National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

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

Found 17,128 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

This is page 129 out of 172

Result pages: prev   30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172   next


VAERS ID: 1421860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-05-13
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Diarrhoea, Dyspnoea, Psychomotor retardation, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARDEGIC; SERETIDE DISKUS; PERINDOPRIL; OMEPRAZOLE; FUROSEMIDE; VITAMINE B12; DOLIPRANE; DILTIAZEM HCL; UVEDOSE; SPIRIVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Hypertension arterial; Obesity; Respiratory failure; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 antigen test; Test Result: Positive ; Comments: for variant
CDC Split Type: FRPFIZER INC2021728740

Write-up: Vaccination failure; COVID-19; COVID-19 antigen test positive; Cough; Liquid stools; Dyspnea; Psychomotor slowing; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021060880. Additional identifier: FR-AFSSAPS-AM20211422. A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM0477), via intramuscular route of administration on 19Jan2021 as 1st dose, single for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EK9788) via intramuscular route of administration on 09Feb2021 on deltoid Left, as 2nd dose, single for COVID-19 immunization. Medical history of the patient included hypertension arterial, respiratory failure, sleep apnoea syndrome, cardiac insufficiency, obesity. It was unknown if patient had any history of COVID-19 infection. Concomitant medications included acetylsalicylate lysine (KARDEGIC); fluticasone propionate, salmeterol xinafoate (SERETIDE DISKUS); perindopril; omeprazole; furosemide cyanocobalamin (VITAMINE B12); paracetamol (DOLIPRANE); diltiazem hcl; colecalciferol (UVEDOSE); tiotropium bromide (SPIRIVA); unknown start, stop date and indication for all. On 13May2021, the patient had appearance of liquid stools, dyspnoea, cough, psychomotor slowing. The COVID 19 antigenic test was positive for variant and vaccine failure was confirmed. The patient was put on O2. On the next day, 14May2021, patient was found dead. It was reported as to be noted that the storage of the vaccine was in accordance with the recommendations with injection on the day of receipt by the city pharmacy preparation and injection of the vaccine in accordance with the recommendations. The patient underwent lab test that included: COVID 19 antigenic test: Positive (for variant as reported) on an unspecified date. The outcome of cough, liquid stools, dysponea and psychomotor slowing was unknown. The outcome of vaccination failure, COVID-19 and COVID-19 antigen test positive was reported as fatal. It was unknown if an autopsy was performed. NB: Imputability score(s) established without prejudice to the elements of investigation that could be carried out in the context of legal or amicable compensation procedures. No follow-up attempts were possible. No further information was expected.; Reported Cause(s) of Death: COVID-19 antigen test positive; COVID-19; Vaccination failure


VAERS ID: 1421863 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-04-20
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; HALOPERIDOL; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cognitive impairment; Heart block sinoauricular
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: Sars-Cov-2 PCR/serology test; Test Result: Positive ; Comments: Detection of the English variant.
CDC Split Type: FRPFIZER INC2021728836

Write-up: Shortness of breath; Covid-19 test: PCR / serology: Positive on 20Apr2021 (2 months after the second injection), Detection of the English variant.; Covid-19 test: PCR / serology: Positive on 20Apr2021 (2 months after the second injection), Detection of the English variant.; Covid-19 test: PCR / serology: Positive on 20Apr2021 (2 months after the second injection), Detection of the English variant.; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB FR-AFSSAPS-AN20212015 Safety Report Unique Identifier FR-AFSSAPS-2021064062. A 98-years-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: ER0641, Expiration date: unknown) intramuscular, administered at an unspecified anatomical location on 16Feb2021 (age at vaccination was unknown) as 2nd dose, single for COVID-19 immunization. The patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6788, Expiration date: unknown) intramuscular, administered at an unspecified anatomical location on 26Jan2021 (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization. Medical history included arterial hypertension, cognitive impairment and heart block sinoauricular/sinoatrial block. Concomitant medications included furosemide, haloperidol and ramipril all taken for an unspecified indication. The time between two injections was 21 days. Previously the patient was not diagnosed with COVID-19. It was reported that the patient received first injection of COMIRNATY vaccine on 26Jan2021 and the second injection on 16Feb2021. The patient was at risk of developing a severe form of COVID-19 disease. There was an appearance of a symptom suggestive of COVID: Shortness of breath. No precision for the start date of the symptom. The patient underwent lab tests which included COVID-19 test: PCR/serology: Positive on 20Apr2021 (2 months after the second injection), Detection of the English variant. On an unspecified date, the patient died. Vaccine failure resulted in death of a patient who had a complete COMIRNATY vaccine regimen schedule against COVID-19 2 months before against COVID-19. The patient was not hospitalized, death of the patient at least 2 months after the 2nd injection. A drug is coded as an active principle when the specialty name is unknown to them. Accountability made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. On PRD 21Jun 2021, it was reported that for this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. TA sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5704146 (see File attachment in this investigation record). The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ER0641. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. HA concluded that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The outcome of the events was fatal. No follow-up attempts possible. No further information expected. Follow-up (21Jun2021): New information received from Product Quality Complaint group included: Updated the details of Product Quality Complaint.; Reported Cause(s) of Death: Covid-19 test: PCR / serology: Positive on 20Apr2021 (2 months after the second injection), Detection of the English variant.; Covid-19 test: PCR / serology: Positive on 20Apr2021 (2 months after the second injection), Detection of the English varian


VAERS ID: 1421877 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death unexplained) in an adult male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy. On 28-May-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 29-May-2021 The patient died on 29-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. This is a case of sudden death in a male subject of Unknown age with a hx of Epilepsy, who died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a male subject of Unknown age with a hx of Epilepsy, who died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1421890 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER OE114783 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdomen scan, Blood pressure systolic, C-reactive protein, Cardiogenic shock, Neutrophil count, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-tobacco user; Obesity; Tachycardia; Umbilical hernia repair
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: thoraco-abdominal scanner; Result Unstructured Data: Test Result:acute peritonitis; Test Date: 20210522; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:60; Test Date: 20210522; Test Name: CRP; Result Unstructured Data: Test Result:90.6 mg/l; Test Date: 20210522; Test Name: PNN; Result Unstructured Data: Test Result:16.39 x10 9/l; Test Name: Covid-19 PCR; Test Result: Negative
CDC Split Type: FRPFIZER INC2021704796

Write-up: Cardiogenic shock; This is a spontaneous report from a contactable pharmacist downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB FR-AFSSAPS-MA20212244. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021070635. A 51-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), dose 1 intramuscular on 19May2021 as 1st dose, single for covid-19 immunization; suxamethonium chloride (CELOCURINE), intravenous from 22May2021 15:30 (Batch/Lot Number: Unknown) to an unspecified date, at 100 mg, single for Intubation; rocuronium bromide (ROCURONIUM B. BRAUN), intravenous from 22May2021 15:30 (Batch/Lot Number: Unknown) to an unspecified date, at 50 mg, single for Intubation; paracetamol (PARACETAMOL MACOPHARMA), intravenous from 22May2021 13:58 (Batch/Lot Number: Unknown) to 22May2021 14:35, at 2 DF, single (2 times 1g/200mg) for peritonitis; ketamine hydrochloride (KETAMINE RENAUDIN), intravenous from 22May2021 15:30 (Batch/Lot Number: Unknown) to an unspecified date, at 50 mg, single for induction of anaesthesia; propofol (PROPOFOL LIPURO), intravenous from 22May2021 15:30 (Batch/Lot Number: Unknown) to an unspecified date, at 400 mg, single for induction of anaesthesia; amoxicillin trihydrate, clavulanate potassium (AMOXICILLINE/ACIDE CLAVULANIQUE SANDOZ), intravenous from 22May2021 13:58 (Batch/Lot Number: Unknown) to 22May2021 14:35, at 2 DF, single (2x 1g/200mg) for peritonitis; iomeprol (IOMERON), intravenous from 22May2021 13:00 (Batch/Lot Number: OE114783) to an unspecified date, at 90 mg, single for peritonitis; phloroglucinol (PHLOROGLUCINOL ARROW), intravenous from 22May2021 11:18 (Batch/Lot Number: Unknown) to an unspecified date, at 80 mg, single for peritonitis; sufentanil citrate (SUFENTANIL CITRATE), intravenous from 22May2021 15:30 (Batch/Lot Number: Unknown) to an unspecified date, at 20 ug, single for induction of anaesthesia. Medical history included umbilical hernia repair, ex-tobacco user, tachycardia, obesity all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced cardiogenic shock on 22May2021 15:40. 51-year-old patient who died of cardiogenic shock after induction anesthesia by PROPOFOL LIPURO, SUFENTANIL MYLAN, KETAMINE RENAUDIN, CELOCURINE and ROCURONIUM, the patient had received within 3 hours of PHLOROGLUCINOL ARROW, AMOXICILLIN CLAVULANIC ACID SANDOZ, PARACETAMOL MACOPHARMA and IOMERON and he had received a first dose of COMIRNATY 4 days before Lot Unknown. The patient is admitted for acute abdominal pain at the end of the morning due to an acute peritonitis objectified on the thoraco-abdominal scanner injected with IOMERON. He is receiving analgesics PHOLROGLUCINOL and PARACETAMOL as well as probabilistic antibiotic therapy with AMOXICILLIN CLAVULANIC ACID. Laboratory tests confirm the infectious picture and he enters the operating room urgently at 3:30 p.m. 10 minutes after the start of the induction he had a cardiogenic shock with systolic blood pressure at 60. He received vasopressor amines and Xylocard without success, death was pronounced at 4:40 pm. The patient had a negative Covid-19 PCR and had received a first dose of COMIRNATY 4 days previously. The tests for Tryptase, Histamine and IgE could not be carried out because hemolysis on perfusion of the sample during resuscitation. The patient underwent lab tests and procedures which included thoraco-abdominal scanner: acute peritonitis on 22May2021, blood pressure systolic: 60 on 22May2021, c-reactive protein: 90.6 mg/l on 22May2021, neutrophil count (1.847 x10^9/l - 6.573 x10^9/l): 16.39 x10^9/l on 22May2021, Covid-19 PCR: negative on an unspecified date. The action taken in response to the event paracetamol and amoxicillin trihydrate, clavulanate potassium was permanently withdrawn on 22May2021 14:35, for other suspect drugs was permanently withdrawn on an unspecified date. Therapeutic measures were taken as a result of cardiogenic shock. The outcome of event was death. The patient died on 22May2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1421893 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-05-20
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (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: 2021-05-25
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CANDESARTAN CILEXETIL; TRAMADOL HYDROCHLORIDE; MIANSERIN HYDROCHLORIDE; PANTOPRAZOLE; DIFFU K; KARDEGIC; HEPARIN CALCIUM; DOLIPRANE; RISPERDAL; FUROSEMIDE
Current Illness: Artificial cardiac pacemaker wearer; Hypertension arterial; Hypertrophic cardiomyopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Fall (with a fracture on a prosthesis); Fracture (fracture surgery); Heart block atrioventricular
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Oxygen saturation; Test Result: 70 %; Comments: requiring the establishment of oxygen therapy; Test Date: 20210520; Test Name: PCR Covid-19; Test Result: Positive ; Comments: presence of a variant
CDC Split Type: FRPFIZER INC2021728786

Write-up: Vaccination failure; acute respiratory distress syndrome with comatose state; 20May2021, positive Covid-19 PCR test, presence of a variant.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority number FR-AFSSAPS-NY20211436, Safety Report Unique Identifier FR-AFSSAPS-2021064802. A 95-year-old female patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EJ6789) via intramuscular route of administration on 16Feb2021 as single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EJ6788) via intramuscular route of administration on 26Jan2021 as single for COVID-19 immunisation. The patient''s medical history included ongoing hypertension, atrioventricular block (with pace-maker), ongoing hypertrophic heart disease, fall with a fracture on a prosthesis, and on 22FEb2021 fracture surgery (favorable operative consequences). Concomitant medication included candesartan cilexetil (CANDESARTAN CILEXETIL) taken for an unspecified indication, start and stop date were not reported, tramadol hydrochloride (TRAMADOL HYDROCHLORIDE) taken for pain from 20May2021 to an unspecified stop date, mianserin hydrochloride (MIANSERIN HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported, pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; potassium chloride (DIFFU K) taken for an unspecified indication, start and stop date were not reported; acetylsalicylate lysine (KARDEGIC) taken for an unspecified indication, start and stop date were not reported; heparin calcium (HEPARIN CALCIUM) taken for an unspecified indication from 20May2021 to an unspecified stop date, paracetamol (DOLIPRANE) taken for an unspecified indication, start and stop date were not reported, risperidone (RISPERDAL) taken for an unspecified indication, start and stop date were not reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported. It was reported as, vaccination failure with acute respiratory distress syndrome in a 95 years old patient, 3 months after vaccination with 2 doses of COMIRNATY (26Jan2021 lot EJ6788, 16Feb2021 lot EJ6789) during hospitalization after a fall with a fracture on a prosthesis (which had a favourable outcome) leading to the patient''s death. The patient''s clinical condition was satisfactory for her age (still walking). On 20May2021, the patient presented with hoarseness of the voice. 1 hour later, she fell. Transported to the emergency room, diagnosis of fracture on prosthesis and evidence of a COVID-19 infection, asymptomatic. 20May2021, positive COVID-19 PCR test, presence of the British variant. On 25May2021, in the afternoon, sudden onset of a severe 70% desaturation requiring the establishment of oxygen therapy. Diagnosis of acute respiratory distress syndrome with comatose state leading to death around midnight. The patient underwent lab tests and procedures which included oxygen saturation: 70 % on 25May2021 requiring the establishment of oxygen therapy, SARS-COV-2 test: positive on 20May2021 with presence of a variant. Treatment added during hospitalization: heparin calcium, tramadol 50 mg (1.0.1). Reduction of the dosage of furosemide to 40 mg/day. The patient died on 25May2021. The death was due to acute respiratory distress syndrome with comatose state. It was not reported if an autopsy was performed. Event vaccination failure was reported with outcome event stop date as 25May2021. No follow-up attempts are needed. No further information was expected.; Reported Cause(s) of Death: acute respiratory distress syndrome with comatose state


VAERS ID: 1421894 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-29
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: RT-PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728815

Write-up: Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 82-years-old female patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an intramuscular route of administration on 28Jan2021 as 1st dose, 0.3 mL, single and received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection) (Batch/Lot Number: EM6950) via an intramuscular route of administration on 18Feb2021 as 2nd dose, 0.3 mL, single for covid-19 immunization. Medical history included dementia. The patient''s concomitant medications were not reported. On 29Apr2021,71 days after second dose the patient had confirmed vaccine failure living in a nursing home. It was reported that the patient presented a severe COVID infection with desaturation leading to death. The search for a variant could not be successful because the result could not be used (linked to the viral load or to the pre-analytical conditions). Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry in charge of Health n 84/50, January 24, 1984 published in therapy 1985: 40: 111-8. The events assessed as serious (Death). The patient died on 29Apr2021 due to COVID-19 pneumonia. On 20Apr2021, Positive RT-PCR test, asymptomatic patient but performed following a positive case in (Nursing Home). An autopsy was not performed. The outcome of the events was fatal. Product quality complaint investigation summary report: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5719794 (see File attachment in this investigation record) The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EM6950A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible, information on batch number (1st dose) cannot be obtained.; Reported Cause(s) of Death: Severe COVID infection


VAERS ID: 1421895 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-24
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (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), Hypersensitivity (broad), Respiratory failure (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: 2021-05-07
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: SARS-COV2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728677

Write-up: Vaccination failure; COVID-19 respiratory infection; Acute respiratory decompensation; Fever; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. A 87-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EP2166) via intramuscular route of administration on 03Mar2021 as single dose and second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EW2239) via intramuscular route of administration on 09Apr2021 as 0.3 ML single dose both for covid-19 immunization (both at the age of 87 years). The patient medical history and concomitant medications were not reported. On 24Apr2021, the patient had respiratory decompensation accompanied by fever. In this context, patient was transferred to the hospital. An anti SARS-COV2 PCR test was carried out and came back positive. In total, vaccination failure demonstrated by a respiratory infection with COVID-19 characterized by respiratory decompensation, which occurred on Day + 16 of a second vaccination with COMIRNATY and evolution to death. The clinical outcome of all the events was fatal and the patient died on 07May2021. All the events were considered as the cause of death. It was not reported if an autopsy was performed. Reporter''s Comments: Reaction(s) Events Assessed All AEs Comitnaty. Time Interval between Beginning of Drug Administration and Start of Reaction Event 16 Days. Time Interval between Last Dose of Drug and Start of Reaction Event 16Days. Did reaction recur on re-administration YES - UNK rechallenge was done, outcome unknown. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19 respiratory infection; Acute respiratory decompensation; Fever


VAERS ID: 1421897 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-01
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, COVID-19, Drug ineffective, Fall, Head injury, Oxygen saturation decreased, SARS-CoV-2 test, Traumatic haemorrhage
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   Days after onset: 47
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: 20210429; Test Name: desaturation; Test Result: 86 %; Comments: it exhibits 86% desaturation and is placed under oxygen; Test Date: 20210427; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728728

Write-up: Fall with a head trauma (finding of bleeding in the head); Fall with a head trauma (finding of bleeding in the head); Fall with a head trauma (finding of bleeding in the head); positive for COVID-19; positive for COVID-19; Bronchitis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-PO20212141, Safety Report Unique Identifier FR-AFSSAPS-2021051240. A 99-years-old female patient received second dose of BNT162B2 (COMIRNATY, formulation solution for injection, Batch/Lot Number: EM6950, expiration date unknown) 0.3 mL, via an intramuscular route of administration, administered in Arm Left on 18Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, formulation solution for injection, Lot Number, and expiration date unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. No information on the patient''s COVID-19 history or her medical history. Oa an unspecified date in Apr2021, the patient presented symptoms of COVID-19 (bronchitis) and on 27Apr2021 a test was done, and it was positive for COVID-19. On 29Apr2021, it exhibits 86 percent desaturation and was placed under oxygen and on the same day she fell with a head trauma (finding of bleeding in the head) and she consulted the emergency department. On return, her general condition deteriorated rapidly. First, she gets up from her bed from time to time with the help of a caregiver. Then gradually she no longer gets up and no longer feeds and on 18May2021 death was declared. and reported cause of death was head trauma. An autopsy was not performed and no death letter available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Head trauma


VAERS ID: 1421903 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-16
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728604

Write-up: Covid-19 infection; Covid-19 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RN20211292; Safety Report Unique Identifier FR-AFSSAPS-2021050333. Case originating from a report by a professional via the Agency portal number 20210429102348169. A 95-years-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EP9598), via intramuscular in left arm on 25Feb2021 and first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration on an unspecified date both as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 16Apr2021, patient presented with a Covid-19 infection and on 29Apr2021 the patient was died. It was not reported if an autopsy was performed. Medicines in the form of an active ingredient, the trade name was not known. The outcome of the event was reported as fatal on 29Apr2021. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: infection covid-19


VAERS ID: 1421904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-04-16
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / 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: 2021-04-29
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728651

Write-up: Therapeutic ineffectiveness/COVID-19; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RN20211296, Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021050675. A 94-years-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EP9598), via an intramuscular route of administration, in arm left on 25Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. On 16Apr2021, she presented with a Covid-19 infection. On 16Apr2021, the patient experienced therapeutic ineffectiveness and with COVID-19. The patient died on 29Apr2021. The clinical outcome of the events was reported as fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Covid-19 infection


VAERS ID: 1421911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-05-04
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdomen scan, Abdominal pain, Acute kidney injury, Blood potassium, C-reactive protein, COVID-19 pneumonia, Chest scan, Computerised tomogram, Diarrhoea, Ejection fraction, Glomerular filtration rate, Hyperkalaemia, PO2, Pyrexia, SARS-CoV-2 test, Vaccination failure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PAROXETINE HYDROCHLORIDE; LEVOTHYROX; UVEDOSE; FUROSEMIDE; PREVISCAN [FLUINDIONE]; CORTANCYL; ATENOLOL; ESOMEPRAZOLE; MONOPROST; OROCAL D; MACROGOL; DAFALGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (Permanent anticoagulated); Agoraphobia; Anxiety neurosis; Arteritis; Bilateral cataracts; Carotid artery atheroma; Cervical conisation; Cholecystectomy; Crossectomy; Decompensation cardiac (2 cardiac decompensation on urinary tract infection); Genital prolapse (operated on in 1972 via the mid-umbilical route); Haematoma muscle (the left gluteus maximus radioembolized in Mar2017, complicated by an acute iatrogenic renal disease with iodinated contrast agent); Hernia hiatal; Herniated disc (L4-5); Hypothyroidism (Right anterior saphenous perphlebitis requiring crossectomy); Insufficiency renal; Ischaemic heart disease (28Sep2020: LVEF (50-55%) preserved without disturbance of kinetics subject to poor echogenicity. LV concentric remodeling. Moderate to moderate IAo. PRVG increased with hypervolemia. DV dilated normokinetic); Knee prosthesis insertion; Lumbar disc herniation; Phlebitis; Pneumonia; Polymyalgia rheumatica; Pulmonary embolism; Recurrent cardiac decompensation (2 cardiac decompensation on urinary tract infection and pneumonia); Renal disease (with iodinated contrast agent); Rhizomelic pseudopolyarthritis; Spinal compression fracture; Total knee replacement; Urinary tract infection (2 cardiac decompensation on urinary tract infection)
Allergies:
Diagnostic Lab Data: Test Date: 20210504; Test Name: abdominal scan; Result Unstructured Data: Test Result:not show any abnormality; Comments: not show any abnormality; Test Date: 20210504; Test Name: K +; Test Result: 5.80 mmol; Test Date: 20210504; Test Name: chest scan; Result Unstructured Data: Test Result:atypical pneumonia <10% for a Covid 19; Comments: Several pseudonodular areas in ground glass evolving towards condensation, bilateral, diffuse predominantly slightly in the periphery in favor of infectious pneumonia, atypical for COVID 19 pneumonia, to be compared with virological samples. The extent of anomalies is minimal (less than10%). Stability of a nodule of the apical segment of the upper right lobe in contact with the fissure measuring 20mm, to be compared to a PET-CT; Test Date: 20210504; Test Name: Abdomino-pelvic CT scan; Result Unstructured Data: Test Result:No argument for sigmoid diverticulitis; Comments: No argument for sigmoid diverticulitis. Remains of digestive tract without inflammatory / infectious change, Sigmoid diverticulosis without clear digestive wall thickening or densification of intra-abdominal peridigestive fat opposite: No clear argument on this spontaneous contrast examination for diverticulitis. No caliber or wall abnormality of the rest of the digestive structures. Left renal atrophy with decrease in contralateral renal parenchymal thickness. Right extrasinusal pelvis, without other peculiarity of the urinary excretory tract. Calcified atherosclerotic overload of the aortoiliac as well as of the proximal segment of the celiac trunk and the origin of the renal arteries. Lack of intraperitoneal effusion. In the bone window, there is no suspicious focal bone lesion. Compaction fracture of Th11, L1, L2, L3, without retreat of the posterior wall. On the lower thoracic sections, we find parenchymal abnormalities suggestive of known infectious changes to SARS Cov2; Test Date: 20210504; Test Name: CRP; Result Unstructured Data: Test Result:144.3 mg/l; Test Date: 20210507; Test Name: CRP; Result Unstructured Data: Test Result:289 mg/l; Test Date: 20200928; Test Name: LVEF; Result Unstructured Data: Test Result:50-55 %; Comments: preserved without disturbance of kinetics subject to poor echogenicity. LV concentric remodeling. Moderate to moderate IAo. PRVG increased with hypervolemia. DV dilated normokinetic); Test Date: 20210504; Test Name: CKD-EPI; Result Unstructured Data: Test Result:21 ml/min; Test Date: 20210509; Test Name: CKD-EPI; Result Unstructured Data: Test Result:13 ml/min; Test Date: 20210509; Test Name: spO2; Test Result: 70 %; Test Date: 20210504; Test Name: Covid-19 antigen test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728890

