Split Type: HUPFIZER INC202100922301

Write-up: Bilateral embolism in pulmonary arteries and pneumonia with infarcion; Bilateral embolism in pulmonary arteries and pneumonia with infarcion; Bilateral embolism in pulmonary arteries and pneumonia with infarcion; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number HU-OGYI-651121. A 54-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Jun2021 (Batch/Lot Number: Unknown) as 0.3 ml single for COVID-19 immunization. Medical history included ongoing asthma, cholelithiasis from an unknown date and unknown if ongoing, ongoing hypertension, ongoing non-insulin-dependent diabetes mellitus, COVID-19 from Mar2021 to an unknown date (not ongoing). He has not taken regularly his medicines. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 intramuscular on an unspecified date (Batch/Lot Number: Unknown) as 0.3 ml single for COVID-19 immunization. This spontaneous, serious report from a physician describes the occurrence of lung embolism after vaccination with COMIRNATY (tozinameran). The patient experienced bilateral embolism in pulmonary arteries and pneumonia with infarcion on 25Jun2021. On 21Jun2021, the 54 years old male patient received the second dose of COMIRNATY (concentrate for dispersion injection; active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine; lot number: unknown, expiry date: unknown, MAH: BioNTech Manufacturing GmbH) intramuscularly for COVID-19 immunisation. On 25Jun2021, the patient had dyspnoea and collapsed after doing physical work. The patient was reanimated and was submitted to intensive care unit. CT- angiography (in 2021) has found bilateral embolism of pulmonary arteries and infarction with pneumonia. Slight cardiomegaly was detected. Invasive ventilation was necessary and thrombolysis was started. The patient''s condition was continuously worsening. The patient died on 07Jul2021. It was not reported if an autopsy was performed. Sender Comment: Lung embolism is not expected adverse event of COMIRNATY. It might have been related to the patient''s uncontrolled cardiovascular diseases and previous COVID-19. TTO was 4 days. Based on the above, causality between the lung embolism and COMIRNATY is unlikely. The case is serious because the patient died. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Bilateral embolism in pulmonary arteries and pneumonia with infarcion; Bilateral embolism in pulmonary arteries and pneumonia with infarcion; Bilateral embolism in pulmonary arteries and pneumonia with infarcion


VAERS ID: 1521353 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HERPES ZOSTER in an 89-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 06-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HERPES ZOSTER (seriousness criterion death). The reported cause of death was Shingles. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. Treatment information was not provided. The batch number of mRNA-1273 (COVID 19 Vaccine Moderna) was unknown. The reporter did not provide causal relationship between mRNA-1273 (COVID 19 Vaccine Moderna) and the events. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the events was not applicable. This is a case of a 89-year-old female patient who developed Herpes zoster two days after receiving mRNA-1273 (lot # unknown). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history nor concomitant medications was available at this moment. Furthermore, it is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age. The translation of the source document has been requested.; Sender''s Comments: This is a case of a 89-year-old female patient who developed Herpes zoster two days after receiving mRNA-1273 (lot # unknown). The patient subsequently died. Very limited information regarding this event has been provided at this time. No information regarding the patient''s medical history nor concomitant medications was available at this moment. Furthermore, it is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age. The translation of the source document has been requested.; Reported Cause(s) of Death: Shingles


VAERS ID: 1521371 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6327 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Loss of consciousness, Peripheral swelling, Pyrexia, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 80
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XATRAL; DIBASE; BLOPRESID; COUMADIN; BRIMICA GENUAIR; DELTACORTENE; CEDRAVIS; CARVEDILOL; LASIX [FUROSEMIDE]; PRODUXEN; APIDRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma-COPD overlap syndrome; Atrial fibrillation; Diabetes mellitus; Heart valvular prosthesis wearer; Left hemicolectomy; Mixed cryoglobulinaemia; Prostate adenoma
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: ITPFIZER INC202100948930

Write-up: After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority. Report number IT-MINISAL02-759694. A 83-year-old male patient received bnt162b2 (COMIRNATY; solution for injection; Lot Number: EW6327; Expiration Date: Jul2021), dose 2 intramuscular, administered in left arm on 23Apr2021 as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included left hemicolectomy from 01Jan2004 and unknown if ongoing, mixed cryoglobulinaemia, heart valvular prosthesis wearer, asthma-COPD overlap syndrome from, diabetes mellitus, atrial fibrillation, prostatic adenoma; all from an unknown date and unknown if ongoing. Concomitant medications included alfuzosin hydrochloride (XATRAL); colecalciferol (DIBASE); candesartan cilexetil/ hydrochlorothiazide (BLOPRESID); warfarin sodium (COUMADIN; tablet; strength: 5 mg); aclidinium bromide/ formoterol fumarate (BRIMICA GENUAIR); prednisone (DELTACORTENE) orally; risedronate sodium (CEDRAVIS; coated tablet; strength: 35 mg); carvedilol orally; furosemide (LASIX [FUROSEMIDE]); dutasteride (PRODUXEN); insulin glulisine (APIDRA); all taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine includes Comirnaty dose 1 (batch number: ET7205) on 31Mar2021 in the left deltoid as dose 1, single for covid-19 immunisation. It was reported that after pfizer vaccine on the third day patient experienced severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum on 26Apr2021. Patient underwent lab test which included body temperature which was 38 centigrade. The patient died on 15Jul2021. It was unknown if an autopsy was performed. Therapeutic measures were taken as a result of events. The outcome of the events was fatal. Reporters comments: Mitral valve replaced, mild diabetes caused by drugs, vasculitis cured by cortisone weakening the bones. I breathe a little labored, sometimes help with oxygen. Regulatory authority comments: 31Mar2021 at 17:23 first dose of Comirnaty vaccine (batch ET7205) in the left deltoid. Attached is the email sent by the daughter who made the report, who was also requested the clinical documentation that will be attached as soon as we receive it. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: Mitral valve replaced, mild diabetes caused by drugs, vasculitis cured by cortisone weakening the bones. I breathe a little labored, sometimes help with oxygen.; Reported Cause(s) of Death: After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the limbs with runny serum.; After Pfizer on the third day severe abdominal pain, fever 38, severe shaking, unconsciousness, swelling of the l


VAERS ID: 1521381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood pressure decreased, Blood test, Discomfort, Dyspnoea, General physical health deterioration, Injury, Loss of consciousness, Lymphadenopathy, Mouth haemorrhage, Oedema peripheral, Peripheral swelling, Platelet count decreased, Pruritus, Pyrexia, Seizure, Sepsis, Serum sickness, Somnolence, Speech disorder, Transfusion, Tremor, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 80
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: blood test; Result Unstructured Data: Test Result:platelets decreased; Comments: a severe drop in platelets was noted from blood counts
CDC Split Type: ITPFIZER INC202100939369

Write-up: no physical recovery in hospital; severe drop in platelets; Blood transfusion bag; shortness of breath; Lymph nodes on the left arm, where the serum leaks out; arm is severely swollen; the serum comes out of the legs; hospital septicemia; lowering of blood pressure; bleeding from mouth; seizures; to relieve the patient''s soul is to give him a little morphine; swollen legs; drowsiness; wheezing; belly speech; unconsciousness with trauma; trauma; itching; fever; Abdominal pain; severe tremor; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 74904], license party for Comirnaty, A Contactable reporter for male patient of an unspecified age received bnt162b2 (Comirnaty solution for injection lot number: not reported), dose 2 via an unspecified route of administration on 23Apr2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. Patients historical vaccine included first dose of bnt162b2 (Comirnaty solution for injection lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. In an emergency, the doctors decide to give two blood transfusion bags, but the clinical picture is very well occupied, shortness of breath, lymph nodes on the left arm where the serum leaks, the arm is severely swollen and very painful, including the legs, the serum comes out. Without further immune defense, obviously hospital septicemia. Lowering blood pressure. Finally, bleeding from the mouth, inhuman seizures in the hospital bed, the only solution to relieve the patients soul is to give them a little morphine. On an unspecified date, the patient experienced no physical recovery in hospital, severe drop in platelets, blood transfusion bag, shortness of breath, lymph nodes on the left arm, where the serum leaks out, arm is severely swollen, the serum comes out of the legs, hospital septicemia, lowering of blood pressure, bleeding from mouth, and to relieve the patients soul is to give him a little morphine. On 26Apr2021, the patient experienced severe abdominal pain, fever, and severe tremor. On 27Apr2021, the patient experienced itching , unconsciousness with trauma and trauma. On an unspecified date, the patient experienced swollen legs, drowsiness, wheezing, belly speech. The patient underwent lab tests and procedures which included blood test: platelets decreased on a severe drop in platelets was noted from blood counts. The patient died on 15Jul2021 in an unrecognizable devastated body that exploded. It was not reported if an autopsy was performed. The outcome of the events abdominal pain, fever, itching, severe tremor, unconsciousness with trauma, trauma, swollen legs, drowsiness, wheezing, and belly speech was unknown. Information regarding lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1521472 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Brain stem haemorrhage, Computerised tomogram head, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210714; Test Name: Head CT; Result Unstructured Data: Test Result:pontine hemorrhage
CDC Split Type: JPPFIZER INC202100918936

Write-up: respiratory failure; Pontine haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120429. An 87-years-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EY0572; Expiration Date: 31Oct2021), dose 1 via an unspecified route of administration on 08Jul2021 as single dose for covid-19 immunisation. Medical history included hypertension, diabetes mellitus, and dyslipidaemia. The patient''s concomitant medications were not reported. The patient was an 87-year and 0-month-old male. Body temperature before vaccination was 36.3 degrees centigrade. Family history was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 14Jul2021 at an unknown time (6 days after the vaccination), the patient experienced pontine haemorrhage. On 18Jul2021 (10 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 14Jul2021, the event occurred with consciousness disturbed. The patient was diagnosed with pontine hemorrhage with a head CT. On 18Jul2021, the patient died from respiratory failure caused by pontine haemorrhage. The patient had underlying diseases such as hypertension, diabetes mellitus, and dyslipidaemia at risk of developing cerebrovascular disorders. A blood test showed no platelets decreased or abnormal coagulation ability. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were hypertension, diabetes mellitus, and dyslipidaemia. The reporting physician commented as follows: It was not clear whether COMIRNATY triggered cerebral haemorrhage, and the causal relationship between the vaccination and pontine hemorrhage was unknown. Patient died on 18Jul2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Respiratory failure caused by pontine haemorrhage; Respiratory failure caused by pontine haemorrhage


VAERS ID: 1521476 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Adrenal insufficiency, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Body temperature, C-reactive protein, C-reactive protein increased, Cardiac failure chronic, Gait disturbance, Guillain-Barre syndrome, Muscular weakness, Oxygen saturation, Oxygen saturation decreased, Pneumonia aspiration, Polymyositis, Procalcitonin, Procalcitonin increased, Pyrexia, Rhabdomyolysis, Septic shock
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (narrow), Myocardial infarction (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), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Demyelination (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: CPK; Result Unstructured Data: Test Result:hyper-CPK-emia; Test Date: 20210713; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination; Test Date: 20210718; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210719; Test Name: C-reactive protein; Test Result: 22.84 mg/dl; Test Date: 20210718; Test Name: Oxygen saturation; Test Result: 80 %; Comments: 22:00, Under Oxygen supplementation 7L/min via reservoir mask.; Test Date: 20210718; Test Name: Oxygen saturation; Test Result: 93 %; Comments: Under Oxygen supplementation 10L/min via reservoir mask.; Test Date: 20210719; Test Name: Procalcitonin; Result Unstructured Data: Test Result:50.00 ng/ml
CDC Split Type: JPPFIZER INC202100919009

Write-up: SpO2 decreased to 80%; a fever of 37.2 centigrade; adrenal hypofunction; polymyositis; Rhabdomyolysis; difficulty in walking; Weakness of both lower extremities; Guillain-Barre syndrome; septic shock; suspected pneumonia aspiration; acute kidney injury; Cardiac failure chronic; hyper-CPK-emia; CRP: 22.84 mg/dL; procalcitonin 50.00 ng/mL; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120927. A 79-years-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 13Jul2021 15:00 (Lot Number: EW0201; Expiration Date: 30Sep2021) as dose 2, single (at age of 79-years-old) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s family history was not reported. body temperature: 35.9 centigrade before vaccination on 13Jul2021. Historical Vaccine included the first dose of BNT162b2 (COMIRNATY, Lot number: FA5765, Expiration date 30Sep2021) on 22Jun2021 for covid-19 immunisation. On 14Jul2021 (1 day after the vaccination), the patient experienced rhabdomyolysis. On 19Jul2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 13Jul2021, after the second vaccination of BNT162b2, the patient experienced weakness of both lower extremities (it had not been confirmed whether the event was Guillain-Barre syndrome). On 14Jul2021, the patient had difficulty in walking. On 15Jul2021, the weakness improved. On 16Jul2021, the weakness worsened again, and the patient was admitted to a nearby hospital (rhabdomyolysis, adrenal hypofunction, and polymyositis were suspected). On 18Jul2021, the patient had a fever of 37.2 centigrade. At around 22:00, the SpO2 decreased to 80% (oxygen 7 L/min reservoir mask) and then increased to 93% (oxygen 10 L/min reservoir mask). Dopamine hydrochloride (INOVAN) at 3 microgram/kg/min was used. On 19Jul2021, the patient was transferred to the reporting hospital (septic shock, suspected pneumonia aspiration, acute kidney injury, Cardiac failure chronic, hyper-CPK-emia, CRP: 22.84 mg/dL, procalcitonin 50.00 ng/mL). At 11:10 the patient died. All events resulted in physician office visit. Outcome of the events was fatal. The patient died on 19Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and considered that the causality between the event and BNT162b2 was unassessable. The reporting physician did not mention other possible causes of the event such as any other diseases. The reporting physician commented as follows: Although the causality between the event and the vaccination was unclear, the patient died in a short period after the vaccination. Therefore, this case is reported. The patient might have developed Guillain-Barre syndrome because he had weakness of the lower extremities. However, no further examination was performed since he was transferred to the reporting hospital after the worsening of his general conditions.; Reported Cause(s) of Death: rhabdomyolysis; Weakness of both lower extremities; Guillain-Barre syndrome; difficulty in walking; adrenal hypofunction; polymyositis; a fever of 37.2 centigrade; SpO2 decreased to 80%; Septic shock; Pneumonia aspiration suspected; Acute renal failu


VAERS ID: 1521499 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Body temperature, Coma scale, Heart rate, PO2, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210713; Test Name: CS; Result Unstructured Data: Test Result:III-300; Test Date: 20210713; Test Name: pulse rate; Result Unstructured Data: Test Result:130/minute; Test Date: 20210713; Test Name: pulse rate; Result Unstructured Data: Test Result:decreased in the ambulance; Test Date: 20210713; Test Name: SpO2; Test Result: 82 %; Comments: SpO2 was 82% (10 L mask, 90%).; Test Date: 20210713; Test Name: Respiratory rate; Result Unstructured Data: Test Result:30/minute
CDC Split Type: JPPFIZER INC202100921032

Write-up: Acute respiratory failure; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative, from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution, from a same contactable pharmacist received from the Regulatory Authority. Regulatory authority report number is v21120611. A 50-year and 6-month-old female patient received the 2nd dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0203, Expiration date 30Sep2021) via intramuscular in the arm left on 04Jul2021 at 11:30 at age of 50 years old as single dose for COVID-19 immunization. Medical history included ongoing hypertension and being treated. The patient had body temperature 36.6 Centigrade before vaccination. Concomitant medications were unknown. On 13Jun2021 at 11:15, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021) intramuscular in the arm left for COVID-19 immunization. On 13Jul2021 (9 days after the vaccination), the patient experienced death. On 13Jul2021 (9 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had underlying disease of hypertension only, and her primary physician judged that the patient was able to receive BNT162b2 vaccination. On 13Jun2021, the patient received the first dose of BNT162b2 vaccination, and no side reactions were observed. On 04Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 11Jul2021 (7 days after vaccination), the patient had respiratory discomfort. On 12Jul2021 (8 days after vaccination), the patient visited a cardiovascular clinic. A Holter ECG was attached. On 13Jul2021, at 06:00 (9 days after vaccination), the patient felt difficulty in breathing while out for a walk, and she went home. The patient had loss of consciousness at her home. An ambulance was called. In the ambulance, the patient had cardio-respiratory arrest at 06:47 (9 days, 6 hours, and 47 minutes after vaccination). The patient was transferred to the reporting hospital. Although cardiopulmonary resuscitation and administration of adrenaline (EPINEPHRINE) were performed, the cardiopulmonary resuscitation was discontinued, and the patient was confirmed to die at 07:50 (9 days, 7 hours, and 50 minutes after vaccination). The causality between the event and BNT162b2 vaccination was un-assessable. The course of the event from the same contactable pharmacist was as follows: On 13Jul2021 at 06:00, the patient experienced respiratory failure acute. The additional clinical course of the event was as follows: On 12Jul2021 (7 days after vaccination), the patient visited the cardiovascular specialist clinic (nothing was pointed out). A Holter ECG was attached. The patient was to visit the clinic next week. On 13Jul2021, at 6:00 (8 days after vaccination), the patient had respiratory discomfort while out for a walk. The patient had loss of consciousness for several seconds at her home, and she was emergently transferred. When the ambulance service arrived, the patient had tachycardia (130/minute) and tachypnoea (30/minute), and the SpO2 was 82% (10 L mask, 90%). The pulse rate decreased in the ambulance. At 06:47 (8 days, 19 hours, and 17 minutes after vaccination), the patient had cardio-pulmonary arrest. At 06:55 (8 days, 19 hours, and 25 minutes after vaccination), the patient arrived at the emergency outpatient department of the reporting hospital. At the time of arrival, the consciousness level was III-300. The patient had respiratory arrest. Cardiopulmonary resuscitation was initiated, adrenaline (BOSMIN INJECTION) and atropine sulfate hydrate (ATROPINE SULFATE) were administered; however, no response was obtained. At 07:45 (8 days, 20 hours, and 15 minutes after vaccination), the patient''s death was pronounced to the husband. Approval for the completion of cardiopulmonary resuscitation was obtained. At 07:50 (8 days, 20 hours, and 30 minutes after vaccination), it was confirmed that vital reactions such as light reflex disappeared, and cardiopulmonary resuscitation was terminated. 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: Since one week had passed from the vaccination to the onset of the event, it was considered unlikely that the event was related to BNT162b2 vaccination. Under this situation, it was impossible to judge the presence or absence of the causality. The physician reported that the patient''s cause of death was reported as acute respiratory failure. Autopsy was not performed.; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1521517 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-07-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Body temperature, Cardio-respiratory arrest, Cerebral haemorrhage, Chronic kidney disease, Coma scale, Computerised tomogram, Echocardiogram, Incontinence, Magnetic resonance imaging, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Blind left eye; Carotid endarterectomy; Cerebral infarction; Chronic kidney disease; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210709; Test Name: CS; Result Unstructured Data: Test Result:10; Comments; Test Date: 20210709; Test Name: CT; Result Unstructured Data: Test Result:Cerebral haemorrhage; Test Date: 20210709; Test Name: CT; Result Unstructured Data: Test Result:No increased haemorrhage; Test Date: 20210709; Test Name: echocardiography; Result Unstructured Data: Test Result:EF 61 %; Comments: Left ventricular ejection fraction 61%; Test Date: 20210709; Test Name: MRI; Result Unstructured Data: Test Result:cerebral haemorrhage
CDC Split Type: JPPFIZER INC202100923738

