National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

From the 11/26/2021 release of VAERS data:

Found 19,532 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

This is page 125 out of 196

Result pages: prev   26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196   next


VAERS ID: 1304021 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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: RAMIPRIL
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491315

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100050361. A 65-year-old male patient received BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EW8904), via an unspecified route of administration on 15Apr2021 at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history included ongoing hypertension. Concomitant medication included ramipril taken for an unspecified indication, start and stop date were not reported. The patient experienced acute myocardial infarction on 16Apr2021 with fatal outcome. The patient died on 16Apr2021. It was not reported if an autopsy was performed. This report is serious - death (as reported). Causal relationship between the adverse event(s) and the administration of Comirnaty was assessed as "inconsistent causal association to immunization" by the Regulatory Authority. No follow-up attempts are needed/possible, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1304022 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Atrial fibrillation, Cardiogenic shock, Haematochezia, Hyponatraemia, Hypotension, Myocarditis, Normocytic anaemia, Pericardial effusion, Septic shock, Transaminases increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal haemorrhage (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 45
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021496575

Write-up: Tachyarrhythmia absoluta; Acute hypotension; Anaemia normocytic; Bloody stool; Acute renal failure; Hyponatraemia; Septic shock; Cardiogenic shock; Perimyocarditis; Transaminases increased; Effusion pericardial; This is a spontaneous report from a physician downloaded from the regulatory authority. Regulatory Authority Number is DE-PEI-202100050709. This report was serious due to death. An 83-year-old female patient received BNT162B2 (COMIRNATY, lot number EP9598) at 03.3 ml single dose on 08Mar2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. On 12Mar2021 the patient experienced bloody stool, tachyarrhythmia absoluta, acute hypotension, transaminases increased, anaemia normocytic, hyponatraemia, perimyocarditis, effusion pericardial, septic shock, cardiogenic shock, acute renal failure. Patient dies on 27Apr2021. Outcome of the events was fatal. Autopsy was performed, no results available. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Tachyarrhythmia absoluta; bloody stool; acute hypotension; transaminases increased; anaemia normocytic; hyponatraemia; perimyocarditis; effusion pericardial; acute renal failure; Septic shock; Cardiogenic shock


VAERS ID: 1304026 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021501420

Write-up: breast pain; Chest pain; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is [DE-PEI-CADR2021059564] and Safety Report Unique Identifier [DE-PEI-202100051076]. A 101-year-old male patient received BNT162B2 (COMIRNATY) via unspecified route unknown single for COVID-19 immunization on 27Mar2021. The patient''s medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced breast pain and chest pain, 2 days hospital stay, then discharge on 06Apr2021. On 07Apr2021 the patient experienced unknown cause of death, suddenly deceased on 07Apr2021. Cause of death and other details was unknown, it is unknown if an autopsy was done. The patient''s outcome of the events breast pain and chest pain was not resolved, for unknown cause of death was fatal. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses: No previous illnesses, no medication / chest pain, 2 days hospital stay, then discharge, discharge on 06Apr2021, suddenly deceased on 07Apr2021. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1304028 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker wearer (Pacemaker); Dialysis; Vascular shunt (Shunt in hydrocephalus)
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (4 months ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021467505

Write-up: Pneumonia; This is a spontaneous report from a non-contactable consumer. This is the second of two reports. The first report is a report downloaded from the Agency Regulatory Authority-WEB DE-PEI-CADR2021051718. This consumer reported events for two separate vaccine doses. This is the report reporting events related to the first dose of the vaccine. A 70-years-old male patient received bnt162b2 (COMIRNATY, Strength: 0.3mL), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing dialysis, ongoing Shunt in hydrocephalus, ongoing Pacemaker, Stroke 4 months before. The patient''s concomitant medications were not reported. The patient was landed in hospital with pneumonia in 2 days on 19Mar2021 with no fever, then discharged. The outcome of the event pneumonia was recovered on an unknown date. Sender comments: The person did not concern any allergies. Information on risk factors or previous illnesses: dialysis, Pacemaker. Shunt in hydrocephalus. Stroke 4 months ago / My father, care level 5, dialysis patient, received the first vaccination on March 17th. Landed in hospital with pneumonia in 2 days with no fever, then discharged. And on April 14th. he got the second vaccination, no fever, no complaints, died after 4 days. The emergency doctor could not determine the cause of death. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1304040 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-08
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 28
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary heart disease; Skin cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021507619

Write-up: stroke; This is a spontaneous report from a contactable consumer. A 89-years-old patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Feb2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included coronary artery disease, skin cancer. The patient''s concomitant medications were not reported. The patient experienced stroke on 08Mar2021. Event reported as serious with death, hospitalization, disability, life threatening. The patient died on 06Apr2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Lot/batch number has been requested.; Reported Cause(s) of Death: stroke