Write-up: she presents with acute functional renal failure complicated by hyperkalaemia; she presents with acute functional renal failure complicated by hyperkalaemia; feverish diarrhea; Vaccination failure; atypical pneumonia less than 10% for a Covid 19; feverish diarrhea; abdominal pain; vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-ST20211840, Safety Report Unique Identifier FR-AFSSAPS-2021052449. A 87-year-old female patient received second dose BNT162B2 (COMIRNATY, solution for injection, lot number: EK9788 and expiry date were not reported), via intramuscularly, on 21Feb2021, as single dose, 03 mL, for COVID-19 immunisation. The patient received second dose BNT162B2 (COMIRNATY, solution for injection, lot number: EJ6788 and expiry date were not reported), via intramuscularly, on 31Jan2021, as single dose, 03 mL, for COVID-19 immunisation. The patient''s medical history included polymyalgia rheumatica from Dec2006, postoperative pulmonary embolism of uterovaginal prolapse in 1972, phlebitis from 1991, hypothyroidism, right anterior saphenous perphlebitis requiring crossectomy, carotid artery atheroma from Nov2006, recurrent cardiac decompensation (2 cardiac decompensation on urinary tract infection and pneumonia), hernia hiatal, ischemic heart disease (28Sep2020: LVEF (50-55%) preserved without disturbance of kinetics subject to poor echogenicity. LV concentric remodeling. Moderate to moderate IAo. PRVG increased with hypervolemia. DV dilated normokinetic), knee prosthesis insertion, lumbar disc herniation, arteritis, insufficiency renal, AFib (permanent anticoagulated), hematoma of the right psoas (the left gluteus maximus radioembolized in Mar2017, complicated by an acute iatrogenic renal disease with iodinated contrast agent), acute iatrogenic renal disease (with iodinated contrast agent), urinary tract infection (2 cardiac decompensation on urinary tract infection), pneumonia, atheroma carotid artery from Nov2016, rhizomelic pseudopolyarthritis from Dec2006, bilateral scapulohumeral periarteritis, anxiety neurosis from Nov2017, agoraphobia from Nov2017, herniated disc (L4-5) from 1996, total knee replacement, cholecystectomy, vertebral compression fracture, bilateral cataract, genital prolapse (operated on in 1972 via the mid-umbilical route) from 1972, and conization of the cervix from Feb1972. Concomitant medications at the time of the reaction included paroxetine hydrochloride anhydrous, levothyroxine sodium (LEVOTHYROX) cholecalciferol (UVEDOSE), furosemide, fluindione (PREVISCAN), prednisone (CORTANCYL), atenolol, esomeprazole, latanoprost (MONOPROST), calcium, colecalciferol (OROCAL D), macrogol, and paracetamol (DAFALGAN). On 04May2021, the patient experienced vaccination failure. The patient was referred to the emergency room on 04May2021 for digestive symptoms such as abdominal pain, vomiting and feverish diarrhea for 3 days. On arrival at the emergency room, the patient remains hemodynamically stable under 2L of oxygen. The Covid-19 antigen test was positive. The low dose chest scan showed several pseudonodular areas in ground glass evolving towards condensation, bilateral, diffuse predominantly slightly in the periphery in favor of infectious pneumonia, atypical for COVID 19 pneumonia, to be compared with virological samples. The extent of anomalies is minimal (less than10%). Stability of a nodule of the apical segment of the upper right lobe in contact with the fissure measuring 20mm, to be compared to a PET-CT and atypical pneumonia less than 10% for a Covid 19. An abdomino-pelvic CT scan showed sigmoid diverticulosis without clear digestive wall thickening or densification of intra-abdominal peridigestive fat opposite: No clear argument on this spontaneous contrast examination for diverticulitis. No caliber or wall abnormality of the rest of the digestive structures. Left renal atrophy with decrease in contralateral renal parenchymal thickness. Right extrasinusal pelvis, without other peculiarity of the urinary excretory tract. Calcified atherosclerotic overload of the aortoiliac as well as of the proximal segment of the celiac trunk and the origin of the renal arteries. Lack of intraperitoneal effusion. In the bone window, there is no suspicious focal bone lesion. Compaction fracture of Th11, L1, L2, L3, without retreat of the posterior wall. On the lower thoracic sections, we find parenchymal abnormalities suggestive of known infectious changes to SARS Cov2 and concluded no argument for sigmoid diverticulitis. Remains of digestive tract without inflammatory / infectious change. She presented with acute functional renal failure complicated by hyperkalaemia on an unspecified date. Establishment of antibiotic therapy with C3G in the face of a suspicion of febrile bibasal pneumonia and possible upper urinary tract infection and biological inflammatory syndrome. The patient underwent lab data and procedure included CKD-EPI = 21 mL/min on 04May2021; K+ = 5.80 mM; CRP = 144.3 mg /L. On 07May2021, CRP = 289; stop ceftriaxone and start Tazocillin and add dexamethasone. On 09May/2021, the patient deteriorated, SpO2 = 70% under 15L of O2 with a high concentration mask. Administration of 20 mg of morphine over 24 hours in an electric syringe pump sc and 20 mg of midazolam over 24 hours in an electric syringe pump. Stop taking oral medications. CKD-EPI = 13 mL/min on 09May2021. On 10May2021, patient on a 50 mg morphine and 50 mg midazolam syringe pump. Sleeping patient, not woken up. Breathing breaks, no bronchial congestion. The patient died on 11May2021 due to unknown cause of death. No information on autopsy was provided. Outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1421939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-29
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Haemorrhage intracranial, Platelet count, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Visual disturbance
Allergies:
Diagnostic Lab Data: Test Name: ct brain; Result Unstructured Data: Test Result:Intra-parenchymal haemorrhage with subarachnoid an; Test Name: Platelet count; Result Unstructured Data: Test Result:normal; Comments: no evidence of clots; Test Date: 20210529; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021671338

Write-up: Intracranial haemorrhage/ intra-parenchymal hemorrhage; This is a spontaneous report received from a contactable physician from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106021714374860-GQV7C, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25407193. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included visual impairment and headache. The patient''s concomitant medications were not reported. No significant past medical history known Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. The patient experienced intracranial haemorrhage/ intra-parenchymal hemorrhage on 29May2021 with fatal outcome. The patient underwent COVID-19 virus test: No - Negative on 29May2021. The patient died on 01Jun2021. Autopsy has not done yet. Patient received vaccine 2 weeks prior to developing intra-parenchymal hemorrhage. Platelets normal and no evidence of clots. CT angiogram not performed so cause for ICH not identified. catastrophic injury with no neurosurgical options - supported on ICU until met death by neurological criteria. Please note had a history of visual disturbances and headaches prior to this event - unknown duration though of these symptoms. Awaiting Coroners post-mortem. Unclear as to cause of hemorrhage but given two weeks since vaccine we felt appropriate to report in case vaccine etiology of bleed identified. Patient has not tested positive for COVID-19 since having the vaccine. The report did not relate to possible blood clots or low platelet counts. Suspect Reactions: details of any relevant investigations or tests conducted: "CT brain - Intra-parenchymal haemorrhage with subarachnoid and subdural extension." No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Haemorrhage intracranial


VAERS ID: 1421942 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain hypoxia, Cardiac arrest, Echocardiogram, Extrasystoles, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), 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), Acute central respiratory depression (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL
Current Illness: Heart failure (Very minor)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: Echocardiogram; Result Unstructured Data: Test Result:No abnormalities detected; Comments: no abnormalities, blockages or any other concerns relating to her heart. Only very minor heart failure treated with ramipril; Test Date: 20210121; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021671651

Write-up: Brain hypoxia; Cardiac arrest; Heartbeats skipped; This is a spontaneous report from a contactable consumer received from the Regulatory Authority, Regulatory authority report number GB-MHRA-WEBCOVID-202106031957590890-HDCO7, Safety Report Unique Identifier GB-MHRA-ADR 25416304. An 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 08Apr2021 (Lot Number: ER1749) as dose 2, single for covid-19 immunisation. The patient previously took the first dose bnt162b2 on unknown date for covid-19 immunization. Medical history included ongoing cardiac failure. Concomitant medication included ramipril taken for Left heart failure from 06Apr2021. The patient experienced heartbeats skipped and cardiac arrest on 15May2021 , brain hypoxia on an unspecified date. The patient had an Echocardiogram on her heart on 06Apr2021 prior to her second Pfizer injection which detected no abnormalities, blockages or any other concerns relating to heart. Only very minor heart failure for which she was on a tiny dose of ramipril. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Jan2021. The patient died on 20May2021. It was not reported if an autopsy was performed. The outcome of events was fatal. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. No follow-up attempts possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: Brain hypoxia; Heartbeats skipped; Cardiac arrest


VAERS ID: 1421943 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-28
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cardiac failure congestive, Left ventricular failure, Pulmonary oedema, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive cardiac failure
Allergies:
Diagnostic Lab Data: Test Name: CT angiogram; Result Unstructured Data: Test Result:No PE, CAP, pulmonary oedema, large left; Comments: No PE, CAP, pulmonary oedema, large left ventricle; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021671425

Write-up: congestive cardiac failure; pulmonary oedema; Failure heart left; This is a spontaneous report received from a contactable Physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106041550401690-LGQ6N. Safety report unique identifier GB-MHRA-ADR 25421638. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not known) as DOSE 2, SINGLE dose for covid-19 immunisation. Medical history included cardiac failure congestive from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced congestive cardiac failure (death) on an unspecified date, pulmonary oedema (death) on an unspecified date, failure heart left (death) on 28May2021,all with fatal outcome, also experienced significant deterioration in chronic shortness of breath (SOB) (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests which included angiogram:No PE, CAP, pulmonary oedema, large left ventricle, sars-cov-2 test: no - negative covid-19 test, both on unknown date. The patient died on 04Jun2021. It was not reported if an autopsy was performed. Source verbatim: Significant deterioration in chronic shortness of breath (SOB) around the time of second dose of pfizer vaccine. Culminating in an admission with severe congestive cardiac failure to intensive therapy unit (ITU). Patient has not tested positive for COVID-19 since having the vaccine. Suspect Reactions: details of any relevant investigations or tests conducted: ''CT pulmonary angiogram - No PE, CAP, pulmonary oedema, large left ventricle''. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Left ventricular failure; Congestive cardiac failure; pulmonary oedema


VAERS ID: 1421946 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-23
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN3924 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Brain injury, Cerebral venous sinus thrombosis, Cerebrovascular accident, Headache, Lumbar puncture, Magnetic resonance imaging, Meningitis bacterial, SARS-CoV-2 test, Seizure, Somnolence, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 30
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: ASPIRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Lumbar puncture; Result Unstructured Data: Test Result:unknown results; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negative
CDC Split Type: GBPFIZER INC2021671784

Write-up: Intracranial venous sinus thrombosis; Suspected major stroke; convulsions; non-responsive; bacterial meningitis; Very weak; slept most; Headache; major brain damage; This is a spontaneous report received from a contactable consumer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051050388970-AWZ95. A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 (lot number EN3924) at single dose for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN) from an unspecified date to 07Feb2021. It was reported headaches started approximately 23Feb2021. Phoned doctor for appointment 26Feb2021 - appointment offered for 03Mar2021. Headaches became severe approximately 01Mar2021. Visited 03Mar2021- prescribed co-codamol. General practitioner (GP) prescribed steroids 03Mar2021. Headaches worsened - GP confirmed to increase dose of co-codamol and steroids 04Mar2021. Very weak and slept most of 05Mar2021. Convulsions and non-responsive 5am on 06Mar2021. Ambulance called. Taken to hospital. Bacterial meningitis suspected. Treatment started. Transferred to high dependency unit (HDU) with intracranial venous sinus thrombosis on 14Mar2021. Suspected major stroke. All medical support removed 18Mar2021 when it became clear that there was major brain damage. Died on HDU on 26Mar2021. Lab data included Lumbar puncture and magnetic resonance imaging (MRI) scans regularly carried out, negative COVID-19 virus test on unspecified date. The outcome of the events were fatal. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Intracranial venous sinus thrombosis; Very weak; Headache; slept most; convulsions; non-responsive; bacterial meningitis; Suspected major stroke; major brain damage


VAERS ID: 1421948 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2021-02-11
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Decreased appetite, Dehydration, Diarrhoea, Echocardiogram, Illness, Ischaemic stroke, Nausea, Pneumonia, Pulmonary oedema, SARS-CoV-2 test, X-ray
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Ischaemic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 90
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: HRI WATER BALANCE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Failure heart; Ischemic stroke; Lung infection
Allergies:
Diagnostic Lab Data: Test Date: 20210223; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210423; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210211; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Test Date: 20210223; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210423; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC2021671476

Write-up: lung infection; fluid on the lung; Dehydration; not eating; diarrhoea; sickness/feels sick; Nausea; partial heart failure; Ischemic stroke; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106052132504810-KM5DX, Safety Report Unique Identifier GB-MHRA-ADR 25426521. A 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Dec2020 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included cardiac failure, ischaemic stroke, pneumonia. Concomitant medications included agathosma betulina leaf, aphanes arvensis herb, arctostaphylos uva-ursi leaf, taraxacum officinale root (HRI WATER BALANCE) taken for an unspecified indication, start and stop date were not reported. The patient experienced ischemic stroke on 11Feb2021, partial heart failure, lung infection, fluid on the lung, nausea, dehydration, not eating, all on an unspecified date; diarrhoea and sickness/feels sick on 28Apr2021. Events were reported as serious with hospitalization and fatal outcome. The patient was hospitalized for ischemic stroke, partial heart failure, nausea from 11Feb2021 to 23Feb2021. The patient was hospitalized for lung infection and fluid on the lung from 19Apr2021 to 23Apr2021. The patient was hospitalized for diarrhoea, dehydrated, not eating, sickness/feels sick from 03May2021 to 07May2021. Events diarrhoea and sickness caused Physician Office Visit. The patient underwent lab tests and procedures which included echocardiogram: unknown results on 23Feb2021 and on 23Apr2021, COVID-19 virus test: negative on 11Feb2021, x-ray: unknown results on 23Feb2021 and 23Apr2021. The patient died on 13May2021. An autopsy was not performed. The outcome of the all events was fatal. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. Clinical course reported as follows: 11Feb2021 Ischemic Stroke went into hospital till 23Feb2021. Had various scans and X-rays. Partial heart failure. 23Feb2021, home with carers going in but wasn''t coping. 06Mar2021 went into residential home for care had to do 2 weeks isolation. Really struggled as no family could visit. 19Apr2021, back to hospital for lung infection, fluid on the lung. Various scans X-rays and electrocardiogram (ECG) on 23Apr2021 and came out of hospital, back to residential home, on strong antibiotics and water tablets. 28Apr2021 visit by doctor, bad diarrhoea and sickness from strong antibiotics. Told she has to stay on them, not eating as feels sick. 03May2021, dehydrated, back in hospital more tests and scans. 07May2021 back to residential home. Died on 13May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ischemic stroke; Failure heart; Lung infection; Pulmonary oedema; Nausea; Diarrhea; Dehydration; Sickness; Decreased appetite


VAERS ID: 1421949 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cerebral haemorrhage, Confusional state, Headache, Magnetic resonance imaging, Myocardial infarction, Renal disorder, SARS-CoV-2 test, Subarachnoid haemorrhage, Weight increased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:increased; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021671731

Write-up: subarachnoid haemorrhage; heart attack/pulseless electrical activity (PEA) heart attack; confused; Haemorrhage brain; Blood pressure increased; Renal disorder/problems with kidneys; Weight increased/Gained weight; Headache; This is a spontaneous report received from a non-contactable consumer from the Regulatory Authority. The regulatory authority report number is (GB-MHRA-WEBCOVID-202106061209297470-F1FLZ) Safety Report Unique Identifier GB-MHRA-ADR 25427145. An 81-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included myocardial infarction. Concomitant medication included levothyroxine sodium (THYROXINE). On unspecified date in on 2021, the patient experienced subarachnoid haemorrhage, heart attack/pulseless electrical activity (PEA) heart attack, confused, haemorrhage brain, blood pressure increased, renal disorder/problems with kidneys, weight increased/gained weight, headache. The patient underwent lab tests and procedures in 2021 which included blood pressure: increased, magnetic resonance imaging (MRI): unknown results, COVID-19 virus test: negative. Therapeutic measures were taken as a result of blood pressure increased (put on medication). The outcome of the events was fatal. The patient died on 19Mar2021. 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: Subarachnoid haemorrhage; heart attack/pulseless electrical activity (PEA) heart attack; confused; Haemorrhage brain; Blood pressure increased; Renal disorder/problems with kidneys; Weight increased/Gained weight; Headache


VAERS ID: 1422003 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-05
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (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? No
Previous Vaccinations:
Other Medications: FOSTAIR; MONTELUKAST
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (in very early pregnancy); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test in very early pregnancy
CDC Split Type: GBPFIZER INC2021671284

Write-up: Pregnancy loss; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is [GB-MHRA-WEBCOVID-202106071636271310-HWKUJ]. Safety Report Unique Identifier GB-MHRA-ADR 25432035. A 31-year-old female patient received her first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19May2021 (Lot Number: ET8885) as dose 1, single for COVID-19 immunisation. Medical history included suppressed lactation and COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included beclometasone dipropionate, formoterol fumarate (FOSTAIR) and montelukast; both taken for asthma, start and stop date were not reported. Patient was not enrolled in clinical trial and was not breastfeeding. Patient was COVID positive in very early pregnancy. Patient was exposed to the medicine Second-trimester (13-28 weeks). Patient has not had symptoms associated with COVID-19. On 05Jun2021, patient was found to have Intrauterine death at her 28 week scan by antenatal staff. The mother was 28 Weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Patient has not tested positive for COVID-19 since having the vaccine. Physician was unsure if the vaccine had an adverse effect on any aspect of the pregnancy. The report did not relate event to possible blood clots or low platelet counts. Relevant investigations or tests conducted was reported as awaiting PM. The patient died on 05Jun2021. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pregnancy loss


VAERS ID: 1422367 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Illness
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021759425

Write-up: feeling unwell; chest pain; Cardiac arrest; This is a spontaneous report from a contactable pediatrician through a Pfizer sales representative and a contactable consumer. A 61-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 19Jun2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included underlying diseases NOS and COVID-19 in Dec2020. The patient''s concomitant medications were not reported. On Sunday 20Jun2021 the patient was feeling unwell, experienced chest pain and was admitted to the hospital where he expired. The most possible cause was cardiac arrest. Autopsy would be performed in the following days. Autopsy results were not yet available. The outcome of the cardiac arrest was fatal on 20Jun2021, the outcome of the feeling unwell and chest pain was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender''s Comments: Based on chronological connection to the vaccine causality between events cardiac arrest, feeling unwell and chest pain and BNT162B2 (COMIRNATY) vaccine 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: Cardiac arrest


VAERS ID: 1422378 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Circulatory collapse, Cyanosis, Dyspnoea, Malaise, Pulmonary embolism, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol dependence syndrome; Bipolar disorder; Coagulation disorder; Heart failure class II; Hepatopathy alcoholic; Obesity; Transient ischemic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021669668

Write-up: pulmonary embolism; feeling unwell; dyspnoea; cyanosis; did not breath; asystole; no circulation; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB HU-OGYI-362221. A 53-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6134 and expiration date not provided), via intramuscular, in arm left, on 31Jan2021, at 0.3 mL single dose, for COVID-19 immunization. Medical history included transient ischemic attack, obesity, heart failure class II, alcoholic hepatopathy, unspecified coagulation disorder, bipolar disorder, alcohol dependence syndrome, all from unknown date to unknown date. Concomitant medications were not reported. The patient experienced death on 14Feb2021. On 14Feb2021, the patient told the nurses that he was feeling unwell, had dyspnoea, and then he suddenly collapsed. An ambulance was called, chest compression was started. When paramedics arrived, the patient did not breath, had no circulation, cyanosis and asystole occurred. Resuscitation was continued for 10 minutes. A large amount of gastric content was continuously emptied from the patient''s mouth, so it was not possible to intubate and provide airway, the patient died. The physician of the outgoing ambulance unit assumed pulmonary embolism, which was also confirmed by the physician who examined the dead body. The cause of death was determined based on medical history and on-site circumstances. Autopsy was not done. The outcome of the events "pulmonary embolism" was fatal, of other events was unknown. Patient died on 14Feb2021. The cause of death was pulmonary embolism. An autopsy was not performed. Sender Comment: The 53-year-old patient died 14 days after Comirnaty vaccination. Pulmonary embolism was assumed to be the cause of death, autopsy was not done. The causal relationship between the reported death and Comirnaty is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1422383 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Blood count, Endoscopy upper gastrointestinal tract, Oesophageal varices haemorrhage
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic cardiomyopathy; Anemia; Atherosclerosis; Chronic alcoholism; Diabetes mellitus; Gastritis; Hepatic cirrhosis; Ischemic heart disease; Pancreatic fibrosis
Allergies:
Diagnostic Lab Data: Test Name: blood count; Result Unstructured Data: Test Result:did not improve; Comments: transfusion due to anemia, but his blood count did not improve and emptied black stool multiple times; Test Name: Gastroscopy; Result Unstructured Data: Test Result:esophageal varices; Comments: stage IV esophageal varices for which the patient received sclerotherapy
CDC Split Type: HUPFIZER INC2021669683

Write-up: stage IV esophageal varices/ vomiting blood and had tarry stool/black stool multiple times as a result of gastrointestinal bleeding; received transfusion due to anemia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-383521. A 70-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 17Apr2021 (Batch/Lot Number: EW4815) as 1st dose, 0.3 ml single for covid-19 immunization. Medical history included alcoholic cardiomyopathy, chronic alcoholism, anemia, atheroslecoris, diabetes mellitus, gastritis, hepatic cirrhosis, ischemic heart disease and pancreatic fibrosis, unknown if ongoing. The patient''s concomitant medications were not reported. The patient was hospitalized on 27Apr2021 because he has been vomiting blood and had tarry stool for the last 2 days. Gastroscopy showed stage IV esophageal varices for which the patient received sclerotherapy. The patient also received transfusion due to anemia, but his blood count did not improve and emptied black stool multiple times as a result of gastrointestinal bleeding. The patient''s general condition progressed and passed away on 02May2021 at 06:30. Outcome of anemia was unknown, of other event was fatal. Sender Comment: The cause of death was heavy bleeding due to esophageal varices, which is in association with alcoholic cirrhosis. The patient''s primary diseases also contributed to his condition. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: vomiting blood and tarry stool/black stool multiple times as a result of gastrointestinal bleeding/esophageal varices


VAERS ID: 1422384 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-30
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Hydrothorax, Loss of consciousness, Neoplasm progression, Oxygen saturation, Oxygen saturation decreased, Respiratory failure, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Malignancy related conditions (narrow), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphocytic leukemia (advanced stage); Diabetes mellitus; Diverticulosis; Hypertension; Polyposis intestinal
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: oxygen saturation; Test Result: 50 %; Test Name: Covid-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021669678

Write-up: Death; he was found unconscious in his home; Hydrothorax; oxygen saturation was 50%; multiple metastasis due to the patient''s untreated, advanced stage chronic lymphatic leukemia; severe respiratory insufficiency; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-383621. A 63-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 09Apr2021 (Lot Number: EW9127) as 2nd dose, 0.3ml, single for covid-19 immunisation. Patient took the first dose of vaccine on 05Mar2021 (batch number: ET1831) for covid-19 immunization. Medical history included diabetes mellitus, diverticulosis, polyposis intestinal, advanced stage chronic lymphocytic leukaemia, hypertension, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death (death, hospitalization) on 04May2021, multiple metastasis due to the patient''s untreated, advanced stage chronic lymphatic leukemia (death, hospitalization) in 2021, severe respiratory insufficiency (death, hospitalization) in 2021, he was found unconscious in his home (hospitalization, medically significant) on 30Apr2021 with outcome of recovering, hydrothorax (hospitalization, medically significant) on 30Apr2021 with outcome of recovering, oxygen saturation was 50% (hospitalization, medically significant) on 30Apr2021 with outcome of recovering. On 30Apr2021 the patient was taken to the hospital via ambulance after he was found unconscious in his home. His oxygen saturation was 50%, but after receiving oxygen the patient became conscious again. Hydrothorax was confirmed in the hospital and after treatment, the patient respiratory parameters started to get better. As the patient had known but untreated, advanced stage chronic lymphatic leukemia, improvement in his general condition was not expected. The patient was transferred from the PRIVACY for further treatment, but severe respiratory insufficiency occurred and despite therapy, passed away on 04May2021 at 03:30. An autopsy was performed and results were not provided. Covid-19 PCR (Polymerase chain reaction) tests were negative on an unknown date. Sender comments: Based on the autopsy report, the cause of death was multiple metastasis due to the patient untreated, advanced stage chronic lymphatic leukemia, therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; severe respiratory insufficiency; multiple metastasis due to the patient''s untreated, advanced stage chronic lymphatic leukemia


VAERS ID: 1422386 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-05-11
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Breast cancer, Computerised tomogram, Death, Histology, Hydrothorax, Investigation, Mammogram, Metastases to adrenals, Metastases to liver
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Breast malignant tumours (narrow), Arthritis (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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: Hypertension; Metastatic breast cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: CT; Result Unstructured Data: Test Result:hydrothorax; Test Date: 20210520; Test Name: histological examination; Result Unstructured Data: Test Result:no results; Test Date: 20210511; Test Name: investigation; Result Unstructured Data: Test Result:Metastases were found in the liver, in the adrenal; Comments: Metastases were found in the liver, in the adrenal gland; Test Name: Several tets; Result Unstructured Data: Test Result:no alterations were found; Test Date: 20210511; Test Name: mammography; Result Unstructured Data: Test Result:breast cancer
CDC Split Type: HUPFIZER INC2021669685