Write-up: generalised convulsion; cardiopulmonary arrest; CKD aggravated; Cerebral haemorrhage; incontinence; aphasia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120564. A 72-year and 6-month-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration on 20Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had past medical history of cerebral infarction in 2008, left carotid endarterectomy (CEA) in 2016, chronic kidney disease (CKD), diabetes mellitus (DM), angina pectoris (no assessment of coronary artery was performed because of CKD), blind left eye and hypertension. Concomitant medication included oral warfarin and no anti platelet agents was administered. Body temperature before vaccination was 36.3 degrees Centigrade on 20Jun2021. On 09Jul2021 (also reported as uncertain) (19 days after the vaccination), the patient experienced cerebral haemorrhage. On 09Jul2021 (same day of the vaccination), the patient was admitted to the hospital. On 11Jul2021 (21 days after the vaccination), the outcome of the event was Fatal. The course of the event was as follows: On 09Jul2021 (19 days after the vaccination), in the morning, the patient did not get up. When his wife tried to wake him up, the patient did not speak, and he had incontinence. The patient was urgently transported to the hospital by ambulance. Computerised tomogram (CT) and magnetic resonance imaging revealed cerebral haemorrhage, so the patient was admitted to the reporting hospital. The patient was under the following condition; coma scale, 10; 3/5 of right upper and lower limbs; and presence of aphasia motor possible to respond to command. On the same day (09Jul2021, 19 days after the vaccination), CT was performed again, without showing increased haemorrhage. Ejection fraction (EF) was 61% on echocardiography. On 10Jul2021 (20 days after the vaccination), CKD was aggravated. At 22:05, the patient had generalised convulsion, and went into cardiopulmonary arrest (CPA), for which cardiac massage was started. After that, bradycardia and cardiac arrest were repeated but no improvement was noted. On 11Jul2021 (21 days after the vaccination) at 0:05, after informed consent was obtained from his family, the patient was confirmed dead. The reporting physician classified the event as serious (Hospitalized) and assessed that the event was unrelated to BNT162b2. Other possible causes of the event such as any other diseases were cerebral infarction, CKD, DM, angina pectoris, hypertension, and administration of warfarin. The reporting physician commented as follows: It was thought that there was no causal relationship between BNT162b2 and the event, but this report was made based on strong request of the bereaved family.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Cerebral Haemorrhage, incontinence, Aphasia, Chronic kidney disease, Seizure and Cardo-Respiratory arrest and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: Cerebral haemorrhage


VAERS ID: 1521519 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-01-26
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Atrial flutter, Body temperature, Computerised tomogram, Multiple organ dysfunction syndrome, Thrombosis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 150
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: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:suspected thrombosis
CDC Split Type: JPPFIZER INC202100923752

Write-up: Multi-organ failure due to thrombosis; Multi-organ failure due to thrombosis; Atrial flutter; consciousness disturbed; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120933. A 92-year and 5-month-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) via an unspecified route of administration on 24Jun2021 at an unknown time as DOSE 2, SINGLE for covid-19 immunisation. Family history, 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). Body temperature before vaccination was 36.4 degrees centigrade on 24Jun2021. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# was not reported, Expiration date was not reported). On 26Jun2021 at 16:00 (2 days after the vaccination), the patient experienced multi-organ failure due to thrombosis. On 26Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26Jun2021, the patient was transported by ambulance due to consciousness disturbed, and he had atrial flutter. Resuscitation was performed; however, the symptoms did not improve, and the patient died. A CT after the death revealed findings of suspected thrombosis. The reporting physician classified the event as serious (death) and assessed the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Multi-organ failure due to thrombosis was considered to be the cause of death.; Reported Cause(s) of Death: Atrial flutter; Multi-organ failure due to thrombosis; Multi-organ failure due to thrombosis


VAERS ID: 1521529 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Blood pressure measurement, Blood test, Body temperature, Computerised tomogram, Culture urine, Disseminated intravascular coagulation, Hepatic necrosis, Intestinal ischaemia, Myocardial infarction, Pyelonephritis acute, Renal function test, Renal graft infection, Septic shock, Splenic infection, Urinary tract infection, Urine analysis
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Toxic-septic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Ischaemic colitis (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: 2021-06-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunosuppressant drug therapy
Preexisting Conditions: Medical History/Concurrent Conditions: Living donor renal transplant
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: blood culture; Result Unstructured Data: Test Result:gram-positive coccus was detected; Comments: gram-positive coccus was detected on the blood culture and the urine culture (later, it was revealed as methicillin-resistant Staphylococcus aureus [MRSA]); Test Date: 20210627; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210623; Test Name: blood examination; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210627; Test Name: blood examination; Result Unstructured Data: Test Result:significant inflammatory reaction; Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:39s Centigrade; Comments: pyrexia of 39s degrees Celsius; Test Date: 20210627; Test Name: CT; Result Unstructured Data: Test Result:no obvious cause of fever; Test Date: 20210628; Test Name: urine culture; Result Unstructured Data: Test Result:gram-positive coccus was detected; Comments: gram-positive coccus was detected on the blood culture and the urine culture (later, it was revealed as methicillin-resistant Staphylococcus aureus [MRSA]); Test Date: 20210627; Test Name: renal function; Result Unstructured Data: Test Result:aggravation; Test Date: 20210623; Test Name: urine examinations; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210627; Test Name: urine examinations; Result Unstructured Data: Test Result:pyuria and bacteriuria
CDC Split Type: JPPFIZER INC202100923793

Write-up: Septic shock; urinary tract infection (pyelonephritis acute); urinary tract infection (pyelonephritis acute); haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion; map-like macula was observed in the liver, and necrosis was suspected; intestinal ischaemia; infectious spleen; myocardial infarction suspected; disseminated intravascular coagulation; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120430. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 24Jun2021 at 74-year-old (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included renal transplant, ongoing immunosuppressant drug therapy. The patient was a 74-year-old (at vaccination) male. Since the patient was after living donor renal transplant, he was receiving immunosuppressant drug therapy. She had concomitant Therapy. The patient experienced septic shock on 27Jun2021 with fatal outcome, urinary tract infection (pyelonephritis acute) on 25Jun2021 with fatal outcome, disseminated intravascular coagulation on 27Jun2021 with outcome of unknown, haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion , map-like macula was observed in the liver, and necrosis was suspected, intestinal ischaemia, infectious spleen, and myocardial infarction suspected, all on unknown date with unknown outcome. The patient was hospitalized for septic shock, urinary tract infection (pyelonephritis acute) from 27Jun2021 to an unknown date. The patient died on 29Jun2021. Treatment received for all events. On 24Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2. On 25Jun2021 (1 day after the vaccination), the patient experienced urinary tract infection (pyelonephritis acute). On 27Jun2021 (3 days after the vaccination), the patient experienced septic shock and was admitted to the hospital. On 29Jun2021 (5 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: On 23Jun2021, when the patient was usually examined at the outpatient department, the blood and urine examinations showed no abnormalities. On 24Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 25Jun2021 (one day after vaccination), the patient had pyrexia of 39s degrees Celsius. On 27Jun2021 (3 days after vaccination), since the pyrexia persisted, the patient visited the reporting hospital. Diarrhoea and vomiting were noted as other symptoms. The blood examination showed significant inflammatory reaction. Since aggravation of renal function was observed, and pyuria and bacteriuria were noted, the patient was diagnosed with urinary tract infection (pyelonephritis acute). CT showed no obvious cause of fever. The patient was admitted to the hospital, and a drip infusion of an antibiotic and fluid replacement was performed; however, blood pressure decreased was noted. It was considered that the patient had septic shock, which required catecholamine support. The patient also had disseminated intravascular coagulation (DIC). On 28Jun2021 (4 days after vaccination), gram-positive coccus was detected on the blood culture and the urine culture (later, it was revealed as methicillin-resistant Staphylococcus aureus [MRSA]), and an antibiotic was added; however, the condition was aggravated. The patient was admitted to the cardiac care unit (CCU), and tracheal intubation was performed, and hemodialysis therapy was initiated. However, the condition did not improve. On 29Jun2021 (5 days after vaccination), the patient was confirmed to die. A pathologic autopsy (macroscopic) showed haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion. In addition, map-like macula was observed in the liver, and necrosis was suspected, and intestinal ischaemia was also noted. In addition, infectious spleen and myocardial infarction suspected were also noted. The reporting physician classified the septic shock 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 pyelonephritis acute. The reporting physician commented as follows: It was considered that the cause of death was septic shock, and cause of septic shock was pyelonephritis acute. It was impossible to judge whether the vaccination was involved or not; however, the timing of the event was immediately after the vaccination, and thus, this case was reported. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Septic shock; urinary tract infection (pyelonephritis acute); urinary tract infection (pyelonephritis acute); Autopsy-determined Cause(s) of Death: intestinal ischaemia; infectious spleen; myocardial infarction suspected; haemorrhage and white shadows on the transplanted kidney, and infection was suspected, which was considered as primary lesion; map-like macula was observed in the liver, and ne


VAERS ID: 1521542 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100923871

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. An 86-year-old female patient (non-pregnant) received bnt162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021) intramuscular, administered in Arm Left on 25Jun2021 09:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, and dyslipidaemia. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications (drugs name unspecified) within 2 weeks of vaccination. On 04Jun2021 at 9:00, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA7338, Expiration date 30Sep2021) via intramuscular route of administration in the arm left for COVID-19 immunization. On unknown date in Jul2021, the patient died. The cause of death was unknown. An autopsy was performed that revealed unknown cause of death. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19. The reported event was as follows: On 04Jun2021 at 09:00, the patient received the first dose of BNT162b2 vaccination. On 25Jun2021 at 09:00 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 17Jul2021 (22 days after the 2nd dose of vaccination), the patient was confirmed dead in a rotten condition at her home. According to an autopsy result which was performed by the police, it was considered that one week or longer had passed since the patient had died; however, the decomposition was severe, and the cause of death was unknown.; Sender''s Comments: Based on the limited information given, a causal association between the event "death" and bnt162b2 (COMIRNATY) cannot be completely excluded. The case will be reassessed once more 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: Unknown cause of death; Autopsy-determined Cause(s) of Death: Unknown cause of death


VAERS ID: 1521820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Malaise, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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: ATORVASTATIN; AERIUS [DESLORATADINE]; CLOPIDOGREL; GIONA; BETAPRED; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; CREON; ALVEDON; BRICANYL; FLUCONAZOLE; CITODON [CODEINE PHOSPHATE HEMIHYDRATE;PARACETAMOL]; JEXT; LOSARSTAD
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Amaurosis fugax; Angioedema; Cerebrovascular accident NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100920830

Write-up: Shortness of breath; coughing during the week; Feeling unwell; Sudden cardiac death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-054978. A 67-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EX8680, Expiry date: unknown), via an unspecified route of administration on unspecified date in May2021 as dose 1, single for covid-19 immunization. Medical history included hypertension, amaurosis fugax, cerebral insult and angioedema of wasp sting. Concomitant medications included atorvastatin at 40 mg, once a day, desloratadine (AERIUS (DESLORATADINE)) as needed, clopidogrel at 75 mg, once a day, budesonide (GIONA), betamethasone sodium phosphate (BETAPRED) as needed, esomeprazole magnesium trihydrate (NEXIUM (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)) as needed, pancreatin (CREON) as needed, paracetamol (ALVEDON) as needed, terbutaline sulfate (BRICANYL) as needed, fluconazole, codeine phosphate hemihydrate, paracetamol (CITODON) as needed, epinephrine bitartrate (JEXT) as needed, losartan potassium (LOSARSTAD, Film-coated tablet) at 100 mg, once a day. On an unspecified date one week after receiving the vaccine the patient had been feeling unwell with shortness of breath and coughing during the week as per her medical records, then the patient was found lying supine in the garden, CPR was started and ambulance was called, on arrival they took over, about 45 minutes later the resuscitation attempts were terminated, the ECG (Echocardiogram) showed no electrical activity during CPR and the patient''s skin already had blue mottled skin on her face and lower body parts at the start of CPR. There were also no corneal reactions, no breathing and no cardiac activity. The patient probably died three to five hours earlier in an unspecified date in May2021. The reporter assessed case as serious, fatal. The outcome of events was fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information about batch number has been obtained. ; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1521829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / 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: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; CARVEDILOL; ALFACALCIDOL; FUROSEMIDE; IMDUR; ESOMEPRAZOLE; CANDESARTAN; FELODIPINE
Current Illness: Aortic dissection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100916021

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-061025. A 53-year-old male patient (also reported as 62-years-old, pending clarification) received BNT162B2 (COMIRNATY), intramuscular on Jun2021 (Batch/Lot Number: FD6840) as dose 2, 0.3ml single for COVID-19 immunisation. Medical history included ongoing chronic aortic dissection. Concomitant medications included allopurinol; carvedilol; alfacalcidol; furosemide; isosorbide mononitrate (IMDUR); esomeprazole; candesartan and felodipine, all taken for an unspecified indications, start and stop dates were not reported. Historical vaccine included BNT162B2 (COMIRNATY), intramuscular on May2021 (Batch/Lot Number: FD6840) as dose 1, single for COVID-19 immunisation. The reported side effect was sudden death in Jul2021, 15 days after the introduction of Comirnaty. The person was found dead by a neighbor. The police were called in for a forensic autopsy due to a medical measure within 4 weeks. The case was considered serious, death. An autopsy was performed, and results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death, cause unknown


VAERS ID: 1521868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: TNPFIZER INC202100927573

Write-up: I just lost my dad to covid despite having the first and second dose vaccinated.; I just lost my dad to covid despite having the first and second dose vaccinated.; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that, just lost their dad to covid despite having the first and second dose vaccinated and also stated if the vaccine doesn''t protect them, then what are all these vaccine companies for. It was very shocked that it happened to his/her father. They stated they kept all their trust in our laboratory but finally they lost their father. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: covid


VAERS ID: 1522402 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210764863

Write-up: DEATH; This spontaneous report received from a consumer via social media concerned multiple patients. The patient''s weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, it was reported that in the middle age group people (healthy, active group people), there were no problem after vaccination but death (unknown cause of death) was recorded. 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). This case, from the same reporter is linked to 20210764876, 20210764838, 20210764866, 20210764885 and 20210764857.; Sender''s Comments: 20210764863-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1522498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-05
Submitted: 0000-00-00
Entered: 2021-08-03
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: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100924262

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 584822. An 85-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection, Lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 05Jul2021, the patient had adverse event following immunization with fatal outcome. 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: Adverse event following immunisation


VAERS ID: 1522499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-03
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: 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 INC202100924284

Write-up: adverse event following immunization with fatal outcome; This is a spontaneous report from a contactable health care professional via the Regulatory Authority. Regulatory authority report number is 584827. A 65-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced adverse event following immunization with fatal outcome on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: adverse event following immunization with fatal outcome


VAERS ID: 1522500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-06
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation, Myalgia, Presyncope
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100924285

Write-up: Adverse event following immunisation; Myalgia; Presyncope; Adverse event following immunisation; Myalgia; Presyncope; Adverse event following immunisation; Myalgia; Presyncope; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 584829. A 49-year-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced adverse event following immunization, myalgia and presyncope, all on 06Jul2021. 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; Myalgia; Presyncope


VAERS ID: 1522501 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-03
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Concomitant disease aggravated, Pneumonia
SMQs:, Guillain-Barre syndrome (broad), 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: 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 INC202100924287

Write-up: asthenia; concomitant disease aggravated; pneumonia; asthenia; concomitant disease aggravated; pneumonia; asthenia; concomitant disease aggravated; pneumonia; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 585806. A 90-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on an unspecified date (batch/lot number and expiry date unknown) as dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 03Jul2021, the patient experienced asthenia; concomitant disease aggravated; pneumonia. The patient died on an unspecified date due to the events. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: asthenia; concomitant disease aggravated; pneumonia; asthenia; concomitant disease aggravated; pneumonia; asthenia; concomitant disease aggravated; pneumonia


VAERS ID: 1522593 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-13
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Cardiogenic shock, Myocardial fibrosis, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 21
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: Aldactone; ATENURIX; DIALVIT; Nexium; ROCALTROL; ARANESP; FERINJECT; FRAGMIN; VITAMIN B12 NOS; FRAGMIN
Current Illness: D-hypervitaminosis (Vitamin D)); Dialysis; Gastrooesophageal reflux; Gout; Hyperuricaemia; Renal necrosis NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Myocardial fibrosis; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS, CARDIAC ARREST, CARDIOGENIC SHOCK and MYOCARDIAL FIBROSIS (Myocardial fibrosis) in a 67-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Renal necrosis NOS, Dialysis, Gastrooesophageal reflux, Hyperuricaemia, Gout and D-hypervitaminosis (Vitamin D)). Concomitant products included Spironolactone (Aldactone), FEBUXOSTAT (ATENURIX), ASCORBIC ACID, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE MONONITRATE (DIALVIT), Esomeprazole magnesium (Nexium), CALCITRIOL (ROCALTROL), DARBEPOETIN ALFA (ARANESP), FERRIC CARBOXYMALTOSE (FERINJECT), DALTEPARIN SODIUM (FRAGMIN), VITAMIN B12 NOS and DALTEPARIN SODIUM (FRAGMIN) for an unknown indication. On 17-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 100 microgram. On 13-Apr-2021, the patient experienced MYOCARDITIS (seriousness criteria death, hospitalization, medically significant and life threatening) and CARDIAC ARREST (seriousness criteria death, hospitalization, medically significant and life threatening). In May 2021, the patient experienced CARDIOGENIC SHOCK (seriousness criteria death, hospitalization, medically significant and life threatening). On an unknown date, the patient experienced MYOCARDIAL FIBROSIS (Myocardial fibrosis) (seriousness criterion death). The patient died on 04-May-2021. The reported cause of death was Cardiogenic shock. An autopsy was performed. The autopsy-determined cause of death was Myocarditis and Myocardial fibrosis. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDITIS, CARDIAC ARREST and CARDIOGENIC SHOCK to be possibly related. No further causality assessment was provided for MYOCARDIAL FIBROSIS (Myocardial fibrosis). Company Comment: Very limited information regarding this events has been provided at this time.; Reporter''s Comments: Covid-19 Vaccine Moderna? mRNA Covid-19; Senders Comments: Very limited information regarding this events has been provided at this time.; Reported Cause(s) of Death: Cardiogenic shock; Autopsy-determined Cause(s) of Death: Myocarditis; Myocardial fibrosis


VAERS ID: 1522606 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-06-10
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30380777700688 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   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:
Current Illness: Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Respiratorische Verschlechterung; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Respiratorische Verschlechterung) in a 92-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 30380777700688 and 3001942) for COVID-19 vaccination. The patient''s past medical history included Acute renal failure and Dementia. Concurrent medical conditions included Arterial hypertension. On 04-May-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. Death occurred on 10-Jun-2021 The patient died on 10-Jun-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Respiratorische Verschlechterung) to be unlikely related. Concomitant and treatment medications were not reported Company comments:Although a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the event, it was considered unlikely per the treating physician.; Sender''s Comments: Although a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the event, it was considered unlikely per the treating physician.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1522610 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, C-reactive protein, Cardiac arrest, Echocardiogram, Electrocardiogram
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), 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: 2021-05-05
   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: ASPIRIN CARDIO; BILOL; LISITRIL COMP.; CRESTOR
Current Illness: Arterial hypertension; Chronic renal insufficiency; Chronic venous insufficiency; Coronary disease; Dyslipidemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: C-reactive protein; Result Unstructured Data: high; Test Date: 202104; Test Name: Echocardiography; Result Unstructured Data; Test Date: 202104; Test Name: Electrocardiogram; Result Unstructured Data:.
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Cardiac arrest; Atrial fibrillation; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest) and ATRIAL FIBRILLATION (Atrial fibrillation) in an 83-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Coronary disease, Arterial hypertension, Dyslipidemia, Chronic renal insufficiency and Chronic venous insufficiency. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISITRIL COMP) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 22-Apr-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 27-Apr-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria death and medically significant). On 05-May-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The patient died on 05-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, C-reactive protein: 32mg/l (High) high. In April 2021, Echocardiogram: abnormal (abnormal). In April 2021, Electrocardiogram: abnormal (abnormal). For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered CARDIAC ARREST (Cardiac arrest) and ATRIAL FIBRILLATION (Atrial fibrillation) to be unlikely related. No treatment information was provided. Company Comment: Very limited information regarding these events has been provided at this time. However, multiple underlying co-morbidities may remain as confounding factors. No follow up is possible.; Sender''s Comments: Very limited information regarding these events has been provided at this time. However, multiple underlying co-morbidities may remain as confounding factors.No follow up is possible.; Reported Cause(s) of Death: Unknown


VAERS ID: 1523535 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Platelet factor 4, Pulmonary embolism, 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), Embolic and thrombotic events, venous (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: 2021-07-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Name: antiPF4 antibodies; Test Result: Negative
CDC Split Type: ESPFIZER INC202100920846