VAERS ID: 1304048 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATIN "KRKA"; ALLOPURINOL; TOSTRAN; ANCOZAN
Current Illness: Atrial fibrillation; Dyspnoea; Shooting pain
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (No alcohol in a year.); COVID-19; Comments: The dyspnoea was recovering around christmas, but then worsening.
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Blood test; Result Unstructured Data: normal; Test Date: 20210409; Test Name: C-reactive protein; Result Unstructured Data: 18; Test Date: 20210409; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: Sinus tachycardia. Incomplete left sided bundle branch block. Suspected left sided ventricular hypertrophy with repolarising changes in all leads.; Test Date: 20210409; Test Name: Hemoglobin; Result Unstructured Data: 7.9 (slight hypohaemoglobinaemia and units not specified); Test Date: 20210409; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 117 heart beats per minute; Test Date: 20210409; Test Name: Blood neutrophils; Result Unstructured Data: 7.5 (slightly increased) Units not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: death 1.5 days after vaccination.; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death 1.5 days after vaccination.) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. The dyspnoea was recovering around christmas, but then worsening. The patient''s past medical history included COVID-19 in November 2020 and Alcohol abuse (No alcohol in a year.) in 2020. Concurrent medical conditions included Dyspnoea since November 2020, Shooting pain since December 2020 and Atrial fibrillation. Concomitant products included Simvastatin from 17-Dec-2019 to an unknown date for Blood cholesterol increased, LOSARTAN POTASSIUM from 07-Jan-2015 to an unknown date for Blood pressure high, ALLOPURINOL from 01-Feb-2013 to an unknown date for Gout, TESTOSTERONE (TOSTRAN) from 06-Mar-2019 to an unknown date for Testosterone low. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 10-Apr-2021 The patient died on 10-Apr-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood test: normal (normal) normal. On 09-Apr-2021, C-reactive protein: 18 (High) 18. On 09-Apr-2021, Electrocardiogram: sinus tachycardia. incomplete left sided bundle br (Inconclusive) Sinus tachycardia. Incomplete left sided bundle branch block. Suspected left sided ventricular hypertrophy with repolarising changes in all leads.. On 09-Apr-2021, Haemoglobin: 7.9 (abnormal) 7.9 (slight hypohaemoglobinaemia and units not specified). On 09-Apr-2021, Heart rate: 117 (Inconclusive) 117 heart beats per minute. On 09-Apr-2021, Neutrophil count: 7.5 (High) 7.5 (slightly increased) Units not specified. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Senders comments confirmed date of death confirmed and lab data updated.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1304049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Encephalitis, Epilepsy, Meningitis, Seizure
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 65
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: CLOPIDOGREL; CITALOPRAM; XARELTO
Current Illness: Chronic obstructive airways disease; Overweight; Smoker; Wheelchair user
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021496680

Write-up: meningitis; encephalitis; seizures; epileptic seizures; cerebral hemorrhage with consequences that resulted in death; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority. A 73-years-old female patient received BNT162B2 (COMIRNATY), dose 1, via an unspecified route of administration on 26Jan2021 (Batch/Lot Number: EJ6134; Expiration Date: 30Apr2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing wheelchair user, ongoing Smoker, cerebral thrombosis from 2006 to an unknown date, ongoing Chronic obstructive airways disease, ongoing overweight. Concomitant medication(s) included clopidogrel taken for thrombosis prophylaxis from 13Oct2015; citalopram taken for depression from 01Jan2008; rivaroxaban (XARELTO) taken for thrombosis prophylaxis from 17Sep2015. The patient experienced cerebral hemorrhage with consequences that resulted in death (death, hospitalization) on 04Feb2021. As a consequence of Cerebral hemorrhage the patient experienced meningitis, encephalitis and after 2 months of treatment increasing seizures and epileptic seizures. The patient is operated and gets a bleeding again the next day with and is operated a second time. Treatment was discontinued and the patient dies on 11Apr2021. An autopsy was not performed. There is no information regarding test results. The outcome of the events was Fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: meningitis; encephalitis; seizures; epileptic seizures; Cerebral hemorrhage