Write-up: joint pain; death; hydrothorax; breast cancer; Metastases were found in the liver, in the adrenal gland; Metastases were found in the liver, in the adrenal gland; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number HU-OGYI-384621. A 71-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular, administered in Arm Left on 24Apr2021 (Batch/Lot Number: ET6956) as 0.3ml single for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing breast cancer metastatic. The patient''s concomitant medications were not reported. On an unreported date, the patient experienced joint pain. The patient was examined via several tests, no alterations were found. On 11May2021, mammography found breast cancer. Metastases were found in the liver, in the adrenal gland. On 20May2021, histological examination was performed, no results were provided. CT showed hydrothorax. On 21May2021, the patient died. The patient underwent lab tests and procedures which included computerised tomogram: hydrothorax on 20May2021, histology: no results on 20May2021, investigation: Metastases were found in the liver, in the adrenal gland on 11May2021, investigation: no alterations were found on unknown date, mammogram: breast cancer on 11May2021. The patient died on 21May2021. It was not reported if an autopsy was performed. The outcome of event death was fatal. The outcome of other events was unknown. Sender Comment: Death after vaccination with Comirnaty is not expected. TTO is 27 days until death. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered not assessable per lack of information. The case is considered serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: died


VAERS ID: 1422387 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA165994 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORMODIPINE; XANAX; NEBIBETA; ACETYLSALICYLIC ACID; NITRODERM; ADEXOR MR; ZOCOR; VEROSPIRON
Current Illness: Chronic bronchitis; Chronic pyelonephritis; Decompensation cardiac; Emphysema pulmonary; Hyperlipidaemia; Hypertension; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis generalized
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: biopsy; Result Unstructured Data: Test Result:direct cause of death was congestive heart failure
CDC Split Type: HUPFIZER INC2021669688

Write-up: congestive heart failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-385221. A 100-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 03May2021 (Batch/Lot Number: PAA165994) as 0.3 ML SINGLE for covid-19 immunisation. Medical history included hypertension, chronic bronchitis, cardiac decompensation, pulmonary emphysema, ischaemic heart disease, chronic pyelonephritis and hyperlipidaemia, all were ongoing, and general atherosclerosis. Concomitant medications included amlodipine besilate (NORMODIPINE); alprazolam (XANAX); nebivolol hydrochloride (NEBIBETA); acetylsalicylic acid; glyceryl trinitrate (NITRODERM); trimetazidine hydrochloride (ADEXOR MR); simvastatin (ZOCOR); spironolactone (VEROSPIRON), all taken for an unspecified indication, start and stop date were not reported. The paient previously received the first dose of bnt162b2 (COMIRNATY) on an unknown date for covid-19 immunisation. On 06May2021, the patient died. According to the biopsy results, the direct cause of death was congestive heart failure. The patient''s primary disease was general atherosclerosis, which also affected the coronary arteries. The outcome of the event congestive heart failure was fatal. Sender''s Comment: Death after vaccination with Comirnaty is not expected. TTO is 3 days until death. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered unlikely because death can be attributed to underlying diseases. The case is considered serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Congestive heart failure; Autopsy-determined Cause(s) of Death: Congestive heart failure


VAERS ID: 1422388 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Laboratory test, Macrocephaly, Maternal exposure during pregnancy, PTEN gene mutation, Stillbirth
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-06-12
   Days after onset: 97
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: biochemical tests; Result Unstructured Data: Test Result:PTEN Hamartoma tumor syndrome; Test Name: DNA tests; Result Unstructured Data: Test Result:PTEN Hamartoma tumor syndrome
CDC Split Type: ILPFIZER INC2021720556

Write-up: A genetic disease diagnosed by biochemical tests or DNA tests: PTEN Hamartoma tumor syndrome; Structural malformation: Macrocephaly; had a stillbirth on Saturday 12Jun2021, this is the 33rd week of pregnancy; a woman aged 35 had a stillbirth on Saturday 12Jun2021, this is the 33rd week of pregnancy; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and fetus. This is a fetus report. A fetus patient mother (35-year-old) received bnt162b2 second single dose on 06Mar2021 (Batch/Lot number was not reported) for covid-19 immunisation at age of 35-year-old. The patient''s mother medical history and concomitant medications were not reported. The mother was vaccinated on 06Mar2021 with the second dose of the corona vaccine. She had a stillbirth on Saturday 12Jun2021, this was the 33rd week of pregnancy. A genetic disease diagnosed by biochemical tests or DNA tests: PTEN Hamartoma tumor syndrome and structural malformation was macrocephaly. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2021720247 mother/fetus case; Reported Cause(s) of Death: a woman aged 35 had a stillbirth on Saturday 12Jun2021, this is the 33rd week of pregnancy; had a stillbirth on Saturday 12Jun2021, this is the 33rd week of pregnancy; A genetic disease diagnosed by biochemical tests or DNA tests: PTEN Hamartoma tumo


VAERS ID: 1422674 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021674905

Write-up: Ischaemic heart disease; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was an 86-year-old male. It was unknown if the patient had allergies to medications, food, or other products, or other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 21Mar2021 at 11:15, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. During 15 minutes for side reaction confirmation, no abnormality was noted. After that, the patient had a meal, and no particular changes had been observed. On 21Mar2021 at 18:00 (6 hours and 45 minutes after the vaccination), the patient experienced ischaemic heart disease. the patient''s wife found the patient dead while taking bath. Ischaemic heart disease was diagnosed at the hospital which the patient was transported to. Ischaemic heart disease was also diagnosed by a police surgeon. Cause of death was reported as ischaemic heart disease. An autopsy was not performed. It was unknown if the patient received treatment. The reporting physician classified the event as serious (death).; Sender''s Comments: Given the nature of the event, the patient''s age and the limited information provided in this report, the company does not attribute the event ischemic heart disease to the suspect product BNT162b2 (COMIRNATY). The following relevant key information is not available: medical, psychosocial, and family histories; patient''s lifestyle habit(s); laboratory/diagnostic tests results; concomitant medications and other risk/related factors that may contribute to the occurrence of the event. This case will be re-assessed should additional information becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Ischaemic heart disease


VAERS ID: 1422683 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Interleukin level, Pneumonia, Pneumonitis, Pyrexia
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: sIL2R; Result Unstructured Data: Test Result:increased
CDC Split Type: JPPFIZER INC2021678887

Write-up: headache; pyrexia; pneumonia; Pneumonitis (suspected); This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21112655. A 73-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17May2021 at 13:00 (Batch/Lot number was not reported) at 73-years-old as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 17May2021, the patient experienced headache (hospitalization), and pyrexia (hospitalization). On 24May2021, the patient experienced pneumonitis (suspected) (death). On an unspecified date, the patient experienced pneumonia (medically significant). The patient was hospitalized for headache and pyrexia from 20May2021 to an unknown date. The clinical course was reported as follows: The patient was a 73-year and 1-month-old male. Body temperature before vaccination was not provided. The family history and medical history were not provided. On 17May2021 at 13:00 (the day of vaccination), the patient received the first 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 17May2021 (the day of the vaccination), the patient experienced headache and pyrexia. On 20May2021 (3 days after the vaccination), the patient was admitted to the hospital. On 24May2021 (7 days after the vaccination, as reported), pneumonitis was suspected. On 08Jun2021 (21 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 17May2021 (the day of vaccination), the patient received vaccination of COVID-19 vaccine, and experienced pyrexia and headache after went home, and visited nearby hospital. On 20May2021 (3 days after the vaccination), the symptoms were not recovered, visited reporting hospital and admitted. On 24May2021 (6 days and 11 hours after vaccination), the patient visited the respiratory medicine department, and increased sIL2R was observed. The possibility of pneumonitis caused by polyethylene glycol (PEG) which was additive of the vaccine was pointed out. On 25May2021 (7 days and 11 hours after vaccination), Nasal High Flow was attached. On 28May2021 (10 days and 11 hours after vaccination), the biphasic positive airway pressure (BIPAP) was initiated. On 08Jun2021 (21 days and 11 hours after vaccination), the patient died. From 22May2021 (4 days and 11 hours after vaccination) to 24May2021 (6 days and 11 hours after vaccination), methylprednisolone (mPSL) 1000 mg was administered. From 25May2021 (7 days and 11 hours after vaccination) to 26May2021 (8 days and 11 hours after vaccination), mPSL 500 mg was administered. From 27May2021 (9 days and 11 hours after vaccination) to 28May2021 (10 days and 11 hours after vaccination), mPSL 250 mg was administered. From 29May2021 (11 days and 11 hours after vaccination) to 30May2021 (12 days and 11 hours after vaccination), mPSL 125 mg was administered. Other possible cause(s) of the event such as any other diseases were headache, pyrexia, and pneumonia. The patient underwent lab tests and procedures which included serum soluble interleukin 2 receptor (sIL2R): increased on 24May2021. Therapeutic measures were taken as a result of pneumonitis (suspected), headache, pyrexia, pneumonia. The clinical outcome of the events: headache, pyrexia and pneumonia were unknown. The clinical outcome of the event, pneumonitis (suspected), was fatal. The patient died on 08Jun2021 due to pneumonitis (suspected). It was unknown if an autopsy was performed. The batch/lot numbers for the vaccine, bnt162b2 (COMIRNATY), were not provided and will be requested during follow up. ; Reported Cause(s) of Death: Pneumonitis (suspected)


VAERS ID: 1422685 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       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:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Cirrhosis alcoholic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021680524

Write-up: Death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21112919. An 88-year and 2-month-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FA7338; Expiration Date: 30Sep2021), via an unspecified route of administration, on 03Jun2021 at 09:35 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included cirrhosis alcoholic and cardiac failure chronic. The patient''s concomitant medications were not reported. The patient experienced death on 10Jun2021 (reported as: 7 days after the vaccination), which was reported as fatal. The clinical course was reported as follows: On 03Jun2021, the patient received BNT162B2. On 10Jun2021 in the morning, family member found that the patient was dead in a toilet at home. The cause of death was reported as unknown. An autopsy was not performed. The reporting physician assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event, such as any other diseases, was reported as cirrhosis alcoholic.; Reported Cause(s) of Death: Death


VAERS ID: 1422688 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Cardiac failure chronic; Myasthenia gravis
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:further increased Centigrade
CDC Split Type: JPPFIZER INC2021702701

Write-up: Cardiac arrest; Pneumonia aspiration; Vomiting; Low grade fever; This is a spontaneous report from a contactable pharmacist received via the Agency and from a contactable emergency physician received from the Regulatory Authority. Regulatory authority report number is v21114211. An 87-year and 2-month-old female patient received first dose of BNT162B2 (COMIRNATY, Lot Number: EY5422; Expiration Date: 31Aug2021) intramuscular single dose for COVID-19 immunisation on 12Jun2021 10:00, at 87-year-old. Medical history included cardiac failure chronic, angina pectoris, myasthenia gravis. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no family history. The patient had no allergies to medications, food, or other products. The patient''s concomitant medications included: unspecified oral medications for cardiac failure chronic, angina pectoris, myasthenia gravis. The emergency physician reported the event as cardiac arrest. On 13Jun2021 (1 day after the vaccination) (as reported), the patient experienced cardiac arrest. On14Jun2021 (2 days after the vaccination), the outcome of the event was fatal. Clinical course was as follows: On 13Jun2021 (1 days after the vaccination), when the patient had low grade fever, the patient also vomited, and pneumonia aspiration developed. Thereafter, body temperature further increased, and cardiac arrest developed on 14Jun2021. Resuscitation was performed. However, the patient did not respond to it and death of the patient was confirmed. The patient died on 14Jun2021. It was unknown if autopsy was performed. The reporting pharmacist and emergency physician classified the event as serious (death) and the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was pneumonia aspiration.; Sender''s Comments: Based on the information available, a contributory role of the usage of the vaccine BNT162B2 to the reported events "Cardiac arrest and Pneumonia aspiration" cannot be excluded. The history of cardiac failure chronic, angina pectoris, and myasthenia gravis, may have contributed to the development of the events.; Reported Cause(s) of Death: Pneumonia aspiration; Cardiac arrest


VAERS ID: 1422689 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Cardiac failure, Chest X-ray, Death, Disease recurrence, Oxygen saturation, Pneumonia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Dementia Alzheimer''s type; Diabetes mellitus; Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Body temperature; Test Date: 20210605; Test Name: Chest X-ray; Result Unstructured Data: Test Result:suspected cardiac failure; Comments: suspected cardiac failure and pneumonia; Test Date: 20210605; Test Name: SpO2; Test Result: 70 %; Test Date: 20210605; Test Name: SpO2; Test Result: 90 %; Comments: At the time of visit to a hospital
CDC Split Type: JPPFIZER INC2021703342

Write-up: suspected cardiac failure; suspected cardiac failure; suspected pneumonia; bronchial asthma; died; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114029. The patient was an 84-year and 4-month-old male. Body temperature before vaccination was 36.3 degrees Centigrade. Medical history included dementia Alzheimer''s type, hypertension, cardiac failure chronic, diabetes mellitus, and osteoporosis. Concomitant medications and family history were not provided. On 04Jun2021 at 12:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY4834, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 05Jun2021 at 10:10 (1 day after the vaccination), the patient experienced suspected cardiac failure, suspected pneumonia and bronchial asthma. On 05Jun2021 (1 day after the vaccination), the patient was admitted to a hospital. On 13Jun2021 (9 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The outcome of events ''suspected cardiac failure, suspected pneumonia and bronchial asthma'' was unknown The course of the events was as follows: The patient was transferred to a hospital upon referral for the treatment of dementia Alzheimer''s type, hypertension, cardiac failure chronic, diabetes mellitus, and osteoporosis. On 04Jun2021 at around 12:30, the patient received the first dose of BNT162b2. On 05Jun2021 in the morning, as wheezing and decreased SpO2 (oxygen saturation percutaneous) (70%) appeared, the patient visited the reporter''s hospital. At the time of visit, SpO2 was 90%. Chest X-ray showed findings suspecting the presence of cardiac failure and pneumonia. Therefore, at around 10:00, the patient was referred to another hospital and hospitalized for bronchial asthma. The reporter was informed that the patient died on 13Jun2021. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported if there was possible cause of the events. The reporting physician commented as follows: The causal relationship with BNT162b2 was uncertain. However, the reporter considered that it was natural for his family was distrustful.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1422692 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Cardiac failure acute, Chest X-ray, Malaise, Pyrexia, Respiratory arrest, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Drug allergy; Hypertension; Sarcoidosis
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: after vaccination; Test Date: 20210614; Test Name: Chest x-ray; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC2021710554

Write-up: cardiac arrest; Respiratory arrest; cardiac failure acute; Malaise; Pyrexia of 38.5 degrees Centigrade; Vaccination site pain; This is a spontaneous report from a contactable physician received via the Agency and the Regulatory Authority with the regulatory authority report number v21114780. The patient was a non-pregnant 82-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified drug(s) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had allergy to penicillin. Other medical history included sarcoidosis, hypertension, and diabetes mellitus. On 10Jun2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration for COVID-19 immunization. On 11Jun2021 (1 day after the vaccination), the patient only had vaccination site pain. On 12Jun2021 (2 day after the vaccination), the patient only had vaccination site pain. On 13Jun2021 (3 day after the vaccination), the patient had pyrexia of 38.5 degrees centigrade, but it resolved in short time, thereafter. On 14Jun2021 (4 day after the vaccination), the patient had malaise, and visited the reporting physician. Chest x-ray showed no abnormality, and the patient had no pyrexia. The patient returned home. On 15Jun2021 at 0:50, (4 day after the vaccination), the patient was found with respiratory arrest and cardiac arrest at home and transferred to a hospital. A local internist made death certificate of the patient. (According to the death certificate, the death cause was reported as cardiac failure acute). The events resulted in emergency room. Autopsy was not performed. The reporting physician assessed the event as serious (Death). The reporting physician considered the causal relationship between the events and BNT162b2 could not be determined. However, it could not be ruled out. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event ''pyrexia'' was recovered in Jun2021; of events ''vaccination site pain and malaise'' was unknown; while of the events ''respiratory arrest, cardiac arrest and cardiac failure acute'' was fatal without treatment.; Reported Cause(s) of Death: Respiratory arrest; Cardiac failure acute; cardiac arrest


VAERS ID: 1422693 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Catheter removal (repeated espisodes); Cerebral infarction; Dementia; Lung cancer; Mediastinal mass; Pleural effusion; Pneumonia aspiration (repeated espisodes); Urinary tract infection (repeated espisodes)
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021710577

Write-up: Cardio-respiratory arrest; choked on the tea; could not eat meals; exhausted; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114252. The patient was a 79-year and 8-month-old male. Body temperature before vaccination was 36.2 degrees centigrade (on 01Jun2021). Family history was unknown. Medical history included suspected left lung cancer, suspected left anterior mediastinal tumor, left pleural effusion, angina pectoris, cerebral infarction, advanced dementia, as well as repeated episodes of pneumonia aspiration, urinary tract infection, and self-removal of urethral balloon. On 01Jun2021 in the afternoon (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EY5420, Expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jun2021 at 8:00 (9 days after the vaccination), the patient experienced cardio-respiratory arrest. On 10Jun2021 (9 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: After the vaccination, no particular change was noted. On 09Jun2021 at 10:00, when the patient drank tea at the facility, the patient choked on the tea, for which a nurse performed suctioning. Subsequently, the patient rested in bed all day and could not eat meals (in Jun2021). There was no particular problem in vital signs. The patient had no particular change during nighttime. On 10Jun2021 at 07:00, a helper visited the patient''s room for breakfast and tried to move the patient into a wheelchair; however, the patient was exhausted (in Jun2021). The patient was moved to a bed again and laid down. At that time, respiration status was good, so the helper temporarily left the room. At 08:00, the helper visited the room again and found that the patient had cardio-respiratory arrest in bed. Phone call was made to the patient''s daughter and situation was explained. With previous consultation, the daughter did not want ambulance transport and at 10:00, the patient died. The outcome of event cardio-respiratory arrest was fatal and of 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 not provided. The reporting physician commented as follows: Causality between the event and the vaccine was considered unrelated; however, the case was reported just in case because the patient died 10 days after the vaccination.; Sender''s Comments: Based on the current available information, the event Cardio-respiratory arrest is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of suspected left lung cancer, suspected left anterior mediastinal tumor, left pleural effusion, angina pectoris, cerebral infarction, as well as repeated episodes of pneumonia aspiration may provide plausible explanation for the event. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1422694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Bypass surgery; Chest pain; Dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021710846

Write-up: Heart disease (angina pectoris); This is a spontaneous report from a contactable physician via a company representative. The patient was a male in his 70s. Medical history included angina pectoris, dialysis, bypass operation, and the patient had frequently experienced attacks of chest pain. Concomitant medications were not reported. In May2021 or Jun2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. In around Jun2021 at unknown time (2 weeks after the vaccination), the patient experienced heart disease (angina pectoris). On an unknown date, the outcome of the event was fatal. It was unknown whether autopsy was done. The course of the event was as follows: On an unknown date (before the vaccination), the dialysis patient had angina pectoris and underwent a bypass operation at a different facility. After discharge, the patient received the first vaccination in May2021 or Jun2021 at the reporting hospital. About two weeks later (Jun2021), the patient died. It was reported that the patient had frequently experienced attacks of chest pain. The reporting physician classified the event as serious (death) and assessed that the event was possibly related to BNT162b2.; Sender''s Comments: Based on the current available information, the event Angina pectoris is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history angina pectoris may provide a plausible explanation for the event. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Heart disease (angina pectoris)


VAERS ID: 1422695 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   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: ELIQUIS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210613; Test Name: Head imaging examination; Result Unstructured Data: Test Result:cerebral haemorrhage was noted
CDC Split Type: JPPFIZER INC2021711363

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114302. A n84-year-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 10Jun2021 10:05 at the age of 84 years old, (Lot Number: FA4597; Expiration Date: 31Aug2021) at single dose for covid-19 immunisation. The patient was an 84-year and 10-month-old male. Body temperature before vaccination on 10Jun2021 was 36.4 degrees centigrade. Family history was not reported. The patient medical history was not reported. Concomitant medication included apixaban (ELIQUIS) 2.5, 2 tablets taken orally twice daily after breakfast and supper, start date was not reported and ongoing. On 10Jun2021 at 10:05 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jun2021 at 19:50 (3 days 9 hours 45 minutes after the vaccination), the patient experienced cerebral haemorrhage. On 13Jun2021 (3 days after the vaccination), the outcome of the event was fatal. On 13Jun2021 in the evening, family member who lived together returned home and found the patient unconscious. Ambulance was requested and the patient was transferred to another hospital. Diagnosis of cerebral haemorrhage was made based on head imaging examination. Subsequently, the condition aggravated and death was confirmed. The patient died on 13Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1422696 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021711372

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114281. The patient was an 86-year and 7-month-old male. Body temperature before vaccination was 37.0 degrees centigrade. Family history was 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 10Jun2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 12Jun2021 at 13:30 (1 day 22 hours 30 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 12Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The case was reported because the patient died 2 days after the vaccination. The patient was male and lived alone. The patient ate meals irregularly and drank large amounts of alcohol with tendency for dehydration. Consciousness was clear and the patient was able to make phone calls using mobile phone. On 10Jun2021, the patient visited the reporting hospital with a helper and received the vaccine. After the vaccination, the patient did not have pyrexia or other symptoms and returned home. On 11Jun2021, the patient called the reporting hospital and reported clearly that there was a lack of medication. The patient seemed not different from usual. On 12Jun2021 at around noon, a helper visited the patient''s room, found the patient in cardio-respiratory arrest, and called the hospital. Physician visited the patient''s home and the patient was in cardio-respiratory arrest. Body was examined but there were no findings suggestive of accidental death such as injury. The patient had meals irregularly and it was considered as geromarasmus; thus, causality between the event and the vaccination was assessed as unlikely. The case was reported because it was 2 days after the vaccination. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was advanced age. The reporting physician commented as follows: Causality between the event and the vaccination was considered unlikely.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the event cardiorespiratory arrest is conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest; Geromarasmus; advanced age


VAERS ID: 1422697 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic 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: 2021-06-13
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: Body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Comments: in the early hours
CDC Split Type: JPPFIZER INC2021711382

Write-up: left-side pneumonia; fever; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21114329. A 90-year-old male patient received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on 02Jun2021 15:05 (Lot Number: EX3617; Expiration Date: 31Aug2021) at age of 90 years old as a single dose for covid-19 immunisation. Body temperature before vaccination was 36.3 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). It was uncertain if the patient had relevant family history. The patient''s medical history and concomitant medications were not reported. The patient experienced left-side pneumonia on 03Jun2021 02:30 and reported as being death, hospitalization, medically significant, fever on 03Jun2021.The outcome of the ''fever'' was unknown. The patient died on 13Jun2021. It was not reported if an autopsy was performed. Clinical course: On 02Jun2021 at 15:05 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EX3617, Expiration date 31Aug2021) via an unspecified route of administration as the first single dose for COVID-19 immunization. On 03Jun2021 in the early hours (1 day after the vaccination), the patient had fever (39.2 degrees Centigrade). On 03Jun2021 at 02:30 (1 day after the vaccination), the patient experienced left-side pneumonia. On 03Jun2021 at 08:30, the patient visited the reporter''s hospital and he was hospitalized because of left-side pneumonia. Although he was treated with antibiotics, the symptom did not show improvement. On 13Jun2021 at 23:16 (11 day after the vaccination), the patient died. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was a possible cause of the event such as any other diseases.; Reported Cause(s) of Death: left-side pneumonia


VAERS ID: 1422698 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021711410

Write-up: Death; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 69-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EY5423; Expiration Date: 31Aug2021), via an unspecified route of administration on 13Jun2021 at the age of 69-year-old as single dose for covid-19 immunization. Medical history included gastric cancer from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Allergic information was not provided. The patient experienced death on 16Jun2021 (3 days after the vaccination). The patient died on 16Jun2021. It was not reported if an autopsy was performed.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. It is noted that the patient has the medical history of gastric cancer. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1422699 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: at 16:00
CDC Split Type: JPPFIZER INC2021711460

Write-up: found in respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114301. The patient was an 88-year and 4-month-old female at vaccination. Body temperature before vaccination was 36.3 degrees Centigrade. Medical history, concomitant medications and family history were not provided. On 18May2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 08Jun2021 at 14:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA2453, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 09Jun2021 at 08:25 (1 day after the vaccination), the patient developed respiratory arrest. On 09Jun2021 at 08:28 (1 day after the vaccination), the patient died. It was not reported if an autopsy was performed. The outcome of event was fatal. The course of the events was as follows: On 08Jun2021, after the vaccination, no marked change was noted. On 08Jun2021 at 16:00, body temperature was 36.9 degrees Centigrade. The patient ate 90 percent of her dinner and consumed 150 mL of water. She slept well that night. On 09Jun2021 at 08:25, she was found in respiratory arrest. On 09Jun2021 at 08:28, the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome). The assessment of causality between the events and BNT162b2 was not provided. It was not reported if there was possible cause of the event such as any other diseases. The reporting physician commented as follows: It is hard to say about the causal relationship with BNT162b2.; Reported Cause(s) of Death: respiratory arrest


VAERS ID: 1422700 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest discomfort, Pneumonia aspiration
SMQs:, Anaphylactic reaction (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebellar infarction; Dysphagia; Home care; Hospitalization; Hypertension; Lipids abnormal; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021711620