Write-up: Cardio-respiratory arrest; Pulmonary thromboembolism; Several vomiting episodes; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-944658. A 48-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection; lot number FE3065; strength: 0.3mL), intramuscularly on 07Jul2021 (at the age of 48-year-old) as single dose for COVID-19 immunization. Medical history of the patient included migraine and no other notable history. Patient previously received first dose of bnt162b2 (COMIRNATY, solution for injection; lot number FC3098) on 15Jun2021 (at the age of 48-year-old) as single dose for COVID-19 immunization. On 07Jul2021 at night after second dose of vaccination, patient experienced several vomiting episodes. On 08Jul2021 when she woke up, her husband found her unconscious, and later realized that she was in respiratory arrest and requested a clinical necropsy, pending the result. The COVID 19 disease has not passed. Patient went to the hospital emergency room on 08Jun2021, transferred by the Emergency Medical Service in cardiorespiratory arrest, which she did not recover after 120 minutes, resulted in death. In the autopsy study, a hemorrhagic area was identified that occupies a large part of the lower lobe of the right lung, compatible with a pulmonary infarction of a few days of evolution secondary to pulmonary thromboembolism. On the other hand, possible causes of sudden death such as acute myocardial infarction, aortic dissection or acute intracranial bleeding have been ruled out. Cerebrospinal fluid study was pending to rule out a neuroinfectious process. The cause of death can be provisionally attributed to a pulmonary infarction. During the necropsy, serum was extracted and analyzed for antiPF4 antibodies result was negative. There was no analytical while the patient was alive. Analysis of fluid cytology and histopathology is pending. The outcome of event vomiting was unknown. No follow-up attempts possible. No further information expected. Information about batch number has been obtained.; Reported Cause(s) of Death: Cardiorespiratory arrest; Autopsy-determined Cause(s) of Death: Pulmonary infarction


VAERS ID: 1523641 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-07-11
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E56788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100973154

Write-up: Occurrence of COVID with patients death; Occurrence of COVID with patients death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20215662. An elderly male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Batch/Lot Number: E56788, Expiration date not reported) via intramuscular route of administration in an unspecified anatomical location on 22Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that occurrence of covid with patient''s death on 11Jul2021. The patient died on an unspecified date in Jul2021. It was reported as not specified whether the patient was tested. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Covid 19


VAERS ID: 1523642 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Diarrhoea, Influenza like illness, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; ROSUVASTATIN; ANORO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dyslipidemia; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021140049

Write-up: COVID-19 aggravated; Diarrhea; Influenza like illness; Nausea; fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20210263. An 85-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EK9788), intramuscular on 29Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included dyslipidaemia, Iatrogenic hypothyroidism and chronic obstructive pulmonary disease (COPD). Concomitant medications included levothyroxine sodium (LEVOTHYROX), rosuvastatin, umeclidinium bromide/vilanterol trifenatate (ANORO). On 31Jan2021, the patient experienced diarrhea, influenza like illness, nausea. The patient experienced covid-19 aggravated on 06Feb2021. The patient died on 17Feb2021. It was not reported if an autopsy was performed. On 29Jan2021, the patient received 1st vaccination of COMIRNATY. On 31Jan2021, the patient experienced fever, body aches, nausea and diarrhea. No local effect. Then a call to SOS doctor was done, which resulted in a prescription of paracetamol (manuafcturer unknown), metoclopramide hydrochloride (PRIMPERAN) and phloroglucinol, trimethylphloroglucinol (SPASFON). At the time of the report, the patient was not recovered from events stated above (fever, body aches, nausea and diarrhea). On 06Feb2021, the patient was hospitalized for worsening of symptoms. At the hospital, covid-19 was diagnosed to the patient. Despite the care given, fatal evolution on 17Feb2021. No variant search performed. Medical opinions diverged: some said the vaccine caused it all, some others said that the contamination dated from before the vaccination. In total, patient developed covid-19 in the days following his 1st vaccination. Doubt about an exacerbation of covid-19 by the vaccine. No follow-up attempts are possible. No further information is expected. Follow-up (27Jul2021): This is a follow-up report downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20210263. New information includes: suspect vaccine details, medical history, concomitant medications, new events (fever, body aches), event details. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 aggravated; Influenza like illness; Diarrhea; Nausea; fever; body aches


VAERS ID: 1523766 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003610 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Infarct myocardial; Osteoporosis; Parkinsonism hyperpyrexia syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in an 86-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003610) for COVID-19 vaccination. The patient''s past medical history included Parkinsonism hyperpyrexia syndrome, Infarct myocardial in 2014, Hypercholesterolaemia and Osteoporosis. On 21-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 22-Jul-2021 The patient died on 22-Jul-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. No concomitant medication reported. No Treatment medication reported. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-SE20211893. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Reported Cause(s) of Death.


VAERS ID: 1523801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood test, Chest X-ray, Dyspnoea, Hyperkalaemia, Pneumonia, Pulmonary oedema
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
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: CAPASAL; TAMSULOSIN; WARFARIN; SERTRALINE; BISOPROLOL; PREGABALIN; LACTULOSE; FINASTERIDE; ALOGLIPTIN; RITUXIMAB; RAMIPRIL; PARACETAMOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CABG; Pain; Thoracic outlet surgery
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:renal function was reduced; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pulmonary oedema; Test Date: 20201214; Test Name: Chest X-ray; Result Unstructured Data: Test Result:cardiomediastinal and hilar contours showed no; Comments: interval features, background of previous CABG and thoracic surgery noted. A new airspace opacification seen in the right mid zone has almost completely resolved when compared with the previous imaging. No new acute pulmonary features identified, very subtle inflammatory change persisting; Test Date: 20210106; Test Name: Chest X-ray; Result Unstructured Data: Test Result:1
CDC Split Type: GBPFIZER INC202100956788

Write-up: Pneumonia; Acute kidney injury; Hyperkalaemia; Pulmonary oedema; short of breath; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25641800, Safety Report Unique Identifier is GB-MHRA-ADR 25641800. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0141; Expiration Date: 11Jan2021) via intramuscular at single dose on 08Jan2021 for COVID-19 immunisation. Medical history included CABG, thoracic surgery, pain. 1 PA chest on 14Dec2020 compared with the previous imaging: cardiomediastinal and hilar contours showed no interval features, background of previous CABG and thoracic surgery noted. A new airspace opacification seen in the right mid zone has almost completely resolved when compared with the previous imaging. No new acute pulmonary features identified, very subtle inflammatory change persisting, followup chest x-ray in additional 6 weeks was advised to ensure complete resolution. Stable bony review. Concomitant medications included coal tar/cocos nucifera oil/salicylic acid (CAPASAL) from 01May2020; tamsulosin from 08Dec2020; warfarin from 16Nov2020; sertraline from 29Dec2020; bisoprolol; pregabalin from 31Dec2020; lactulose from 07Jun2019; finasteride from 31Dec2020; alogliptin from 16Nov2020; rituximab from 03Dec2020; ramipril from 31Dec2020; paracetamol for pain from 03Nov2020; sertraline from 31Dec2020. The patient experienced pneumonia, acute kidney injury, hyperkalaemia, pulmonary oedema and short of breath on an unspecified date. Patient was admitted on 11Jan2021 after patient was unable to get himself out of bed and had to lower himself to the floor. Pressed his care on call wrist buzzer and was attended to by paramedics. On admission it was noted that patient was more short of breath. Investigated with chest x-rays, blood tests and diagnosed with community acquired pneumonia. Patient was treated with oral antibiotics, intravenous fluids and oxygen therapy. It was noted on routine blood tests that renal function was reduced and diagnosed with an acute kidney injury and hyperkalaemia. For the hyperkalaemia, patient received intravenous fluids, calcium gluconate, sodium bicarbonate, insulin/dextrose infusions and salbutamol nebulisers. Despite appropriate medical therapy, patient continued to require increasing amounts of oxygen to maintain target saturations. It was also noted on 14Jan2021 that his renal function and inflammatory markers were worsening (although his hyperkalaemia improved). Due to this worsening of his clinical state, patient was catheterised and his antibiotics were escalated to intravenous antibiotics. Repeat chest x-rays noted that there was pulmonary oedema and patient was diuresed with intravenous furosemide. Patient continued to deteriorate and on 15Jan21 it was felt that he was approaching the end of his life and was placed on the end of life pathway. Patient subsequently died on 17Jan2021. Referral to Coroner No. An autopsy was not performed. The patient underwent lab tests and procedures which included blood test showed renal function was reduced; Chest X-ray was 1 on 06Jan2021. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute kidney injury; Pneumonia; Hyperkalaemia; Pulmonary oedema; short of breath


VAERS ID: 1523802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Cheyne-Stokes respiration, Dysarthria, Heart rate, Hemiparesis, Hypophagia, Transient ischaemic attack
SMQs:, Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   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: CONOTRANE [BENZALKONIUM CHLORIDE;DIMETICONE]; TIMOLOL MALEATE; MIRTAZAPINE; COLECALCIFEROL; DOCUSATE; SENNA ACUTIFOLIA; OMEPRAZOLE; LEVOTHYROXINE SODIUM; HYPROMELLOSE; PARACETAMOL; PROCHLORPERAZINE
Current Illness: Acquired hypothyroidism; Glaucoma; Hypertensive; Lipid metabolism disorder; Ocular hypertension; Osteoporosis; Pain in calf; Vitamin B12 deficiency; Vitamin D deficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Angina unstable; Constipation; Depressive disorder; Dry eye; DVT; Fragility fracture; Frailty; Incontinence; Penicillin allergy (Adverse reaction to penicillins); Radius fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/90; Test Date: 20210108; Test Name: Pulse rate; Result Unstructured Data: Test Result:98
CDC Split Type: GBPFIZER INC202100956803

Write-up: Cheyne Stokes respiration pattern; blood pressure: 150/90; Transient ischaemic attack; Muscle weakness right-sided; Slurred speech; reduced oral intake; Asthenia/gradually deteriorated over week, becoming frailer/frailty of old age; This is a spontaneous report from a contactable Other Health Professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25641803. Safety Report Unique Identifier GB-MHRA-ADR 25641803. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 31Dec2020 (Lot Number: EJ1688) as 0.3ml single for COVID-19 immunisation. Medical history included asthenia from an unknown date and unknown if ongoing, adverse reaction to penicillins from an unknown date to 13May2015, angina unstable from 16Jan2001 to 30Jan2016, radius fracture from 10Dec2010 to 29Jan2016, pathological fracture from 10Jan2011 to 29Jun2016, depression from 30May2018 to 23Aug2018, depression from 28Nov2019 to 05Mar2020, deep vein thrombosis from 24Oct2018 to an unknown date, constipation from 27May2020 to 25Jun2020, hypothyroidism from 01Jan1960 and ongoing, lipid metabolism disorder from 16Jan2001 and ongoing, osteoporosis from 25Jan2007 and ongoing, ocular hypertension from 08Apr2008 and ongoing, glaucoma from 05Nov2013 and ongoing, Vitamin B12 deficiency from 21May2014 and ongoing, Vitamin D deficiency from 02Oct2017 and ongoing, pain in extremity from 08Jan2020 and ongoing, dry eye and incontinence, both from unknown date. Concomitant medications included benzalkonium chloride, dimeticone (CONOTRANE [BENZALKONIUM CHLORIDE;DIMETICONE]) taken for incontinence; timolol maleate, mirtazapine, colecalciferol, senna acutifolia, omeprazole, levothyroxine sodium, paracetamol, prochlorperazine, all taken for an unspecified indication; docusate taken for constipation; hypromellose taken for dry eye; all with start and stop date were not reported. The patient previously took citalopram from unknown date to 13May2015 and experienced adverse drug reaction, simvastatin from unknown date to 30Jan2008 and experienced adverse drug reaction, nifedipine from unknown date to 16Jan2001, vibramycine from unknown date to 16Mar1998. The patient experienced transient ischaemic attack on 08Jan2021 with outcome of fatal, muscle weakness right-sided and slurred speech, both on 07Jan2021 with outcome of recovered on 07Jan2021. The patient underwent lab tests and procedures which included blood pressure: 150/90 on 08Jan2021, heart rate: 98 on 08Jan2021. The patient died on 16Jan2021. It was not reported if an autopsy was performed. Clinical course was reported as background of increasing frailty. Nursing home resident. Presented with right sided weakness and slurred speech on 07Jan2021. Lasted several hours. Assessed by a colleague on 08Jan2021 no persistent neurological deficit. Started on clopidogrel. Gradually deteriorated over week, becoming frailer, reduced oral intake. Out of hours contacted early on 16Jan2021 as had Cheyne Stokes respiration pattern. Died later that day on 16Jan2021. Outcome of reduced oral intake, Cheyne Stokes respiration pattern and blood pressure: 150/90 was unknown. Reporter thought this was natural causes but felt obliged to report as within 1 month of new COVID vaccine. Cause of death 1a cerebrovascular disease and frailty of old age. This case was reported as serious with seriousness criteria-results in death, caused/prolonged hospitalization. No Follow-up attempts are needed. No further information is expected. ; Reported Cause(s) of Death: Transient ischaemic attack; Asthenia/gradually deteriorated over week, becoming frailer/frailty of old age


VAERS ID: 1523803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0274 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bone contusion, Malaise, Monoplegia, Musculoskeletal chest pain, Oxygen saturation, Pneumonia, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIDAZOLAM; GLYCOPYRRONIUM BROMIDE; CYCLIZINE; WATER FOR INJECTIONS; AMOXICILLIN; CODEINE; MORPHINE SULFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Bed rest; Fall (banged chest); Nausea; Pain; Rib contusion
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: Oxygen saturation; Test Result: 95 %
CDC Split Type: GBPFIZER INC202100956811

Write-up: off legs; Pneumonia; Pyrexia; Musculoskeletal chest pain; Malaise; rib contusion; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25641805. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EJ0274) via intramuscular at 30 ug single on 31Dec2020 for covid-19 immunization. Medical history included fall from 03Jan2020, banged chest, bone contusion, gradually became bed bound; pain, nausea and anxiety all from 14Jan2021. The patient previously took lercanidipine from 20Aug2020 for blood pressure measurement; estriol from 20Aug2020; clopidogrel from 20Aug2020 for cerebrovascular accident; metformin from 20Aug2020 for diabetes mellitus; cinnarizine from 20Aug2020 for dizziness; labetalol from 23Jun2004 and experienced headache; felodipine from 12May2004 but caused oedema; moxonidine from 20Mar2002 and caused fatigue; doxazosin mesylate from 30Oct1998 and caused micturition urgency; nicardipine hydrochloride (CARDENE SR) from 05Jun1996 and caused oedema; amlodipine besilate from 29May1996 and caused oedema. Concomitant medications included midazolam for anxiety from 14Jan2021; glycopyrronium bromide from 14Jan2021 and from 13Jan2021; cyclizine taken for nausea from 14Jan2021; water for injection (WATER FOR INJECTIONS); amoxicillin from 13Jan2021; codeine for pain from 06Jan2021; morphine sulfate for pain from 14Jan2021. The patient experienced pneumonia on an unspecified date, pyrexia on 06Jan2021, musculoskeletal chest pain on 06Jan2021, malaise on 06Jan2021, rib contusion on 03Jan2021, off legs on an unspecified date. Oxygen saturation was 95% on 06Jan2021. The patient died on 14Jan2021. An autopsy was not performed. Physician stated patient died of pneumonia. Physician suspected unrelated to vaccine but obliged to report. It was a serious report - but not really PTO. Physician thought was a natural death. Went "off legs" progressively after fall. Seen 06Jan2021- oxygen saturation 95%, mild fever, right-sided chest wall tenderness. Family phoned 12Jan2021 requesting details of carers as needing more help. Family phoned 13Jan2021 - bed bound on 03Jan2021, they felt she was dying. Insited lunchtime 14Jan2021 - dismally had rt (right) basal pneumonia. It was unwell. Decision made to palliative rather than admit. Patient died peacefully the next day. Physician had only reported this as it was within a month of the new vaccine - but physician thought it was natural causes. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and a possible contributory role of the suspect BNT162B2 to the reported event pneumonia can be completely excluded/unrelated;The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: Pneumonia; Pyrexia; Musculoskeletal chest pain; Malaise; rib contusion; off legs


VAERS ID: 1524362 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cerebral haemorrhage, Confusional state, Headache, Mobility decreased, Monoparesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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:
CDC Split Type: ITPFIZER INC202100927012

Write-up: Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; severe lumbosacral pains that prevent her from moving; Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-757301. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 26May2021 13:52 (Batch/Lot Number: FA8016) as dose 2, single (at the age of 69 years) for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of COMIRNATY on 05May2021 at 13:27 (batch/lot: EX7389) in the left deltoid for Covid-19 immunisation. The patient had lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion. It was further reported that the patient accuses severe lumbosacral pains that prevent her from moving with symptoms of hemiparesis in both lower limbs on 26May2021. On 30May2021 she develops very strong headache which brought the patient to hospitalization in a confused state the following day (31May2021). The day after admission, death from cerebral haemorrhage which occurred on 01Jun2021. The outcome of the events was fatal as the patient died on 01Jun2021. It was not reported if an autopsy was performed. Senders comment: 05May2021 at 13:27 first dose of Comirnaty vaccine (batch EX7389) in the left deltoid. 14Jul2021 Request documentation and clinical report to the referring physician No follow up attempts needed, no further information is expected; Reporter''s Comments: 1st vaccine dose 05May2021 After the 2nd dose of vaccine 26May2021 the patient accuses severe lumbosacral pains that prevent her from moving with symptoms of hemiparesis in both lower limbs on 30May2021 she develops very strong headache which brought the patient to hospitalization in a confused state the following day (31May2021). The day after admission, death from cerebral haemorrhage occurred (01Jun2021).; Reported Cause(s) of Death: Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitalization the following day for confusion.); Lumbosacral pain, lower limb hemiparesis. On 30/05 diffuse headache, which lead the subject to hospitali


VAERS ID: 1524371 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Overdose, Pneumonia, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug abuse and dependence (broad), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 71
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RETACRIT [EPOETIN ALFA EPBX]; PANTORC; LASIX [FUROSEMIDE]
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100926903

Write-up: Bronchopneumonia; Pain chest; Thrombosis leg; overdose/dose 2, 45 ml single; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-757952. A 74-year-old male patient received bnt162b2 (COMIRNATY; Batch/Lot number was not reported) intramuscularly on 18Apr2021 as dose 2, 45 mL, single for COVID-19 immunisation. Medical history included multiple myeloma from 2011 and ongoing. Concomitant medications included epoetin alfa epbx (RETACRIT) taken for multiple myeloma; pantoprazole sodium sesquihydrate (PANTORC); furosemide (LASIX). Historical vaccine include first dose of bnt162b2 (COMIRNATY) on 28Mar2021 for COVID-19 immunization. On 18Apr2021 patient received the second dose as dose 2, 45 mL, single and was reported as overdose. On 23Apr2021 patient experienced bronchopneumonia, pain chest, thrombosis leg and was hospitalized from 23Apr2021 to 30Apr2021 treated with antibiotic therapies not yet known. In the days following discharge, the pulmonary symptoms worsened and the treating physician deemed it appropriate to prescribe a cortisone therapy associated with oxygen therapy (tank of 02+ Soldesam drops). The patient died on 28Jun2021. An autopsy was not performed. Reporter comment: 15Jul: not yet in possession of any documentation despite hospital record have been requested a month ago. Sender Comment: 16Jul: requested to the reporter for the 2nd dose, hospital medical record, clinical course and therapies performed in hospital. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reporter''s Comments: 15Jul: not yet in possession of any documentation despite hospital record have been requested a month ago.; Reported Cause(s) of Death: thrombus in his right leg; Bronchopneumonia; Pain chest


VAERS ID: 1524396 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003601 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: DECESSO; DECESSO; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (DECESSO) and PYREXIA (DECESSO) in a 71-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003601) for COVID-19 vaccination. No Medical History information was reported. On 18-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DEATH (DECESSO) (seriousness criteria death and medically significant) and PYREXIA (DECESSO) (seriousness criterion death). The patient was treated with PARACETAMOL 17-Jul-2021 for Fever, at an unspecified dose and frequency. The patient died on 18-Jul-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 product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding these events have been provided at this time. No further information is expected at this time. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-Jul-2021, contains information about event pyrexia and concomitant drug paracetamol.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1524420 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Endocarditis, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: POLARAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement ((biological valve))
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 antigen test; Test Result: Negative ; Comments: Nasopharyngeal swab
CDC Split Type: JPPFIZER INC202100922491

Write-up: multiple cerebral haemorrhage; Endocarditis infective; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 69-year-old male patient received first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) intramuscular in the left arm at the age of 69 years old for COVID-19 immunization. Medical history included postoperative status of aortic valve replacement (biological valve) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included dexchlorpheniramine maleate (POLARAMINE) taken for an unspecified indication, start and stop date were not reported (within 2 weeks of vaccination). Since the vaccination, the patient has been tested for COVID-19. On 13Jul2021 (6 days after the vaccination), nasopharyngeal swab was performed, and the result of COVID-19 antigen test was negative. On 14Jul2021 (7 days after the vaccination), the patient experienced endocarditis infective. On 16Jul2021 (9 days after the vaccination), the outcome of the event was fatal despite treatment including antibiotic and thrombomodulin alfa (RECOMODULIN). Cause of death was multiple cerebral haemorrhage (unknown date). The patient died on 16Jul2021. An autopsy was not performed.; Sender''s Comments: A causal association cannot be completely excluded for the reported events and BNT162B2 based on temporal association. However, the patient''s history of aortic valve replacement might also have played a contributory role towards the fatal events. 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: Endocarditis infective; multiple cerebral haemorrhage