VAERS ID: 1304077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-01-21
Onset:2021-04-22
   Days after vaccination:457
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatinine, Blood glucose, Blood glucose increased, Blood lactic acid, Blood potassium, Blood pressure increased, Blood pressure measurement, Blood sodium, Body temperature, Cerebral haemorrhage, Chest X-ray, Coma scale, Coma scale abnormal, Computerised tomogram, Eosinophil count, Haematocrit, Haemoglobin, Heart rate, International normalised ratio, International normalised ratio increased, Loss of consciousness, Lymphocyte count, Mean cell volume, Monocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Platelet count decreased, Pneumonia aspiration, Prothrombin level, Prothrombin level increased, Red blood cell analysis, SARS-CoV-2 test, Scan brain, Vomiting, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified (Hypertension excluded); Iron deficiency; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: HCO3; Result Unstructured Data: Test Result:26.9; Test Name: Creatinine; Test Result: 0.7 mg/dl; Test Name: Glucose; Test Result: 260 mg/dl; Test Date: 20210422; Test Name: Glucose; Test Result: 240 mg/dl; Test Name: Lactate ion; Result Unstructured Data: Test Result:2.4; Test Name: K; Result Unstructured Data: Test Result:4.0 mEq/l; Test Name: Blood pressure; Result Unstructured Data: Test Result:187/97 mmHg; Test Name: Sodium; Result Unstructured Data: Test Result:139 mEq/l; Test Name: temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Name: Chest Rx; Result Unstructured Data: Test Result:possible bronchoaspiration; Test Date: 20210422; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:No signs of acute cardiopulmonary decompensation.; Comments: In both lung bases, some ill-defined millimeter nodular images are identified that in the context could be secondary to occupation of a small airway by bronchoaspiration. No signs of acute cardiopulmonary decompensation.; Test Date: 20210422; Test Name: glasgow; Result Unstructured Data: Test Result:4; Test Name: CT; Result Unstructured Data: Test Result:massive intraventricular hemorrhage; Test Name: Eosinophils; Test Result: 0.1 %; Test Name: Hematocrit; Test Result: 41.6 %; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.1 g/dl; Test Name: Heart rate; Result Unstructured Data: Test Result:79; Comments: bpm; Test Date: 20210422; Test Name: INR; Result Unstructured Data: Test Result:3.8; Test Date: 20210422; Test Name: Lymphocytes; Test Result: 8.2 %; Test Name: MCV; Result Unstructured Data: Test Result:94.5; Comments: fL; Test Name: Monocytes; Test Result: 3.0 %; Test Name: Neutrophils; Test Result: 88.5 %; Test Name: Sat O2; Test Result: 95 %; Test Name: SatO2; Result Unstructured Data: Test Result:41.6; Test Name: pCO2; Result Unstructured Data: Test Result:51.0; Test Name: pH; Result Unstructured Data: Test Result:7.345; Test Name: Platelets; Result Unstructured Data: Test Result:133.0; Comments: 10e3 / uL; Test Date: 2018; Test Name: Platelets; Result Unstructured Data: Test Result:133.0; Comments: 10e3 / uL; Test Date: 2020; Test Name: Platelets; Result Unstructured Data: Test Result:150.0; Comments: 10e3 / uL; Test Date: 20210422; Test Name: Low platelets; Result Unstructured Data: Test Result:133000; Comments: Units:/uL; Test Name: PO2; Result Unstructured Data: Test Result:26.0; Test Name: Prothrombin Activity; Result Unstructured Data: Test Result:18.0; Test Name: Red blood cells; Result Unstructured Data: Test Result:4.4; Comments: 10e3 / uL; Test Date: 20210422; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210422; Test Name: Scan brain; Result Unstructured Data: Test Result:Extensive hemoventricle with hydrocephalus; Comments: Extensive hem ventricle with hydrocephalus and transependymal transudation; Test Name: Leukocytes; Result Unstructured Data: Test Result:9.4; Comments: 9.4 10e3 / uL
CDC Split Type: ESPFIZER INC2021491305

Write-up: Haemorrhage intracerebral; Unconscious; vomiting; possible broncho aspiration; Blood pressure was 187/97 mmHg; Glasgow 4.; Glucose: 260 mg / dL; INR(international normalized ratio): 3.8; Prothrombin Activity: 18.0; Low platelets: 133000/uL; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-842453. A 83-years-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: EW4815) as single dose for COVID-19 immunisation; acenocoumarol (SINTROM), oral from 21Jan2020 (Batch/Lot number was not reported) to an unspecified date, at 4 mg for atrial fibrillation. Medical history included PD of iron deficiency and type II diabetes mellitus September 2020. Reasons for the patient''s vaccination was Over 65 years of age, Cardiovascular disease (excluding HT(Hypertension)). Concomitant medication(s) included bisoprolol (BISOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient has Chronic treatment with Bisoprolol 2.5 1/2-0-0, Sintrom 4mg according to calendar. The patient previously received first dose of COMIRNATY (Lot number: ET7205) on 29Mar2021 for COVID-19 immunisation. On 22Apr2021, Patient who lived alone and had been found by a relative on the floor of her home with traces of vomiting around. BP(Blood pressure): 187/97 mmHg; Temperature 36.3 C; HR 79 bpm; Sat. O2 (%) 95; Unconscious. Glasgow 4. Summary of additional tests: Biochemistry Emergencies: Glucose: 260 mg / dL, Creatinine: 0.7 mg / dL, Sodium: 139 mEq / L, K+(Potassium): 4.0 mEq / L. Emergency blood count: Hemoglobin: 14.1 g / dL, Hematocrit: 41.6%, MCV(Mean corpuscular volume): 94.5 fL, Red blood cells: 4.4 10e3 / uL, Platelets: 133.0 10e3 / uL, Leukocytes: 9.4 10e3 / uL, Neutrophils: 88.5%, Lymphocytes: 8.2% , Monocytes: 3.0%, Eosinophils: 0.1%. Coagulation Emergencies: INR(international normalized ratio): 3.8, Prothrombin Activity: 18.0. Venous blood gases: pH: 7.345, pCO2(partial pressure of carbon dioxide): 51.0, PO2(partial pressure of oxygen): 26.0, HCO3(Bicarbonate): 26.9, SatO2(Oxygen saturation): 41.6, Lactate ion: 2.4, Image: CT(computed tomography) scan: massive intraventricular hemorrhage. Chest Rx(X/Ray): possible bronchoaspiration. Applied treatment: vitamin K. In analysis of 2018 platelets of 133.0 10e3 / uL and in 2020 150.010e3 / uL. In analysis of 2018, platelets of 133.0 10e3 / uL and in 2020, 150.010e3 / uL. On 22Apr2021, the patient had Glucose 240mg/dl, Thorax X-ray: In both lung bases, some ill-defined millimeter nodular images are identified that in the context could be secondary to occupation of a small airway by bronchoaspiration. No signs of acute cardiopulmonary decompensation, INR:3.8, lymphocytes: 8.2%, Low platelets: 133000/uL, COVID-19 PCR test was negative, Scan brain: Extensive hemoventricle with hydrocephalus and transependymal transudation. On an unknown date in 2021, the patient died. It is unknown if autopsy was done. No follow-up attempts are possible. No further information expected. Information about batch number already obtained.; 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. 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: Blood pressure was 187/97 mmHg; vomiting; Unconscious; Haemorrhage intracerebral; possible broncho aspiration; Glucose: 260 mg / dL; Glucose: 260 mg / dL; INR(international normalized ratio): 3.8; Prothrombin Activity: 18.0; Low platelets: 133000/uL