Write-up: death the day after the vaccination/Pneumonia aspiration; rumbling chest; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES) and then from the same contactable physician received from the Regulatory Agency, the Regulatory authority report number is v21114484. The patient was a non-pregnant 92-year-old elderly female. On 15Jun2021 at 13:45 (the day of vaccination), the patient received?the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscularly in the Arm Left at age of 92-year-old for COVID-19 immunization. The body temperature before vaccination (36.3 degrees Celsius). Other medical history included late effect of cerebellar infarction from Mar2021, dysphagia, hypertension, lipids abnormal, rheumatoid arthritis. The patient had no known allergy. It was reported as no to 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). Family history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified drugs within 2 weeks of vaccination, however, the patient was not orally taking them properly as prescribed. Prior to vaccination, the patient was not diagnosed with COVID-19. On 16Jun2021 at 11:35 (1 day after the vaccination), the patient experienced death the day after the vaccination. The event was reported as no symptoms. The outcome of the event was fatal without treatment. Since the vaccination, the patient had not been tested for COVID-19. The reporting physician assessed the event as serious (life threatening and death) and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was pneumonia aspiration. The course of the event was as follows: On 15Jun2021 (the day of vaccination), the patient had no anaphylactic symptoms. After the patient was confirmed to be dead, it was reported by the family that the patient had a rumbling chest in the evening. The reporting physician commented as follows: The patient had dysphagia as late effects of cerebellar infarction which occurred 3 months ago, and she was just discharged from the hospital for end-of-life care at home on 08Jun2021. Since there was a cancellation of the vaccination, the vaccination was hastily performed based on the family''s wish. It was comprehensively judged that the death was caused by pneumonia aspiration, and this case was considered as an adverse event.; Reported Cause(s) of Death: Pneumonia aspiration; rumbling chest


VAERS ID: 1422701 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-06-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: URSODEOXYCHOLIC ACID; BIOFERMIN [BIFIDOBACTERIUM BIFIDUM]; MIYA BM; GALANTAMINE [GALANTAMINE HYDROBROMIDE]; ELDECALCITOL; LANSOPRAZOLE; SENNOSIDES; ALPINY; ASPARA POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (??); Hepatic function disorder; Hypokalaemia; Osteoporosis; Reflux oesophagitis
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:39 degrees Centigrade
CDC Split Type: JPPFIZER INC2021711679

Write-up: died; Pyrexia; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was an 87-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received ursodeoxycholic acid, bifidobacterium bifidum (BIOFERMIN), clostridium butyricum (MIYA BM), galantamine hydrobromide (GALANTAMINE), eldecalcitol, lansoprazole, sennoside a+b (SENNOSIDES), paracetamol (ALPINY) and potassium aspartate (ASPARA POTASSIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included hepatic function disorder, dementia, osteoporosis, Reflux oesophagitis, and Hypokalaemia. On 28May2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5715, Expiration date 31Aug2021), intramuscular in the left arm for COVID-19 immunization. On 31May2021 (3 days after the vaccination), the patient experienced pyrexia. On 03Jun2021 (6 days after the vaccination), the patient experienced death. The clinical course was reported as follows: On 31May2021 (3 days after the vaccination), the patient had pyrexia of 39 degrees Centigrade. Pyrexia was recovering by antifebrile. On 03Jun2021 (6 days after the vaccination), the patient died. An autopsy was not performed. The event resulted in hospitalization for 4 days and death. The outcome of the event death was fatal and that of the event pyrexia was recovering with treatment including antifebrile. Since the vaccination, the patient has not been tested for COVID-19.; 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.; Reported Cause(s) of Death: died


VAERS ID: 1422702 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   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: ASPIRIN [ACETYLSALICYLIC ACID]; LANSOPRAZOLE; AMLODIPINE; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hypertension; Reflux oesophagitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021711755

Write-up: Cardiac failure; This is a spontaneous report from a contactable pharmacist and contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 84-year-old female. The patient medical history included cerebral infarction, hypertension and reflux oesophagitis, 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 acetylsalicylic acid (ASPIRIN) enteric-coated drug, amlodipine, lansoprazole and clopidogrel and an unspecified prescribed drug within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 24May2021 14:00, the patient previously received first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via intramuscular at age of 84 years for COVID-19 immunization. On 14Jun2021 14:00, (the day of vaccination), the patient received?the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via intramuscular at age of 84 years for COVID-19 immunization. On 15Jun2021(1 day after the vaccination), the patient experienced cardiac failure. The outcome of the event was fatal. Treatment including cardiopulmonary resuscitation, ventilator management, cardiac massage and administration of an unspecified cardiotonic agent. The reporting pharmacist and reporting physician assessed the event as serious (fatal). Death date was 15Jun2021. Cause of death was cardiac failure. It was unknown if autopsy was performed. Causal relationship was assessed as unknown by pharmacist and reporting physician. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of cardiac failure. The reported event likely represent intercurrent medical condition in this elderly patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1422703 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastralgia; Gastric ulcer; Gastrointestinal perforation; Heartburn; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021711874

Write-up: Convulsion; This is a spontaneous report from a contactable physician received from the Pharmacy. Regulatory authority report number is v21114342. The patient was a 75-year and 7-month-old male. Body temperature before vaccination was 37.0 degrees centigrade. Medical history included gastralgia, heartburn, gastric ulcer was pointed out on the medical checkup last year, and it seemed that emergency surgery had been performed for gastrointestinal perforation. Family history and concomitant medications were not reported. On 02Jun2021 at 15:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 05Jun2021 at unknown time (3 days after the vaccination), the patient experienced convulsion. The outcome of the event was fatal. It was unknown whether autopsy was done. The course of the event was as follows (information from the family): On 05Jun2021 (3 days after the vaccination for the new coronavirus), the patient experienced convulsion at home. The patient was transported by ambulance, but on 07Jun2021 (5 days after the vaccination), he died. 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: present (gastric ulcer was pointed out on the medical checkup last year). The reporting physician commented as follows: The initial symptom was convulsion, but according to the information from the family, it seemed that emergency surgery had been performed for gastrointestinal perforation. The causal relationship was unlikely.; Reported Cause(s) of Death: Convulsion


VAERS ID: 1422704 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Hypophagia, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Frailty
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021711898

Write-up: respiratory arrest; Pyrexia; Depressed level of consciousness; Difficulty with oral intake/choking; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114356. The patient was a 96-year-old elderly female. Body temperature before vaccination was 37.0 degrees centigrade on 14May2021. Family history was not reported. Medical history included dementia and ongoing frailty. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported). On 15May2021 at 13:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15May2021 (Saturday, the day of vaccination), the patient received the second vaccination. Immediately after the vaccination, there was no abnormality. On 16May2021 at 08:00 (18 hours 45 minutes after the vaccination), the patient experienced difficulty with oral intake. Since the morning of 16May2021 (Sunday), the patient had poor oral intake. Since the morning of 17May2021 (Monday, 2 days after vaccination), the patient developed pyrexia and depressed level of consciousness. The patient was unable to ingest and received fluid replacement. In the evening, pyrexia resolved and consciousness recovered; however, at 19:49, the patient had respiratory arrest. The physician visited the patient and death was confirmed. On 17May2021 (2 days after the vaccination), the outcome of the event was fatal. The patient was died on 17May2021. It was unknown if an autopsy performed. The reporting physician classified the event as serious (life-threatening) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were frailty which gradually progressed due to dementia and aging. Since one month ago, oral intake decreased and frailty was progressing. The reporting physician commented as follows: Geromarasmus was in progress; however, the intention of the family member was confirmed and the second vaccination was conducted. On the following day, the patient had decreased oral intake, and experienced choking; thus, the patient probably developed pneumonia aspiration. The case was reported because the influence of the vaccination on the course of debility, which was already experienced, could not be denied.; Reported Cause(s) of Death: Difficulty with oral intake; Pyrexia; Depressed level of consciousness; respiratory arrest; respiratory arrest; pneumonia aspiration


VAERS ID: 1422705 (history)  
Form: Version 2.0  
Age: 102.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adrenal insufficiency, Body temperature, Decreased appetite, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: Geromarasmus; Prostate cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021711909

Write-up: pyrexia after the vaccination; Adrenal insufficiency acute; inappetence; somnolence; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114357. The patient was a 102-year-old male. Body temperature before vaccination was 36.7 degrees Centigrade. The family history was not provided. The patient had medical histories of prostate cancer and geromarasmus. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunization. On 15May2021 at 14:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) at the age of 102-year-old, via an unspecified route of administration as a single dose for COVID-19 immunization. On 18May2021 at 08:00 (2 days after the vaccination), the patient experienced adrenal insufficiency acute, inappetence, and somnolence. On 23May2021 (8 days after the vaccination), the outcome of the event adrenal insufficiency acute was fatal. The outcome of other events was unknown. The course of the event was as follows: On unknown date, the patient had pyrexia after the vaccination. On 18May2021, at 08:00 (2 days after vaccination), the patient experienced inappetence and he had difficulty in orally taking drugs. The patient was originally orally taking an adrenocortical steroid. The patient was judged to have adrenal insufficiency acute, and an injection of a steroid in addition to fluid replacement was performed. The patient temporarily recovered; however, he had difficulty in orally taking again. As a result of progression of debility, the patient died at 07:58 on 23May2021 (Sunday, 7 days after vaccination). The reporting physician classified the event adrenal insufficiency acute as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The patient was during the course of prostate cancer and geromarasmus. The reporting physician commented as follows: This was a death case after the vaccination during the course of geromarasmus and prostate cancer. The primary disease could be judged as the main cause of death; however, the effect by the vaccination also could not be ruled out.; Reported Cause(s) of Death: prostate cancer; Geromarasmus; Adrenal insufficiency acute


VAERS ID: 1422706 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Chest pain, Malaise, Muscular weakness, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (stable with the treatment of oral candesartan cilexetil (CANDESARTAN) tablet 8 mg)
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210611; Test Name: Body temperature; Result Unstructured Data: Test Result:no fever Centigrade
CDC Split Type: JPPFIZER INC2021712964

Write-up: cardio-respiratory arrest; vomiting; queasy; chest pain; General malaise; hard to raise her arm; This is a spontaneous report from a contactable physician via a Pfizer sales representative; a contactable physician (medical examiner). Regulatory authority report number is v21114428. The patient was a 75-year and 2-month-old female. Body temperature before vaccination was 36.2 degrees Centigrade. Medical history included hypertension. Concomitant medications included oral candesartan cilexetil (CANDESARTAN 8MG) tablet for hypertension. The patient had no relevant family history. On 10Jun2021 at 09:30 (the day of vaccination) at the age of 75-year-old, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0779, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jun2021 at evening (after the vaccination), the patient experienced hard to raise her arm. On 11Jun2021 (1 day after the vaccination), the patient complained of generalized malaise. On 12Jun2021 (2 days after the vaccination), the patient experienced chest pain and vomiting. On 12Jun2021 (2 days after the vaccination), the patient died. An autopsy for death investigation was performed. Pathological analysis was planned to be performed. The course of the events was as follows: Regarding activities of daily living (ADL), the patient could do basic activities necessary for independent living, and she did housework. She had a chronic disease of hypertension, but it was diagnosed that her condition was stable with the treatment of oral candesartan cilexetil (CANDESARTAN 8MG) tablet. On 10Jun2021 at around 09:30, the patient received the first dose of the vaccination. In the evening, she complained that it was hard to raise her arm. On 11Jun2021, she complained of generalized malaise, but she had no fever. On 12Jun2021, she complained of generalized malaise, but she went for a meal etc. At around 16:00, she had coffee and bracken-starch dumpling. At around 17:00, she ate one bite of grilled rice ball, but she complained of malaise and chest pain and rested in bed. At 17:30, vomiting was noted (there was a complaint of queasy and chest pain). At around 18:55, she could talk on the phone. At around 21:50, she was found in cardio-respiratory arrest. She was transferred to a hospital by an ambulance. Without performing resuscitation, the patient''s death was confirmed. The reporting physician (medical examiner) classified the event as serious (Death) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician (medical examiner) commented as follows: On 14Jun2021, an autopsy for death investigation was performed, but abnormal findings which could result in the death were not recognized. (There was a finding suggesting sudden death, there was no macroscopic thrombus in the coronary artery and just mild arteriosclerotic change was noted.) Pathological analysis was planned to be performed. The outcome of cardio-respiratory arrest was fatal, outcome of other events was unknown.; Reported Cause(s) of Death: cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: There was a finding suggesting sudden death


VAERS ID: 1422707 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haemolysis, Hypersensitivity, Pulmonary oedema, Scratch
SMQs:, Cardiac failure (narrow), Haemolytic disorders (narrow), Angioedema (broad), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021713046

Write-up: Haemolysis; Pulmonary oedema; Some kind of allergy; Trace of scratch on body; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21114330. A 79-year-old male received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA5765, Expiration date: 30Sep2021) via an unspecified route of administration on 09Jun2021 at 09:13 (at the age of 79-year-old) as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.0 degrees centigrade. Family history was not reported. Medical history and concomitant medications were unknown. On an unspecified date, haemolysis, trace of scratch on body, pulmonary oedema, and some kind of allergy were noted. The outcome of the events was fatal. The course of the events was as follows: Haemolysis, trace of scratch on body, pulmonary oedema, and some kind of allergy were noted. At the time of this report, forensic autopsy was being conducted and details were being investigated. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable (at the time of this report, examination was being conducted; thus, causality was unknown). Other possible cause of the events such as any other diseases was not provided. The reporting physician commented as follows: This was an autopsy case requested by the police according to the law on cause of death or identity examination of dead body that were handled by the police, etc.; Reported Cause(s) of Death: haemolysis; Trace of scratch on body; pulmonary oedema; Some kind of allergy


VAERS ID: 1422708 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-05-11
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Oxygen saturation, Pneumonia aspiration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis obliterans (hospitalized on 10Dec2018); Atrial fibrillation (hospitalized on 10Dec2018); Cerebral infarction (hospitalized on 10Dec2018)
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210511; Test Name: SpO2; Test Result: 64 %
CDC Split Type: JPPFIZER INC2021713097

Write-up: Pneumonia aspiration; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21114469. The patient was an 89-year and 2-month-old male (age at event onset and vaccination). Body temperature before vaccination was 36.5 degrees Centigrade. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 10Dec2018, the patient was admitted to the hospital for arteriosclerosis obliterans (ASO), cerebral infarction, and atrial fibrillation. Thereafter, no significant changes were observed. On 26Apr2021 at 13:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ET9096, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 11May2021 at 07:10 (14 days, 18 hours, and 10 minutes after the vaccination), the patient experienced pneumonia aspiration. On 11May2021 (14 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26Apr2021 (the day of vaccination), at 13:00, the patient received the first dose of BNT162b2 vaccination, and thereafter, no significant changes were observed. On 11May2021, at 07:10 (14 days, 18 minutes, and 10 minutes after vaccination), when the physician visited the patient''s room for collecting the tubal feeding, the patient was found to have large amount of vomiting. The SpO2 was 64%, and the patient had cyanosis. Immediately, cardiopulmonary resuscitation (CPR, oxygen, suction, anview, an intravenous injection of adrenaline [Bosmin]) was performed. However, they were ineffective, and the patient died. According to the situation, the patient was suspected to have pneumonia aspiration and airway obstruction. It''s unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was unknown. The reporting physician commented as follows: Although the cause of death was unknown, the above symptoms were suspected.; Sender''s Comments: Based on the information currently available, the event pneumonia aspiration most likely represents an intercurrent medical condition and is unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1422709 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoxia, Oxygen saturation, Pneumonia, Pyrexia
SMQs:, Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 21
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: AMLODIN; ZOLPIDEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Emphysema; Hypertension; Interstitial pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: first measurement after vaccination; Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Comments: second measurement after vaccination; Test Date: 20210513; Test Name: SpO2; Test Result: 60 %; Comments: first measurement after vaccination; Test Date: 20210513; Test Name: SpO2; Test Result: 97 %; Comments: second measurement after vaccination; Test Date: 20210513; Test Name: SpO2; Test Result: 64 %; Comments: third measurement after vaccination
CDC Split Type: JPPFIZER INC2021713234

Write-up: Acute pneumonia; Pyrexia; Hypoxia; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21114419. The patient was an 89-year and 7-month-old female. Body temperature before vaccination was 36.4 degrees centigrade on 13May2021. Family history was not reported. Medical history included interstitial pneumonia, emphysema, and hypertension. The patient was taking two concomitant medications: amlodipine besilate (AMLODIN) and ZOLPIDEM (5). On 13May2021 at 14:13 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 13May2021 at 18:30 (4 hours and 17 minutes after the vaccination), the patient experienced pyrexia, hypoxia, and acute pneumonia. On 13May2021 (the day of vaccination), the patient was admitted to the hospital. On 03Jun2021 (21 days after the vaccination), the outcome of the events was fatal. It was unknown whether autopsy was done. The course of the events was as follows: On 13May2021 (the day of vaccination), the patient was interviewed while having a pleasant chat. At 14:13, the patient was vaccinated. After a 30-minute observation, she went home. On the same day at 18:30 (4 hours and 17 minutes after the vaccination), her temperature was measured and was 37.9 degrees centigrade. CALONAL 1 tablet (T) (illegible character) was taken. On the same day at 20:00 (5 hours and 47 minutes after the vaccination), the temperature was measured as 38.6 degrees centigrade. Although malaise alone was strong (respiratory discomfort absent (-), headache (-), queasy (-)), the SpO2 decreased to 60%, and oxygen 5L was immediately given. The SpO2 recovered to 97% 5 minutes later, but it decreased to 64% when checked again 5 minutes later. (illegible character) was difficult. On the same day at 21:00 (6 hours and 47 minutes after the vaccination), the patient was urgently transported to the hospital where he was admitted for acute pneumonia. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: On 03Jun2021 (21 days after the vaccination), the family reported that the patient died at 01:18 on the same day. However, the causal relationship with the vaccine was unknown.; Reported Cause(s) of Death: Pyrexia; Hypoxia; Acute pneumonia


VAERS ID: 1422710 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Body temperature, Cellulitis
SMQs:, Dementia (broad), Hostility/aggression (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bilateral hydronephrosis; Cervix carcinoma (about 30 years ago); Difficulty in walking; Lymphoedema; Nephrostomy (in right kidney); Pressure sore; Pyrexia; Radiotherapy to uterine cervix (about 30 years ago); Renal failure chronic (G4); Wound infection
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021716902

Write-up: rejected treatment, meals, and infusion as well as using abusive language and acting violently, which were stronger than usual; Cellulitis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114510. The patient was a 78-year and 2-month-old female. Body temperature before vaccination was 36.7 degrees centigrade on 01Jun2021. Family history was not reported. Medical history included nephrostomy due to bilateral hydronephrosis after radiotherapy for cervix carcinoma, renal failure chronic, lymphoedema of legs, and refractory pressure sore. The patient''s concomitant medications were not reported. On 01Jun2021 at 10:00 (the day of vaccination, at 78-year-old), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 06Jun2021 (5 days after the vaccination), the patient experienced cellulitis. On 15Jun2021 (14 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had bilateral hydronephrosis as a complication after radiotherapy for cervix carcinoma which developed about 30 years ago. At the time of this report, the patient had nephrostomy in the right kidney and renal failure chronic (G4). The patient also had marked lymphoedema and difficulty in walking, which led to hip pressure sore and it was refractory due to the influence of radiation. Thus, the patient developed wound infection repeatedly. Recently, the patient developed pyrexia once every 3 months on average and received treatment. In May 2021, the patient had similar symptom and received treatment. On 01Jun2021 after the symptom was cured, the patient was vaccinated. On 06Jun2021, the patient developed pyrexia as well as pain and feeling hot of legs, for which diagnosis of cellulitis was made. Treatment was initiated; however, therapeutic effect was poor and on 15Jun2021, the patient died. The reporting physician classified cellulitis as serious (life-threatening) and assessed that the causality between cellulitis and BNT162b2 as unassessable. Other possible causes of cellulitis such as any other diseases were infection of refractory pressure sore and infection of lymphoedema. The reporting physician commented as follows: Although causality was considered not related, the patient rejected treatment, meals, and infusion as well as using abusive language and acting violently, which were stronger than usual this time even when the patient was already negative about treatment. The outcome of event cellulitis was fatal. The outcome of the other event was unknown. It was unknown if the autopsy is performed. The case was reported because it was considered that causality could not be denied completely.; Reported Cause(s) of Death: Cellulitis


VAERS ID: 1422711 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiovascular disorder, Pneumonia aspiration, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   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: Parkinson''s disease (suffered for a long term)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021716939

Write-up: Pneumonia aspiration; rapid deterioration of respiratory and circulatory dynamics; rapid deterioration of respiratory and circulatory dynamics; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114487. The patient was an 84-year and 6-month-old female. On 07Jun2021 at 15:20 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA4597, Expiration date 31Aug2021) an unspecified route of administration at age of 84-year-old at a single dose for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade. Medical history included ongoing Parkinson''s disease. Concomitant medications were not provided. The patient had no relevant family history. On 15Jun2021 at 23:13 (8 days after the vaccination), the patient experienced pneumonia aspiration and died. It was not reported if an autopsy was performed. The course of the events was as follows: The patient suffered from an underlying disease of Parkinson''s disease for long time which was stable. However, this time, pneumonia aspiration was also developed, and the course until death was a rapid deterioration of respiratory and circulatory dynamics. Therefore, this case was reported. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Pneumonia aspiration was considered as a possible cause. ; Reported Cause(s) of Death: Pneumonia aspiration; rapid deterioration of respiratory and circulatory dynamics; rapid deterioration of respiratory and circulatory dynamics


VAERS ID: 1422712 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-06-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:Unknown Results; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021717026

Write-up: unknown cause of death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was a 75-year-old male. Body temperature before vaccination was not provided. The family history was not provided. The patient had medical history of hypertension. On an unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 14Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as dose 2, single for COVID-19 immunization. On 16Jun2021 (2 days after the vaccination), the patient experienced unknown cause of death. On 16Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 14Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 15Jun2021 (one day after vaccination), the patient had no pyrexia. He could eat meals completely. On 16Jun2021 (2 days after vaccination), the physical condition suddenly changed, and at 07:33 (2 days, 7 hours, and 33 minutes after vaccination), the patient died. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was judged that the event was unrelated to the BNT162b2 vaccination.; Sender''s Comments: Based on chronological connection to the vaccine, a causal relationship between the reported event of death (unknown cause) and BNT162b2 (COMIRNATY) vaccine cannot be completely excluded. The case will be reevaluated should additional information including the cause of death 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


VAERS ID: 1422713 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram thorax, Oxygen saturation, Pneumonia aspiration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Cerebral infarction; Dementia Alzheimer''s type; Depression; Extremity contracture; Gastrostomy tube insertion; Late effects of cerebral infarction; Quadriplegia
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:37s Centigrade; Comments: at around 19:00; Test Date: 20210614; Test Name: Chest CT; Result Unstructured Data: Test Result:revealed infiltrative shadow in the right lung; Comments: Chest CT revealed infiltrative shadow in the right lung, for which diagnosis of pneumonia aspiration was made and the patient was hospitalized.; Test Date: 20210613; Test Name: SpO2; Result Unstructured Data: Test Result:decreased to 90; Comments: at around 19:00; Test Date: 20210613; Test Name: SpO2; Result Unstructured Data: Test Result:increased to 95; Comments: after oxygen was given
CDC Split Type: JPPFIZER INC2021717101

Write-up: Pneumonia aspiration; This is a spontaneous report from contactable physicians received from the Regulatory Authority. Regulatory authority report number is v21114498 and v21114572. The patient was a 78-year-old female. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no family history. Medical history included depression, dementia Alzheimer''s type, cerebral infarction, all not ongoing and the patient was placed on percutaneous endoscopic gastrostomy tube, paralysis and contracture of extremities due to late effects of cerebral infarction, and bedridden. The patient had no allergic reaction or past adverse effect history and there were no remarkable points to be considered. On 13Jun2021 at around 10:30 (at age of 78 years old, the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscularly as a single dose for COVID-19 immunization. On 13Jun2021 at around 19:00 (around 8 hours 30 minutes after the vaccination), the patient experienced pneumonia aspiration. On 14Jun2021 (1 day after the vaccination), the patient was admitted to the hospital. On 15Jun2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 13Jun2021, the condition was as usual and the patient was vaccinated at around 10:30. Subsequently, no change was observed; however, at around 19:00, pyrexia of 37s degrees centigrade and respiratory failure (SpO2 90) developed. Oxygen 1 L was given and SpO2 increased from 90 to 95. On 14Jun2021, the condition did not improve, for which, the patient visited another hospital and was hospitalized. On 14Jun2021, the patient was referred to the reporting hospital by a physician at facility. Chest CT revealed infiltrative shadow in the right lung, for which diagnosis of pneumonia aspiration was made and the patient was hospitalized. After the hospital admission, pneumonia was treated with administration and inhalation of oxygen and infusion of antibiotic; however, respiratory status did not improve. On 15Jun2021 at 00:00, the patient died. It was unknown if autopsy done. The patient was admitted to the hospital from 14Jun2021 to 15Jun2021. The reporting physician classified the event as serious (hospitalization) and assessed that the causality between the event and BNT162b2 as unknown. Other possible cause of the event such as any other diseases was acute pneumonia/pneumonia aspiration. The reporting physician commented as follows: The patient had medical history of depression, dementia Alzheimer''s type, and cerebral infarction. Extremity contracture was advanced and the patient was placed on percutaneous endoscopic gastrostomy tube. It was considered that the aspiration was caused. The patient was bedridden and activities of daily living required full assistance. Since the patient had general debility, the possibility of aspiration was considered.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1422714 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Arrhythmia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021717344