VAERS ID: 1524439 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Computerised tomogram, Dyspnoea, Interstitial lung disease, Pyrexia
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic interstitial pneumonia; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: CT scan; Result Unstructured Data: Test Result:Ground-glass-pattern shadow; Comments: in both lungs
CDC Split Type: JPPFIZER INC202100924551

Write-up: Acute respiratory failure; Breathing difficulty; Interstitial pneumonia aggravated; Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21120641. A 90-year and 6-month-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number: FA2453; expiration date: 31Aug2021), via an unspecified route of administration on 12Jul2021 14:00 (at the age of 90-years-old) as dose 1, single for COVID-19 immunisation. Medical history included rheumatoid arthritis and chronic interstitial pneumonia. The patient''s concomitant medications were not reported. On 12Jul2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162B2. On 12Jul2021 at around 21:00 (7 hours after the vaccination), the patient experienced interstitial pneumonia aggravated (based on diagnosis). On 16Jul2021 (4 days after the vaccination), the patient was hospitalized. The clinical course of the events was as follows: The patient was regularly visiting a nearby hospital for the treatment of rheumatoid arthritis. On 12Jul2021 at night (the day of vaccination), the patient developed pyrexia. On 16Jul2021 (4 days after the vaccination), breathing difficulty appeared, and she visited the reporter''s hospital. Acute respiratory failure was noted. CT scan showed ground-glass-pattern shadow in both lungs. The patient was hospitalized to receive the treatment under diagnosis of interstitial pneumonia. On 19Jul2021 (7 days after the vaccination), the patient died due to interstitial pneumonia aggravated. It was not reported if an autopsy was performed. The outcome of the remaining events was unknown. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was related to BNT162B2. Interstitial pneumonia aggravated associated with rheumatoid arthritis was considered as another possible cause of the event. The reporting physician commented as follows: It was considered that the patient had a background of chronic interstitial pneumonia caused by rheumatoid arthritis. Interstitial pneumonia aggravated occurred followed by pyrexia after the vaccination. The possibility that BNT162B2 triggered acute aggravation could not be denied.; Reported Cause(s) of Death: Interstitial pneumonia aggravated


VAERS ID: 1524458 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Apnoea, Body temperature, C-reactive protein increased, Chest X-ray, Electrocardiogram, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 8
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: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination; Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:about 37.5 Centigrade; Comments: at night; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:around 37.5 Centigrade; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: after taking antipyretic; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: during the night; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Test Date: 20210707; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210707; Test Name: CRP; Result Unstructured Data: Test Result:23.06; Comments: increased to 23.06; Test Date: 20210707; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202100925896

Write-up: Ascending aortic dissection; apnoea; pyrexia of approximately 37.5 degrees centigrade/low-grade fever; general malaise; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120670. A 63-year and 9-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 30Jun2021 at 13:30 (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Body temperature before vaccination was 35.8 degrees centigrade. The patient had no family history. 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). On 09Jun2021, the patient previously received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration (Lot# EY0779, Expiration date 31Aug2021) as dose 1, single for COVID-19 immunisation. On 08Jul2021 around 07:00 (approximately 7 days, 17 hours, and 30 minutes after the vaccination), the patient experienced ascending aortic dissection. On 08Jul2021 at 07:57 (7 days, 18 hours, and 27 minutes after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 09Jun2021, the patient received the first dose of the vaccine (no abnormalities were noted until the second dose). On 30Jun2021, the patient received the second dose of the vaccine. From after the vaccination to the night, the patient had a pyrexia of approximately 37.5 degrees centigrade. The patient had a general malaise. On 01Jul2021, the patient had a pyrexia of around 37.5 degrees centigrade (the patient took 1 tablet of acetaminophen (CALONAL)). On 02Jul2021, the body temperature was 36.5 degrees centigrade (after taking antipyretic). The body temperature was 37.6 degrees centigrade during the night. On 03Jul2021, the body temperature was 36.2 degrees centigrade. The fever went down. On 04Jul2021, pyrexia of 37.6 degrees centigrade recurred. On 05Jul2021, the patient had a general malaise (35.8 degrees centigrade). On 06Jul2021, the patient had a general malaise and low-grade fever. On 07Jul2021, since the general malaise and low-grade fever persisted, the patient visited the reporting clinic. Chest X-ray and ECG showed no abnormalities. The blood test results of the following day would be awaited. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was unknown. The patient died on 08Jul2021. It was not reported if an autopsy was performed. The reporting physician commented as follows: On 08Jul2021 around 07:00, the patient was taken to Hospital by ambulance because of apnoea. The patient was confirmed dead at 07:57 due to ascending aortic dissection at the hospital (on 07Jul2021, CRP increased to 23.06). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: On 08Jul2021 around 07:00, the patient was taken to Hospital A by ambulance because of apnoea. The patient was confirmed dead at 07:57 due to ascending aortic dissection at the hospital (on 07Jul2021, CRP increased to 23.06).; Sender''s Comments: Medical Review completed. Regulatory authority case. Fatal event noted.; Reported Cause(s) of Death: Ascending aortic dissection


VAERS ID: 1524459 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-18
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   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 Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 degrees Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100925975

Write-up: Death; This is a spontaneous report from a contactable physician (forensic anatomist) received from the Regulatory Authority. Regulatory authority report number is v21120640. A 77-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 14Jul2021 (the day of vaccination; at the age of 77 years old) (hearsay) (Batch/Lot Number: EY0583; Expiration Date: 31Oct2021) as dose 2, single for COVID-19 immunization. The patient previously received BNT162b2 (COMIRNATY, Solution for injection) on an unspecified date (Batch/Lot number and Expiration date were unspecified) as dose 1, single for COVID-19 immunization. As for the patient''s family history, it was reported that the patient had lived alone (unknown details, hearsay). The 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) was reported as unknown. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 18Jul2021 at 03:39. On 18Jul2021 (4 days after the second dose of the vaccination) at 03:39 (estimated time of death through the clinical diagnosis), the patient died. The reporting physician classified the event as serious (Death), and assessed the causality between the event and BNT162b2 as unassessable (because the investigation was in progress, details were unknown at the time of the reporting). Other possible causes of the event such as any other diseases were not reported. The reporting physician commented as follows: This was the case of autopsy which was requested by the police according to the law regarding investigation of the cause of death or the identity of corpse handled by police, etc. The patient underwent lab test and procedure, which included body temperature of 36.6 degrees Centigrade on 14Jul2021 before vaccination. The outcome of the event was fatal. The cause of death was not reported. The patient died on 18Jul2021. An autopsy was being performed and results were not provided.; Reported Cause(s) of Death: Death


VAERS ID: 1524460 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Physical deconditioning
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 15
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: 20210620; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100925982

Write-up: Physical deconditioning; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120682. A 72-year and 3-month-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 30May2021 (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on 20Jun2021 (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for COVID-19 immunisation. Body temperature before vaccination on 20Jun2021 was 36.5 degrees centigrade. Family history was not reported. The patient medical history and concomitant medications were not reported. The patient experienced physical deconditioning (resulting in death) on 07Jun2021. The patient died on 22Jun2021. It was not reported if an autopsy was performed. ''The patient had a symptom (feeling dull) at the time of second vaccination on 22Jun2021''. Physical deconditioning had continued after the previous vaccination. On 07Jun2021 (8 days after the first vaccination), the patient experienced physical deconditioning but made no hospital visit for it, and physical deconditioning still continued afterwards. On 20Jun2021 at unknown time, despite the persisting physical deconditioning, the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 22Jun2021 in the morning (2 days after the second vaccination), an ambulance was called because of physical deconditioning, but the patient was confirmed dead when transported to the hospital.(The reporting physician heard the above course from the patient''s wife after receiving a request from the physician on duty to prepare a death certificate). It was not reported whether autopsy was done. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported whether there were other possible causes of the event such as any other diseases. The reporting physician commented as follows: Reported this case because the time between the vaccination and the physical deconditioning and death was close.; Reported Cause(s) of Death: Physical deconditioning


VAERS ID: 1524461 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Body temperature, Cardiac arrest, Coma scale, Cyanosis, Feeling cold, Heart rate, Loss of consciousness, Mouth breathing, Nausea, Oxygen saturation, Oxygen saturation decreased, Pupillary reflex impaired, Pupils unequal, Pyelonephritis, Pyrexia, Respiratory distress, Respiratory rate, Sepsis, Skin discolouration, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), 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), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Spinocerebellar disease
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:118/85; Comments: at 22:00; Test Date: 20210610; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:111/81; Comments: at 00:00; Test Date: 20210610; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:fluctuated widely; Comments: at 02:30; Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: at 08:25; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: at 13:50; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:40.1 Centigrade; Comments: at 18:40; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: at 22:00; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: at 00:00; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: at 00:56; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: at 02:30; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at 06:00; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Comments: at 07:45; Test Date: 20210610; Test Name: Consciousness level; Result Unstructured Data: Test Result:III-300; Comments: at 07:45; Test Date: 20210610; Test Name: Pulse rate; Result Unstructured Data: Test Result:110s; Comments: at 06:00; Test Date: 20210609; Test Name: SpO2; Test Result: 93 %; Comments: at 18:40; Test Date: 20210609; Test Name: SpO2; Test Result: 96 %; Comments: at 22:00; Test Date: 20210610; Test Name: SpO2; Result Unstructured Data: Test Result:80s %; Comments: at 00:00; Test Date: 20210610; Test Name: SpO2; Test Result: 81 %; Comments: at 00:56; on room air, it became 99% with 5 L of oxygen; Test Date: 20210610; Test Name: SpO2; Test Result: 88 %; Comments: with 8 L of oxygen; Test Date: 20210610; Test Name: SpO2; Result Unstructured Data: Test Result:90-91 %; Comments: at 07:48; with 10 L of oxygen; Test Date: 20210610; Test Name: RR; Result Unstructured Data: Test Result:26; Comments: at 00:56
CDC Split Type: JPPFIZER INC202100926045

Write-up: cardiac arrest; jaw breathing; pupil laterality; loss of light reflex; did not respond to a call / consciousness level was III-300; respiratory distress; blood pressure fluctuated widely; feeling cold; ill color of fingers; cyanosis of the right toe(s); queasy; vomited; SpO2 93%; body temperature was 37.9 degrees centigrade; sepsis due to pyelonephritis; sepsis due to pyelonephritis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120723. A 68-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration on 08Jun2021 14:00 (at the age of 68-years-old) at dose 1, single for COVID-19 immunization. Medical history included spinocerebellar degeneration and hypothyroidism. Concomitant medication was not reported. Body temperature before vaccination was 36.7 degrees centigrade. On 08Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 09Jun2021 at 08:25 (18 hours 25 minutes after the vaccination), the patient experienced sepsis due to pyelonephritis. On 10Jun2021 (2 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: On 08Jun2021, the patient received BNT162b2. On 09Jun2021 at 08:25, body temperature was 37.9 degrees centigrade. At 13:50, body temperature was 39.4 degrees centigrade. At 18:40, the patient vomited. Body temperature was 40.1 degrees centigrade and SpO2 was 93%. At 22:00, body temperature was 37.1 degrees centigrade, blood pressure was 118/85, and SpO2 was 96%. The patient had queasy. On 10Jun2021 at 00:00, the patient vomited a small amount. Body temperature was 37.7 degrees centigrade, blood pressure was 111/81, and SpO2 was 80s. At 00:35, 2 L of oxygen was initiated. At 00:56, respiratory rate (RR) was 26, body temperature was 37.7 degrees centigrade, and SpO2 was 81% (on room air), which became 99% with 5 L of oxygen. At 02:30, SpO2 was not measurable, body temperature was 37.6 degrees centigrade, and blood pressure fluctuated widely. The patient had respiratory distress, feeling cold, ill color of fingers, and cyanosis of the right toes. At 06:00, body temperature was 38.5 degrees centigrade and pulse rate was 110s. The patient had respiratory distress, SpO2 was not measurable, feeling cold was present, and the patient did not respond to a call. At 07:45, the patient did not respond to a call. The patient had jaw breathing, pupil laterality and loss of light reflex. Consciousness level was III-300, body temperature was 39.5 degrees centigrade, and blood pressure and SpO2 were not measurable. Oxygen 8 L was initiated and SpO2 was 88%. At 07:48, oxygen 10 L was initiated and SpO2 was 90-91%. At 08:05, the patient was found to have cardiac arrest. At 08:09, chest compression was initiated, BOSMIN 1 ampoule was intravenously administered, and automated external defibrillator (AED) was placed. At 08:10, spontaneous circulation returned. At 08:23, Bosmin 1 ampoule was intravenously administered. At 08:25, the patient was transferred to a city hospital. At 10:27, the patient repeatedly had cardiac arrest. Family member was consulted and resuscitation was discontinued and then the patient died on 10Jun2021. Cause of death was sepsis due to pyelonephritis (information was received from the city hospital). It was unknown if autopsy was performed. Outcome of the other events was unknown. 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 pyelonephritis (as reported). Reporter comment: According to the information received from the city hospital, cause of death was pyelonephritis and sepsis. Thus, there was no clear relationship between the vaccination and the events; however, the case was reported since the patient died 2 days after the vaccination.; Reported Cause(s) of Death: sepsis due to pyelonephritis; sepsis due to pyelonephritis


VAERS ID: 1524481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest X-ray
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: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: Chest x-ray; Result Unstructured Data: Test Result:Pulmonary oedema
CDC Split Type: JPPFIZER INC202100927153

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120742.??The patient was a 77-year (at vaccination) female. On 10Jul2021 (the day of vaccination), the patient received?the second dose of COVID-19 Vaccine (manufacturer unknown) via an unspecified route of administration as dose 2, single for COVID-19 immunization. On 11Jul2021 at 03:00 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. On 11Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 10Jul2021, the patient received the second dose of COVID-19 vaccine. After the vaccination, the patient experienced dyspnoea. As the symptom did not improved, she called an ambulance at 02:24 on 11Jul2021. When the ambulance arrived at her home, cardio-respiratory arrest was found. Resuscitation was performed while the patient was urgently transferred to the reporting hospital. Chest X-ray showed the findings of pulmonary oedema. The patient died at 03:50 on 11Jul2021. The reporting physician classified the event as serious (death) and assessed that the event was related to the vaccine. It was not reported if autopsy was performed. The reporting physician commented as follows: The causality between the event and the vaccine was considered to be present. Pfizer is a marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1524482 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac disorder, Oxygen saturation, Pyrexia, Respiratory failure, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LIXIANA; NORVASC; MAINTATE; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; MUCOSOLVAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Emphysema (surgery conducted in Mar2016); Lung cancer (surgery conducted in Mar2016); Obesity; Oxygen saturation decreased (on mild exertion); Oxygen therapy (SpO2 was 80 to 90% on mild exertion); Respiratory failure (respiratory failure was aggravated); Respiratory failure aggravated (underwent surgery in Mar2016. Thereafter); Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: On waking on the vaccination date; Test Date: 2021; Test Name: SpO2; Result Unstructured Data: Test Result:80 to 90 %; Test Date: 20210716; Test Name: SpO2; Result Unstructured Data: Test Result:50s %
CDC Split Type: JPPFIZER INC202100927180

Write-up: respiratory failure/SpO2 decreased to 50s%/respiratory condition were aggravated; cardiac function; were aggravated; pyrexia; tremor; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120754. A 65-year-old male patient with a body temperature before vaccination (15Jul2021) of 36.5 degrees centigrade, received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 15Jul2021 09:30 (batch/lot number EW0201 and expiry date 30Sep2021) as dose 1, single for covid-19 immunization. Medical history included emphysema, lung cancer (surgery conducted in Mar2016), respiratory failure, atrial fibrillation, obesity. The family history was not provided. The patient had a high risk of COVID-19 infection. In early Mar2021, the patient was receiving home oxygen therapy. Although the patient was receiving home oxygen therapy, the SpO2 was 80 to 90% on mild exertion, and respiratory failure was significant. Concomitant medications included edoxaban tosilate (LIXIANA), amlodipine besilate (NORVASC), bisoprolol fumarate (MAINTATE), esomeprazole magnesium trihydrate (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]), ambroxol hydrochloride (MUCOSOLVAN); all taken for an unspecified indication from an unspecified start date. On 15Jul2021 (the day of vaccination) on awaking, the body temperature was 37 degrees Celsius; however, the body temperature before vaccination was 36.5 degrees Celsius. On 15Jul2021 at 09:30 (the day of vaccination), the patient received the first dose vaccine. On 16Jul2021 at around 13:00 (one day after the vaccination), the patient experienced tremor and pyrexia. The SpO2 decreased to 50s% reported by phone. On 16Jul2021 13:00, the patient experienced respiratory failure, pyrexia. An emergency hospitalization was asked to another hospital, and the patient was admitted to the hospital on 16Jul2021. On 21Jul2021 (5 days after the vaccination), the patient died due to events. It was unknown if an autopsy was performed. The reporting physician classified the events "respiratory failure aggravated", "heart disease aggravated", "pyrexia" as serious (hospitalization and death) and assessed that the events were related to BNT162b2. Other possible cause of the event such as any other diseases was aggravation of the underlying diseases due to pyrexia. The reporting physician commented as follows: It was considered that the patient died because the cardiac function and the respiratory condition were aggravated due to pyrexia caused by a side reaction to the vaccination.; Reported Cause(s) of Death: cardiac function; were aggravated; respiratory failure/SpO2 decreased to 50s%/respiratory condition were aggravated; Pyrexia


VAERS ID: 1524484 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Eating disorder, Heart rate, Heart rate increased, Hepatic function abnormal, Oedema, Oxygen saturation, Pallor, Pyrexia, Respiratory arrest, Somnolence
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), 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), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   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: Medical History/Concurrent Conditions: Dementia; Dysphagia; Fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: blood pressure; Result Unstructured Data: Test Result:126/77; Comments: before vaccination; Test Date: 20210708; Test Name: blood pressure; Result Unstructured Data: Test Result:110-120; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:67/46; Comments: at around 03:00; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:118/74; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: at around 03:00; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:unable to measure; Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: in the moring; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before report; Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: at night; Test Date: 20210707; Test Name: body temperature; Result Unstructured Data: Test Result:38 to 39 Centigrade; Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:40.1 Centigrade; Comments: at around 03:00; Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: at Periodic call; Test Date: 20210704; Test Name: pulse rate; Result Unstructured Data: Test Result:67; Test Date: 20210709; Test Name: pulse rate; Result Unstructured Data: Test Result:116; Comments: at around 03:00; Test Date: 20210709; Test Name: SpO2; Result Unstructured Data: Test Result:97 (RA) %; Comments: at around 03:00; Test Date: 20210709; Test Name: SpO2; Result Unstructured Data: Test Result:98 to 99 %
CDC Split Type: JPPFIZER INC202100927197