VAERS ID: 1304080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Atrial fibrillation, Body temperature, Cardiac failure congestive, Cholangitis, Complications of transplanted kidney, Confusional state, Dyspnoea, Jaundice, Malaise, Multiple organ dysfunction syndrome, Ocular icterus, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Physical examination, Pulmonary oedema, Pyrexia, Respiratory failure, SARS-CoV-2 test, Sepsis
SMQs:, Cardiac failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Infectious biliary disorders (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conjunctival disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 9
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: Ankylosing spondylitis (on treatment with adalimumab); Chronic kidney disease; Cognitive impairment (oriented as dementia); Dementia; Ex-smoker; Hypertension; Hypertensive retinopathy (grade II-III); Hyperuricemia; Kidney failure; Kidney graft dysfunction (requiring hemodialysis); Kidney transplant (Cadaveric donor kidney transplant with suboptimal graft function and kidney failure.); Major depression (with ideas of autolysis); Physical impairment (oriented as dementia)
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: low-grade fever; Test Date: 20210315; Test Name: saturation; Test Result: 86 %; Test Date: 20210315; Test Name: palpation; Result Unstructured Data: Test Result:with crackles at the bases and a distended and tym; Comments: with crackles at the bases and a distended and tympanic abdomen that was not painful; Test Date: 20210209; Test Name: Ag SARS.CoV2 test; Test Result: Negative ; Test Date: 20210324; Test Name: SARS.CoV2 PCR; Test Result: Negative
CDC Split Type: ESPFIZER INC2021491362

Write-up: sepsis due to probable cholangitis; sepsis due to probable cholangitis; decompensated congestive heart failure (CHF); atrial fibrillation with rapid ventricular response; hyperactive confusional syndrome; multiple organ failure; Acute pulmonary oedema/acute lung edema with respiratory failure; Acute pulmonary oedema/acute lung edema with respiratory failure; deterioration in graft function/Cadaveric donor kidney transplant with suboptimal graft function; saturation of 86%; dyspnea; conjunctival jaundice; distended and tympanic abdomen; mild skin jaundice; malaise; edema in both LES (lower extremities); low-grade fever (37.5C); This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-845123. A 67-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), on 20Feb2021 (Lot: EM0477) as 1 st dose, single and on 13Mar2021 (Lot: ER7812) as 2 nd dose, 0.3 mL, single; both intramuscular for covid-19 immunisation. Medical history included hypertension; hypertensive retinopathy (grade II-III); ankylopoietic spondylitis (on treatment with adalimumab); hyperuricemia; major depression (with ideas of autolysis); former smoker; chronic kidney disease in 2004; kidney transplant (Cadaveric donor kidney transplant with suboptimal graft function and kidney failure.) on 27Nov2018; cognitive and functional impairment (oriented as dementia); dementia; kidney failure and suboptimal graft function (requiring hemodialysis). No known allergies. The patient''s concomitant medications were not reported. The patient previously took bleomycin, dacarbazine, doxorubicin hydrochloride, vinblastine sulfate (ABVD) and experienced dependent (institutionalized). Rapid Ag SARS.CoV2 test on 09Feb2021 was negative. On 15Mar2021 (two days after receiving the second dose), she presented conjunctival jaundice and mild skin jaundice, malaise, dyspnea, and edema in both lower extremities (LES). At 24 hours (on 15Mar2021), he presented a low-grade fever (37.5C), increased dyspnea, circulation and saturation of 86%, with crackles at the bases and a distended and tympanic abdomen that was not painful on palpation. He was admitted with sepsis due to probable cholangitis, which triggered decompensated congestive heart failure (CHF) refractory to diuretic treatment and acute lung edema with respiratory failure. He also presented deterioration in graft function, requiring hemodialysis, atrial fibrillation with rapid ventricular response, and hyperactive confusional syndrome. SARS.CoV2 PCR 24Mar2021 was negative. Despite the treatment instituted, no clinical or analytical improvement was observed, triggering multiple organ failure. The outcome of the event dyspnoea was not recovered while for sepsis, cholangitis, cardiac failure congestive, atrial fibrillation, confusional state, ocular icterus, jaundice, malaise, oedema peripheral, pyrexia, oxygen saturation decreased and abdominal distention was unknown. Given the baseline situation of the patient, comfort measures were prioritized, with death on 24Mar2021. The patient died due multiple organ failure and acute pulmonary oedema/acute lung edema with respiratory failure on 24Mar2021. It was unknown if an autopsy was performed. Main Diagnosis was acute respiratory failure due to acute pulmonary edema. Other diagnostics decompensated heart failure refractory to diuretic treatment; Sepsis due to probable acute obstructive cholangitis; deterioration of kidney graft function; atrial fibrillation with rapid ventricular response; Hyperactive confusional syndrome and cognitive impairment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute pulmonary oedema/acute lung edema with respiratory failure; Acute pulmonary oedema/acute lung edema with respiratory failure; Multiple organ failure