Write-up: Death; This is a spontaneous report from a contactable pharmacist via a sales representative. The patient was a female of unknown age. Underlying disease/complication included arrhythmia. Concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown) for COVID-19 immunisation. On an unknown date at unknown time (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 immunisation. On an unknown date at unknown time (the next day of the vaccination), the patient was found dead in the bathtub. It was not reported whether an autopsy was done. The reporting pharmacist assessed that the causality between the event and BNT162b2 as unknown.; 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.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1422715 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / -

Administered by: Other       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: 2021-06-10
   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: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021717561

Write-up: unknown cause of death; High fever; This is a spontaneous report from a contactable physician and an other health professional. The patient was a non-pregnant 98-year-old female. The patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. The patient did not receive any other medications within 2 weeks of vaccination: Not provided. Prior to vaccination, the patient was not diagnosed with COVID-19: Unknown. It was not provided if the patient had allergies to medications, food, or other products or not. Other medical history included ongoing dementia. On 09Jun2021 (the day of vaccination), the patient received a single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration in the unknown site (at the age of 98-year-old) for COVID-19 immunization. On 10Jun2021, the patient experienced high fever and treated with sodium (VOLTAREN SUPPO) at 19:00 (one day, 19 hours after the vaccination), then at 21:24 (one day, 21 hours, and 24 minutes after the vaccination), the patient experienced unknown cause of death. The outcome of the event was fatal with treatment including: diclofenac sodium (VOLTAREN SUPPO) 25 mg for pyrexia. Outcome of high fever was unknown. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19: Unknown Reported event was as follows: On 10Jun2021, at 19:00 (one day and 19 hours after vaccination), diclofenac sodium (VOLTAREN SUPPO) 25 mg was used for high fever. At 21:24 (one day, 21 hours, and 24 minutes after vaccination), the patient was confirmed to die.; Sender''s Comments: Based on chronological connection to the vaccine a causal relationship between event Death (unknown cause) and BNT162b2 (COMIRNATY0 vaccine cannot be completely excluded. . The case will be reevaluated should additional information, including the cause of death, 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


VAERS ID: 1422730 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrioventricular block complete, Chest pain, Dyspnoea, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Primary hypertension (Well controlled)
Preexisting Conditions: Medical History/Concurrent Conditions: Brain tumor NOS (Patient was in remission)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVMODERNATX, INC.MOD20212

Write-up: AV block complete; Syncope; Shortness of breath; Profusely sweating; Mild chest pain; This regulatory authority case was reported by a physician and describes the occurrence of ATRIOVENTRICULAR BLOCK COMPLETE (AV block complete), SYNCOPE (Syncope), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Profusely sweating) and CHEST PAIN (Mild chest pain) 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 Brain tumor NOS (Patient was in remission) in 2014. Concurrent medical conditions included Primary hypertension (Well controlled). On 02-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (AV block complete) (seriousness criteria death and medically significant), SYNCOPE (Syncope) (seriousness criteria death and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria death and medically significant), HYPERHIDROSIS (Profusely sweating) (seriousness criteria death and medically significant) and CHEST PAIN (Mild chest pain) (seriousness criteria death and medically significant). The patient died on 03-Jun-2021. The reported cause of death was AV block complete. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided. Company comment: This is a case of sudden death in a 70-year-old female subject with hx of primary hypertension and history o brain tumor (currently in remission) who died 1 day after receiving second dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 70-year-old female subject with hx of primary hypertension and history o brain tumor (currently in remission) who died 1 day after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: AV block complete


VAERS ID: 1422875 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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: MDS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: MRI; Result Unstructured Data: Test Result:detected brain haemorrhage
CDC Split Type: NLPFIZER INC2021668540

Write-up: Cerebral bleeding; This is a spontaneous report from a contactable consumer, downloaded from the Regulatory Authority-WEB, Regulatory Authority Number: NL-LRB-00566246. A 78-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing myelodysplastic syndrome (MDS). The patient had no previous COVID-19 infection. Concomitant medications included non-specified blood thinner. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 16Mar2021 for COVID-19 immunisation. The patient had cerebral bleeding/hemorrhage on 27Apr2021, 7 days after the administration of COVID-19 vaccine Pfizer injectable solution for COVID-19 immunisation. The patient underwent diagnostic procedures not associated with vaccination which included magnetic resonance imaging (MRI) on 27Apr2021 which detected brain haemorrhage. Therapeutic measures were taken as a result of the event. The patient died on 27Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reporter''s Comments: summary of reporter''s comments: description of past Comirnaty therapy yes, events, concomitant drug, medical history, lab test and no previous COVID-19 infection; Reported Cause(s) of Death: cerebral hemorrhage


VAERS ID: 1422882 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angiocardiogram, Blood test, C-reactive protein, Chest X-ray, Computerised tomogram head, Computerised tomogram thorax, Confusional state, Headache, Injection site pain, Magnetic resonance imaging, Magnetic resonance imaging head, Malaise, Neurological symptom, Polyomavirus test, SARS-CoV-2 test, Sepsis, Single photon emission computerised tomogram, Ultrasound abdomen
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 36
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: NATRIUM HYDROGENCARBONATE; INSULIN ISOPHANE; CEFTRIAXON; SEVELAMEERCARBONAAT SANDOZ; LEVOTHYROXINE; AIROMIR [SALBUTAMOL]; ALFACALCIDOL; SERETIDE; SPIRIVA; ESOMEPRAZOL [ESOMEPRAZOLE]; ACETYLSALICYLZUUR; CODEINE; CINACALCET; ROSUVASTATINE [RO
Current Illness: Atherosclerosis of renal artery; Chronic renal insufficiency ; Cirrhosis liver; COPD (Gold II); Dialysis (dialysis patient); Hepatic steatosis; Hypercholesterolaemia; Hypertension; Iliac artery disease; Superficial femoral arterial stenosis; Type II diabetes mellitus; Vascular disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Abscess drainage - drainage; Appendicitis perforated; Drug-eluting stent placement (CX and LAD); Percutaneous coronary intervention (Drug eluting stent placement)
Allergies:
Diagnostic Lab Data: Test Date: 2008; Test Name: CAG; Test Result: Inconclusive ; Result Unstructured Data: CAGTest Date: 202104; Test Name: Lab onderzoek; Test Result: Inconclusive ; Result Unstructured Data: Test Date: 202104; Test Name: X Thorax; Test Result: Inconclusive ; Result Unstructured Data: Test Date: 202104; Test Name: CT ; Test Result: Inconclusive ; Result Unstructured Data: Blanco-CT . Test Date: 2014; Test Name: CT thorax; Test Result: Inconclusive ; Result Unstructured Data: unknown; Test Date: 20210506; Test Name: CRP; Test Result: Inconclusive ; Result Unstructured Data: 100 (hoogste meting tijdens opname); Test Date: 2008; Test Name: MRI rechter a iliaca communis; Test Result: Inconclusive ; Result Unstructured Data: significant letsel; Test Date: 202104; Test Name: MRI ; Test Result: Inconclusive ; Result Unstructured Data: CT-scan DD 23/4/2021. ; Test Date: 202104; Test Name: BK virus; Test Result: Inconclusive ; Result Unstructured Data: BK virus negative; Test Date: 202104; Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 2008; Test Name: SPECT scan; Test Result: Inconclusive ; Result Unstructured Data: Test Date: 202104; Test Name: Echo abdomen; Test Result: Inconclusive ; Result Unstructured Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis eci), NEUROLOGICAL SYMPTOM , CONFUSIONAL STATE , MALAISE and HEADACHE in a 69-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product MULTIVITAMINS [VITAMINS NOS] for an unknown indication. The patient''s past medical history included Appendicitis perforated in 2010, Percutaneous coronary intervention (Drug eluting stent placement) in 2008, Abscess drainage transrectaal), Dialysis (dialysis patient) since an unknown date and Drug-eluting stent placement (CX and LAD) in 2008. Concurrent medical conditions included Hypercholesterolaemia since 2004, Cirrhosis liver, Hypertension since 2004, Type II diabetes mellitus since 2004, Chronic renal insufficiency , Atherosclerosis of renal artery, Vascular disorder , Iliac artery disease since 2008, COPD (Gold II) since 2008, Hepatic steatosis and Superficial femoral arterial stenosis since 2008. Concomitant products included SODIUM BICARBONATE (NATRIUM HYDROGENCARBONATE), INSULIN ISOPHANE BOVINE (INSULIN ISOPHANE), CEFTRIAXONE SODIUM (CEFTRIAXON), SEVELAMER CARBONATE , LEVOTHYROXINE, SALBUTAMOL (AIROMIR [SALBUTAMOL]), ALFACALCIDOL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ESOMEPRAZOL [ESOMEPRAZOLE], ACETYLSALICYLZUUR, CODEINE, CINACALCET, ROSUVASTATINE [ROSUVASTATIN] and METOPROLOL for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient started MULTIVITAMINS [VITAMINS NOS] (unknown route) at an unspecified dose. On 13-Apr-2021, the patient experienced NEUROLOGICAL SYMPTOM (seriousness criteria death and hospitalization), CONFUSIONAL STATE (seriousness criteria death and hospitalization), MALAISE (seriousness criterion death), HEADACHE (Hoofdpijn) (seriousness criterion death) and INJECTION SITE PAIN. In April 2021, the patient experienced SEPSIS (Sepsis eci) (seriousness criteria death and medically significant). The patient died on 07-May-2021. The reported cause of death was sepsis. It is unknown if an autopsy was performed. At the time of death, INJECTION SITE PAIN outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2008, Angiocardiogram: unknown (Inconclusive) CAG SPECT-scan. In 2008, Magnetic resonance imaging: unknown (Inconclusive) In 2008, Single photon emission computerised tomogram: unknown (Inconclusive) In 2014, Computerised tomogram thorax: unknown (Inconclusive) unknown. In April 2021, Blood test: unknown (Inconclusive) In April 2021, Chest X-ray: unknown (Inconclusive) In April 2021, Computerised tomogram head: unknown (Inconclusive) In April 2021, Magnetic resonance imaging head: unknown (Inconclusive) CT-scan DD 23/4/2021. In April 2021, Polyomavirus test: unknown (Inconclusive) BK virus negative. In April 2021, SARS-CoV-2 test: negative (Negative) negative. In April 2021, Ultrasound abdomen: unknown (Inconclusive) On 06-May-2021, C-reactive protein: unknown (Inconclusive) 100 For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events reported by Authority as resulting in death retained as such although it is unclear what the cause of death was. Events seriousness per assessment by Authority and per IME list.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events reported by Authority as resulting in death retained as such although it is unclear what the cause of death was. Events seriousness per assessment by Authority and per IME list.; Reported Cause(s) of Death: MRI-scan


VAERS ID: 1422885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Neuralgia, Peripheral swelling, Poor peripheral circulation, Sepsis, Vascular shunt
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 51
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disorder; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Vascular shunt
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021713774

Write-up: sepsis; a vascular shunt in her left leg, because of poor blood flow; a vascular shunt in her left leg, because of poor blood flow; swelling of legs; neuralgia/nerve pain; This is a spontaneous report from a contactable consumer downloaded from the WEB NL-LRB-00566855. The contactable reporter described events for both doses of Comirnaty. This report describes events for the first dose. An elderly female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 06Apr2021 as dose 1, single for covid-19 immunisation. Medical history included vascular shunt, ongoing heart disorder (problems with heart), ongoing hypertension (blood pressure). The patient''s concomitant medications were not reported. There is no specified antibiotics (as reported). The patient did not have previous COVID-19 infection. After the first vaccination the patient had neuralgia and swelling in her left leg. She already had a vascular shunt in her left leg, because of poor blood flow. In between vaccinations she had sepsis for which she was treated with antibiotics twice. The patient had plastic vein in left leg, nerve pain after 1st vaccination, thick leg left on 06Apr2021, blood infection treated with 2 antibiotics between vaccines. The outcome of neuralgia is fatal (as reported), the outcome of the other events was unknown. The patient died on 27May2021. It was not reported if an autopsy was performed. No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021705082 The same patient, different dose of vaccine; Reported Cause(s) of Death: neuralgia


VAERS ID: 1422895 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001937 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Administration site erythema, Asphyxia, Autopsy, C-reactive protein, Vaccination site discomfort, Vaccination site pain, White blood cell count
SMQs:, Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: NEURONTIN; MAVENCLAD
Current Illness: Multiple sclerosis; Trigeminal neuralgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Autopsy; Result Unstructured Data: Found residue of food in airways. Suspected cause of death is obstruction of airways with following asphyxia and death.; Test Date: 20210422; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 9 mg/L; Test Date: 20210422; Test Name: White blood cell count; Result Unstructured Data: 0.3
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: Asphyxia; Erythema; This regulatory authority case was reported by a physician and describes the occurrence of ASPHYXIA (Asphyxia) in a 66-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001937) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Multiple sclerosis and Trigeminal neuralgia. Concomitant products included CLADRIBINE (MAVENCLAD) from 11-Feb-2021 to an unknown date for Multiple sclerosis, GABAPENTIN (NEURONTIN) from 14-Apr-2021 to an unknown date for Trigeminal neuralgia. On 19-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE DISCOMFORT (Erythema), ADMINISTRATION SITE ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Erythema). On 28-Apr-2021, the patient experienced ASPHYXIA (Asphyxia) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Asphyxia. An autopsy was performed. At the time of death, VACCINATION SITE DISCOMFORT (Erythema), ADMINISTRATION SITE ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Erythema) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Autopsy: asphyxia (abnormal) Found residue of food in airways. Suspected cause of death is obstruction of airways with following asphyxia and death. On 22-Apr-2021, C-reactive protein: 9 (Inconclusive) 9 mg/L. On 22-Apr-2021, White blood cell count: 0.3 (Low) 0.3. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered VACCINATION SITE DISCOMFORT (Erythema), ADMINISTRATION SITE ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Erythema) to be probably related. No further causality assessment was provided for ASPHYXIA (Asphyxia). No treatment information was provided. For "vaccination site pain", "vaccination site discomfort" and "administration site erythema": 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. for the event "asphyxia", based on autopsy results and medical judgement, the event is assessed as unlikely related to mRNA-1273.; Sender''s Comments: For "vaccination site pain", "vaccination site discomfort" and "administration site erythema": 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. for the event "asphyxia", based on autopsy results and medical judgement, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: ASPHYXIA


VAERS ID: 1422906 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lung cancer (With spread to the head and back)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pulmonary oedema (It was evident that the lungs gradually re-filled with fluid)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021673949

Write-up: Aggravated trouble breathing (Pulmonary oedema aggravated); This is a spontaneous report from a non-contactable consumer, received via a lawyer from a Regulatory Authority. A 73-year-old female patient received 1st dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 12Jan2021 (Batch/Lot number was not reported) at age of 73-year-old at single dose for COVID-19 immunisation. Medical history included ongoing lung cancer with spread to the head and back, emptied 2 l of fluid from the lungs in Nov2020 (It was evident that the lungs gradually re-filled with fluid). The patient''s concomitant medications were not reported. The patient experienced aggravated trouble breathing (pulmonary oedema aggravated) resulting in that the patient death on 17Jan2021. It was not reported if an autopsy was performed. Claim report: lived at health institution and had cancer. She received the COVID-19 vaccine on 12Jan2021 and died on 17Jan2021 early in the morning. In Nov2020, she was sent to hospital to empty 2 L of fluid from her lungs. It was evident that the lungs gradually re-filled with fluid. When she received the COVID-19 vaccine she was going to hospital on 21Jan2021 for CT and control. With her condition, the reporter as her next in kin think it was odd that she received the COVID-19 vaccine and from what the reporter understand without consultation from her general physician. Reporter think that the COVID-19 vaccine gave her aggravated troubles breathing resulting in death. She was seriously ill with lung cancer with spread to the head and back. Reporter didn''t know how long she could have lived but hoped that she would have had more months at health institution. It was mentioned that patient was living in nursing home. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Aggravated trouble breathing


VAERS ID: 1422977 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KATALIP; PRENESSA; VASILIP; ASPIRIN PROTECT; ALDACTONE [SPIRONOLACTONE]; RANEXA; CONCOR; ULTOP [OMEPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC2021669384

Write-up: Heart failure; Sudden cardiac death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [SI-JAZMP-NCPHV-2021SI0650_0650] An 86-years-old female patient received second dose of BNT162B2 (COMIRNATY), intramuscularly on 19Mar2021 (Batch Number: ET3620) as single dose for covid-19 immunisation. Medical history included heart failure from 13Mar2021. Concomitant medications included fenofibrate (KATALIP); perindopril erbumine (PRENESSA); simvastatin (VASILIP); acetylsalicylic acid (ASPIRIN PROTECT); spironolactone (ALDACTONE); ranolazine (RANEXA); bisoprolol fumarate (CONCOR); omeprazole (ULTOP). The patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on unknown date at single dose for covid-19 immunisation. On 08Apr2021 sudden cardiac death. The patient had heart failure which led to her being examined at internistic first aid on 13Mar2021, then at the hospital on 22Mar2021. The patient was hospitalized from 27 Mar2021 to 08Apr2021, when an unexpected death occurred. The physician at the hospital did not decide on an autopsy. The patient died on 08Apr2021. An autopsy was not performed. The outcome of the event heart failure was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1423888 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Cardiomyopathy (broad), 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: NORVASC
Current Illness: Hypertension arterial (first diagnosed after surgery)
Preexisting Conditions: Medical History/Concurrent Conditions: Cosmetic allergy; Hysteromyoma; Nickel sensitivity; Ovariohysterectomy (Hysterectomy with partial ophorectomy for myoma)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021068095

Write-up: Sudden death; anaphylaxis (flush, exanthema, trunk-accentuated and face and forearms starting with wheal formation, furry feeling of the tongue and strange taste); This is a spontaneous report received from a contactable physician via downloaded from the WEB local regulatory authority AT-BASGAGES-2021-00404. A 44-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number EJ6797, expiration date 30Apr2021) intramuscular on 19Jan2021 in the left (upper) arm at a single dose for Covid-19 immunization. Medical history included hypertension arterial from Nov2019 and ongoing, first diagnosed after surgery; hysteromyoma; Ovariohysterectomy- Hysterectomy with partial ophorectomy for myoma in Nov2019. The patient did not mention any allergies previously, but subsequently expressed against nickel, reportedly the patient so far only reacted to cosmetics. Concomitant medication included amlodipine besilate (NORVASC) from Nov2019 at 5mg. The patient experienced anaphylaxis (flush in the face and neck, itching, exanthema trunk-accentuated and face and forearms starting with wheal formation, furry feeling of the tongue and strange taste) on 19Jan2021 after 12min after receiving BNT162B2. The observed Anaphylaxis was a Type 1 reaction which was clarified with the allergy department. The patient circulation stable, but still in a lying position, on 17:23 300 micrograms Jext-Pen (adrenaline) in right thigh intra-muscular, 17:28 all symptoms completely regressed. All symptoms completely vanished after 5 minutes. Further observation period of approximately 1 hour, without symptoms. 1 pen Jext 300 micrograms given as a precaution, patient was taught. Causality between the event Anaphylaxis and BNT162B2 was probable/likely by reporter. Investigation received on 26Jan2021, the product did not reasonably suggest a device malfunction. The severity of harm was not applicable. Site Sample Status: not received. Conclusion: The complaint for Adverse Event Safety Request of PFIZER-BIONTECH COVID-19 was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6797. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. As per site evaluation, no investigation will be conducted: This lot was investigated in PR5570166 for Adverse Event Safety Request For Investigation and/or Lack Of Effect. Therefore, this complaint record can be trended. Upon follow-up (PRD 26Mar2021 SRD 07Jun2021): on an unknown date, it was reported that Sudden death of patient. The outcome was fatal and outcome of the other event was recovered on 19Jan2021 17:28. Follow-up (26Jan2021): New information received from product quality complaints in response to investigation request includes: product investigation information. Follow-up (PRD 26Mar2021 SRD 07Jun2021): This is a follow-up report from Product Complaint Team. New information provided from division includes: Product Complaint Exchange: Initial PRD/SRD (25Jan2021), FU PRD (23Jan2021), SRD (25Jan2021): Comirnaty anaphylactic reaction Reporter requested investigation/Testing. Attached to the Supporting Documents Section in the Complaint Contact Record PR#5596918. Conclusion: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6797. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1423978 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210638373

Write-up: DEATH; This spontaneous report received from a health care professional via social media (media article) concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced death, the cause of death was unknown. 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 20210638382, 20210638405, 20210638416 and 20210638397.; Sender''s Comments: V0:20210638373-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: 1424338 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021674417

Write-up: Found dead; This is a spontaneous report downloaded from the Regulatory Authority-WEB via The Regulatory Authority. The regulatory authority report number is DK-DKMA-WBS-0069232. Two contactable physicians reported that a 62-years-old female patient received BNT162B2 (COMIRNATY), via intramuscular route on 09May2021 (Batch/Lot Number: EW6126; Expiration Date: Jul2021) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was found dead on 12May2021, 3 days after vaccination. Reported cause of death was ''Unknown cause of death.'' Autopsy was performed on 17May2021 due to possible link between death and vaccination. So far, no findings can be attributed to the vaccination; awaiting results of additional investigations. There was no information regarding test results. Causality: The reporter was the patient''s general practitioner, and she was contacted by the law enforcement authority and informed that the patient was found dead 3 days after vaccination. She has not described whether she suspects a connection to the vaccine. So far, no autopsy findings can be attributed to the vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1424514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-05-20
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: Medical History/Concurrent Conditions: Chronic lymphocytic leukaemia; Diabetes mellitus non-insulin-dependent; Hypertension arterial; Ischaemic leukoencephalopathy; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728883

Write-up: COVID-19 infection; COVID-19 infection; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-2021072456. A 99-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: EJ6795 and expiry date was not reported), dose 2 intramuscular on 18Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included diabetes mellitus non-insulin-dependent, ischaemic leukoencephalopathy, hypertension arterial, chronic lymphocytic leukaemia and stroke. Reportedly, patient was bedridden and living in nursing home. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date was not reported), administered on an unknown date in Jan2021 as single dose for COVID-19 immunisation. On 20May2021, the patient had COVID-19 infection and died on an unspecified date in May2021. The patient underwent lab tests and procedures which included PCR sars-cov-2 test: positive on 20May2021. The patient died on an unspecified date in May2021 due to COVID-19. It was not reported if an autopsy was performed. Investigation summary from PQC conclusion includes that reference ID (see File attachment in this investigation record). The complaint for fatal outcome of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6795. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. 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: 1424515 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of prostate; Auricular fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: Serology: IgG anti spike of Sars CoV2; Result Unstructured Data: Test Result:0.5 AU/mL; Comments: 0.5 AU/mL (< 50); Test Date: 20210517; Test Name: Covid-19 test: PCR; Test Result: Positive ; Comments: 501Y.V1 English variant
CDC Split Type: FRPFIZER INC2021728747