Write-up: respiratory arrest; blood pressure decreased/67/46; pulse rate was 116; oedema on the back; pallor facial; shivering; somnolence; Hepatic function disorder; Consciousness disturbed; Pyrexia/38 degrees Celsius; Eating disorder/unable to take meals; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority. Regulatory authority report number is v21120954. A 79-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot: EW0207, expiry: 30Sep2021) via an unspecified route of administration on 04Jul2021 at 13:31 (the day of vaccination) (at the age of 79-years-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.0 degrees centigrade. The family history was not provided. The patient had medical histories of after fracture, dementia, and dysphagia. Concomitant medications were not reported. On 05Jul2021 at 08:00 (18 hours/29 minutes after the vaccination), the patient experienced hepatic function disorder, pyrexia, eating disorder and disturbed consciousness. On 10Jul2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 04Jul2021 at 13:31, the body temperature was 36 degrees Celsius, the pulse rate was 67, and the blood pressure was 126/77. The condition was not poor, and meal intake was possible, and thus, the patient received the first dose of BNT162b2 vaccination. On 05Jul2021, at 10:20, it was reported that no change was observed in the blood pressure, and the body temperature was 37.2 degrees Celsius in the morning by the phone. However, the body temperature before the report was 36.8 degrees Celsius, and the patient was followed up. On 06Jul2021, at 09:48, in the morning, the patient was unable to have breakfast. The patient had pyrexia of 38 degrees Celsius last night, but the fever decreased to 36.8 degrees Celsius in this morning. Administration of fluid replacement was instructed, and BFLUID INJECTION 1000 mL was administered. On 07Jul2021, a phone call was made to confirm the situation. The patient tended to have somnolence, and she was unable to take meals. The effect of the vaccination was possibly potent. The body temperature was 38 to 39 degrees Celsius. It was difficult for the patient to orally take BFLUID INJECTION 1000 mL, and acetaminophen (ANHIBA) 400 mg was used twice. On 08Jul2021, at 15:47, the condition was reported. Although acetaminophen was used, the fever did not decrease. The blood pressure was 110 to 120s. The patient also had shivering, and administration of fluid replacement 1500 mL was instructed. Acetaminophen 400 mg was instructed to be used. On 09Jul2021, at around 03:00, since blood pressure decreased was noted, the physician visited the patient. The body temperature was 40.1 degrees Celsius, the blood pressure was 67/46, the pulse rate was 116, and the SpO2 was 97% (room air). The patient had pyrexia of 40 degrees Celsius, and no abnormalities were observed on the chest auscultation. The fever focus was unknown. On 09Jul2021, the physician visited the patient regularly. The body temperature was 37 degrees Celsius, the SpO2 was 98 to 99%, and the blood pressure was 118/74. The patient was slightly more active than the previous day. The blood examination was performed. Administration of hydrocortisone sodium succinate (SOLU-CORTEF) was instructed (at 16:00, a drip injection was performed). Since the patient had oedema on the back, a drip infusion was instructed to be decreased to 1000 mL. In the daytime, acetaminophen 400 mg was used twice. At 23:00 on the same day, the blood pressure was unable to be measured. It could be measured in a different way; however, the patient had pallor facial, and emergency call was made. Administration of fluid replacement of 500 mL was instructed. 15 minutes later, the respiratory condition tended to be aggravated, and house visit by a doctor was asked to the physician. On 10Jul2021, at around 00:00, when the patient arrived at the patient''s home, she had respiratory arrest. At 00:12, the patient was confirmed to die. The reporting other healthcare professional 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 were after fracture, dementia, and dysphagia. The outcome of the events altered state of consciousness, pyrexia, eating disorder, somnolence, chills, blood pressure decreased, heart rate increased, oedema and pallor was unknown. The patient died on 10Jun2021 due to hepatic function abnormal and respiratory arrest. It was unknown if autopsy was done.; Reported Cause(s) of Death: respiratory arrest; Hepatic function disorder


VAERS ID: 1524556 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100935431

Write-up: unable to eat orally and hospitalized; felt ill; patient died; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An elderly patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The course of the event was as follows: The patient received the vaccination at the facility for elderly by the reporting physician. Immediately after that, the patient felt ill and was unable to eat orally and hospitalized. After that, the patient was transferred to another hospital. On an unknown date (about one month after the vaccination), the patient died. Outcome of the event unable to eat was unknown. The reporting physician classified the event as serious (fatal) and the causality between the event and BNT162b2 was not reported.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: patient died


VAERS ID: 1524557 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Myocardial infarction, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   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: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID antigen test; Test Result: Negative
CDC Split Type: JPPFIZER INC202100935437

Write-up: Myocardial infarction; Cardiac arrest; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. An 85-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number was not reported), intramuscularly on 17Jul2021 (at the age of 85-years-old) as dose 2, single for COVID-19 immunisation. Medical history included Parkinson''s disease. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 COMIRNATY; lot number was not reported) on an unspecified date in 2021 for COVID-19 immunisation. On 18Jul2021 (1 day after the vaccination), the patient experienced myocardial infarction. The clinical course of the event was as follows: On 18Jul2021 (1 day after vaccination), the patient had cardiac arrest, and she was transferred to the reporting hospital. It was confirmed that the patient received the second dose of BNT162B2 vaccination on 17Jul2021 (the day of vaccination) by her family (according to her age, the vaccination was assumed to be BNT162b2 vaccination). The patient was confirmed to be alive until at 20:30 on 17Jul2021 (20 hours and 30 minutes after vaccination) by her family. On 18Jul2021 at around 06:30 (1 day, 6 hours, and 30 minutes after vaccination), the patient was emergently transferred. On the same day, COVID antigen test was performed (the result of negative was confirmed). On 18Jul2021 (1 day after the vaccination), the patient died due to myocardial infarction. It was not reported if an autopsy was performed or not. The outcome of the event cardiac arrest was unknown. The reporting pharmacist classified the event as serious (death) and assessed that the event was probably related to BNT162B2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on available information and the drug temporal relationship, the causality between the events myocardial infarction, cardiac arrest and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1524561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-24
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100952107

Write-up: Aortic dissection; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121151. A 65-year-old male patient received second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of COVID-19 Vaccine on an unspecified date. The patient''s medical history and concomitant medications were not reported. On 24Jul2021 at 14:00 (unknown day(s) after the vaccination), the patient experienced aortic dissection. On 24Jul2021, the patient died of aortic dissection. The outcome of the event was Fatal. Clinical course of the event aortic dissection was as follows: The patient''s breath became hard, and he went into cardiac arrest. After transported to the hospital, the patient was diagnosed with aortic dissection. The reporting physician classified the event as serious (Death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Aortic dissection


VAERS ID: 1524563 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bronchiectasis, Condition aggravated, Mycobacterial infection, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pseudomonas infection, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiectasis; Infection Pseudomonas aeruginosa; Mycobacterial infection
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210607; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210623; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Test Date: 20210623; Test Name: oxygen saturation; Test Result: 68 %
CDC Split Type: JPPFIZER INC202100967392

Write-up: pyrexia of 37.4 degree; Oxygen saturation decreased to 68%; pneumonia; pulmonary nontuberculous mycobacterial infection; bronchiectasis; Infection Pseudomonas aeruginosa chronic; pulmonary nontuberculous mycobacterial infection, bronchiectasis, and infection pseudomonas aeruginosa chronic; respiratory failure type 2; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120493. An 83-year-old female received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration on 02Jun2021 at 13:00 as 0.3mL single dose for COVID-19 immunization. Body temperature before vaccination was 36.8 degrees centigrade. The patient had no family history. The patient had medical histories of pulmonary nontuberculous mycobacterial infection from 2006, bronchiectasis, infection pseudomonas aeruginosa chronic from 2014. Concomitant medications were not reported. On 03Jun2021 (1 day after the vaccination), the patient developed a variety of symptoms that were diagnosed as pneumonia, pulmonary nontuberculous mycobacterial infection, bronchiectasis, and infection pseudomonas aeruginosa chronic. On 07Jun2021 (4 days after the vaccination), the patient was admitted to the hospital. On 23Jun2021 (20 days after the vaccination), the patient experienced pyrexia of 37.4 degree and oxygen saturation decreased of 68%, and was readmitted to the hospital. On unknown date (after the vaccination), the patient experienced respiratory failure type 2. On 02Jul2021 (one month after the vaccination), the outcome of the event was fatal. It was unknown if autopsy was performed. The clinical course was as follows: On 03Jun2021, the patient experienced pyrexia of 37.7 degrees Celsius. On 05Jun2021, the patient experienced sputum bloody. On 07Jun2021, the patient experienced pyrexia of 38 degrees Celsius and dyspnoea. On the same day, the patient was admitted to another hospital. The patient was diagnosed with pneumonia, pulmonary nontuberculous mycobacterial infection (pulmonary NTM infection), bronchiectasis, and infection Pseudomonas aeruginosa chronic on the detailed examination. From 07Jun2021 to 18Jun2021, tazobactam (TAZ) and piperacillin (PIPC) were administered. On 19Jun2021, the patient was recovering, and she was discharged. On 23Jun2021, the patient experienced pyrexia of 37.4 degrees Celsius again. Since the patient experienced oxygen saturation decreased to 68%, she was readmitted to the same hospital on the same day. After the hospitalization, meropenem (MEPM) was administered. However, although the pneumonia improved, the patient had respiratory failure type 2. On 02Jul2021, the patient died. The reporting physician classified the event as serious (hospitalization and 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 physician commented as follows: From 2006, the patient had nontuberculous mycobacterial infection. From 2014, the patient had infection Pseudomonas aeruginosa chronic. Thus, the condition of respiratory function decreased. The possibility could not be ruled out that these diseases were aggravated triggered by the vaccination.; Reported Cause(s) of Death: Respiratory failure type 2; pneumonia; pulmonary nontuberculous mycobacterial infection; bronchiectasis; Infection Pseudomonas aeruginosa chronic; pneumonia, pulmonary nontuberculous mycobacterial infection, bronchiectasis, and infection pseudomonas


VAERS ID: 1524580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: LBPFIZER INC202100955437

Write-up: Pulmonary embolism; This is a spontaneous report from a Pfizer colleague, who has seen this on social media, not sure how accurate it was. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was mentioned that Pulmonary embolism and death occurred to a patient after Pfizer BioNtech COVID-19 vaccine. Event took place after use of product. It was not reported if Autopsy Done. 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: Pulmonary embolism


VAERS ID: 1524588 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202100956038

Write-up: 13-year-old dies after receiving Pfizer vaccine; This is a spontaneous report from a non-contactable consumer received via a Pfizer program. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. It was reported that the 13-year-old patient died after receiving the BNT162B2 vaccine on an unspecified date. It was not reported if an autopsy was performed and the cause of death was not provided. No follow-up attempts possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: 13-year-old dies after receiving Pfizer vaccine


VAERS ID: 1524632 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   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: FLUVOXAMINE; IRBESARTAN; PANTOPRAZOLE; CLOZAPINE; LORAZEPAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:no thrombocytopenia; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202100973243

Write-up: Lung embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number NL-LRB-00640152. A 61-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Jul2021, as single dose (Batch/Lot Number was unknown) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fluvoxamine tablet taken withdrawal for an unspecified indication on an unspecified date; irbesartan (tablet strength 75 mg) taken for an unspecified indication on an unspecified date; pantoprazole (gastro resistant tablet strength 20 mg) taken for an unspecified indication on an unspecified date; clozapine taken for an unspecified indication on an unspecified date; lorazepam taken for an unspecified indication on an unspecified date. The patient had not gotten COVID-19 infection previously. The patient experienced lung embolism on 24Jul2021. The patient underwent lab tests and procedures which included blood test: no thrombocytopenia and CT scan with unknown results on an unspecified date. Lung embolism was treated with heparine. The patient died on 26Jul2021. It was not unknown if an autopsy was performed. The outcome of event was fatal. Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; pulmonary embolism. Additional information ADR: there was no question of thrombocytopenia. BSN available: yes. COVID-19. Previous COVID-19 infection: No. Other, diagnostic procedures: CT scan, blood test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; pulmonary embolism. Additional information ADR: there was no question of thrombocytopenia. BSN available: yes. COVID-19. Previous COVID-19 infection: No. Other, diagnostic procedures: CT scan, blood test.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1524668 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Polymerase chain reaction, Pyrexia, Vaccination site pain
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: 2021-07-17
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: RT-PCR TEST; Result Unstructured Data: Test Result:negative; Test Date: 20210717; Test Name: RT-PCR TEST; Result Unstructured Data: Test Result:postive
CDC Split Type: PHPFIZER INC202100970918

Write-up: difficulty breathing/shortness of breath; fever; Vaccination site pain; RT-PCR test positive, oxygen level down; RT-PCR test postive, oxygen level down; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093266. A 75-year-old male patient received second dose of bnt162b2 (COMIRNATY Solution for injection Batch/Lot Number: FD5996) via intramuscularly on 08Jul2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY Solution for injection Batch/Lot Number: FD5996) via intramuscularly on 17Jun2021 as dose 1, single (at the age of 75-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In 2021 03:00, the patient experienced rt-pcr test postive, oxygen level down. On 10Jul2021 18:00, patient experienced difficulty breathing/shortness. Patient was hospitalized on 12Jul2021. The patient underwent lab tests and procedures which included RT-PCR test resulted negative on 13Jul2021, RT-PCR test resulted as positive on 17Jul2021. The clinical outcome of the event RT-PCR test positive, oxygen level down was fatal, and rest of the events was unknown. The patient died on 17Jul2021 around 3-4am. It was not reported if an autopsy was performed. Cremated on 18Jul2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: RT-PCR test postive, oxygen level down; RT-PCR test postive, oxygen level down


VAERS ID: 1524717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202100931820

Write-up: died 3 days later; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The doctor mentioned that after the vaccination, the patient died 3 days later on an unspecified date. The doctor also specified that they would have preferred the vaccine to be in the form of a pre-filled syringe, so that there would be no dosing errors and mentioned that sometimes 6 doses could not be withdrawn from a vial. In addition, they added that it was complicated to dilute and considered this issue to be a problem, especially when the room might be more than 30 degrees Celsius. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more 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.,Linked Report(s) : RO-PFIZER INC-202100931821 same reporter, suspect product, and event; different patient; Reported Cause(s) of Death: died 3 days later


VAERS ID: 1524718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202100931821

Write-up: died; This is a spontaneous report from a contactable physician. This report was received via a sales representative. This physician reported the same event under the same suspect product for two patients. This is the second of two reports. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The doctor mentioned that after the vaccination one patient died 3 days later, and another patient died in the time between the two doses. The doctor also specified that they would have preferred the vaccine to be in the form of a pre-filled syringe so that there would be no dosing errors and mentioned that sometimes 6 doses could not be withdrawn from a vial. In addition, they added that it is complicated to dilute and considers this issue to be a problem, especially when the room may be more than 30 degrees Celsius. 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.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-202100931820 same reporter, suspect product, and event; different patient; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1524743 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Incorrect route of product administration, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202100960058

Write-up: heart attack; Inappropriate route of vaccination, subcutaneous; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number E-54398317-510.01.05-490739. A 25-year-old male patient (reporter''s relative) received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), via subcutaneous on 18Jun2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on 18Jun2021 and had no health problems, passed away on 21Jun2021 with a heart attack at his home. The patient experienced heart attack (death) on 21Jun2021, inappropriate route of vaccination (subcutaneous) on 18Jun2021. The patient died on 21Jun2021. It was not reported if an autopsy was performed. The outcome of the event heart attack was fatal. The outcome of the event inappropriate route of vaccination was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart attack


VAERS ID: 1525235 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-05-10
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001652 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lung disorder, Lung opacity
SMQs:, Interstitial lung disease (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Ground glass opacity in thoracic CT; Pneumopathy; This regulatory authority case was reported by a physician and describes the occurrence of LUNG OPACITY (Ground glass opacity in thoracic CT) and LUNG DISORDER (Pneumopathy) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001652) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced LUNG DISORDER (Pneumopathy) (seriousness criterion death). On 25-May-2021, the patient experienced LUNG OPACITY (Ground glass opacity in thoracic CT) (seriousness criterion death). The patient died on 02-Jun-2021. The reported cause of death was Ground glass opacity in thoracic CT and Pneumopathy. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-NC20212962 Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority. Both events retained as resulting in death as per Authority report, although the specific cause of death is not clear from the Regulatory Authority; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority. Both events retained as resulting in death as per Authority report, although the specific cause of death is not clear from the ; Reported Cause(s) of Death: Ground glass opacity in thoracic CT; Pneumopathy


VAERS ID: 1525417 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose increased, Condition aggravated, Death, Investigation
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: Diabetes; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: blood glucose; Result Unstructured Data: Test Result:strongly elevated; Test Date: 20210414; Test Name: infection test; Result Unstructured Data: Test Result:free of infections
CDC Split Type: ATPFIZER INC202100954816

Write-up: Condition worsened on the 4th day of stay at the hospital; Blood sugar levels greatly increased; deceased; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number AT-BASGAGES-2021-38112. A 99-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing renal failure and ongoing diabetes mellitus. The patient''s weight was not reported, and height was not reported. The patient''s concomitant medications were not reported. Patient was free of infection at time of vaccination. On 16Apr2021, blood glucose levels strongly elevated, hospitalization. Treatment of the side effect included rapid insulin and fluid administration in hospital, condition improved the next day, condition deteriorated on the 4th day of hospitalisation on 19Apr2021 and died on 20Apr2021. The patient underwent lab tests and procedures which included infection test: free of infections on 14Apr2021. The patient died on 20Apr2021. It was not reported if an autopsy was performed. Cause of death not known. The patient''s outcome was recovering/resolving for blood glucose increased, fatal for death, not recovered/not resolved for condition worsened. Senders comments: Agency-comment: Follow-up information has been requested. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: deceased


VAERS ID: 1525419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypertensive heart disease, Ischaemia
SMQs:, Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100924286

Write-up: Hypertensive heart disease; Ischaemia; Hypertensive heart disease; Ischaemia; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is 584834. A 71-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hypertensive heart disease and ischaemia on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Pfizer is a marketing authorization holder of COVID-19 VACCINE in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 VACCINE has submitted the same report to the regulatory authorities. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Hypertensive heart disease; Ischaemia


VAERS ID: 1525433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-04
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: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100957885

Write-up: passed away; This is a spontaneous report from a contactable consumer (Pfizer colleague). A 35-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Advised by phone from a Pfizer colleague that he had received a phone call earlier on 27Jul2021 from an industry colleague that a friend (of the industry colleague) had passed away. It was noted that the patient was a 35yo female and had received what the industry colleague thought was the bnt162b2 vaccine yesterday (26Jul2021) and had passed away in their sleep sometime between the evening of the 26Jul2021 morning of 27Jul2021. The Pfizer colleague noted that the reporter had mentioned the patient was otherwise well and did not note any pre-existing conditions. The patient died on Jul2021. 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: passed away


VAERS ID: 1525516 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100929854

Write-up: anaphylactic reaction; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reporter stated she has a relative and she had an anaphylactic reaction to the vaccine, and she died on an unspecified date. The outcome of the event was fatal. It was unknown if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: anaphylactic reaction


VAERS ID: 1525526 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-05-09
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9093 / 2 LA / OT

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

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-10
   Days after onset: 62
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100991812

Write-up: Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks; Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks; This is a spontaneous report from a contactable consumer (patient''s mother). This consumer reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), transplacental, administered in Arm Left on 16Jun2021 17:15 (Batch/Lot Number: FA9093) as dose 2, single, transplacental, administered in Arm Right on 09May2021 17:30 (Batch/Lot Number: EW0193) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The mother is a 37-year-old female, last menstrual period date (22Apr2021), Pregnancy Due Date (27Jan2022). Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic Administration facility. Mother had missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment was given. The patient died on 10Jul2021. It was not reported if an autopsy was performed.; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-202100941550 baby case; Reported Cause(s) of Death: Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks; Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks


VAERS ID: 1525533 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Low density lipoprotein, Sudden death, Vaccination site pain
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: 2021-05-01
   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: PRADIF; VALSARTAN/HCT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (treated, well-controlled); Low density lipoprotein increased; Nicotine abuse; Overweight
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:29; Test Name: LDL; Result Unstructured Data: Test Result:4.44
CDC Split Type: CHPFIZER INC202100961682

Write-up: pain in the area of the injection site on the left arm; unclear case of death; This is a spontaneous report. A 69-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown), at the age of 69 years old, via intramuscular in left arm on 25May2021 at 11:25 at single dose for COVID-19 immunisation. Medical history (cardiovascular risk factors, CVRF) included body mass index (BMI) 29, nicotine abuse, low density lipoprotein (LDL) 4.44, arterial hypertension (treated, well-controlled). Concomitant medications included tamsulosin hydrochloride (PRADIF) and hydrochlorothiazide, valsartan (VALSARTAN/HCT). The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 69 years old, via intramuscular on 27Apr2021 at single dose for COVID-19 immunisation and was tolerated without complications. External anamnesis showed pain in the area of the injection site on the left arm on 26May2021. The patient died during the night between 26May2021 21:00 and 27May2021 8:00. The patient experienced sudden death; death treated as potentially unnatural; autopsy ordered by coroner; unexplained death. Swissmedic assessed this case as serious (results in death). The patient underwent lab tests and procedures which included BMI: 29, LDL: 4.44 on an unspecified date. An autopsy was performed and results were not provided. The outcome of the event unclear case of death was fatal. The outcome of the event pain in the area of the injection site was unknown. A causal relationship between BNT162B2 and "sudden death, cause unknown" and "injection site pain" was assessed by Swissmedic according to WHO as being possible. Sender''s comment (Swissmedic): In this unclear death, which was designated as sudden death according to the primary reporter and which was treated as potentially unnatural, there was suspected drug-induced reaction after 2nd vaccination with COVID-19 mRNA vaccine (BNT162B2). The Swiss SPC for BNT162B2 did not list death of unknown cause or a fatal course of event listed under various organ classes. In the WHO database on single case reports (VigiBase, accessed via VigiLyze), 887 reports were found (accessed 22Jun2021) on the association of "TN: BNT162B2" with preferred term "death", of which 203 reports were on low level term "unknown cause of death". The number of reports was lower than statistically expected. In this case, an autopsy had been ordered by the forensic medicine. No further data are available in this regard. Evidence for the presence of other possible drug triggers was not reported. The causal relationship for death of unknown cause was judged as possible for BNT162B2 according to the criteria of Swissmedic in case of plausible temporal correlation and missing data on the findings of the ordered autopsy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unclear case of death