VAERS ID: 1304083 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Electroencephalogram, Oxygen saturation, SARS-CoV-2 test, Scan brain, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL; CALCIUM CARBONATE AND VITAMIN D; ACETYLSALICYLIC ACID; AMLODIPINE; SODIUM VALPROATE; PROLIA; TRAZODONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment (Mild); Disorientation; Dysarthria; Facial droop (Right hemiparesis from childhood due to Infantile Paralysis); Hospitalization (due to dysarthria and disorientation, with a diagnosis of isovolemic hypotonic hyponatremia); Hypertension arterial; Hyponatremia; Inappropriate ADH secretion (uncertain etiology); Pain loin; Paraphasia; UTI (due to multisensitive E. Coli.); Ventricular bigeminy
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: EEG; Result Unstructured Data: Test Result:Focal status epilepticus; Test Date: 20210420; Test Name: SatO2; Test Result: 87 %; Test Date: 20210420; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Date: 20210420; Test Name: Scan brain; Result Unstructured Data: Test Result:Residual areas of left frontoparietal encephalomal; Comments: Residual areas of left frontoparietal encephalomalacia. No signs of acute intracranial pathology
CDC Split Type: ESPFIZER INC2021496694

Write-up: Status epilepticus; SARS-COV2 PCR: Positive; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is ES-AEMPS-846623. A 79-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot: EW2246), intramuscularly on 10Apr2021 at 0.3 mL single for COVID-19 immunisation. Medical history included arterial hypertension, pain loin, ventricular bigeminy, facial droop (right hemiparesis from childhood due to infantile paralysis), and mild cognitive impairment. She was admitted from 01Apr2021 to 09Apr2021 due to dysarthria and disorientation, with a diagnosis of isovolemic hypotonic hyponatremia, SIAD (syndrome of inappropriate antidiuretic hormone secretion) (uncertain etiology), and UTI (urinary tract infection) due to multisensitive E. Coli. Concomitant medications included omeprazole, calcium carbonate/colecalciferol (CALCIUM CARBONATE AND VITAMIN D), acetylsalicylic acid 100 mg, amlodipine, sodium valproate, denosumab (PROLIA), and trazodone. On 16Apr2021 she went to the Emergency Service of a hospital due to paraphasia and disorientation, starting treatment with valproic and was discharged. On 20Apr2021, she was admitted due to a non-convulsive status, with progressive onset in recent weeks despite treatment with valproic acid ((poor compliance). No evidence of epilepsy until Apr2021, but there were episodes of similar characteristics on admission in 2020 Therefore, it does not seem like status epilepticus in the context of any acute trigger, but rather a serious epileptic decompensation within an infectious occurrence such as covid19. Previous etiological study without significant alterations, although the patient suffered from infantile cerebral palsy and had mild-moderate cognitive impairment. Diagnostics: Complex focal epileptic status, in a patient with residual brain injury that might be the etiology of the seizure, the injury was old and had decompensated 10 days after vaccination. Severe bilateral pneumonia from COVID19. Lab data on 20Apr2021 included: CT (computed tomography): No signs of acute intracranial pathology. Residual areas of left frontoparietal encephalomalacia; SARS-COV2 PCR: Positive; EEG (electroencephalogram) on admission: Focal status epilepticus; The main novelty was a respiratory worsening, with work of breathing and SatO2(Oxygen saturation) 87% with GN at 6lp. At the respiratory level: Bilateral pneumonia due to severe covid19, requiring oxygen therapy with GN at 5 bpm. COURSE: No improvement despite pharmacological adjustment after 24h. The patient died on 23Apr2021. No autopsy was done. Assessment of causality (SEFV): The patient had severe bilateral Covid-19 pneumonia. Status epilepsy had been described in positive CoVID-19 patients, so there was an alternative causal explanation to the vaccine that could explain the condition. Outcome of event SARS-COV2 PCR: Positive was unknown. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Status epilepticus


VAERS ID: 1304085 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-10
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal wall haematoma, Cardio-respiratory arrest, Post-traumatic stress disorder, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021496501