Write-up: COVID-19 pneumonitis; Vaccination failure; This is a spontaneous report from a contactable Physician downloaded from the WEB FR-AFSSAPS-AN20211947, Safety Report Unique Identifier FR-AFSSAPS-2021062350. A 98-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EX7389), via intramuscular, route of administration in arm left on 06May2021 as 2nd dose, single, bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW2239) intramuscular, administered in arm left on 08Apr2021 as 1st dose, single for covid-19 immunisation Patient did not had covid-19 previously. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, prostate cancer from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 pneumonitis and vaccination failure on 17May202. On 17May2021, No symptoms suggestive of COVID, on 22May2021 (D5), Bronchial congestion not present yesterday, on 23May2021 (D6), Bronchial congestion ++ - Auscultation: bilateral crackles, on 24May2021 (D7), Deterioration this morning with increase O2 G 10 (Y3, M5, V2), on 25May2021 (D8), Deterioration of the general state FR 10/min. Therapeutic measures were taken as a result of covid-19 pneumonitis on 22May2021 (J5), Introduction of Augmentin 1g x 3 for bronchial congestion, on 23May2021 (D6), Oxygen therapy - Scopolamine patch - ATB IV, on 24May2021 (D7), Degradation with increase O2 to 6L/min at Midazolam and morphine started. Update 01Jun2021: Patient died on 28May2021- modification of severity criteria: change from hospitalization to death - addition of vaccine failure effect. The patient underwent lab tests and procedures which included Covid-19 test: PCR positive on 17May2021 (501Y.V1 English variant) and Serology: IgG anti spike of Sars CoV2: negative: 0.5 AU/mL (< 50) on 18May2021. Clinical course, therapeutic measures, and additional relevant information 98 years old Man who has COVD-19 pneumonia with secondary bronchial infection 11 days after the 2nd dose of COMIRNATY vaccine. The patient died on 28May2021. A drug is coded as active ingredient when the name of the speciality is unknown. It was not reported if an autopsy was performed. The outcome of the events covid-19 pneumonitis, vaccination failure was fatal. Imputation is made without prejudice to the elements of investigation which could be carried out in the context of legal or amicable compensation procedures. CONCLUSION: 98-year-old patient with COVD-19 pneumopathy with bronchial superinfection 11 days after the 2nd dose of COMIRNATY vaccine, absence of AC detected. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: HISTORY OF THE DISEASE Patient vaccinated with two doses of COMIRNATY vaccine, second dose on 0621. Incidental discovery of Covid-19 pneumopathy on 17May2021 Hospitalization in the cardiology department for global cardiac decompensation. Covid PCR performed before transfer to SSR; positive on 17May2021 Transfer to the infectious disease department for further management Vaccination information: 1st dose on 08Apr2021 batch EW2239 left arm 2nd dose on 06May2021 batch EX7389 left arm Patient information in relation to COVID-19 : Person at risk of developing severe COVID-19 disease: yes (age) Previous Covid-19: no Covid-19 test: PCR positive on 17May2021 (501Y.V1 English variant) Serology: IgG anti spike of Sars CoV2: negative: 0.5 AU/mL (< 50) on 18May2021 Allergy/hypersensitivity history: Don''t know CLINICAL EXAMINATION 17May: No symptoms suggestive of COVID 22May (D5) :Bronchial congestion not present yesterday 23May (D6) :Bronchial congestion ++ - Auscultation: bilateral crackles 24May (D7) :Deterioration this morning with increase O2 G 10 (Y3, M5, V2) 25May (D8) :Deterioration of the general state 10/min TREATMENT AND EVOLUTION 22May2021 (J5) :Introduction of Augmentin 1g x 3 for bronchial congestion 23May2021 (D6) :Oxygen therapy - Scopolamine patch - ATB IV 24May2021 (D7) :Degradation with increase O2 to 6L/min at Midazolam and morphine started Update 01Jun2021: Patient died on 28May2021 - modification of severity criteria: change from hospitalization to death - addition of vaccine failure effect. CONCLUSION 98 year old patient with COVD-19 pneumopathy with bronchial superinfection 11 days after the 2nd dose of COMIRNATY vaccine, absence of Ac detected. SUMMARY 98 years old Man who has COVD-19 pneumonia with secondary bronchial infection 11 days after the 2nd dose of COMIRNATY vaccine. A drug is coded as active ingredient when the name of the speciality is unknown. Imputation is made without prejudice to the elements of investigation which could be carried out in the context of legal or amicable compensation procedures.; Reported Cause(s) of Death: Pneumopathie Covid-19


VAERS ID: 1424517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-13
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: FRPFIZER INC2021728886

Write-up: COVID-19 respiratory infection; COVID-19 respiratory infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-LL20211639. A 97-year-old female patient received BNT162B2 (COMIRNATY) Solution for injection, intramuscular on 28Jan2021 (Lot Number: Unknown, at unknown age) as dose 1, single, intramuscular on 18Feb2021 (Lot Number: Unknown, at unknown age) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that 13Mar2021 was D23, after the last injection, appearance of dyspnea and respiratory infection COVID. The patient died on 17Mar2021. 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: COVID-19 respiratory infection; COVID-19 respiratory infection


VAERS ID: 1424519 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-10
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cardiac arrest, Computerised tomogram, Deep vein thrombosis, Dyspnoea, Electrocardiogram, Fibrin D dimer, Pulmonary embolism, Syncope, Ultrasound Doppler
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 12
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: SUBUTEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankle sprain (left ankle sprain); Deep vein thrombosis recurrent (treated with 3 months of injectable curative anti-coagulant treatment (triggering factor not known, left ankle sprain and POP); 2nd episode of DVT left lower limb from date unknown and context unknown, left leg TVS GVS treated with 3 weeks of oral anticoagulant treatment, left GVS TVS in thigh to be considered as DVT treated with 3 months of oral anticoagulant treatment); Substance abuse
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: Thoracic CT angiography; Result Unstructured Data: Test Result:aspect of massive pulmonary thrombosis; Comments: aspect of massive pulmonary thrombosis, bilateral, proximal with thrombus taking a bilateral marginal aspect compatible with an aspect of massive pulmonary embolism which is partly chronic.; Test Date: 20210512; Test Name: TAP scanner; Result Unstructured Data: Test Result:No evidenced progressive lesion; Comments: Bilateral massive pulmonary embolism. An upper right micronodule measuring 7mm long axis. A right ovarian cystic formation that may be related to a follicular cyst, to be checked again by pelvic ultrasound.; Test Date: 20210510; Test Name: ECG; Result Unstructured Data: Test Result:Elevated; Comments: suggestive of pulmonary embolism; Test Date: 20210510; Test Name: D-dimers; Result Unstructured Data: Test Result:Elevated; Comments: suggestive of pulmonary embolism; Test Date: 20210512; Test Name: Venous doppler ultrasound; Result Unstructured Data: Test Result:proximodistal DVT of the right lower limb; Comments: Venous doppler ultrasound of the lower limbs; proximodistal DVT of the right lower limb, recent to semi-recent. (superficial femoral veins, popliteal and gastrocnemius, posterior tibial and fibular)
CDC Split Type: FRPFIZER INC2021728821

Write-up: Acute massive pulmonary embolism; Deep venous thrombosis proximal; cardiac arrest; faintness; dyspnea; This is a spontaneous report from a contactable physician downloaded from the WEB regulatory authority number FR-AFSSAPS-MP20213729, Safety Report Unique Identifier FR-AFSSAPS-2021068144. A 44-year-old female patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 intramuscularly on 21Apr2021 as single dose for COVID-19 immunization. Medical history included deep vein thrombosis from 2000 to 2005 treated with 3 months of injectable curative anti-coagulant treatment (triggering factor not known, left ankle sprain and Pelvic organ prolapse (POP)); 2nd episode of Deep Vein Thrombosis (DVT) left lower limb from date unknown and context unknown, left leg Transvaginal ultrasound , great saphenous vein (TVS, GVS) treated with 3 weeks of oral anticoagulant treatment, left GVS TVS in thigh to be considered as DVT treated with 3 months of oral anticoagulant treatment; ligament sprain from an unknown date and unknown if ongoing and Substance abuse substituted by SUBUTEX. Concomitant medication included buprenorphine hydrochloride (SUBUTEX) taken for an unspecified indication, start and stop date were not reported. On 10May2021, the patient was in emergency room for faintness and dyspnea with Elevated D-dimers and ECG suggestive of pulmonary embolism. After the lab tests, the patient was further diagnosed with acute massive pulmonary embolism, deep venous thrombosis proximal on 10May2021 and hospitalized. On 11May2021, the patient was in hospitalization with strict bed rest advised. On 13May2021, the patient got up in the chair. Onset of a recovered Cardiac arrest, no thrombolysis after collegial discussion (no sign of shock, no involvement of the right ventricle, no positive marker). Until 18May, mobilization was in bed, on the edge of the bed. On 22May2021, the patient had Cardiac arrest that was not recovered on asystole. The patient died on 22May2021, with unknown autopsy result. The patient underwent lab tests and procedures on 10May2021 which included angiogram: aspect of massive pulmonary thrombosis, bilateral, proximal with thrombus taking a bilateral marginal aspect compatible with an aspect of massive pulmonary embolism which is partly chronic. Electrocardiogram: elevated (suggestive of pulmonary embolism), fibrin d dimer: elevated (suggestive of pulmonary embolism). The lab tests and procedures performed on 12May2021 was computerized tomogram: (no evidenced progressive lesion) Bilateral massive pulmonary embolism. An upper right micronodule measuring 7mm long axis. A right ovarian cystic formation that may be related to a follicular cyst, to be checked again by pelvic ultrasound and ultrasound doppler: (proximodistal DVT of the right lower limb) Venous doppler ultrasound of the lower limbs; proximodistal DVT of the right lower limb, recent to semi-recent. (superficial femoral veins, popliteal and gastrocnemius, posterior tibial and fibular). The patient received treatment for the events acute massive pulmonary embolism, deep venous thrombosis proximal. Outcome of the events cardiac arrest, acute massive pulmonary embolism and deep venous thrombosis proximal was reported as fatal; and outcome of the events syncope and dyspnea was reported as unknown. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: History: - left proximal DVT between 2000 and 2005 treated with 3 months of injectable curative anti-coagulant treatment (triggering factor not known, left ankle sprain and POP) EP and DVT (date and context not known), 2nd episode of DVT left lower limb from date unknown and context unknown, left leg TVS GVS treated with 3 weeks of oral anticoagulant treatment, left GVS TVS in thigh to be considered as DVT treated with 3 months of oral anticoagulant treatment - Substance abuse substituted by SUBUTEX HISTORY OF THE DISEASE, TIMELINE OF FACTS: 44-year-old patient vaccinated as part of the COVID-19 vaccination campaign Usual treatments: SUBUTEX Vaccination Vaccine name: COMIRNATY Route of administration: intramuscular injection Vaccine rank: D1 Lot number: unknown Date and time of injection: 21Apr2021 DESCRIPTION OF THE SIDE EFFECT AND RELATED EXAMINATIONS: 10May: goes to the PRIVACY emergency room for faintness and dyspnea Elevated D-dimers and ECG suggestive of pulmonary embolism Thoracic CT angiography on 10May: aspect of massive pulmonary thrombosis, bilateral, proximal with thrombus taking a bilateral marginal aspect compatible with an aspect of massive pulmonary embolism which is partly chronic. This aspect affects both the common pulmonary axes as well as the upper right, middle and lower right lobe pulmonary axes as well as the left upper and lower lobe. No associated pleural or pericardial effusion. In parenchymal window, no sign of infarction. No interstitial alveolar focus. No obvious bronchial syndrome. Venous doppler ultrasound of the lower limbs on 12May: proximodistal DVT of the right lower limb, recent to semi-recent. (superficial femoral veins, popliteal and gastrocnemius, posterior tibial and fibular) TAP scanner: No evidenced progressive lesion. Bilateral massive pulmonary embolism. An upper right micronodule measuring 7mm long axis. A right ovarian cystic formation that may be related to a follicular cyst, to be checked again by pelvic ultrasound. EVOLUTION : 10May: initiation of curative anticoagulation with heparin 11May: hospitalization in USIC, strict bed 13May: get up in the chair. Onset of a recovered RCA, no thrombolysis after collegial discussion (no sign of shock, no involvement of the right ventricle, no positive marker). Until 18May: mobilization in bed, on the edge of the bed. 18May: hospitalization in a conventional sector with telemetry 22May: ACR not recovered on asystole; Reported Cause(s) of Death: Massive proximal bilateral pulmonary embolism


VAERS ID: 1424523 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-05-10
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Asymptomatic COVID-19, Fall, Irritability, SARS-CoV-2 test, Sudden death, Vaccination failure, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   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: Adenocarcinoma of prostate; Behavioural disorder; Bladder neoplasm (Multiple history of neoplasms, currently not treated with chemotherapy.); Rectal adenocarcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: sars-cov-2 test; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC2021728719

Write-up: The patient is more agitated than usual; Annoyed by other residents of his establishment; Then he fell suddenly while walking; He vomits profusely; Death is noted in the following minutes, without a cause found; Patient tests positive for COVID-19/ he has no symptoms; Patient tests positive for COVID-19; This is a spontaneous report from a contactable other healthcare professional downloaded from an Agency, regulatory authority number FR-AFSSAPS-PO20212359, Safety Report Unique Identifier FR-AFSSAPS-2021060775. An 84-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: ET3620) via intramuscular on 11Mar2021 in left arm as 0.3 ml single dose for COVID-19 immunization. Medical history included behaviour disorder, rectal adenocarcinoma, prostate cancer and bladder neoplasm (all from an unknown date and unknown if ongoing). The patient had multiple history of neoplasms but was not currently being treated with chemotherapy. No information on the patient''s covid-19 history and if he had been tested. The patient''s concomitant medications were not reported. The patient historical vaccine included first dose of COMIRNATY (BNT162B2, Solution for injection) on an unspecified date for COVID-19 immunization. On 10May2021, the patient was tested positive for COVID-19 English variant and had no symptoms. On 13May2021, the patient was more agitated than usual, annoyed by other residents of his establishment. He was not exhibiting any other symptoms or unusual behaviour. He had fallen suddenly while walking and was accompanied by his caregiver. He vomited profusely and death was noted in the following minutes, without a cause found. Autopsy was not performed and there was no mail or death report available. The patient underwent lab tests and procedures which included sars-cov-2 variant test as positive on 10May2021. The outcome of the event sudden death was fatal and for all other events was unknown.; Reporter''s Comments: Reporter Comment Summary: Suspicion of vaccine failure with COMIRNATY vaccine. Multiple history of neoplasms. On 10May2021: patient positive for COVID-19, variant with no symptoms. On 13May2021: The patient is more agitated than usual, not exhibiting any unusual behavior. Then he fell suddenly while walking, and vomits profusely. Death is noted in the following minutes, without a cause found. No autopsy performed.; Reported Cause(s) of Death: Death is noted in the following minutes, without a cause found


VAERS ID: 1424527 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-05-02
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Blood sodium, Body temperature, Brain natriuretic peptide, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Coma scale, Drug ineffective, Glomerular filtration rate, Heart rate
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD (Only one lung)
Preexisting Conditions: Medical History/Concurrent Conditions: Living in nursing home; Lung infection NOS (multiple lung infections in recent years)
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: potassium; Result Unstructured Data: Test Result:5.2; Test Date: 20210505; Test Name: sodium; Result Unstructured Data: Test Result:157; Test Date: 20210505; Test Name: body temperature; Result Unstructured Data: Test Result:39.8 Centigrade; Test Date: 20210505; Test Name: BNP; Result Unstructured Data: Test Result:greatly increased.; Test Date: 20210505; Test Name: Chest x-ray; Result Unstructured Data: Test Result:diffuse interstitial syndrome; Test Date: 20210505; Test Name: Glasgow; Result Unstructured Data: Test Result:15; Test Date: 20210505; Test Name: CRP; Result Unstructured Data: Test Result:65; Test Date: 20210505; Test Name: GFR; Result Unstructured Data: Test Result:12; Test Date: 20210505; Test Name: heart rate; Result Unstructured Data: Test Result:tachycardia at 109 bpm
CDC Split Type: FRPFIZER INC2021728858

Write-up: pneumonia Covid-19; Vaccination failure; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB regulatory authority number FR-AFSSAPS-ST20212334, Safety Report Unique Identifier FR-AFSSAPS-2021072213. A 93-years-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EJ6789), via intramuscular on 18Feb2021 as single dose and first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EJ6788) via intramuscular on 28Jan2021 as single dose for covid-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease Only one lung, living in nursing home from an unknown date and unknown if ongoing, pneumonia from an unknown date and unknown if ongoing multiple lung infections in recent years. No concomitant medications were not reported. On 02May2021 the patient experienced vaccination failure, pneumonia covid-19. The patient was hospitalized for vaccination failure and pneumonia covid-19 from 05May2021 to an unknown date. The patient underwent lab tests and procedures which included blood potassium: 5.2 on 05May2021, blood sodium: 157 on 05May2021, body temperature: 39.8 centigrade on 05May2021, brain natriuretic peptide: greatly increased on 05May2021, chest x-ray: diffuse interstitial syndrome on 05May2021, coma scale: 15 on 05May2021, c-reactive protein: 65 on 05May2021, glomerular filtration rate: 12 on 05May2021, heart rate: tachycardia at 109 bpm on 05May2021. The patient died on 05May2021. An autopsy was not performed. Follow-up (21Jun2021): new information received from Product Complaint Team. New information received from division RA includes: The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021724814 same reporter, same drug, different patient;FR-PFIZER INC-2021706594 same reporter, same drug, different patient;FR-PFIZER INC-2021697580 same reporter, same drug, different patient; Reported Cause(s) of Death: COVID respiratory distress syndrome


VAERS ID: 1424530 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain tumor operation
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021729389

Write-up: myocardial infarction; This is a spontaneous report from a contactable consumer. A 35-years-old male patient received unknown dose of BNT162B2 (COMIRNATY), via an unspecified route of administration in Jun2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included brain tumour operation in 2000''s. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction (death) on 10Jun2021. The patient died on 10Jun2021. 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: Myocardial infarction


VAERS ID: 1424643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cerebral haemorrhage, Cerebral thrombosis, Cerebrovascular accident, Deep vein thrombosis, Fatigue, Influenza like illness, Pain in extremity, Pulmonary embolism, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOL; LOSARTAN
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210216; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC2021677549

Write-up: pulmonary embolism; tested positive for covid; pain in her leg; Stroke; bleed on the brain; she received treatment for a clot; collapsed with what we now know was a bleed on the brain; DVT (Deep vein thrombosis); Influenza like illness; fatigue and feeling generally fluish; This is a spontaneous report received from a contactable consumer by Pfizer from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106060242168970-PMNPP, Safety Report Unique Identifier GB-MHRA-ADR 25426673. A 78 years old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration in Feb2021 at single dose for COVID-19 immunisation. The medical history was Suspected COVID-19 from 03FEB2021 and ongoing. The concomitant medications were lansoprazol and losartan. The reporter''s grandmother was an outgoing healthy very alert woman who was doing everything asked of her by isolating and taking every precaution asked of her as was we, she received her first injection and literally within a couple of days fell ill, she then tested positive for covid on 16FEB2021, the reporter''s mother and uncle both living with her tested negative, she was bed ridden with fatigue and feeling generally fluish for around 10 days and Influenza like illness in Feb2021, as she started to feel better she came downstairs insisting to make her own breakfast and Stroke, collapsed with what we now know was a bleed on the brain in Feb2021, she received treatment for a clot but was also diagnosed as having a pulmonary embolism on 20FEB2021, we later found out a couple of days after the injection she had complained of a pain in her leg in FEB2021, we think was a DVT (Deep vein thrombosis), the patient did have underlying health issues but the reporter has no doubt in the mind that she became ill after her vaccination. Also considering she had a positive covid result covid was not added to her death certificate. The patient underwent lab tests and procedures, which included COVID-19 virus test Positive on 16FEB2021. The patient died on 20FEB2021. It''s not reported if an autopsy was performed. The cause of death was Pulmonary embolism. The outcome of the event Pulmonary embolism was fatal, the others was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1424774 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-18
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 test; Test Result: Negative ; Comments: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBPFIZER INC2021677635

Write-up: Heart attack; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202106082240246130-LTHVV and the safety report unique identifier is GB-MHRA-ADR 25441963. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 28Jan2021 at dose 1, single for COVID-19 immunisation. Medical history included mild high blood pressure. He has not had symptoms associated with COVID-19, has not had a COVID-19 test, and was not enrolled in a clinical trial. The patient''s concomitant medications were not reported. On 18Feb2021, the patient experienced heart attack. The patient underwent lab test and procedure which included COVID-19 test: negative on an unspecified date in 2021. He has not tested positive for COVID-19 since having the vaccine. The patient died on an unspecified date in 2021. The cause of death was heart attack. Autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1424894 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Congenital anomaly, Maternal exposure timing unspecified
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: 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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021664565

Write-up: This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the Regulatory Agency. This is a fetus case created as a split from master case. A fetus patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ew2245, Expiration date: unknown) via transplacental route of administration on 15May2021 as 1st dose, single for COVID-19 immunization. The medical history of the patient''s mother was not reported. Concomitant medications of patient''s mother included folic acid taken for Folic acid supplementation. On 18May2021, the patient had congenital anomaly. The patient died on an unspecified date. 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: Congenital Anomaly


VAERS ID: 1424934 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-14
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210639320

Write-up: CARDIAC ARREST; This spontaneous report received from a consumer via a company representative via social media concerned a 32 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported), dose was not reported, 1 total administered on 14-MAR-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 14-MAR-2021, within 12 hours of vaccination the patient died of a cardiac arrest, sudden death. The cause of death was cardiac arrest. It was unknown whether an autopsy was performed or not. 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 20210639314, 20210639262 and 20210639330.; Sender''s Comments: V0: 20210639320- covid-19 vaccine ad26.cov2.s-CARDIAC ARREST. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: CARDIAC ARREST


VAERS ID: 1424979 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001943-65 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DELTACORTENE; XARELTO; DUROGESIC; LANSOPRAZOLE; ESIDREX; ALLOPURINOL; LASIX [FUROSEMIDE]; FERRO GRAD C
Current Illness: Aortic valve stenosis; Atrial fibrillation; Chronic anemia; Chronic ischemic heart disease, unspecified; Decompensation cardiac; Dyspnoea; Kyphosis; Polymyalgia rheumatica
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy; Inguinal hernia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST and CARDIAC FAILURE in a 91-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001943-65) for COVID-19 vaccination. The patient''s past medical history included Inguinal hernia and Benign prostatic hypertrophy. Concurrent medical conditions included Decompensation cardiac since 01-Apr-2016, Atrial fibrillation, Aortic valve stenosis, Polymyalgia rheumatica, Dyspnoea, Kyphosis, Chronic anemia and Chronic ischemic heart disease, unspecified. Concomitant products included PREDNISONE (DELTACORTENE), RIVAROXABAN (XARELTO), FENTANYL (DUROGESIC), LANSOPRAZOLE, HYDROCHLOROTHIAZIDE (ESIDREX), ALLOPURINOL, FUROSEMIDE (LASIX [FUROSEMIDE]) and ASCORBIC ACID, FERROUS SULFATE (FERRO GRAD C) for an unknown indication. On 15-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 17-May-2021, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant) and CARDIAC FAILURE (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was Standstill cardiac and Decompensation cardiac. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added other medical relevant history. Added concomitant medicines.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Standstill cardiac; Decompensation cardiac


VAERS ID: 1425070 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Body temperature, Cerebral infarction, Hemiplegia, Investigation, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: body temperature; Result Unstructured Data: Test Result:37 level Centigrade; Comments: after the vaccination; Test Date: 20210607; Test Name: brain examination; Result Unstructured Data: Test Result:diagnosed with cerebral infarction
CDC Split Type: JPPFIZER INC2021673186

Write-up: Cerebral infarction; right incomplete hemiplegia; Pneumonia; suspected Speech loss; Pyrexia at 37 centigrade degree; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report numbers are v21112152 and v21115456. An 84-year-old male patient received the first dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Jun2021 at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pneumonia, which was serious for death. On 06Jun2021, the patient experienced pyrexia at 37 degrees Centigrade. On 07Jun2021 at 03:00, the patient experienced right incomplete hemiplegia, which was serious for hospitalization from 07Jun2021 to an unknown date. On 07Jun2021 at 03:10, the patient experienced cerebral infarction and suspected speech loss. The clinical course was as follows: on 06Jun2021 (the day of vaccination), the patient received?the first dose of vaccine. On 07Jun2021 at around 03:10 (1 day after the vaccination), the patient experienced adverse events. On 07Jun2021 (1 day after the vaccination), the patient was admitted to the hospital. The events were further described as: on 06Jun2021, the patient got vaccinated. It seems that there was a pyrexia at 37 level centigrade degree. On 07Jun2021 around 03:00, staff suspected speech loss and right hemiplegia during a patrol and made an emergency request. At the first visit, Speech loss was suspected, and right incomplete hemiplegia was confirmed. After a brain examination, he was diagnosed with cerebral infarction on 07Jun2021. Now the patient was under treatment. On an unspecified date, outcome of event was not provided. On 06Jun2021 (the day of vaccination), the patient received?the first dose of BNT162b2. On an unspecified date (after the vaccination), the patient experienced pneumonia. The event resulted in death. The outcome of the event pneumonia was fatal. The causality between the events and BNT162B2 as unassessable. On 21Jun2021, the patient died from pneumonia. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included body temperature: 37 level degrees Centigrade on 06Jun2021 after the vaccination. Therapeutic measures were taken as a result of cerebral infarction, right incomplete hemiplegia, and suspected speech loss. The patient died on 21Jun2021 due to pneumonia. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (hospitalized from 07Jun2021) and assessed the causality between the event and BNT162B2 as unassessable. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1425122 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GALANTAMINE; QUETIAPINE; FOLIAMIN; FUROSEMIDE
Current Illness: Chronic kidney disease; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021676684

Write-up: Death; This is a spontaneous report from a contactable physician received via reporting system. A 93-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EY5420; Expiration Date: 31Aug2021), intramuscularly in the left arm, on 06Jun2021 14:00 (at the age of 93-years-old) as a single dose for COVID-19 immunisation in the doctor''s office or urgent care room (as reported). Medical history included ongoing dementia and ongoing chronic kidney disease. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included galantamine (MANUFACTURER UNKNOWN), quetiapine (MANUFACTURER UNKNOWN), folic acid (FOLIAMIN), and furosemide (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced death on 07Jun2021 at 19:30 (1 days 5 hours and 30 minutes after the vaccination), which was reported as fatal. The patient did not receive any treatment as a result of death. The cause of death was reported as unknown. An autopsy was not performed. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: Based on the available information, a possible contributory role of the subject vaccine cannot be excluded for the event of Unknown cause of death. However, there was no information provided regarding specific cause of death, complete medical history, co-morbid conditions, and concomitant medications, which does not allow a full assessment of the case. Of note, the reported event may possibly be associated with intercurrent medical condition in this elderly 93 year old patient with history of ongoing chronic kidney disease. 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: Death