VAERS ID: 1525534 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Cold sweat, Decreased appetite, Dyspnoea, General physical health deterioration, Nausea, Oxygen saturation decreased, Pyrexia, Respiratory rate increased, Restlessness, Somnolence, Unresponsive to stimuli, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications: ELIQUIS; MARCOUMAR; ALDACTONE [SPIRONOLACTONE]; BILOL; DEXILANT; DONEPEZIL; LEFLUNOMIDE; ALLOPURINOL; TORASEMIDE; VITAMIN D3; VITARUBIN [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic; Chronic renal failure; COVID-19; Deep vein thrombosis; Dementia (development); Gastroesophageal reflux disease; Gout; Granulomatous liver disease; Heart failure; Pneumonia; Seronegative rheumatoid arthritis; Thromboembolic event (unprovoked thromboembolic events with pneumonia both sides and 3-story deep vein thrombosis); Upper gastrointestinal bleeding (for gastroesophageal reflux ulcer (under anticoagulant with Marcoumar)); Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: auscultatory; Result Unstructured Data: Test Result:breath sounds variable in- and expiratory; Comments: breath sounds variable in- and expiratory (a.e. secretion), no obstruction, no definite infiltrate; Test Date: 20210423; Test Name: temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: status subfebrilis; Test Date: 202105; Test Name: temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: In the night, dropped; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: morning; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: around 16:00; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:40.2 Centigrade; Comments: 18:00; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: 19:00; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Comments: 21:15; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Comments: 21:30; Test Date: 20210520; Test Name: Heart rate; Result Unstructured Data: Test Result:115/min; Comments: 18:00; Test Date: 20210520; Test Name: Heart rate; Result Unstructured Data: Test Result:98/min; Comments: 19:00; Test Date: 20210520; Test Name: Heart rate; Result Unstructured Data: Test Result:45/min; Comments: 21:15, during few minutes according to nurses; Test Date: 20210520; Test Name: Heart rate; Result Unstructured Data: Test Result:85/min; Comments: 21:30; Test Date: 202105; Test Name: SpO2; Result Unstructured Data: Test Result:81-88 %; Comments: In the night; Test Date: 20210520; Test Name: SpO2; Test Result: 57 %; Comments: approximately 17:20; Test Date: 20210520; Test Name: SpO2; Test Result: 66 %; Comments: below 6l/min O2 administration via mask; Test Date: 20210520; Test Name: SpO2; Test Result: 80 %; Comments: 19:00, under 9L O2 administration via mask; Test Date: 20210520; Test Name: SpO2; Test Result: 88 %; Comments: 21:15; Test Date: 20210520; Test Name: Respiratory rate; Result Unstructured Data: Test Result:$g40/min; Comments: 18:00; Test Date: 20210520; Test Name: Respiratory rate; Result Unstructured Data: Test Result:36/min; Comments: 19:00; Test Date: 20210520; Test Name: Respiratory rate; Result Unstructured Data: Test Result:28/min; Comments: 21:30
CDC Split Type: CHPFIZER INC202100961646

Write-up: restlessness; cold sweaty; unresponsive; Respiratory rate $g 40/min, 36/min, 28/min; dyspnea/rapidly increasing dyspnea; saturation drop to SpO2 57%/66%/80% (under 9l O2 administration via mask)/88%/from 88% to 81%; temperature 38.3C/40.2C/39C/38.8C/38.2C; vomiting of previously drunk fluid; mild general condition decrease; loss of appetite (lunch); somnolent, unable to awaken; nausea; This is a spontaneous report received from a contactable physician via Regulatory Agency, the regulatory authority. Regulatory authority report number CH-SM-2021-16726. This physician reported different dose and events for the same patient. This is the first of two reports-regarding the second dose. A 87-year-old male patient (resident of a nursing home) received the second dose of BNT162B2 (COMIRNATY, lot number: unknown), at the age of 87 years old, via intramuscular on 19May2021 at 11:00 at 0.3 ml single dose for COVID-19 immunisation. Prior to vaccination, the patient had been in good general health. Medical history included unprovoked thromboembolic events from 2014 (Status after unprovoked thromboembolic events with pneumonia both sides and 3-story deep vein thrombosis 2014), pneumonia both sides from 2014, 3-story deep vein thrombosis from 2014, heart failure, gastroesophageal reflux ulcer, anemic upper gastrointestinal bleed from 23Apr2021 (for gastroesophageal reflux ulcer ,under anticoagulant with Marcoumar), seronegative erosive rheumatoid arthritis, granulomatous sclerosing hepatitis of unclear etiology, gout, chronic renal failure, vitamin B12 deficiency, dementia (development), COVID-19 from Dec2020 and allergies: Co-Amoxi (diarrhea immediately). Concomitant medications included apixaban (ELIQUIS, strength: 5 mg) orally at 5mg 2x/d from 02May2021 to 20May2021; phenprocoumon (MARCOUMAR) orally until 24Apr2021; spironolactone (ALDACTONE, strength: 25 mg) orally at 25mg 1x/d from 11Aug2020 to 20May2021; bisoprolol fumarate (BILOL, strength: 1.25 mg) orally at 1.25mg 1x/d from 12Dec2018 to 20May2021; dexlansoprazole (DEXILANT, strength: 60 mg) orally at 60mg 1x/d from 02May2021 to 20May2021; donepezil (strength: 10 mg) orally at 10mg 1x/d from 16Sep2018 to 20May2021; leflunomide (strength: 10 mg) orally at 10mg 1x/d from 17Sep2018 to 20May2021; allopurinol (strength: 150 mg) orally at 150mg 1x/d from 16Sep2018 to 20May2021; torasemide (strength: 10 mg) orally at 10mg 1x/d from 20Oct2020 to 20May2021; colecalciferol (VITAMIN D3, strength: 10 drop) orally at 10drop 1x/d from 18Oct2018 to 20May2021; cyanocobalamin (VITARUBIN , strength: 1000 ug, also reported as 1000 mcg) subcutaneously at 1000ug every 3 months from 03Jul2019 to 20May2021. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 87 years old, via intramuscular on 22Apr2021 at 0.3 ml single dose for COVID-19 immunisation. Approximately 3 to 4 days after vaccination, on 23Apr2021, the patient occurred emesis (with fresh blood, under Marcoumar) with gastroesophageal ulcer and status subfebrilis (37.8C). According to the primary reporter, these complaints could also be interpreted as a vaccination reaction, since the symptoms (status febrilis and emesis) occurred within 24 hours after the first and second administration of BNT162B2, respectively. On 20May2021 morning, temperature 35.6C. Late morning on 20May2021, nurses noticed mild general condition decrease and loss of appetite (lunch); around 16:00, temperature 38.3C and vomiting of previously drunk fluid. Administration of paracetamol (DAFALGAN) 600mg supp. around 15:30. In the course dyspnea and saturation drop to SpO2 57%, gray color, cool periphery approximately at 17:20. Administration of 6L O2 via mask. At 18:00 (first home visit), temperature 40.2C, respiratory rate $g 40/min, heart rate 115/min; SpO2 66% below 6l/min O2 administration via mask; auscultatory breath sounds variable in- and expiratory (a.e. secretion), no obstruction, no definite infiltrate. Patient experienced somnolent, unable to awaken and integument without evidence of exanthem. Patient positioning (cardiac position), covering patient. Physical fever reduction by cool wash down, cool compresses groin/calf; O2 increased to 9l/min. Fractionated 2 x 2.5mg morphine subcutaneous and 0.5mg haloperidol (HALDOL) subcutaneous for nausea. 500 ml NaCl subcutaneous with 44 ml/h infusomat (500 ml/12h). At 19:00 (reported as 09:00), temperature 39C; respiratory rate 36/min; heart rate 98/min; SpO2 80% (under 9l O2 administration via mask); patient briefly wakeable (open eyes). At 21:15, the patient experienced cold sweaty, unresponsive; temperature 38.8C; heart rate 45/min (during few minutes according to nurses); SpO2 88%. At 21:30 (second home visit), temperature 38.2?; respiratory rate 28/min; heart rate 85/min; patient briefly wakeable (open eyes with facial expression); dyspnea objectively better (fewer subcostal retractions, deeper breaths, calmer rate). In the night of May2021 according to night nurse, temperatures dropped (to 37.2C) and SpO2 saturations from 88% to 81%, wakeability documented. On 21May2021 around 04:45, the patient experienced restlessness, rapidly increasing dyspnea. Rapid death with onset of death on 21May2021 at 05:20. Fatal adverse event according to primary notifier: General condition decrease and appetite loss, within a few hours status febrilis to maximum temperature 40.2 degree celcius, vomiting, dyspnea. Autopsy determination of cause of death was refused by relatives. Sender''s Comment: The causal relationship for the fatal complaints (status febrilis, vomiting, dyspnea) after the second administration of BNT162B2 was judged to be possible according to Regulatory Agency criteria with plausible temporal correlation, unreported evidence for the presence of clinical causes and no autopsy determination of the cause of death. The causal relationship for the complaints (vomiting, status subfebrilis) after the first administration of BNT162B2 was also judged to be possible with plausible temporal correlation and the presence of a clinical cause that cannot be ruled out (gastrointestinal bleeding with known gastroesophageal reflux ulcer). The extent to which the chronology suggests the presence of immune-mediated reactions remains speculative. A causal relationship between BNT162B2 and reduced general condition, appetite lost, vomiting, fever and dyspnea was assessed as possible. Regulatory Authority assessed this case as serious (medically significant and fatal outcome). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-202100962493 Same reporter, same patient, different event, different drug/dose; Reported Cause(s) of Death: loss of appetite (lunch); vomiting of previously drunk fluid; temperature 38.3C/40.2C/39C/38.8C/38.2C; mild general condition decrease; dyspnea/rapidly increasing dyspnea


VAERS ID: 1526404 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: TEE; Result Unstructured Data: Test Result:Malfunction of the mechanical aortic valve with ao; Comments: Malfunction of the mechanical aortic valve with aortic stenosis (grade III) and aortic insufficiency (grade III); Test Name: INR; Result Unstructured Data: Test Result:18,081; Test Name: platelets; Result Unstructured Data: Test Result:low
CDC Split Type: DEPFIZER INC202100928187

Write-up: Dyspnea two days after vaccination; Malfunction of the mechanical aortic valve with aortic stenosis (grade III) and aortic insufficiency (grade III); suspicion of thrombosis of the aortic replacement; laboratory INR $g 7; low normal platelets; progressive cardiogenic shock; This is a literature spontaneous report 2021, 7; 52-55 entitled INR Changes after COVID-19 VACCINATION. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. In an 80-year-old woman hospitalized with suspected myocardial infarction. Five days and two weeks after vaccination with the mRNA vaccine from BioNTech/Pfizer (BNT162b2; COMIRNATY) an INR of greater than 7 was determined at admission (18,081). To what extent the acute diseases may have influenced the INR value remains unclear. Reported adverse events for this patient:- Dyspnea two days after vaccination- Hospital admission five days after vaccination, here echocardiographic (TEE) Malfunction of the mechanical aortic valve with aortic stenosis (grade III) and aortic insufficiency (grade III), - suspicion of thrombosis of the aortic replacement - laboratory INR $g 7 - low normal platelets - in the course progressive cardiogenic shock - Exitus lethalis six days after vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. This information on side effect originates from a spontaneous reporting system (NETWORK OF MUTUAL INFORMATION). The reports show, from the point of view of the reporter, abnormal or unexpected events of the treatment, which are associated with drug therapy. Therefore, events associated with drug therapy are recorded, without causality having been proven or verified (suspected reports). It is also not possible to draw conclusions from these data regarding the frequency of occurrence of these adverse effects assigned to the drugs. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The Company cannot completely exclude the possible causality between the reported events Dyspnoea, Aortic stenosis, Thrombosis, International normalised ratio increased, Platelet count decreased, Cardiogenic shock and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. Additional information is needed to better assess the case, including complete medical history, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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: progressive cardiogenic shock; Platelet count decreased; INR increased; Thrombosis; Aortic stenosis; Dyspnea


VAERS ID: 1526434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-11
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100956137

Write-up: stroke; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported), at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced stroke on 11Apr2021 and died on 26Apr2021. The outcome of event stroke was fatal. It was unknown if the autopsy was done. The event stroke occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stroke


VAERS ID: 1526436 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-05
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D018A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100962389

Write-up: sinus vein thrombosis; This is a spontaneous report received by Pfizer from Biontech (manufacturer control number: 76161), license party for COMIRNATY. Contactable reporter reported for a 36-years-old male patient, received COMIRNATY (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 (Lot Number: 1D018A expiry date was not reported) via an unspecified route of administration on 11Jun2021 as a dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine COMIRNATY (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection dose 1 (Lot number EX8680 and expiry date not reported) via unspecified route of administration on 12May2021 as a single dose for covid-19 immunisation.On 05Jul2021 the patient experienced fulminant sinus venous thrombosis without thrombocytopenia, The patient died on 09Jul2021 and the cause of death was sinus vein thrombosis, It was not reported if an autopsy was unknown. No follow-up attempts are possible. No further information is expected. ; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Cerebral Venous Sinus thrombosis and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: sinus vein thrombosis


VAERS ID: 1526457 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial (HTA)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100960420

Write-up: death, there is no other clinic; Overdose vaccine administered; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, ES-AEMPS-836109 via RA. A 78-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EW2246) via intramuscular on 13Apr2021 at age of 78 years old as 0.5 ml single for COVID-19 immunisation. Medical history included hypertension arterial (HTA). Concomitant medications were unknown. The patient experienced death, there is no other clinic on the 16Apr2021. Overdose vaccine administered. It was communicated for knowledge purposes. The ultimate cause of death (judicial autopsy) was being studied. The patient suffered sudden death on 16Apr2021, when the medical services arrived, the patient was lying in bed. No vital signs on examination. Presented lividities on exploration. Rhythm strip was performed. Outcome of the event death, there is no other clinic was fatal.; Reported Cause(s) of Death: sudden death


VAERS ID: 1526646 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cholecystectomy; Tobacco user; Comments: tabac hta cholecystectomie
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100948996

Write-up: Death sudden; chest pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-MA20212801. A 66-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly on 15Jul2021 (Lot Number: FE2296) as DOSE 2, SINGLE at age of 66-year-old for COVID-19 immunisation. Medical history included tobacco user, arterial hypertension, cholecystectomy, from an unknown date. Concomitant medication(s) included enalapril (ENALAPRIL) taken for an unspecified indication, start and stop date were not reported, doubt about ENALAPRIL (patient has not consulted from more than 12 months). The patient experienced death sudden on 19Jul2021. According to his partner patient complained to chest pain since the day before (18Jul2021). The patient died on 19Jul2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1526647 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-07-09
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-tobacco user (for 20 years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100948999

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB [FR-AFSSAPS-MA20212804]. A 58 years old male patient of an unspecified age received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 26May2021 at the age of 57 years old (Batch/Lot Number: FA5831) as single dose for covid-19 immunisation. Medical history included Smoking cessation for 20 years, no current treatment, no known cardiovascular history. The patient''s concomitant medications were not reported. The patient vaccinated with bnt162b2 on 25Jun2021 (as reported), and presented on 09Jul2021 i.e. 6 weeks after vaccination, a cardiorespiratory arrest. Death occurred suddenly at work, no etiology found. Cyanotic patient. 2 electric shocks by DSA (semi-automatic defibrillator). Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number) 45 days (as reported). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1526665 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Pulmonary malformation, Ultrasound scan
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-05-28
   Days after onset: 45
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: 20210528; Test Name: echography; Result Unstructured Data: Test Result:pulmonary malformation/2 pulmonary spots/lung spot
CDC Split Type: FRPFIZER INC202100948992

Write-up: pulmonary malformation/2 pulmonary spots/lung spot; 3 weeks of amenorrhea +2 days exposed of vaccination with the COMIRNATY vaccine in its mother; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NY20212786. This nurse reported information for both mother and fetus/baby. This is a fetus report. Spontaneous Report (regulatory authority Local Reference number: 2021093455), Initial information received on 11Jul2021, from an health professional (nurse) to the regulatory authority. A fetus of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 13Apr2021 (Lot Number: EW2239) as single dose for immunisation against sars-cov-2. The fetus medical history was not specified. Concomitant medications were not reported. The mother was pregnant while receiving bnt162b2. The mother''s last menstrual period date was 20Mar2021, and the mother was due to deliver on 25Dec2021. The fetus was exposed of vaccination with the comirnaty vaccine in its mother on 13Apr2021, at 3 weeks and 2 days of amenorrhea (first-trimester). On 28May2021, the fetus had a pulmonary malformation on echography (pulmonary malformation/2 pulmonary spots/lung spot), which resulted in fetus''s congenital anomaly and death. Lab tests and procedures included ultrasound: pulmonary malformation/2 pulmonary spots/lung spot on 28May2021. Miscarriage of the mother on the same day (28May2021) which required the mother''s hospitalization. The fetus died on 28May2021. It was unknown if an autopsy was performed. The outcome of the event pulmonary malformation/2 pulmonary spots/lung spot (also reported malformation foetale) was fatal. Reporter comment: Discovery on ultrasound of 2 pulmonary spots in a fetus of 9 weeks of amenorrhea + 6 days, 3 weeks of amenorrhea +2 days exposed of vaccination with the COMIRNATY vaccine in its mother (1st vaccination, batch not specified). Miscarriage the same day. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Discovery on ultrasound of 2 pulmonary spots in a fetus of 9 weeks of amenorrhea + 6 days, at 3 weeks of amenorrhea + 2 days exposed to the vaccination with the COMIRNATY vaccine in its mother (1st vaccination, batch not specified). Miscarriage the same day.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100949216 fetus/mother case, same vaccine, different events; Reported Cause(s) of Death: pulmonary malformation/2 pulmonary spots/lung spot


VAERS ID: 1526683 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   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: ELIQUIS; LANSOPRAZOLE; ATORVASTATIN; AMLODIPINE; AMIODARONE; BISOPROLOL; RAMIPRIL; FUROSEMIDE; DIFFU K; PAROXETINE; ZYMAD; BROMAZEPAM; TOVIAZ; DITROPAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Atrial fibrillation; Cholecystectomy; Chronic renal insufficiency; Claudication; Coronary stent user; Diphtheria; Dyslipidaemia; Ex-tobacco user; Horton''s disease; Hypertension arterial (HTA); Ischaemic heart disease (ACS (acute coronary syndrome) ST- ischemic heart disease in the lower territory in 2011); Lower urinary tract infection; Lung edema; Peripheral arterial disease; Total knee replacement; Type 2 diabetes mellitus; Umbilical hernia repair
Allergies:
Diagnostic Lab Data: Test Name: coronary angiography; Result Unstructured Data: Test Result:intra-stent thrombosis of the right coronary...; Comments: ...artery balloon dilation then loading dose + heparin therapy + cangrelor + tirofiban; Test Name: baseline creatinemia; Result Unstructured Data: Test Result:158 umol/l; Test Name: ECG; Result Unstructured Data: Test Result:no clear signs of ischemia; Test Name: Troponinemia; Result Unstructured Data: Test Result:0.13 ng/ml
CDC Split Type: FRPFIZER INC202100948978