Write-up: bilateral PTE (Pulmonar thromboembolism); sudden cardiorespiratory arrest due to PTSD (Post-traumatic stress disorder); PTSD (Post-traumatic stress disorder); serious hemorrhagic complication (hematoma of the abdominal wall); This is a spontaneous report received from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-847195. An 89-year-old female patient received bnt162b2 (COMIRNATY) dose 1 via unknown route of administration on 31Mar2021 (Lot Number: EW2239) as 0.3 mL, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Apr2021, patient without risk factors for thrombophilia was admitted for bilateral PTE (pulmonar thromboembolism) 10 days after Covid19 COMIRNATY vaccine without another trigger. Subsequently. On 14Apr2021, the anticoagulant was discontinued due to a serious hemorrhagic complication (hematoma of the abdominal wall) that required embolization. On 15Apr2021 she experienced sudden cardiorespiratory arrest due to PTSD (Post-traumatic stress disorder), with death on 16Apr2021. Cause of death was reported as pulmonar thromboembolism. The outcome of event Pulmonar thromboembolism was fatal and other events was unknown. It is unknown if autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonar thromboembolism


VAERS ID: 1304250 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic shock, Dyspnoea, Hypoxia, Tryptase
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MASDIL; EUCREAS; TORASEMID; SEGURIL; PRAVASTATINA [PRAVASTATIN]; ELIQUIS; DIOVAN
Current Illness: Atrial fibrillation; Chronic kidney disease; Hypertension; Hypertrophic cardiomyopathy; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: Blood tryptase; Result Unstructured Data: 30.8 microgram per litre; Test Date: 20210410; Test Name: Blood tryptase; Result Unstructured Data: 33.5 microgram per litre
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: Anaphylactic shock; Hypoxia; Dyspnea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), HYPOXIA (Hypoxia) and DYSPNOEA (Dyspnea) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. The patient''s past medical history included Cardiovascular disease, unspecified Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Chronic kidney disease , Atrial fibrillation and Hypertrophic cardiomyopathy. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, METFORMIN HYDROCHLORIDE, VILDAGLIPTIN (EUCREAS) for Diabetes mellitus, VALSARTAN (DIOVAN) for Hypertension, DILTIAZEM HYDROCHLORIDE (MASDIL), TORASEMIDE (TORASEMID), FUROSEMIDE (SEGURIL) and PRAVASTATINA [PRAVASTATIN] for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death and hospitalization), HYPOXIA (Hypoxia) (seriousness criteria death and hospitalization) and DYSPNOEA (Dyspnea) (seriousness criteria death and hospitalization). The patient died on 11-Apr-2021. The reported cause of death was Anaphylactic shock, Dyspnea and Hypoxia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Tryptase: 30.8 microgram per litre abnormal. On 10-Apr-2021, Tryptase: 33.5 microgram per litre abnormal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.; Reported Cause(s) of Death: Anaphylactic shock; Dyspnea; Hypoxia


VAERS ID: 1304251 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 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? Yes
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve calcification; Arterial bypass operation; Bladder cancer; Chronic lymphoid leukaemia; Ischaemic cardiomyopathy; Peripheral arterial occlusive disease; Prostatitis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Sudden death unexplained; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (Sudden death unexplained) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. The patient''s past medical history included Bladder cancer, Aortic valve calcification, Arterial bypass operation, Prostatitis, Chronic lymphoid leukaemia, Peripheral arterial occlusive disease, Type 2 diabetes mellitus and Ischaemic cardiomyopathy. On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with the mRNA-1273 was not applicable. Company Comment: Very limited information regarding the event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1304282 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood pressure measurement, Death, Heart rate, Malaise, Oxygen saturation, Oxygen saturation decreased, Pallor, Respiratory distress, Restlessness, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; ABASAGLAR; ESOMEPRAZOLE; BISOCE; KARDEGIC; CORN STARCH; ANHYDROUS CALCIUM SULFATE; MICROCRYSTALLINE CELLULOSE; CROSPOVIDONE; DIMETICONE; TITANIUM DIOXIDE; HYPROMELLOSE; MACROGOL 400; MAGNESIUM STEARATE; ACETYLSALICYLATE LYSINE;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Carotid artery atheroma; COVID-19 (requiring up to 5L of O2, corticosteroids and antibiotics.); Diabetes (on insuline); Mixed dementia; Osteoporosis; Tachyarrhythmia
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: blood pressure; Result Unstructured Data: Test Result:130/60 mmHg; Test Date: 20210410; Test Name: blood pressure; Result Unstructured Data: Test Result:130/80 mmHg; Test Date: 20210409; Test Name: heart rate; Result Unstructured Data: Test Result:60 bpm; Test Date: 20210409; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 20210410; Test Name: oxygen saturation; Test Result: 90 %; Comments: 6 am; Test Date: 20210410; Test Name: oxygen saturation; Test Result: 94 %; Comments: 6.15 am; Test Date: 20210410; Test Name: oxygen saturation; Test Result: 85 %; Comments: 6:30 am
CDC Split Type: FRPFIZER INC2021496576