VAERS ID: 1425168 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cardiac failure, Chest discomfort, Glycosylated haemoglobin, Spinal osteoarthritis
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Cardiomyopathy (broad), Arthritis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TENELIA; DIGOXIN; LASIX [FUROSEMIDE]; GLICLAZIDE; RABEPRAZOLE; AMVALO; CARVEDILOL; ATELEC; ATORVASTATIN; ORENGEDOKUTO; MOHRUS; HYALEIN; RESTAMIN KOWA; RINDERON-VG
Current Illness: Cardiac failure chronic; Cerebral aneurysm (unruptured); Oedema lower limb
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic gastritis; Diabetes mellitus; Dyslipidaemia; Gonarthrosis; Insomnia
Allergies:
Diagnostic Lab Data: Test Name: HbA1C; Result Unstructured Data: Test Result:around 10 %
CDC Split Type: JPPFIZER INC2021679202

Write-up: Cardiac failure; Chest fullness; right shoulder pain; Cervical spondylosis; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 94-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly, administered in the left arm on 20May2021 11:15 (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) at 94-years-old as a single dose for COVID-19 immunisation. Medical history included ongoing chronic cardiac failure from an unknown date, diabetes mellitus from an unknown date and unknown if ongoing, ongoing unruptured cerebral aneurysm from an unknown date, dyslipidaemia from an unknown date and unknown if ongoing, chronic gastritis from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, gonarthrosis from an unknown date and unknown if ongoing, ongoing oedema lower limb aggravated from an unknown date. Concomitant medications included teneligliptin hydrobromide (TENELIA); digoxin (MANUFACTURER UNKNOWN); furosemide (LASIX); gliclazide (MANUFACTURER UNKNOWN); rabeprazole (MANUFACTURER UNKNOWN); amlodipine besilate, valsartan (AMVALO); carvedilol (MANUFACTURER UNKNOWN); cilnidipine (ATELEC); atorvastatin (MANUFACTURER UNKNOWN); coptis spp. rhizome, gardenia jasminoides fruit, phellodendron spp. bark, scutellaria baicalensis root (ORENGEDOKUTO); ketoprofen (MOHRUS); hyaluronate sodium (HYALEIN); diphenhydramine (RESTAMIN KOWA); betamethasone valerate, gentamicin sulfate (RINDERON-VG); all taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced right shoulder pain (non-serious; physician office visit required), and cervical spondylosis (non-serious). On an unspecified date, the patient experienced cardiac failure (death, medically significant; physician office visit required), and chest fullness (non-serious). The clinical course was reported as follows: The patient was a non-pregnant 94-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received teneligliptin hydrobromide (TENELIA) at 20 mg, digoxin (MANUFACTURER UNKNOWN) at 0.25 mg, furosemide (LASIX) at 40 mg, gliclazide (MANUFACTURER UNKNOWN) at 40 mg, rabeprazole (MANUFACTURER UNKNOWN) at 10 mg, amlodipine besilate/valsartan (AMVALO combination tablet), carvedilol (MANUFACTURER UNKNOWN) at 2.5 mg, cilnidipine (ATELEC) at 10 mg, atorvastatin (MANUFACTURER UNKNOWN) at 10 mg, coptis spp. rhizome, gardenia jasminoides fruit, phellodendron spp. bark, scutellaria baicalensis root (OSUGI 15 ORENGEDOKUTO), ketoprofen (MOHRUS Tape), hyaluronate sodium (HYALEIN eye drops 0.1%), diphenhydramine (RESTAMIN KOWA cream), betamethasone valerate, gentamicin sulfate (RINDERON-VG ointment) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included ongoing chronic cardiac failure, diabetes mellitus, ongoing unruptured cerebral aneurysm, dyslipidaemia, chronic gastritis, insomnia, gonarthrosis, and oedema lower limb aggravated. Since the vaccination, the patient has not been tested for COVID-19. On 20May2021 at 11:15 (the day of vaccination), the patient received?the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617; Expiration Date: 31Aug2021) intramuscular in the left arm for COVID-19 immunization. Event clinical course was reported as follows: Since before, the patient was treated for cardiac failure and had existing unruptured cerebral aneurysm, diabetes mellitus with HbA1C of around 10 %. Her oedema lower limb aggravated before vaccination. On 20May2021, the patient received vaccination. Around 24May2021, the patient had right shoulder pain and cervical spondylosis was suggested by an orthopedist. Thereafter, chest fullness was noted. On 05Jun2021, the patient found dead at home. Death cause was reported as cardiac failure. An autopsy was not performed. The event resulted in doctor or other healthcare professional office/clinic visit and death. Treatment for the event included prescription of pain killer and visit to orthopedist. Since the vaccination, the patient did not test for COVID-19. The patient underwent lab tests and procedures which included glycosylated haemoglobin (HbA1C): around 10 % on an unspecified date. Therapeutic measures were taken as a result of cardiac failure, and cervical spondylosis. The clinical outcome of the events: right shoulder pain, cervical spondylosis, chest fullness was unknown. The clinical outcome of the event, cardiac failure, was fatal. The patient died on 05Jun2021 due to cardiac failure. An autopsy was not performed.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of cardiac failure and Cervical spondylosis, which likely represent intercurrent medical conditions in this elderly patient. Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the other reported events due to temporal relationship . There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1425181 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Electrocardiogram, Loss of consciousness, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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: Pancreatic carcinoma (under treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Prostatic hypertrophy
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210515; Test Name: electrocardiogram; Result Unstructured Data: Test Result:slight heartbeat
CDC Split Type: JPPFIZER INC2021680623

Write-up: death; Loss of consciousness; Respiratory arrest; This is a spontaneous report from a contactable Other Health Professional. This is a report received from the Regulatory Authority. Regulatory authority report number is v21112787. A 64-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 13May2021 14:45 (Batch/Lot Number: EX3617; Expiration Date: 31Aug2021) at 64-years-old as a single dose for COVID-19 immunisation. The patient''s medical history included diabetes mellitus from an unknown date and unknown if ongoing, prostatic hypertrophy from an unknown date and unknown if ongoing, pancreatic carcinoma from Mar2021 and ongoing (under treatment). Concomitant medications were not reported. On 15May2021, the patient experienced: loss of consciousness (medically significant), respiratory arrest (medically significant), and death (death, medically significant). All events required an emergency room visit. The clinical course was reported as follows: The patient was a 64-year and 8-month-old male. Body temperature before vaccination was 36.8 degrees Centigrade. Medical history included diabetes mellitus, prostatic hypertrophy, and pancreatic carcinoma. Concomitant medications and family history were not provided. On 13May2021 at 14:45 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EX3617, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 15May2021 at 00:00 (2 days after the vaccination), the patient was no longer breathing and unconscious. And then the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 15May2021, the patient was transferred to a hospital by an ambulance. When arriving at the hospital, slight heartbeat was recognized by electrocardiogram, but he had become unconscious and he was no longer breathing. Although emergency procedures were done for 30 minutes, he died. The physician who made emergency procedures (his attending doctor) stated that pancreatic carcinoma was detected in Mar2021 and he was receiving the treatment at another hospital and it was unlikely to consider that there was a causal relationship with BNT162b2. The reporting other health professional classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Pancreatic carcinoma was considered as a possible cause of the event. The patient underwent lab tests and procedures which included body temperature: 36.8 Centigrade on 13May2021 (before vaccination), electrocardiogram: slight heartbeat on 15May2021. Therapeutic measures were taken as a result of death, loss of consciousness, and respiratory arrest. The clinical outcome of the events: loss of consciousness and respiratory arrest, was unknown. The clinical outcome of the event, death, was fatal. The patient died on 15May2021 due to unknown cause of death. It was unknown if an autopsy was performed.; Sender''s Comments: Based on the current available information, the reported events Unknown cause of death, Loss of consciousness, and Respiratory arrest are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Pancreatic carcinoma may provide a plausible explanation for the events. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1425182 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Respiratory arrest
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   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: Brain operation; Cerebral arterial aneurysm; Consciousness disturbed; Cystitis; Gastric fistula; Gavage; Hartmann''s pouch procedure; Hypoxic encephalopathy; Living in care; Pneumonia recurrent; Postresuscitation encephalopathy; Tracheostomy
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021680632

Write-up: This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority. A 66-year-old male patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: FA4597; Expiration Date: 31Aug2021), via an unspecified route of administration on 09Jun2021 at 13:42 at a single dose for covid-19 immunisation. Medical history included hypoxic encephalopathy at the time of cerebral arterial aneurysm surgery in Nov2012, postresuscitation encephalopathy from Nov2012 to an unknown date, consciousness disturbed/prolonged consciousness disturbed, tracheostomy, gastric fistula/nutritional management with the gastric fistula, Hartmann''s pouch procedure in Apr2021, he had required total assistance, and there had been repetitive episodes of pneumonia and cystitis. Family history was not reported. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on an unknown date for covid-19 immunization. On 09Jun2021 at 14:40, the patient experienced respiratory arrest and anaphylaxis, which was serious for death. The clinical course was as follows: on 09Jun2021 at 13:42 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 09Jun2021 at 14:40 (58 minutes after the vaccination), the patient experienced anaphylaxis and respiratory arrest. On 09Jun2021 at 15:15 (1 hour and 33 minutes after the vaccination), the death of the patient was confirmed. On 09Jun2021 (the day of vaccination), the outcome of the events was fatal. It was unknown whether autopsy was done. The course of the events was as follows: on 09Jun2021 at 14:40 (58 minutes after the vaccination), there was a call from the hospital ward reporting respiratory arrest. At 14:45 (1 hour and 3 minutes after the vaccination), resuscitation was started by several physicians. At 15:15 (1 hour and 33 minutes after the vaccination), the patient was confirmed dead. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause(s) of the events such as any other diseases: present (there had been repetitive episodes of pneumonia and cystitis). The patient underwent lab tests and procedures which included body temperature: 37.1 degrees Centigrade on 09Jun2021 before vaccination. Therapeutic measures were taken as a result of respiratory arrest and anaphylaxis. The clinical outcome of the events, respiratory arrest and anaphylaxis, was fatal. The patient died on 09Jun2021 on 15:15 due to respiratory arrest and anaphylaxis. It was not reported if an autopsy was performed. REPORTER COMMENT: The patient had had prolonged consciousness disturbed, undergone tracheostomy, and been on nutritional management with the gastric fistula. As a general status, he had required total assistance.; Reported Cause(s) of Death: respiratory arrest; anaphylaxis


VAERS ID: 1425183 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-05-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Cardio-respiratory arrest, Computerised tomogram, Face crushing, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   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: Cancer surgery (3 years before with favorable course); Pancreatic carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210531; Test Name: CT from the head through the pelvis; Result Unstructured Data: Test Result:no haemorrhage intracranial; Test Name: PCR; Result Unstructured Data: Test Result:negative (-) to COVID-19; Test Name: Qualitative antigen test; Result Unstructured Data: Test Result:negative (-) to COVID-19
CDC Split Type: JPPFIZER INC2021680634

Write-up: This is a spontaneous report from a contactable physician received from regulatory authority. A 65-year and 5-month-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: FA4597; Expiration Date: 31Aug2021), via an unspecified route of administration, on 30May2021 at 14:32 (at the age of 65-years-old) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included history of surgery at another hospital for pancreatic carcinoma (3 years before with favorable course). The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot number: EX3617; Expiration date: 31Aug2021), intramuscularly, on 09May2021, at 0.3 mL for COVID-19 immunisation and experienced 39 degrees centigrade for half a day. The patient experienced cardiac failure acute on 31May2021 at 17:25 (1 day after the vaccination), which was reported as fatal. The patient also experienced cardio-respiratory arrest on 31May2021 at 17:25, crushing-like traumatic injury on the face on 31May2021, and pyrexia and malaise on 30May2021. The clinical course was reported as follows: The body temperature before vaccination was 36.1 degrees centigrade on 30May2021. On 30May2021 (the day of vaccination), the patient received the second vaccination with the new coronavirus vaccine in the city. The patient experienced symptoms such as pyrexia and malaise from the evening on 30May2021 (the day of vaccination). On 31May2021 (1 day after the vaccination), the patient''s family went to work, and he was alone at home. Around 12:30, the family were contacting the patient through phone calls and messaging app. Pyrexia and malaise were present, and his activities such as having a light lunch were checked. At 17:25, when getting home from work, the patient''s wife found him lying prone. Because of no breathing and other reasons, an ambulance was called. When the ambulance arrived, the patient was in a state of cardio-respiratory arrest. While performing cardiopulmonary resuscitation (with interventions such as securing an infusion route, using a laryngeal mask, and giving adrenaline (MANUFACTURER UNKNOWN) intravenously), they arrived at the hospital. A crushing-like traumatic injury was noted on the face. Computerised tomography (CT) from the head through the pelvis was performed (no haemorrhage intracranial) on 31May2021. Cardiopulmonary resuscitation and others were continued but were not successful. At 18:41, the patient died. The reporting physician commented as follows: The patient had history of surgery at another hospital for pancreatic carcinoma 3 years before with favorable course. The qualitative antigen test and polymerase chain reaction (PCR) test were negative (-) to COVID-19 on an unspecified date. Therapeutic measures were taken as a result of cardiac failure acute and cardio-respiratory arrest as aforementioned. The clinical outcome of crushing-like traumatic injury on the face, pyrexia, and malaise was unknown. The patient died on 31May2021 (1 day after the vaccination). The cause of death was reported as cardiac failure acute and cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the event, cardiac failure acute, and BNT162B2 as unassessable. Other possible causes of the events. such as any other diseases, was unknown.; Reported Cause(s) of Death: Cardiac failure acute; Cardio-respiratory arrest


VAERS ID: 1425229 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood pressure systolic, Body temperature, Cerebral haemorrhage, Heart rate, Oxygen saturation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; AMANTADINE HYDROCHLORIDE; ELIQUIS; RESLIN; MAGNESIUM OXIDE; METHYCOBAL; LEVOTOMIN [LEVOMEPROMAZINE MALEATE]; BROTIZOLAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain stem infarction; Cerebral infarction; Dementia Alzheimer''s type; Hypertension; Subarachnoid haemorrhage; Surgery (20 years ago); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210614; Test Name: blood pressure; Result Unstructured Data: Test Result:164/106; Test Date: 20210614; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:110-120; Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210614; Test Name: Pulse rate; Result Unstructured Data: Test Result:around 60; Test Date: 20210614; Test Name: Pulse rate; Result Unstructured Data: Test Result:97; Test Date: 20210614; Test Name: Oxygen saturation; Test Result: 99 %
CDC Split Type: JPPFIZER INC2021702800

Write-up: right extensive cerebral haemorrhage/depressed level of consciousness and left hemiplegia; This is a spontaneous report from the contactable other health professional received via an agency and a contactable physician via a Pfizer sales representative received from an Agency (RA). Regulatory authority report number is v21114282. The patient was an 80-year-old female (non-pregnant). Body temperature before vaccination was 36.8 degrees centigrade. It was unknown whether the patient had family history or not. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was prescribed with following medications within 2 weeks of vaccination: clopidogrel (CLOPIDOGREL tablet) at 75 mg once a day (in the morning); amantadine hydrochloride (AMANTADINE HYDROCHLORIDE 10%) at 1 g/day (twice a day; in the morning and afternoon); apixaban (ELIQUIS 2.5MG tablet) at 2.5 mg twice a day (in the morning and evening); trazodone hydrochloride (RESLIN 25MG tablet) at 25 mg twice a day (in the morning and evening); magnesium oxide (MAGNESIUM OXIDE) at 1 g/day (twice a day; in the morning and evening); mecobalamin (METHYCOBAL 500MG) at 500 mg three times a day (after each meal); levomepromazine maleate (LEVOTOMIN 5MG tablet) at 5 mg once a day (before bedtime); brotizolam (BROTIZOLAM 0.25MG tablet) at 0.25 mg as needed (when the patient can''t sleep). Medical history included subarachnoid haemorrhage (higher brain dysfunction/right hemiplegia) from 1994, cerebral thrombotic brainstem infarction from 01Aug2017, cerebral embolic left cerebral infarction from 20Nov2017, cerebral thrombotic left cerebral infarction from 16Nov2019, type 2 diabetes mellitus, hypertension and dementia Alzheimer''s type, Cerebral artery clipping surgery 20 years before unknown date. On 08Jun2021 at 13:30 (at age of 80 years old, no pregnant, the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EY0779; Expiration Date: 31Aug2021) intramuscularly in the left arm for covid-19 immunisation at an elder care facility. On 14Jun2021 at around 17:00 (6 days after the vaccination), the patient experienced depressed level of consciousness and left hemiplegia. The events required the patient to visit a medical office. The patient died of right extensive cerebral haemorrhage on 15Jun2021. On 15JUn2021 at around 08:50, the outcome of the events was fatal. It was unknown whether an autopsy was performed or not. The outcome of the events was fatal with no medical treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 after vaccination. The course of the event was as follows: Around 17:00 on 14Jun2021, depressed level of consciousness and left hemiplegia suddenly appeared when the patient was seated in a wheelchair. The left corner of her mouth drooped and her body trunk became unstable. Her baseline vital signs included systolic blood pressure: 110-120 and pulse rate: around 60. But her vital signs showed that blood pressure 164/106, pulse rate: 97, oxygen saturation: 99 % and body temperature: 36.8 degrees centigrade. Therefore she was transported to the hospital urgently. The patient was transported to the hospital and treated at the department of neurosurgery. Right extensive cerebral haemorrhage and pupils dilated were observed and a surgery was not suited for the patient. Then the patient experienced respiratory arrest. Thereafter the patient died of right extensive cerebral haemorrhage around 08:50 in the morning of 15Jun2021. The patient had past history of cerebral infarction and regularly visited the hospital. The patient had cerebral artery clipping 20 years before and received brain examination annually for follow up of the condition of the surgical site (left side of the brain). Bleeding site of this time was the right side of the brain where there were no problems before. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Sender''s Comments: Based on the current available information, the event Cerebral haemorrhage is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history subarachnoid haemorrhage and cerebral thrombotic may provide explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: right extensive cerebral haemorrhage


VAERS ID: 1425232 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-05-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Pneumonia
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: 2021-06-11
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021717492

Write-up: Cardiac failure; Pneumonia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114548. The patient was an 87-year-old male. Body temperature before vaccination was not reported. Family history and medical history were not reported. On 23May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration at age of 87 years as a single dose for COVID-19 immunization. On 27May2021 (4 days after the vaccination), the patient experienced cardiac failure and pneumonia. On 27May2021 (4 days after the vaccination), the patient was admitted to the hospital. On 11Jun2021 (19 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was admitted to the hospital due to pneumonia and cardiac failure. The patient was treated with diuretic and antibiotic; however, symptoms did not improve. On 11Jun2021, the patient died. The patient was admitted to the hospital from 27May2021 to 11Jun2021. The reporting physician classified the event as serious (hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not reported. The reporting physician commented as follows: The patient developed pneumonia and cardiac failure 4 days after the vaccination; thus, influence of the vaccine could not be denied. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiac failure; Pneumonia


VAERS ID: 1425233 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatinine, Blood lactate dehydrogenase, Blood potassium, Blood pressure decreased, Blood pressure measurement, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Decreased appetite, Dehydration, Dyspnoea, Heart rate, Heart rate decreased, Hepatic failure, Loss of personal independence in daily activities, Oxygen saturation, Pallor, Peripheral coldness, Pneumonia, Pneumonia aspiration, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia (the patient was admitted for the treatment); Respiratory distress; Shellfish allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210608; Test Name: ALT; Result Unstructured Data: Test Result:843 IU/l; Test Date: 20210608; Test Name: AST; Result Unstructured Data: Test Result:1252 IU/l; Test Date: 20210608; Test Name: creatinine; Test Result: 3.61 mg/dl; Test Date: 20210608; Test Name: LDH; Result Unstructured Data: Test Result:633 IU/l; Test Date: 20210608; Test Name: K; Result Unstructured Data: Test Result:6.9 mEq/l; Test Date: 20210606; Test Name: blood pressure; Result Unstructured Data: Test Result:84/46 mmHg; Comments: before the vaccination; Test Date: 20210606; Test Name: blood pressure; Result Unstructured Data: Test Result:81/56 mmHg; Comments: at the time of the examination; Test Date: 20210608; Test Name: blood pressure; Result Unstructured Data: Test Result:60s mmHg; Test Date: 20210608; Test Name: BUN; Test Result: 101.2 mg/dl; Test Date: 20210606; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210608; Test Name: Chest X-ray; Result Unstructured Data: Test Result:aggravated right upper pneumonia; Test Date: 20210608; Test Name: CRP; Test Result: 19.97 mg/dl; Test Date: 20210606; Test Name: pulse rate; Result Unstructured Data: Test Result:54; Comments: before the vaccination Unit: bpm; Test Date: 20210606; Test Name: pulse rate; Result Unstructured Data: Test Result:58; Comments: at the time of the examination Unit: bpm; Test Date: 20210608; Test Name: pulse rate; Result Unstructured Data: Test Result:40s; Comments: Unit: bpm; Test Date: 20210606; Test Name: SpO2; Test Result: 91 %; Comments: before the vaccination; Test Date: 20210606; Test Name: SpO2; Test Result: 89 %; Comments: at the time of the examination
CDC Split Type: JPPFIZER INC2021717705

Write-up: Pneumonia aspiration; Pneumonia aggravated; breathing difficulty; could not move from that morning; Remarkable pallor facial; cold extremities; Blood pressure was 60s mmHg; pulse rate was 40s bpm; renal failure; hepatic failure; severe dehydration; Inappetence; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. Regulatory authority report number is v21114541. The patient was an 87-year and 4-month-old female. Body temperature before vaccination was 36.6 degrees Centigrade. Medical history included pneumonia (From 26May2021 to 29May2021, the patient was admitted for the treatment) and respiratory distress. The patient had shellfish allergy. Concomitant medications included rivaroxaban (XARELTO) ongoing, orally. Family history was not provided. On 06Jun2021 at 11:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA4597, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 08Jun2021 at 09:30 (1 day 22 hrs 15 min after the vaccination), the patient experienced pneumonia aggravated. On 08Jun2021 at 20:27 (2 days 9 hrs 12 min after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: From 26May2021 to 29May2021, the patient was admitted to the respiratory department of the reporter''s hospital for pneumonia. After being discharged from the hospital, the patient was still in the poor condition, and she was unable to move at home. On 06Jun2021, the patient received the vaccination. Her vital signs before the vaccination was as follows: blood pressure: 84 mmHg/46 mmHg, pulse rate: 54 bpm, SpO2 (oxygen saturation percutaneous): 91%. While the patient was being monitored for 30 minutes (after the vaccination), breathing difficulty was noted. During the medical examination, she said that she had had the symptom from before. Therefore, after the examination, she returned home. (Her vital signs at the time of the examination was as follows: blood pressure: 81 mmHg/56 mmHg, pulse rate: 58 bpm, SpO2: 89%. On 08Jun2021, the patient made a regular visit to the cardiology department and respiratory department of the reporter''s hospital. The patient stated that she had breathing difficulty and she could not move from that morning. Remarkable pallor facial and cold extremities were noted. Blood pressure was 60s mmHg, pulse rate was 40s bpm. The results of the blood test was as follows: Cre (creatinine) 3.61 mg/dL, BUN (blood urea nitrogen) 101.2 mg/dL, K (potassium) 6.9 mEq/L indicating increased kidney function, AST(aspartate aminotransferase) 1252 U/L, ALT (alanine aminotransferase) 843 U/L, LDH (lactate dehydrogenase) 633 U/L indicating increased hepatic function, CRP (C-reactive protein) 19.97 mg/dL indicating increased inflammatory reaction. Chest X-ray showed right upper pneumonia aggravated. Inappetence due to pneumonia aggravated accompanied by renal failure/hepatic failure along with severe dehydration was recognized. Since it was determined that hospital treatment was necessary, corrective drip infusion and the treatment with antibiotics (CEFTRIAXONE) were initiated. However, the patient''s death was confirmed at 20:27 on the same day. The reporting pharmacist classified the event as serious (fatal) and assessed that the event was not related to BNT162b2. Pneumonia aspiration was reported as the possible cause of the event.; Sender''s Comments: The events were considered intercurrent conditions and unrelated to BNT162b2 (COMIRNATY, Solution for injection, Lot# FA4597, Expiration date 31Aug2021).; Reported Cause(s) of Death: breathing difficulty; could not move from that morning; Remarkable pallor facial; cold extremities; Blood pressure was 60s mmHg; pulse rate was 40s bpm; renal failure; hepatic failure; severe dehydration; Inappetence; Pneumonia aggravated; Pneumonia


VAERS ID: 1425235 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-05-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body temperature, Decreased appetite, Discomfort, Disease recurrence, Dysarthria, Dysstasia, Gait disturbance, Hypoaesthesia, Loss of consciousness, Mobility decreased, Pain in extremity, Pyrexia, Sensory disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), 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), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Spinal stenosis (for more than 10 years)
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidaemia; Gastritis; Numbness of lower extremities (visited department of surgery at another hospital once every 4 months)
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade
CDC Split Type: JPPFIZER INC2021718053