Write-up: Arrest cardiac; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-PP20211057. A 75-years-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 07Jul2021 at age of 75 years old (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, single for covid-19 immunisation. Medical history included weaned tobacco, Hypertension arterial (HTA), Dyslipidemia, Type 2 diabetes since 2014, SCA ST- ischemic heart disease in the lower territory in 2011, bare stent on the right coronary artery, Peripheral arterial disease (PAD) known since 2017 with vascular claudication on exertion, Chronic renal insufficiency (CRI) on probable nephroangiosclerosis with baseline creatinemia at 158 micro-mol / L, Atypical Horton''s disease with thoracic aortitis diagnosed in 2015, Repeated lower urinary tract infections, Diphtheria at 3 years, Total knee replacement Sep2020, Appendectomy in 1963, Umbilical hernia treatment in 1995, Cholecystectomy in 2000, ALE (acute lung edema) on transition to rapid atrial fibrillation, minimal ischemic part probable in Apr2021. Concomitant medication(s) included apixaban (ELIQUIS); lansoprazole; atorvastatin; amlodipine; amiodarone; bisoprolol; ramipril; furosemide; potassium chloride (DIFFU K); paroxetine; colecalciferol (ZYMAD); bromazepam; fesoterodine fumarate (TOVIAZ); oxybutynin hydrochloride (DITROPAN), all taken for an unspecified indication, start and stop date were not reported. Patient presenting with cardiac arrest due to intrastent coronary stenosis immediately after (5 min) on 07Jul2021 of a COVID 19 vaccine booster. The same day, immediately after the injection (delay = 5 min), discomfort without prodrome then cardio-respiratory arrest quickly recovered after injection of adrenaline (1 mg) and the installation of a DSA (1 shock delivered initially)On 12Jul2021, the patient died of Multiple organ failure (multivisceral complications) and massive hemoptysis secondary to cardiogenic and vasoplegic shock. Discussion/conclusion of our analysis: Chronological, semiological and bibliographical data are not very suggestive of the role of vaccination against covid19 in the occurrence of this intrastent thrombosis of the right coronary artery in this polyvascular context. However, the very short time between the event and the injection (5 min) does not formally rule out the participation (coincidence?) Of the vaccination as a factor that may have favored this intra-stent thrombosis complicated by cardiac arrest. (arterial hypotension?). The patient underwent lab tests and procedures which included Electrocardiogram (ECG): no clear signs of ischemia, Troponinemia: 0.13 ng / mL, Coronary angiography: intra-stent thrombosis of the right coronary artery balloon dilation then loading dose + heparin therapy + cangrelor + tirofiban, baseline creatinemia at 158 micro-mol / L. The patient died on 12Jul2021. An autopsy was not performed. Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures" Official Bulletin of the Minister in charge of Health n ? 84/50, 24 January 1985. Published in Therapy 1985; 40: 111-8 No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Multiple organ failure; massive hemoptysis; cardiogenic shock; vasoplegic shock; cardiac arrest


VAERS ID: 1527131 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Brain injury, Cardiac arrest, Circulatory collapse, Computerised tomogram head, Computerised tomogram spine, Computerised tomogram thorax, Electrocardiogram, Lung consolidation, Post cardiac arrest syndrome, Rib fracture, SARS-CoV-2 antibody test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Osteoporosis/osteopenia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Head CT; Result Unstructured Data: Test Result:Showed hypoxic ischaemic brain injury*; Test Name: Computerised tomogram spine; Result Unstructured Data: Test Result:Unknown; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:Unknown; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Suspicious of acute myocardial infarction; Test Name: Covid-19 test; Test Result: Negative ; Comments: Negative
CDC Split Type: GBPFIZER INC202100962182

Write-up: Brain injury; Bilateral chest consolidation; rib fractures; suspicious of acute myocardial infarction; cardiac arrest; Post cardiac arrest syndrome; Circulatory collapse; This is a spontaneous report from a contactable physician. This report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107261205489830-B4UXP. Safety Report Unique Identifier GB-MHRA-ADR 25706684. A 53-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 19Jul2021 with unspecified Batch/Lot number was not reported as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Patient previously well. Not known to have sought any medical assistance from general practitioner (GP) or secondary care in last few years. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest (cardiac arrest) (death) on 22Jul2021, post cardiac arrest syndrome (post cardiac arrest syndrome) (death) on 22Jul2021, circulatory collapse (circulatory collapse) (death) on 22Jul2021, brain injury (brain injury) (death) on an unspecified date. The patient died on 23Jul2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included computerised tomogram head: showed hypoxic ischaemic brain injury*, computerised tomogram spine, computerised tomogram thorax: unknown, electrocardiogram: suspicious of acute myocardial infarction, SARS-CoV-2 antibody test: negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient had possibly first COVID vaccination on 19th July. Found collapsed at work on 22nd July in cardiac arrest. Electrocardiogram (ECG) suspicious of acute myocardial infarction but remained too unstable for angiogram for definitive diagnosis or treatment. CT head showed hypoxic ischaemic brain injury. (Bilateral chest consolidation likely secondary to aspiration and rib fractures likely due to CPR). The report did not consider the report relate to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .; Reported Cause(s) of Death: Post cardiac arrest syndrome; suspicious of acute myocardial infarction; Brain injury; Circulatory collapse; cardiac arrest


VAERS ID: 1527174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-05-31
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ischaemia, Multiple organ dysfunction syndrome, Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (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), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100961730

Write-up: Multiple organ failure; Heart attack; Ischaemia; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202107262018076890-ZV5BM], Safety Report Unique Identifier [GB-MHRA-ADR 25710182]. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced heart attack on 31May2021, ischaemia on 31May2021, multiple organ failure on 01Jun2021. Case narrative: Heart attack, ischaemia and multiple organ failure. Patient was not enrolled in clinical trial. The events were reported as serious due to death. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on unknown date. The patient died on 01Jun2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Heart attack; Ischaemia; Multiple organ failure


VAERS ID: 1527200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound foetal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: pregnancy scans; Result Unstructured Data: Test Result:embreo stopped growing; Comments: 2 weeks after vaccination
CDC Split Type: GBPFIZER INC202100962151

Write-up: vaginal bleeding; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107271445109040-AIR2K. Safety Report Unique Identifier (GB-MHRA-ADR 25714872). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jun2021 (Batch/Lot number was not reported) single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced vaginal bleeding on an unspecified date, miscarriage of pregnancy on 24Jun2021. One week post Covid-19 Pfizer vaccination, vaginal bleeding occurred, and based on pregnancy scans, the embreo stopped growing 2 weeks after vaccination subsequently causing a missed miscarriage. Outcome of vaginal bleeding was resolved. The patient died on 24Jun2021 due to miscarriage of pregnancy. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: miscarriage of pregnancy


VAERS ID: 1527306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alcohol poisoning, Myocardial ischaemia
SMQs:, Depression (excl suicide and self injury) (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202100949591

Write-up: ACUTE INTOXICATION; ISCHAEMIC HEART DISEASE; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS002821), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. The 50-year-old male patient received the Tozinameran (COMIRNATY, solution for injection) (lot number: unknown) via unspecified route of administration on an unknown date at unspecified dosing frequency for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient died on an unknown date. The patient had received COVID-19 vaccines within 14 days before passing away. There was no clinical evidence that the incident arose from vaccination. The preliminary autopsy revealed that the cause of death could potentially be acute intoxication or ischaemic heart disease. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: ISCHAEMIC HEART DISEASE; acute intoxication


VAERS ID: 1527352 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Dyspnoea, Hypopnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 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: HRPFIZER INC202100955417

Write-up: shortness of breath / shortness of breath; abdominal pain; fever / temperature; fever; shallow breathing; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number HR-HALMED-300049644. A 76-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 03Jul2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shortness of breath / shortness of breath (dyspnoea) (death) on 07Jul2021, abdominal pain (abdominal pain upper) (death) on 07Jul2021 , fever / temperature (pyrexia) (death) on 07Jul2021, fever (chills) (death) on 07Jul2021, shallow breathing (hypopnoea) (death) on 07Jul2021. The patient died on 08Jul2021. It was not reported if an autopsy was performed. Causality was unassessable/Unclassifiable. Senders comment: 23Jul2021: Additional documentation will be requested. Information on the lot/batch number has been requested.; Reporter''s Comments: 23Jul2021: Additional documentation will be requested.; Reported Cause(s) of Death: Unknown cause of death; Shortness of breath; Stomach pain; fever; Rigors; Breathing shallow


VAERS ID: 1527638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac failure, Dizziness, Headache, Pneumonia aspiration, Vertigo
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 28
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; Parkinson''s disease; Polyneuropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100948905

Write-up: After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis/vertigo; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-759514. An 80-years-old male patient received BNT162B2 (COMIRNATY; formulation: Solution for injection, Lot Number: EW2246 expiry date was not reported) dose 1 via intramuscular route of administration on 09Apr2021 as dose 1, single dose for covid-19 immunisation. Medical history included polyneuropathy, hypertension, Parkinson''s disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 16Apr2021 (after 7 days vaccination), the patient experienced dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis/vertigo. The patient died on 14May2021. The patient died due to events dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis and vertigo. It was not reported if an autopsy was performed. Sender''s comments: request report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After


VAERS ID: 1527643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain
SMQs:, Retroperitoneal fibrosis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 5
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: Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100954753

Write-up: Started having back pain after vaccination; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-759801. A 88-year-old female patient received bnt162b2 (COMIRNATY), via intramuscular, administered in right arm (right shoulder) on 01Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included osteoporosis. The patient had no history of Covid-19. The patient''s concomitant medications were not reported. The patient experienced started having back pain on 06Apr2021 after vaccination. The condition was notified treating physician and impact on quality of life (10/10). Vaccine done on 01Apr2021. No major pathology. The patient lived alone, 100% autonomous. The reporter did not know if there are any contributing causes. The patient''s family doctor, by telephone, had prescribed DICLOFENAC for these severe pains that had come to her a few days after the vaccination. The ''autopsy examination'' was not performed. The lot/batch number was unknown. The patient died in Apr2021. An autopsy was not performed. The outcome of event back pain was fatal. Senders comment: Follow-up in progress: date of vaccine administration, batch number, clinical report, autopsy examination No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Osteoporosis; Reported Cause(s) of Death: Started having back pain after vaccination


VAERS ID: 1527650 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-06-12
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7065 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Apraxia, Coma, Microbiology test, Myocarditis, Sepsis, Ventricular dysfunction
SMQs:, Cardiac failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 30
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: Amyloidosis; Hypertension arterial; IGG myeloma
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Infectious findings; Test Result: Negative ; Comments: Infectious findings were negative
CDC Split Type: ITPFIZER INC202100954732

Write-up: septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; This is a spontaneous report from a contactable physician downloaded from the Agency EudraVigilance-WEB, regulatory authority number IT-MINISAL02-760101. A 59-year-old male patient received bnt162b2 (COMIRNATY) (also reported "COVID 19 Comirnaty vaccine Pfizer"), dose 1 intramuscular, administered in Arm Left (also reported left shoulder) on 17May2021 12:10 (Lot Number: EY7065) as single dose for covid-19 immunisation. Medical history included hypertension arterial from an unknown date and unknown if ongoing; amyloidosis from 01Nov2020 and unknown if ongoing; and IGG myeloma from 01Nov2020 and unknown if ongoing. Concomitant medications were not reported. On 12Jun2021, the patient experienced septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction, which reported as resulted in death. Contacted the reporter for the clinical report that will be attached in a Network. Therapeutic measures were taken as a result of the events: inotropic support, antimicrobial therapy, mechanical circulatory support, ventilatory support. The patient died on 12Jul2021. It was unknown if an autopsy was performed. Sender comment: updated on 22Jul2021: the referring physician who provides the attached clinical report contacted. Reporter comment: The patient died in privacy after a prolonged hospitalization at the privacy hospital. Infectious findings were negative and no clear cause for severe neurological impairment and subsequent myocarditis was identified. The vaccine (we only know that it was mRNA) was administered on 17May2021 probably in privacy. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The patient died in PRIVACY after a prolonged hospitalization at the privacy hospital. Infectious findings were negative and no clear cause for severe neurological impairment and subsequent myocarditis was identified. The vaccine (we only know that it was mRNA) was administered on 17May2021 probably in privacy.; Reported Cause(s) of Death: Myocarditis; Coma; Ideomotor apraxia; Ventricular dysfunction; septic state of unknown cause


VAERS ID: 1527655 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-06-07
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Ascites, Asthenia, Cardiac failure, Diarrhoea, Hepatic failure, Oedema peripheral, Pleural effusion, Pyrexia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 39
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: Cirrhosis liver; Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100955000

Write-up: Violent diarrhoea; fever; asthenia; renal failure; cardiac and hepatic decompensation; hepatic decompensation; limb oedema; ascites; pleural effusion; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-760679. A 77-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Apr2021 (at unknown age) as single dose for COVID-19 immunisation. Medical history included Cirrhosis, cardiopathic. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY), as single dose for COVID-19 immunisation, After 48 hours from the first dose he has a bellyache, nausea, tremors and diarrhoea. On 07Jun2021, The patient experienced violent diarrhoea with fever and asthenia, followed by hospitalization with renal failure, cardiac and hepatic decompensation as well as limb oedema, ascites and pleural effusion (death, hospitalization). It was unknown if Autopsy Done. The patient died on 16Jul2021. Actions taken (Admissions to different hospitals without any improvement.) No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202100960191 same patient, different events for 1st dose of Comirnaty; Reported Cause(s) of Death: violent diarrhoea; fever; asthenia; renal failure; cardiac and hepatic decompensation; cardiac and hepatic decompensation; limb oedema; ascites; pleural effusion


VAERS ID: 1527657 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004499 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   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: Dercum''s disease; Diabetes mellitus; Hypertension; Renal dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH and CARDIAC ARREST in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004499) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Dercum''s disease, Renal dialysis and Diabetes mellitus. On 16-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 20-Jul-2021, the patient experienced SUDDEN DEATH (seriousness criteria death and medically significant) and CARDIAC ARREST (seriousness criteria death and medically significant). The patient died on 20-Jul-2021. The reported cause of death was. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. This a report of dead 4 days after receiving the product in a 57-years old patient with concomitant Hypertension, Diabetes mellitus, Dercum''s disease and Renal dialysis. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This a report of dead 4 days after receiving the product in a 57-years old patient with concomitant Hypertension, Diabetes mellitus, Dercum''s disease and Renal dialysis. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death.


VAERS ID: 1527661 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-09
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction (10 years ago); Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100954662

Write-up: death. Unexpected death. Cardiocirculatory arrest. Before, he was fit and well.; Cardiocirculatory arrest; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-760951. A 83-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 29Apr2021 09:46 (Batch/Lot Number: EX7389; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included prostate cancer, acute myocardial infarction 10 years ago. The patient''s concomitant medications were not reported. The patient experienced death. unexpected death. cardiocirculatory arrest. before, he was fit and well on 09May2021.The patient died on 09May2021. It was not reported if an autopsy was performed. Outcome of events was fatal. Sender comment: Dr. PRIVACY reports death in the kitchen during a meal. No family members present. She will send any death certificates and a report of her in the next week. It also refers to Acute myocardial infarction (10 years ago) and prostate cancer. A report for the precise medical history is awaited. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiocirculatory arrest


VAERS ID: 1527663 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214003 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Bradycardia, Hypotension, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RANEXA; PRADAXA; CRESTOR; TRITTICO; SILODYX; LANOXIN; CIPROXIN [CIPROFLOXACIN HYDROCHLORIDE]; TOUJEO; DOBETIN [CYANOCOBALAMIN]; APIDRA; BINOCRIT
Current Illness:
Preexisting Conditions: Comments: No relevant medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of BRADYCARDIA, ASTHENIA, VOMITING, PYREXIA, and HYPOTENSION in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214003) for COVID-19 vaccination. No relevant medical history was reported. Concomitant products included RANOLAZINE (RANEXA) from 10-Jun-2021 to 16-Jul-2021, DABIGATRAN ETEXILATE MESILATE (PRADAXA) from 10-Jun-2021 to 16-Jul-2021, ROSUVASTATIN CALCIUM (CRESTOR) from 10-Jun-2021 to 16-Jul-2021, TRAZODONE HYDROCHLORIDE (TRITTICO) from 10-Jun-2021 to 16-Jul-2021, SILODOSIN (SILODYX) from 10-Jun-2021 to 16-Jul-2021, DIGOXIN (LANOXIN) from 10-Jun-2021 to 10-Jun-2021, CIPROFLOXACIN HYDROCHLORIDE (CIPROXIN [CIPROFLOXACIN HYDROCHLORIDE]) from 09-Jul-2021 to 15-Jul-2021, INSULIN GLARGINE (TOUJEO), CYANOCOBALAMIN (DOBETIN [CYANOCOBALAMIN]) from 05-Jul-2021 to 16-Jul-2021, INSULIN GLULISINE (APIDRA) and EPOETIN ALFA (BINOCRIT) from 10-Jun-2021 to 16-Jul-2021 for an unknown indication. On 07-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milligram in total. On 15-Jul-2021, the patient experienced BRADYCARDIA (seriousness criteria death and medically significant), ASTHENIA (seriousness criterion death), VOMITING (seriousness criterion death), PYREXIA (seriousness criterion death) and HYPOTENSION (seriousness criterion death). The patient died on 16-Jul-2021. The reported cause of death was Asthenia, Vomiting, Fever chills, Bradycardia and Hypotension. 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 . Treatment information was not provided. Company Comment : This a regulatory/spontaneous report of fatal events, 9 days after receiving an unknown dose of the product in a 85 years old female with multiple concomitant medications, whose medical history was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Sender''s Comments: This a regulatory/spontaneous report of fatal events, 9 days after receiving an unknown dose of the product in a 85 years old female with multiple concomitant medications, whose medical history was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Reported Cause(s) of Death: Asthenia; Vomiting; Fever chills; Bradycardia; Hypotension


VAERS ID: 1527744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Delirium, Generalised tonic-clonic seizure, Hyperhidrosis, Pyrexia, Tachycardia, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral palsy; Excitement; Hospitalization NOS; Psychogenic disorder NOS; Unrest
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: Before vaccination; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:39s Centigrade; Test Date: 20210715; Test Name: Heart rate; Result Unstructured Data: Test Result:130; Comments: Unit: beat per minute
CDC Split Type: JPPFIZER INC202100952096

Write-up: fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority report. A 52-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FC5947; Expiration Date: 30Sep2021), via an unspecified route of administration on 14Jul2021 11:11 (at unknown age) as single dose for COVID-19 immunisation. Medical history included Cerebral palsy, psychogenic response, Unrest, Excitement, hospitalized from 06Oct2014. The patient''s concomitant medications were not reported. The patient was a 52-year and 11-month-old female. Body temperature before vaccination was 35.9 degrees centigrade. The patient''s family history was not reported. On 23Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY3860, Expiration date 31Aug2021). On 14Jul2021 at 11:11 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15Jul2021 at 16:20 (1 day after the vaccination), the patient experienced fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state) and cardio-respiratory arrest. The course of the event was as follows: The patient had been seen for many years by the reporting physician for the treatment of cerebral palsy and psychogenic response since the patient visited the outpatient department. Since 06Oct2014, the patient had been hospitalized although she was repeatedly discharged from the hospital for a short period. On 15Apr2021, she made 13th admission to the hospital. She was physically in good health with no changes noted in her symptoms for years but sometimes became unrest and excited. From around 16:20 of 15Jul2021, the patient experienced fever-tension syndrome with the symptoms including pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating, and confusional and delirium state. While the symptoms persisted, the patient experienced cardio-respiratory arrest. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The number of drugs administered to the patient tended to be rather large, but that was inevitable considering the patient''s condition. On 15Jul2021 (1 day after the vaccination), the outcome of the event was fatal. It was unknown if Autopsy Done.; Reported Cause(s) of Death: fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 bea


VAERS ID: 1527749 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENIDIPINE; TIAPRIDE; RISPERIDONE; QUETIAPINE; RIVASTIGMINE ACINO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100952748

Write-up: Platelets decreased; This is a spontaneous report from a contactable physician received via regulatory authority. A 98-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 15Jul2021 14:00 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) (at the age of 98-year-old) as dose 1, single for covid-19 immunisation. Medical history included angina pectoris and dementia from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient received the following concomitant medications within 2 weeks of vaccination: benidipine (BENIDIPINE), tiapride (TIAPRIDE), risperidone (RISPERIDONE), quetiapine (QUETIAPINE), and rivastigmine (RIVASTIGMINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jul2021 (5 days after the vaccination), the patient experienced platelets decreased. On 26Jul2021 (11 days after the vaccination), the patient died. The patient received no treatment for the event. The reporting physician assessed the event as serious (Death). Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the close temporal association there is possibility of causal association between the fatal event platelet decreased and the suspect drug BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Platelets decreased


VAERS ID: 1527751 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body temperature, Cardiac failure, Fall, Movement disorder
SMQs:, Cardiac failure (narrow), Retroperitoneal fibrosis (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Accidents and injuries (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100957938

Write-up: Cardiac failure; Falling down the stairs; Low back pain; Inability to move lower limbs as intended; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is V21121311. An 87-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Jul2021 10:00 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees centigrade. 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 16Jul2021 at 10:00 (the day of vaccination), the patient received?the first dose of bnt162b2 (Solution for injection, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration as the first single dose for COVID-19 immunization. On 20Jul2021 (4 days after the vaccination), the patient experienced low back pain, which caused inability to move lower limbs as intended. On 21Jul2021 at 03:30 (5 days after the vaccination), the patient got out of bed, experienced cardiac failure, and then fell down the stairs. The outcome of the cardiac failure was fatal, and the outcome of the other events was not reported. It was not reported if an autopsy was performed. The reporting physician classified the event, cardiac failure, as serious (death) and assessed that the causality between the event and bnt162b2 was unassessable. Other possible cause of the event such as any other diseases was not reported. The patient died on Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1527752 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100957961