Write-up: Death unexplained; Extreme pallor; restlessness; respiratory distress; did not feel well; vomit; back pain; SatO2 90%; This is as spontaneous report received from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-ST20211683, Safety report unique identifier FR-AFSSAPS-2021044459. An 87-year-old female patient received bnt162b2 (COMIRNATY) dose 2 intramuscular on 09Apr2021 (Lot Number: ET7205) as 0.3 mL, single for covid-19 vaccination. Medical history included diabetes on insulin, covid-19 from Nov2020 to Dec2020 requiring up to 5L of O2, corticosteroids and antibiotics (Symptoms congestion and fatigue lasting about 1 month), complete tachy-arrhythmia by atrial fibrillation arrhythmia, osteoporosis, carotid artery atheroma without stenosis, severe mixed dementia from 2014 (cognitive disorders ++ with score <10/30), mitral valve heart disease. Patient living in residential care for dependent elderly people. GIR 1. Concomitant medications included levothyroxine sodium (LEVOTHYROX), croscarmellose sodium; gelatin (mammal/beef); insulin glargine (ABASAGLAR, bacteria/escherichia coli); esomeprazole; bisoprolol fumarate (BISOCE); acetylsalicylate lysine (KARDEGIC 75 mg), zea mays seed (CORN STARCH), pregelatinized corn starch; anhydrous calcium (hydrogenphosphate); microcrystalline cellulose; crospovidone; dimeticone 100; titanium dioxide; yellow iron oxide; red iron oxide; hypromellose; macrogol 400; anhydrous colloidal silica; magnesium stearate; talc), powder for oral solution in a sachet-dose (dl-lysine (acetylsalicylate); acetylsalicylic acid; ammonium glycyrrhizinate; aroma/fragrance; glycine), lactose monohydrate. The patient previously received first dose of COMIRNATY without events. On 10Apr2021 06:50 am, the patient experienced unexplained death. Constants before vaccination: blood pressure 130/60 mmHg; 60 bpm; SatO2 98%; afebrile. At 7 pm constants normal; afebrile. The day after the vaccination at 10Apr2021 6 am, the patient did not feel well, described an urge to vomit and back pain, blood pressure 130/80 mmHg; SatO2 90%. She was put under 1 L of O2 and seated in bed. At 6.15 am: SatO2 94% under 1L of O2. At 6:30 am: SatO2 85%. Extreme pallor, restlessness, back pain and respiratory distress. Call for urgent medical aid. Death at 10Apr2021 6:50 am. Possible causes of death mentioned by the geriatrician included acute pulmonary embolism, myocardial infarction, ruptured aneurysm. The outcome of event unexplained death was fatal; other events was unknown. No autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1304539 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-10
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID
Current Illness: Myocardial infarction; Stenosis aortic valve
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021480833

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is HU-OGYI-228821. An 86-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EP2166), intramuscular in the left arm on 19Mar2021 as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing myocardial infarction and ongoing aortic valve stenosis from unknown dates. Concomitant medication included acetylsalicylic acid (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient experienced death on 10Apr2021. The patient died on 10Apr2021. An autopsy was performed and results were not provided. An autopsy was performed and results were not provided. In the opinion of the patients physician, the death was not related to the vaccination. Sender Comment: The patient died 22 days after vaccination. Death is not expected adverse event of COMIRNATY. It might be related to the patient''s chronic cardiovascular diseases. Based on the above, and in lack of detailed medical information, relationship between death and COMIRNATY is not assessable. The case is serious because the patient died. No further information is expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1304540 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: Chemotherapy; Drug therapy; Hypertension; Lymphoma (in terminal stage; she was under palliative chemotherapy treatment and biological therapy.); Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021480834

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (HU-OGYI-229721). A 67-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly in the left upper arm, on 19Mar2021 at 14:00 as 0.3 mL, single for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing obesity, and ongoing lymphoma (in terminal stage; she was under palliative chemotherapy treatment and biological therapy), ongoing palliative chemotherapy, and ongoing biological therapy. The patient''s concomitant medications were not reported. The patient experienced death on 11Apr2021, which was reported as fatal. The patient died at home on 11Apr2021. The cause of death was reported as unknown. An autopsy was not performed. It was reported that the physician does not suppose relationship of the event with the vaccination. Sender''s Comment: Death is not expected adverse event of COMIRNATY. It might be resulted by the patient''s terminal cancer. Time-to-onset (TTO) was 23 days. Based on the above, relationship between death and COMIRNATY is not related. The case is serious because the patient died. No further information is expected. No further information is expected; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the current available information, the event death is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The event might be resulted by the patient''s terminal cancer.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1304541 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Deep vein thrombosis, Inflammatory marker test, Laboratory test, Pneumonia, Pulmonary embolism, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PROSTAMOL UNO; XANAX; SERMION [NICERGOLINE]; GERODORM; NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; RIPEDON; CHINOTAL; ACETYLSALICYLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Dementia; Hospitalization; Hypertension; Injury; Malignant melanoma
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: chest X-ray; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:high; Test Date: 2021; Test Name: laboratory tests; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: Covid PCR results; Test Result: Negative ; Test Date: 20210124; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210127; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210202; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210204; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021484803