Write-up: unconscious; Pyrexia of 39 degrees centigrade; numbness in left lower extremity; numbness in left lower extremity; sensory disturbance; the patient was not able to lift right arm; the speech was not articulate; Appetite impaired; heaviness in waist; difficulty walking; Low back pain; Pain of lower extremities; was not able to stand up; This is a spontaneous report from a contactable physician received via the Agency. The patient was a non-pregnant 95-year-old female. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies or past drug history. Other medical history included Dyslipidaemia, Gastritis, and ongoing Spinal stenosis for more than 10 years. On 22May2021 at 11:00 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) intramuscular in the arm left for COVID-19 immunization. On 24May2021 (2 days after the vaccination), the patient experienced adverse event(s). On 30May2021, the patient died. The outcome of the events was fatal without treatment. Since the vaccination, the patient has not been tested for COVID-19. The course of the events was as follows: Two days after the vaccination in the morning, the patient complained of heaviness in waist and difficulty walking (24May2021). After the patient had lunch and took a nap, the patient complained of low back pain and pain of lower extremities and was not able to stand up (24May2021). The patient had no leg paralysis and was able to sit and have meals there. The patient was able to respond. On day 3 (25May2021), the patient was not able to sit and became bedridden. The patient had appetite impaired but intake of water was possible. The patient could not go to a toilet and used diapers. On day 4 (26May2021), the patient consulted municipality and a physician visited the patient. Condition of lower extremities was the same and the patient was able to respond and use arms. On day 5 (27May2021), the patient was not able to lift right arm and the speech was not articulate. On day 6 (28May2021) in the morning, the patient was unconscious, for which physician''s visit was requested and visited another hospital by ambulance; however, shortly afterward, the patient died. In the ambulance, the patient had pyrexia of 39 degrees centigrade. The patient had medical history of spinal stenosis for more than 10 years and numbness in lower extremities, for which the patient visited department of surgery at another hospital once every 4 months. However, due to advanced age, the patient was not able to undergo surgery or receive oral medication and was placed under observation. Low back pain was within control, numbness in left lower extremity (28May2021) and sensory disturbance (28May2021) were present, and cane walk was possible. Physician office visit for all events. Emergency room visit for unconscious. The reporting physician classified the events as serious (death). An autopsy was not performed.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.; Reported Cause(s) of Death: heaviness in waist; difficulty walking; was not able to stand up; the speech was not articulate; numbness in left lower extremity; Numbness of lower extremities; sensory disturbance; Pain of lower extremities; Low back pain; unconscious; the patient


VAERS ID: 1425236 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210610; Test Name: vital signs; Result Unstructured Data: Test Result:No change
CDC Split Type: JPPFIZER INC2021718215

Write-up: Cerebral infarction right; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114530. The patient was an 82-year-old female. Body temperature before vaccination was 36.4 degrees Centigrade. The family history was not provided. The patient had medical history of non-ongoing cerebral infarction. On 20May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW4811, Expiration date 31Jul2021) for COVID-19 immunisation. On 10Jun2021 at 10:00 (the day of vaccination, at the age of 82 year old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jun2021 at 07:30 (2 days/21 hours/30 minutes after the vaccination), the patient experienced cerebral infarction right. On 13Jun2021 (3 days after the vaccination), the patient was admitted to the hospital. On 16Jun2021 (6 days after the vaccination), the outcome of the event was fatal. It was unknown if autopsy was done. The course of the event was as follows: On 20May2021, the patient received the first dose of BNT162b2 vaccination. On 10Jun2021 at 10:00 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. No change in the vital signs and no symptoms of side reactions were observed, and no significant change was observed in the patient''s daily living. On 13Jun2021, at 07:30 (2 days, 21 hours, and 30 minutes after vaccination), the patient was found to collapse. The patient had paralysis of left upper and lower limbs and inarticulateness. The patient also had involuntary movement of right upper limb. The patient was emergently transferred to the general hospital. The patient was diagnoses with cerebral infarction right and was admitted to the hospital. The reporting physician classified the event as serious (death, hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was medical history of cerebral infarction. The reporting physician commented as follows: The factor of the cerebral infarction was as follows: Since the patient had medical history of cerebral infarction and she was an elderly, the event was predestined to happen rather than a side reaction to the vaccination, according to the opinion of the attending physician at the general hospital. However, this time, the family considered that there was a possibility of a side reaction as one of the factors of cerebral infarction, and this case was reported based on the family''s wish.; Reported Cause(s) of Death: Cerebral infarction right


VAERS ID: 1425237 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood pressure measurement, Body temperature, Cardiac arrest, Diarrhoea, Dysphonia, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Respiratory arrest, Vomiting, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cyanosis (since around April); Lung cancer (a one-year prognosis to live was told as of 2019); Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: Blood pressure; Result Unstructured Data: Test Result:82; Comments: at 06:00; Test Date: 20210613; Test Name: Blood pressure; Result Unstructured Data: Test Result:62; Comments: at 09:00; Test Date: 20210613; Test Name: Blood pressure; Result Unstructured Data: Test Result:50; Comments: at 13:00; Test Date: 20210611; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210612; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210612; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Test Date: 20210613; Test Name: SpO2; Test Result: 67 %
CDC Split Type: JPPFIZER INC2021718772

Write-up: Respiratory arrest; Cardiac arrest; Pyrexia of 38.1 degrees centigrade; Passed a large amount of stools watery; Vomited; Wheezing and dyspnoea; Wheezing and dyspnoea; Hoarseness; Abdominal pain; Decreased SpO2; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114669. The patient was an 87-year and 8-month-old male. Body temperature before vaccination was 36.6 degrees centigrade. Medical history included underlying disease of lung cancer (a one-year prognosis to live was told as of 2019), cyanosis in the fingers (since around Apr2021 and ongoing), and able to propel his wheelchair (ongoing). Family history was unremarkable. Concomitant medications were not reported. On 11Jun2021 around 14:10 (the day of vaccination),at the age of 87-year-old the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 12Jun2021 (1 day after the vaccination), the patient experienced abdominal pain at 10:00, hoarseness at 13:00, wheezing and dyspnoea at 14:00, and decreased SpO2 at unknown time, and vomited at 15:00, passed a large amount of stools watery at 20:00, and pyrexia of 38.1 degrees centigrade at 22:00. On 13Jun2021 (2 days after the vaccination), the patient experienced respiratory arrest and cardiac arrest. On 13Jun2021 (2 days after the vaccination), the outcome of the case was unknown. The patient died on 13Jun2021. It was unknown whether autopsy was done. The course of the events was as follows: On 12Jun2021 (1 day after the vaccination), the patient had abdominal pain at 10:00, hoarseness at 13:00, and wheezing and dyspnoea at 14:00. The patient had decreased SpO2 and started to receive oxygen (O2). He vomited at 15:00 and 15:30, passed a large amount of stools watery at 20:00, and had pyrexia of 38.1 degrees centigrade at 22:00. On 13Jun2021 at 06:00 (2 days after the vaccination), the blood pressure was 82, the SpO2 was 67%, and residual gastric fluid was aspirated by suctioning. At 09:00, jaw breathing was noted, and BP was 62. At 13:00, the BP was 50. At 16:24, respiratory arrest and cardiac arrest developed. The reporting physician classified the case as serious (death) and assessed the causality between the case and BNT162b2 as unassessable. Other possible cause(s) of the case such as any other diseases was lung cancer. The reporting physician commented as follows: Although the patient had cyanosis in the fingers since around Apr2021 and was unable to measure SpO2, he was able to propel his wheelchair, ate full meals, and had stable activities of daily living (ADL). Two years had passed since a one-year prognosis to live was told. It could be a sudden change due to the underlying disease, but the relationship could not be denied because the symptoms occurred on the next day of the vaccination.; Reported Cause(s) of Death: lung cancer


VAERS ID: 1425238 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; Diabetes mellitus; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021724684

Write-up: Cardiac death; This is a spontaneous report from a contactable physician received via the Agency. The patient was an 85-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications received within 2 weeks of vaccination was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included after bypass surgery for cardiac disorder, diabetes mellitus, dyslipidaemia, hypertension. On 10Jun2021 at 10:15 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: FA2453, Expiration Date: 31Aug2021) via intramuscular in left arm at age of 85-year-old for COVID-19 immunization. An autopsy was not performed. On 14Jun2021 (3 days, 13 hours, and 45 minutes after the vaccination), the patient experienced cardiac death. The event resulted in death. The outcome of event was fatal without treatment. Since the vaccination, the patient had not been tested for COVID-19. The reported event was as follows: On 14Jun2021 (3 days, 13 hours, and 45 minutes after vaccination), the patient was found dead in face-up position at his home. As a result of investigation of death by the police, the patient was diagnosed with cardiac death. The cerebrospinal fluid was not bloody.; Sender''s Comments: Based on the information currently available and known drug safety profile, the reported event cardiac death more likely represented intercurrent illness, but not related to BNT162B2. The patient''s advanced age has been assessed to provide an alternative explanation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: cardiac death


VAERS ID: 1425241 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-13
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021727119

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. Regulatory authority report number is v21114675. The patient was an 82-year and 0-month-old male. Body temperature before vaccination was not reported. Medical history included hypertension. The patient was independent ADL (activities of daily living). Concomitant medications and family history were not provided. On unspecified date (reported as: 11Jun2021 or 12Jun2021), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose at the age of 82-year-old for COVID-19 immunisation. On 13Jun2021 at around 00:45 (1 or 2 days after the vaccination), the patient developed cardio-respiratory arrest. On 13Jun2021 at 01:38, the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 12Jun2021 at around 21:00, it was confirmed that the patient took a bath. On 13Jun2021 at around 00:45, the patient''s son found him lying in supine position in the bedroom and called an ambulance. When an emergency service team arrived, he was in cardio-respiratory arrest (CPA). On 13Jun2021 at 01:38, the patient''s death was confirmed. The cause of death was cardio-respiratory arrest. The outcome of event was fatal. The reporting pharmacist classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported if there was possible cause of the event. Information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1425243 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Constipation
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VASOLAN [VERAPAMIL HYDROCHLORIDE]; HALFDIGOXIN; MAGMITT; AMLODIPINE; BONALON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Cancer surgery; Gastric cancer; Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021727205

Write-up: Constipation; This is a spontaneous report from a contactable physician via a Company sales representative. The patient was an 85-year-old female. Medical history included post gastric cancer surgery, atrial fibrillation paroxysmal, hypertension, and osteoporosis. Concomitant medications included verapamil hydrochloride (VASOLAN), digoxin (HALFDIGOXIN), magnesium oxide (MAGMITT), amlodipine, alendronate sodium (BONALON). On 15Jun2021 (the day of vaccination), the patient received BNT162B2 (COMIRNATY, solution for injection, Lot number: EY2173, Expiration Date: 31Aug2021) via an unspecified route of administration at single dose at age of 85-year-old for COVID-19 immunization. On 15Jun2021 (on the same day of the vaccination), the patient experienced constipation (onset date was also reported as 16Jun2021). On 15Jun2021 (on the same day of the vaccination), the patient was admitted to the hospital. On 16Jun2021 (1 day after the vaccination), the outcome of event was fatal. The course of the event was as follows: On 15Jun2021, the patient received BNT162B2. On the same day, the patient visited the hospital with a chief complaint of constipation and was hospitalized in department of surgery at the reporting hospital. On 16Jun2021 in the evening, the patient died. The physician commented that causality between the event and the vaccine was not possible to assess; however, the patient died on the following day of the vaccination. The reporting physician classified the event as serious (death, life-threatening, and hospitalization). It was not reported if an autopsy was performed. Cause of death was reported as unknown.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event constipation (fatal) and the suspect drug. 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: Constipation


VAERS ID: 1425245 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Multiple organ dysfunction syndrome, Pneumonia bacterial, Sepsis
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021727292

Write-up: Pneumonia bacterial; Sepsis; Multi-organ failure; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114557. A 65-year and 5-month-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration on 26May2021, at patient age of 65-year-old, as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees Centigrade on 26May2021. The patient''s medical history and family history was not provided. The patient was undergoing artificial dialysis. On 26May2021 (the day of vaccination), the patient received the first dose of BNT162b2. On unknown date in May2021 (unknown days/hours/minutes after the vaccination), the patient experienced pneumonia bacterial, sepsis, multi organ failure. On 26May2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On unknown date in May2021 (unknown days/hours/minutes after the vaccination), the patient experienced pneumonia bacterial, sepsis, multi organ failure. On unknown date in May2021 (unknown days/hours/minutes after the vaccination), the outcome of the event was fatal. On 28May2021 (2 days after vaccination), the reporter found out that the patient died at another hospital as a later date (the patient''s attending physician was at that hospital). The details such as the clinical course were unknown. However, the primary cause of death was multi organ failure, the factor was sepsis, and the cause was pneumonia bacterial according to the death certificate. 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 reporting physician commented as follows: Since the information was obtained from the reporting hospital, the details and the causality between the event and BNT162b2 vaccination were unknown. No particular changes were observed at the time of the medical interview. ; Reported Cause(s) of Death: Multi-organ failure; Sepsis; Pneumonia bacterial; Autopsy-determined Cause(s) of Death: Pneumonia bacterial; Sepsis; Multi-organ failure


VAERS ID: 1425246 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021727426

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician via the Agency. The patient was a 60-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included antihypertensives. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jun2021 at unspecified time (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) intramuscularly in the left arm for COVID-19 immunization (60-year-old at vaccination). On 15Jun2021 (7 days after the vaccination), the patient experienced subarachnoid haemorrhage. The patient died on 15Jun2021. The outcome of the event was fatal. No autopsy was performed. The reporting physician assessed the event as serious (death). The causality of the event was not reported. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the information currently available, the reported event subarachnoid haemorrhage more likely represented intercurrent illness, but not related to BNT162b2.The patient''s underlying risk factors/predisposing condition hypertension has been assessed to provide an alternative explanation. 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: Subarachnoid haemorrhage


VAERS ID: 1425247 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, General physical health deterioration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic hepatitis B; Renal failure chronic; Tuberculosis
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:in 37s Centigrade; Comments: after taking BUFFERIN; Test Date: 20210612; Test Name: Body temperature; Result Unstructured Data: Test Result:in 39s Centigrade
CDC Split Type: JPPFIZER INC2021727541

Write-up: Aggravated general condition; The patient experienced pyrexia in 39s degrees centigrade, which decreased repetitively down to 37s degrees centigrade after orally taking BUFFERIN; This is a spontaneous report from a contactable physician via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 66-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medical history included renal failure chronic, historical condition of tuberculosis (not ongoing), and chronic hepatitis B. Prior to vaccination, the patient was not diagnosed with COVID-19. On 09Jun2021 at unknown time (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscularly at the age of 66-year-old for COVID-19 immunization. On 12Jun2021 (3 days after the vaccination), the patient experienced pyrexia in 39s degrees centigrade, which decreased repetitively down to 37s degrees centigrade after orally taking acetylsalicylic acid/hydrotalcite (BUFFERIN). On 14Jun2021 (5 days after the vaccination), the patient experienced aggravated general condition and was transported by ambulance to a local physician. Outcome of the pyrexia was reported as not resolved. It was unknown what treatment the patient received for aggravated general condition, although treatment was provided. On the same day, the patient died. It was not reported if an autopsy was performed. The reporter stated that the adverse events resulted in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event Aggravated general condition was fatal and other event was not recovered.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: Aggravated general condition


VAERS ID: 1425248 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-19
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021739384

Write-up: Cardiac death; This is a spontaneous report from a contactable physician received via Medical information group. The patient was a 43-year-old female. Medical history and concomitant medications were not reported. On 08Jun2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date not reported) via an unspecified route of administration at the age of 43-year-old as single dose for COVID-19 immunization at a facility different from the reporter''s. On 19Jun2021 at 21:00 (11 days after the vaccination), the patient died of cardiac death. The reporter performed autopsy but no details were provided.The assessment of causality between the events and BNT162b2 and seriousness of the events were not provided. The reported course is as follows; The reporter performed an autopsy for the patient had vaccination history.1st vaccination was administered at another hospital on 08Jun2021. 11th day after vaccination, the patient died of cardiac death (at 21:00 on 19Jun2021). The outcome of event was fatal. Information on the lot/batch number has been requested.; 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 event cardiac death 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: Cardiac death


VAERS ID: 1425255 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-10
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Death, Fatigue, General physical health deterioration, Pyrexia, Unevaluable event
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: High; Test Date: 20210611; Test Name: Body temperature; Result Unstructured Data: Dropped Down; Test Date: 20210611; Test Name: Blood pressure; Result Unstructured Data: Decreased; Test Date: 20210612; Test Name: Blood pressure; Result Unstructured Data: Significantly dropped
CDC Split Type: KRJNJFOC20210630032

Write-up: DEATH; BLOOD PRESSURE DECREASED; OTHER SYMPTOMS; HEALTH DETERIORATED POST VACCINATION; FATIGUE; HIGH FEVER; This spontaneous report received from a consumer concerned a 30 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included blood related disease (as per the family he was cured at the hospital). He lived healthy life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expire; Unknown) dose was not reported, 1 total, administered on 10-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 10-JUN-2021, the patient experienced fatigue, high fever and other symptoms. His health deteriorated rapidly post vaccination. On 11-JUN-2021, the patient experienced blood pressure decreased. On the same day, fever dropped, but his blood pressure continued to drop. On 12-JUN-2021 afternoon, his blood pressure dropped significantly. His family moved him to emergency room. At the hospital, the patient was treated with fluids and painkillers. On 13-JUN-2021, the patient had died at around 03:00. Cause of death was unknown. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 13-JUN-2021, recovered from high fever on 11-JUN-2021, had not recovered from blood pressure decreased, and the outcome of fatigue, other symptoms and health deteriorated post vaccination was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0 20210630032-COVID-19 VACCINE AD26.COV2.S-Death, blood pressure decreased, other symptoms and health deteriorated post vaccination. 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 20210630032-COVID-19 VACCINE AD26.COV2.S-fatigue. This event(s) is labeled and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1425699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Malaise, Pain in extremity, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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: PANTOPRAZOLE; METFORMIN; PERINDOPRIL ERBUMINE; ALLOPURINOL; ATIMOS; CLOPIDOGREL; ATROVENT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm (abdominal aortic aneurysm requiring stent placement in 2001); Cerebrovascular accident; COPD; Hypertension; Prostate cancer (prostate cancer for which watchful waiting); Stent placement (Abdominal aortic aneurysm for which stent placement); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021698729

Write-up: Acute death: acute cardiac death; Going to die, and then almost immediately slumped away; Suddenly didn''t feel well; Painful arm for 1 day on the second day after vaccination; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00573670. A 82-years-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as a single dose COVID-19 immunisation. Medical history included aortic aneurysm from 2001 for which stent placement in 2001, hypertension from an unknown date, diabetes mellitus 2 from an unknown date, prostate cancer from an unknown date for which watchful waiting, cerebrovascular accident from an unknown date, COPD from an unknown date. Concomitant medications included pantoprazole tablet gastro-resistant 40mg taken for an unspecified indication, start and stop date were not reported; metformin tablet 500mg taken for an unspecified indication, start and stop date were not reported; perindopril erbumine tablet 8mg taken for an unspecified indication, start and stop date were not reported; allopurinol tablet 100mg taken for an unspecified indication, start and stop date were not reported; formoterol fumarate (ATIMOS) aerosol 12ug/dose taken for an unspecified indication, start and stop date were not reported; clopidogrel tablet 75mg taken for an unspecified indication, start and stop date were not reported; ipratropium bromide (ATROVENT) aerosol 20ug/dose taken for an unspecified indication, start and stop date were not reported. No past drug therapy with BioNTech/Pfizer vaccine (Comirnaty). No previous COVID-19 infection. On 21May2021 (reported as 2 days after start of vaccine), the patient experienced painful arm for 1 day on the second day after vaccination. On 27May2021 (reported as 7 days after start of vaccine), the patient experienced acute death: acute cardiac death, going to die, and then almost immediately slumped away and suddenly didn''t feel well. Time Interval between drug administration and start of event (Pain in arm): 2 days. It was reported that "the patient suddenly didn''t feel well and called partner that he was going to die, and then almost immediately slumped away, half hour Cardiopulmonary resuscitation (CPR) failed". The patient was treated with resuscitation, which was unsuccessful. The patient died on 27May2021. The outcome of events acute death: acute cardiac death and suddenly didn''t feel well was fatal whereas the outcome of event painful arm for 1 day on the second day after vaccination was recovered on 21May2021. An autopsy was not performed in consultation with family. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Acute death: acute cardiac death; Going to die, and then almost immediately slumped away; Suddenly didn''t feel well


VAERS ID: 1425704 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Arthralgia, Chills, Fatigue, Headache, Hyperpyrexia, Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth, Loss of consciousness, Malaise, Myalgia, Nausea, Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Hyperpyrexia; Result Unstructured Data: Fever 40.5 to 42 degrees Celsius
CDC Split Type: NLJNJFOC20210640609

Write-up: FEVER 40.5 TO 42 DEGREES CELSIUS; COLD CHILLS; INFLAMMATION REACTION AT INJECTION SITE WARMTH PAIN; MUSCLE PAIN; REACTION AT OR AROUND INJECTION SITE WARMTH; REACTION AT OR AROUND INJECTION SITE: HARDENING OCCURRING LATER THAN A WEEK AFTER THE VACCINATION; JOINT PAIN; REACTION AT OR AROUND INJECTION SITE PAIN; HEADACHE; NAUSEA; FEELING UNWELL; FATIGUE; PALPITATIONS; STABS AT HEART; UNCONSCIOUS; FAINTING; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00577791] concerned a 40 year old male. The patient''s weight was 90 kilograms, and height was 189 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, administered on 01-JUN-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-JUN-2021, the patient experienced stabs at heart, fatigue, palpitations, unconscious, feeling unwell, nausea, fainting, headache and was hospitalized (date unspecified). On 02-JUN-2021, the patient experienced reaction at or around injection site warmth, cold chills, inflammation reaction at injection site warmth pain, fever 40.5 to 42 degrees Celsius, muscle pain, reaction at or around injection site: hardening occurring later than a week after the vaccination. joint pain. reaction at or around injection site pain. On 04-JUN-2021, Laboratory data included: Hyperpyrexia (NR: not provided) Fever 40.5 to 42 degrees Celsius On 05-JUN-2021, the patient died from stabs at heart, unconscious, fainting, fever 40.5 to 42 degrees Celsius, palpitations, cold chills, inflammation reaction at injection site warmth pain, fatigue, muscle pain, feeling unwell, reaction at or around injection site warmth, reaction at or around injection site: hardening occurring later than a week after the vaccination, nausea, joint pain, reaction at or around injection site pain, and headache. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of reaction at or around injection site warmth, cold chills, inflammation reaction at injection site warmth pain, stabs at heart, fever 40.5 to 42 degrees Celsius, fatigue, palpitations, unconscious, muscle pain, feeling unwell, reaction at or around injection site: hardening occurring later than a week after the vaccination, nausea, joint pain, fainting, reaction at or around injection site pain and headache on 05-JUN-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210640609-covid-19 vaccine ad26.cov2.s-reaction at or around injection site warmth, cold chills, inflammation reaction at injection site warmth pain, stabs at heart, fever 40.5 to 42 degrees Celsius, fatigue, palpitations, unconscious, muscle pain, feeling unwell, reaction at or around injection site: hardening occurring later than a week after the vaccination, nausea, joint pain, fainting, reaction at or around injection site pain and headache. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: STABS AT HEART; UNCONSCIOUS; FAINTING; FEVER 40.5 TO 42 DEGREES CELSIUS; PALPITATIONS; COLD CHILLS; INFLAMMATION REACTION AT INJECTION SITE WARMTH PAIN; FATIGUE; MUSCLE PAIN; FEELING UNWELL; REACTION AT OR AROUND INJECTION SITE WARMTH; REACTION AT OR


VAERS ID: 1425708 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Living in nursing home
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021751262

Write-up: Patient is 2nd resident in our nursing home who died of covid19, despite vaccine; Patient is 2nd resident in our nursing home who died of covid19, despite vaccine; This is a spontaneous report from a contactable physician. This is the third of three reports. The first report is a report downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00537347. A elderly female patient received BNT162B2 (COMIRNATY, Solution for injection, 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 included living in residential institution from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported that, the patient was 2nd resident in nursing home who died of covid19, despite vaccine on an unspecified date. The patient died due to covid19 on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021553987 2 patients from the same nursing home, both died; Reported Cause(s) of Death: COVID-19


VAERS ID: 1425711 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002336 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: NOMODERNATX, INC.MOD20212

Write-up: SUDDEN DEATH; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (SUDDEN DEATH) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002336) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-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) (Intramuscular) 1 dosage form. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered SUDDEN DEATH (SUDDEN DEATH) to be possibly related. No concomitant product use was provided. No treatment information was reported. This is a case of sudden death in a 64-year old male subject, who died 6 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 64-year old male subject, who died 6 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


Result pages: prev   30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=129&PERPAGE=100&VAX=COVID19&VAXTYPES=COVID-19&DIED=Yes

Government Disclaimer on use of this data


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