Write-up: Pyrexia; patient was unable to take meals; This is a spontaneous report from a contactable pharmacist communicated to Pfizer sales representative. A 92-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 20Jul2021 (the day of vaccination), as Dose 1 single, for COVID-19 immunisation. The patient medical history and the patient''s concomitant medications were not reported. On an unspecified date in Jul2021, the patient was unable to take meals and admitted at the reporting hospital. That was almost in the stage before death-watch. On 21Jul2021 (1 day after the vaccination), the patient experienced pyrexia. On 23Jul2021 (3 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The outcome for the event pyrexia was fatal, while the outcome for the other event was unknown. The seriousness was reported as serious (death), but causality assessment was not reported. Information regarding lot/batch number has been requested.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, Comirnaty vaccine, cannot be excluded for the reported events of Fever, unable take meals and death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pyrexia


VAERS ID: 1527753 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Interstitial pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100957966

Write-up: Interstitial pneumonia aggravated; This is a spontaneous case from a contactable physician received via a sales representative. A 9-decade-old patient (in his/her 80s) of an unspecified gender received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. First dose received on an unknown date for covid-19 immunisation. Medical history included interstitial pneumonia. The patient''s concomitant medications were not reported. On unknown date in 2021 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On unknown date in 2021 (7 days after the vaccination), the patient experienced interstitial pneumonia aggravated. On unknown date in 2021 (10 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: 7 days after the second dose of bnt162b2 vaccination, it was confirmed that interstitial pneumonia which the patient originally had was aggravated. After the patient was referred to another hospital (10 days after vaccination), the patient died. The patient was usually visiting the reporting hospital and another hospital. Since the interstitial pneumonia was aggravated this time, the patient was referred to the third hospital. The patient died on 2021. It was not reported if an autopsy was performed. The causality between the event and bnt162b2 was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: based on the available information ,the strong temporal relationship between the fatal event aggravated interstitial pneumonia and the suspect vaccine BNT162B2 the causality cannot be complete4ly ruled out .; Reported Cause(s) of Death: Interstitial pneumonia aggravated


VAERS ID: 1527755 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Intractable pain; Paralysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100957978

Write-up: Sudden death; This is a spontaneous report from a non-contactable pharmacist received via the Regulatory Authority. The patient was a 71-year-old male. On 30Jun2021 at 18:15 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) at 71-year-old via intramuscular in the left arm for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Medical history included hypertension, residual paralysis from cerebral haemorrhage, and intractable pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescribed drug within 2 weeks of vaccination. On 09Jun2021 at 15:15, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) at 71-year-old via intramuscular in the left arm for COVID-19 immunization. On 09Jul2021 (9 days after the vaccination), the patient was confirmed to be alive until noon. On unknown date in Jul2021 (within 2 weeks after the vaccination), the patient suddenly died. This was a sudden death within 2 weeks of the vaccination. The patient was confirmed to be alive until noon on 09Jul2021, but the exact date of death was unknown. On 12Jul2021 (12 days after the vaccination), the patient was found dead at home. The cause of death was reported as "Unknown". The patient received no treatments for the event. The reporting physician assessed the event as serious (Death). It was unknown if autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The underlying disease may provide an alternative cause. 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: sudden death


VAERS ID: 1527756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram, Headache
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: 2021-07-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Dyslipidaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: CT; Result Unstructured Data: Test Result:No abnormalities
CDC Split Type: JPPFIZER INC202100957980

Write-up: Cardio-respiratory arrest; Headache; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 56-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included dyslipidaemia, and bronchitis chronic. Concomitant medication included rosuvastatin calcium (CRESTOR) taken for an unspecified indication from Aug2020 and ongoing. On 25Jun2021, the patient previously received the first dose of bnt162b2 (Lot# unknown, Expiration date unknown). On 16Jul2021 (the day of vaccination), the patient received?the second dose of bnt162b2 (Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On around 21Jul2021 (5 days after the vaccination), the patient experienced headache. On 24Jul2021, the patient experienced cardio-respiratory arrest. On 24Jul2021 (8 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had underlying diseases such as dyslipidaemia and chronic bronchitis and had continuously received oral rosuvastatin calcium tablet 2.5 mg since Aug2020. For the profilaxis of novel coronavirus infection, the patient would like to receive bnt162b2 as a patient with underlying diseases and then received the vaccination at the site. On 25Jun2021, she received the first dose of bnt162b2. On 16Jul2021, she received the second dose of bnt162b2. From around 21Jul2021, the patient experienced the symptom of headache, and therefore on 23Jul2021, she visited a medical center, where computed tomography was performed. However, no abnormalities were found, and drip infusion was administered. On 24Jul2021, early in the morning, the patient was confirmed to be in cardio-respiratory arrest at her home and then died. The outcome of event headache was unknown. The patient died on 24Jul2021. It was not reported if an autopsy was performed. The reporting physician did not provide the seriousness and causality of the events. Information on the lot/batch number has been requested.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of cardio-respiratory arrest due to temporal relationship. Case will be re-assessed upon the additional information provided. 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: Cardio-respiratory arrest


VAERS ID: 1527757 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cerebral infarction, Coma scale, Computerised tomogram head, Dehydration, Depressed level of consciousness, Feeding disorder, Pyrexia, Thrombosis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   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: JANUVIA; LUVOX [FLUVOXAMINE MALEATE]; TORASEMIDE OD; URSODEOXYCHOLIC ACID; MAGMITT; TRAMAL; AZULFIDINE EN; PREDNISOLONE; LANSOPRAZOLE; THYRADIN S; ALFACALCIDOL; CLOPIDOGREL SULFATE; DAI-KENCHU-TO; MOSAPRIDE CITRATE; BETANIS
Current Illness: Arteriosclerosis obliterans; Carotid artery stenosis; Dementia; Diabetes mellitus (Since 68-year-old); Hip surgery; Hypertension; Hypothyroidism; Lumbar disc herniation; Primary sclerosing cholangitis; Rheumatoid arthritis (Since 30-year-old)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: blood pressure; Result Unstructured Data: Test Result:78/46 mmHg; Comments: at 18:00; Test Date: 20210719; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: Before vaccination; Test Date: 20210719; Test Name: body temperature; Result Unstructured Data: Test Result:39.9 Centigrade; Comments: at 14:30; Test Date: 20210720; Test Name: body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: at 04:00; Test Date: 20210721; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: at 06:00; Test Date: 20210721; Test Name: CS; Result Unstructured Data: Test Result:200-300; Comments: at 11:00; Test Date: 20210721; Test Name: Head CT; Result Unstructured Data: Test Result:Low density area in the right occipital lobe; Comments: Low density area was confirmed in the right occipital lobe (cerebral infarction).
CDC Split Type: JPPFIZER INC202100958016

Write-up: consciousness decreased; Cerebral infarction; pyrexia; meal intake was difficult; dehydration and thrombosis caused by pyrexia; dehydration and thrombosis caused by pyrexia; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). And from the same contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21122036. A non-pregnant 76-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm right on 19Jul2021 10:00 (Batch/Lot Number: FC9909; Expiration Date: 30Sep2021) as dose 2, single at the age of 76-year-old for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis chronic (since 30-year-old), primary schlerosing cholangitis from Jan2020 and ongoing, ongoing diabetes mellitus (since 68-year-old), ongoing hypertension, ongoing hypothyroidism, ongoing carotid artery stenosis, ongoing arteriosclerosis obliterans, ongoing lumbar disc herniation, ongoing after hip surgery right, ongoing dementia. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included sitagliptin phosphate (JANUVIA); fluvoxamine maleate (LUVOX); torasemide (TORASEMIDE OD); ursodeoxycholic acid; magnesium oxide (MAGMITT); tramadol hydrochloride (TRAMAL); sulfasalazine (AZULFIDINE EN); prednisolone; lansoprazole; levothyroxine sodium (THYRADIN S); alfacalcidol; clopidogrel sulfate from an unspecified start date and ongoing; dai-kenchu-to; mosapride citrate; mirabegron (BETANIS). On 28Jun2021 at 10:30, the patient previously received the first dose of bnt162b2 (Lot# EY3860, Expiration date 31Aug2021) via intramuscular route of administration in the arm left for COVID-19 immunization. On 19Jul2021 at 10:00 (the day of vaccination), the patient received the second single dose of bnt162b2 (Solution for injection, Lot number FC9909, Expiration date 30Sep2021) via intramuscular route of administration in the arm right for COVID-19 immunization. On 19Jul2021 at 14:30 (4 hours and 30 minutes after the vaccination), the patient experienced cerebral infarction. The event resulted in prolongation of hospitalization (the patient received vaccination during hospitalization) and death. The outcome of the event was fatal with treatment as follows: 1. On 19Jul2021, at 14:45 (4 hours and 45 minutes after vaccination), and on 20Jul2021, at 04:00 (18 hours after vaccination), diclofenac sodium (DICLOFENAC NA SUPP) 25 mg was inserted into the anus. 2. On 21Jul2021, and 22Jul2021, a drip infusion of edaravone 30 mg 1A was administered 2 times per day. 3. On 21Jul2021 and 22Jul2021, a drip infusion of fructose, glycerol (GLYCEOL) 200 mL was administered once per day. The reporting physician assessed the event as serious (prolonged hospitalization and death). Since the vaccination, the patient has not been tested for COVID-19. The cause of death was cerebral infarction. Autopsy was not performed. The reported event was as follows: On 19Jul2021 at 14:30 (4 hours and 30 minutes after the vaccination), the body temperature was 39.9 degrees celsius, and meal intake was difficult after the patient received the second dose of bnt162b2 vaccination. On 20Jul2021, at 04:00 (18 hours after vaccination), the body temperature was 39.4 degrees Celsius, and at 18:00 (32 hours after vaccination), the blood pressure was 78/46 mmHg. On 21Jul2021, at 06:00 (2 days after vaccination), the body temperature was 36.5 degrees Celsius. At 11:00 (2 days after vaccination), the patient had consciousness decreased (JCS: Japan Coma Scale was 200 to 300). Head CT showed low density area in the right occipital lobe (cerebral infarction). On 22Jul2021, at 19:19 (3 days, 9 hours, and 19 minutes after vaccination), the patient was confirmed to die. The body temperature before vaccination was 37.0 degrees Celsius. The reporting term was cerebral infarction and pyrexia. The course of the event was as follows: On 19Jul2021 (the day of vaccination), at 10:00, the patient received the second dose of bnt162b2 vaccination (at the age of 76-year-old). At 14:30 (4 hours and 30 minutes after vaccination), the body temperature was 39.9 degrees Celsius, and meal intake was difficult. At 14:45 (4 hours and 45 minutes after vaccination), diclofenac 25 mg, one suppository was inserted into the anus. On 20Jul2021, at 04:00 (18 hours after vaccination), the body temperature was 39.4 degrees Celsius, and diclofenac 25 mg, one suppository was inserted into the anus. At 18:00 (32 hours after vaccination), the blood pressure was 78/46 mmHg. On 21Jul2021, at 06:00 (2 days after vaccination), the body temperature was 36.5 degrees Celsius. At 11:00 (2 days after vaccination), the patient had consciousness decreased (Coma Scale was 200 to 300). Head CT showed low density area in the right occipital lobe (cerebral infarction). A drip infusion of edaravone 30 mg 1A was administered 2 times, and a drip infusion of fructose, glycerol 200 mL was administered once. On 22Jul2021 (3 days after vaccination), a drip infusion of edaravone 30 mg 1A was administered 2 times, and a drip infusion of fructose, glycerol 200 mL was administered once. At 19:19 (3 days, 9 hours, and 19 minutes after vaccination), the patient was confirmed to die. The reporting physician classified the event as serious (death) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was as follows: Since the patient had underlying diseases of carotid artery stenosis and arteriosclerosis obliterans, it was unknown that cerebral infarction occurred directly caused by the vaccination. The cause of death was cerebral infarction. The outcome of other event was unknown. The patient died on 22Jul2021. An autopsy was not performed. The reporting physician commented as follows: After the vaccination, the patient had pyrexia of 39.9 degrees Celsius as a side reaction. Thereafter, the patient had consciousness decreased, and she was diagnosed with cerebral infarction on the imaging examination. Since the causes of cerebral infarction were dehydration and thrombosis caused by pyrexia other than a side reaction to the vaccination, and the patient had underling diseases of carotid artery stenosis and arteriosclerosis obliterans, the causality between the event and bnt162b2 vaccination was unknown.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1527758 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: BLOPRESS; TENORMIN; NORVASC; TAKEPRON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Internal carotid artery stenosis; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100958113

Write-up: cerebral infarction caused by right internal carotid artery stenosis; cerebral infarction caused by right internal carotid artery stenosis; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121317. A 73-year and 2-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EW0201, Expiration date: 30Sep2021), at the age of 73-year and 2-month-old, on 08Jul2021 at 09:30 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.0 degrees Centigrade. Medical history included hypertension, stroke, and right internal carotid artery stenosis. The patient family history was not reported. Concomitant medications included candesartan cilexetil (BLOPRESS, strength: 4 mg) taken for hypertension orally at 12 mg daily, 1 tablet in the evening/8 mg, 1 tablet in the morning; atenolol (TENORMIN, strength: 25 mg) taken for hypertension orally at 1 tablet in the morning; amlodipine besilate (NORVASC, strength: 5 mg) taken for hypertension orally at 1 tablet in the morning; and lansoprazole (TAKEPRON, formulation: orodispersible tablet, strength: 15 mg) orally at 1 tablet in the evening. On 08Jul2021 at 09:30 (the day of vaccination), the patient received the first dose of BNT162B2. On 12Jul2021 at 03:00 (3 days 17 hrs 30 min after the vaccination), the patient experienced cerebral infarction caused by right internal carotid artery stenosis. The patient was admitted to the reporter''s clinic, and then transferred to hospital B. On an unknown date, the patient died. It was not reported if an autopsy was performed. The outcome of the events was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was stroke. The reporting physician commented as follows: Existence of internal carotid artery stenosis had been confirmed before vaccination. Thus, the causal relationship was unknown.; Reporter''s Comments: Existence of internal carotid artery stenosis had been confirmed before vaccination. Thus, the causal relationship was unknown.; Reported Cause(s) of Death: cerebral infarction caused by right internal carotid artery stenosis; cerebral infarction caused by right internal carotid artery stenosis


VAERS ID: 1527759 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Chest X-ray, International normalised ratio, Respiratory arrest
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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: WARFARIN POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Name: Chest X-ray; Test Result: 58.2 %; Comments: CTR; Test Name: PT-INR; Result Unstructured Data: Test Result:1.7
CDC Split Type: JPPFIZER INC202100958392

Write-up: acute exacerbation of cardiac failure; Respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121417. An 84-year-old female patient (reported as 84-year and 3-month-old) received bnt162b2 (COMIRNATY), dose 1 intramuscular on 26Jul2021 13:50 (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation. The patient had no family history. Concomitant medication included warfarin potassium for atrial fibrillation. On 27Jul2021 at 05:20 (15 hours and 30 minutes after the vaccination), the patient experienced respiratory arrest. On 27Jul2021 at 06:27 (16 hours and 37 minutes after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26Jul2021 at 20:00, the patient went to bed with no significant changes from the day before. On 27Jul2021 at 05:20, the patient was found to be in respiratory arrest. The patient was transported to Hospital A by ambulance. On the same day at 06:27, the death was confirmed. Event respiratory arrest caused emergency room visit and treatment was received. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute exacerbation of cardiac failure. The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade before vaccination on 26Jul2021, chest x-ray: 58.2 % CTR on unspecified date, PT-INR (international normalised ratio): 1.7 on unspecified date. The patient died on 27Jul2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Respiratory arrest; acute exacerbation of cardiac failure


VAERS ID: 1527760 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEBURIC; ZAFATEK; ATELEC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Hyperuricaemia; Prostatic hyperplasia; Small cell lung cancer (complete remission); Thoracic aortic aneurysm (48 mm)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100958415

Write-up: The postmortem certificate reported that Unknown cause, time of death, June 24th 22:04; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122028. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Jun2021 18:20 (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021), at same age, as DOSE 2, SINGLE for covid-19 immunisation. Medical history included thoracic aortic aneurysm (48 mm), small cell lung cancer (complete remission), hyperuricaemia, hypertension, prostatic hyperplasia and diabetes mellitus. Concomitant medications included febuxostat (FEBURIC); trelagliptin succinate (ZAFATEK); and cilnidipine (ATELEC). The patient previously received the first dose of BNT162b2 (COMIRNATY) on an unknown date for covid-19 immunisation. The patient experienced cardio-respiratory arrest on 24Jun2021 with outcome of fatal. The patient died on 24Jun2021. An autopsy was performed that revealed unknown cause of death. On 24Jun2021 at unknown time (one day after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: On 23Jun2021, there was no problem. On 24Jun2021 after 20:00, the patient returned home and then spent time alone. On 25Jun2021 in the morning, the patient was in the state of cardio-respiratory arrest in the bathroom at home. Ambulance team confirmed the death and reported to the local police. It was not incidental, but the patient was alone at the time of death, therefore the body was placed at the local police until the medical examiner visit on the following day. On 26Jun2021, an internal examination was performed at the facility of medical examination. No traumatic injury, no rupture of known aortic aneurysm. The postmortem certificate reported that Unknown cause, time of death, June 24th 22:04. On 30Jun2021, the private funeral was completed. Tissue examination was performed at the facility of medical examination, but the result was not received. The reporting physician classified the event as serious (fatal) 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: The patient had many primary diseases, but each of them was stabilized, and the postmortem could not indicate the organic cause of death. The primary physician reported the case because there were many unknown parts in the cause of death and there could be a causal relationship with the vaccination.; Reported Cause(s) of Death: The postmortem certificate reported that Unknown cause, time of death, June 24th 22:04; Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: The postmortem certificate reported that Unknown cause, time of death, June 24th 22:04


VAERS ID: 1527761 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abscess, Bedridden, Blood test, Computerised tomogram, Dysphonia, Ear disorder, Fatigue, Feeling abnormal, Gait disturbance, Physical deconditioning, Pneumomediastinum, Speech disorder
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: Blood test; Result Unstructured Data: Test Result:No renal or hepatic findings; Test Date: 20210718; Test Name: CT; Result Unstructured Data: Test Result:Mediastinal emphysema; Comments: mediastinal emphysema and abscess in the mediastinum of the head
CDC Split Type: JPPFIZER INC202100958441

Write-up: Mediastinal emphysema; abscess in the mediastinum of the head; Difficulty in walking; Inability to say words other than "tired"; tired; Strange feeling in the right ear and the head; Strange feeling in the right ear and the head; Difficulty in emiting a voice; Physical deconditioning; Tendency to stay in bed during the daytime; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121413.?A 69-year and 2-month-old female patient received?the first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration in the right arm on 13Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. Body temperature before vaccination was unknown. It was unknown whether there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s medical history and concomitant medications were not provided. On 16Jul2021 (3 days after the vaccination), the patient claimed strange feeling in the right ear and the head, hard to emit a voice, physical deconditioning, and tendency to stay in bed during the daytime. On 18Jul2021 (5 days after the vaccination), the patient experienced difficulty in walking, inability to say words other than "tired," and mediastinal emphysema. On 19Jul2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16Jul2021, about 3 days after the vaccination, the patient complained of strange feeling in the right ear and the head as well as difficulty in emitting a voice. Thereafter, the patient''s physical conditions worsened and tended to stay in bed even during the daytime. On 18Jul2021, in the morning, the patient experienced difficulty in walking and inability to say words other than "tired." At around 12:00, she visited the reporting hospital, where computed comography (CT) showed mediastinal emphysema and abscess in the mediastinum of the head. Blood test was also performed and no renal or hepatic findings observed. Therapeutic measures were taken as a result of the event mediastinal emphysema included the patient was managed with tracheal intubation. (Abbreviations with no details) but her condition did not improve. At 15:20, the patient died. Events resulted in physician office visit. Outcome of the event mediastinal emphysema was fatal, while of the other events was unknow. 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 was unassessable. Other possible cause of the event such as any other diseases was illegible from illegible was also possible. Reporter comment: Because the vaccine was administered to the right arm and the emphysema was strong near the right clavicle, the pathway of vaccination site (illegible) was also unclear and could not be estimated. The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up. ; Reported Cause(s) of Death: Mediastinal emphysema


Result pages: prev   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 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=157&PERPAGE=100&VAX=COVID19&DIED=Yes


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