Write-up: Pneumonia; Fever; deep vein thrombosis leading to lung embolism; deep vein thrombosis leading to lung embolism; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority. An 83-year-old male patient received the first dose of the bnt162b2 (COMIRNATY), intramuscularly on 28Jan2021 at 0.3 ml, single for covid-19 immunisation. Medical history included hypertension, dementia, malignant melanoma, arteriosclerosis, and needed hospitalization multiple times in the past few months due to physical injuries. Concomitant medications included serenoa repens extract (PROSTAMOL UNO); alprazolam (XANAX); nicergoline (SERMION [NICERGOLINE]); cinolazepam (GERODORM); pantoprazole sodium sesquihydrate (NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]); risperidone (RIPEDON); pentoxifylline (CHINOTAL); and acetylsalicylic acid (MANUFACTURER UNKNOWN). On 29Jan2021, the patient experienced fever, which required hospitalization and was serious for death. On 01Feb2021, the patient experienced pneumonia required hospitalization and was serious for death. In Feb2021, the patient experienced deep vein thrombosis leading to lung embolism, which was serious for death. The clinical course was as follows: on 28Jan2021, 83-year-old male patient received the first dose of bnt162b2. On 29Jan2021, fever occurred. On 01Feb2021, the patient was admitted in the hospital with a suspicion of pneumonia. Several examinations were carried out including laboratory tests and chest X-ray with unknown results in 2021. The patient''s inflammatory parameters were high but Covid PCR results were negative in 2021. The patient received antibiotics for the pneumonia, but as his state of health was already deteriorating, he passed away on 04Feb2021. The patient underwent lab tests and procedures which included covid-19 PCR test: negative on 24Jan2021, sars-cov-2 test: negative on 27Jan2021, sars-cov-2 test: negative on 02Feb2021, sars-cov-2 test: negative on 04Feb2021. The clinical outcome of the events was fatal. The patient died on 04Feb2021 due to fever, pneumonia, and deep vein thrombosis leading to lung embolism. An autopsy was performed and results were provided. Based on the autopsy report, the cause of death was deep vein thrombosis leading to lung embolism. SENDER COMMENT: since immunity may have not developed yet as the patient received the first dose of Comirnaty on 28Jan2021 and pneumonia was confirmed on 01Feb2021, the causal relationship is unlikely between the suspected drug and the cause of death. Also considering the fact that due to the patient''s already deteriorating state of health, he could have developed pneumonia anywhere, anytime. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pneumonia; fever; deep vein thrombosis leading to lung embolism; deep vein thrombosis leading to lung embolism; Autopsy-determined Cause(s) of Death: deep vein thrombosis leading to lung embolism; deep vein thrombosis leading to lung embolism


VAERS ID: 1304542 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-04-15
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK - / 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: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021464088

Write-up: Drug Ineffective; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is HU-OGYI-243321. A 60-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: ET3620), intramuscular on 21Mar2021 as 0.3 mL, single, first dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 on 15Apr2021, at 09:40, which was serious as it lead to death. The patient died on 15Apr2021. It was not reported if an autopsy was performed. Sender Comment: According to the SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient received the first dose of Comirnaty on 21Mar2021 and passed away on 15Apr2021 after getting infected with the virus, therefore immunity may have not developed yet. 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 are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1304543 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021506843

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number HU-OGYI-252321. A 69-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Left Arm on 08Apr2021 (Batch/Lot Number: EW2239) as for covid-19 immunisation. On 06Mar2021 the patient received the first dose of BNT162B2 vaccine. The patient medical history and concomitant medications were not reported. The patient died on 16Apr2021. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1304544 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-04-13
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: COVEREX AS; RIVOTRIL; HALOPERIDOL; NEBIVOLOL; CLEXANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Hypertension; Paranoia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021484804

Write-up: Cardiopulmonary insufficiency; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number HU-OGYI-253221. An 81-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EP2166), intramuscular into the left arm on 18Mar2021 as 0.3 mL, single for covid-19 immunisation. Medical history included dementia Alzheimer''s type, hypertension and paranoia from an unknown date. Concomitant medications included perindopril arginine (COVEREX AS) taken for hypertension from 07Apr2021 to 13Apr2021; clonazepam (RIVOTRIL) taken for agitation from 07Apr2021 to 13Apr2021; haloperidol (MANUFACTURER UNKNOWN) taken for dementia from 07Apr2021 to 13Apr2021; nebivolol (MANUFACTURER UNKNOWN) taken for hypertension from 07Apr2021 to 13Apr2021; enoxaparin sodium (CLEXANE) taken for thrombosis prophylaxis from 07Apr2021 to 13Apr2021. On 13Apr2021, the patient experienced cardiopulmonary insufficiency, which was serious as it lead to death. The patient was hospitalized from 07Apr2021 till 13Apr2021. It was reported that the patient did not require hospitalization due to sequelae of the vaccination but rather because of his worsening condition due to his severe Alzheimer''s type dementia. On 13Apr2021 at 23:15, the patient passed away. According to the patients death certificate, the cause of death was circulatory and respiratory insufficiency. While hospitalized, the patient received nebivolol, perindopril arginine for hypertension, clonazepam for agitation, haloperidol for dementia and enoxaparin sodim for thrombosis prophylaxis. The patient died on 13Apr2021. An autopsy was performed and results were not provided. Sender Comment: The patient received the first dose of Comirnaty on 18Mar2021 and passed away on 13Apr2021 therefore immunity may have not developed yet. The reporter physician also assessed the fatal outcome as not related to the vaccine. Based on the above, the causal relationship is not related between the suspected drug and the adverse event. The case is considered serious because the patient passed away. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: circulatory and respiratory insufficiency; circulatory and respiratory insufficiency


VAERS ID: 1304621 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Cardio-respiratory arrest, Colonoscopy, Headache, Insomnia, Investigation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant 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), Hypertension (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYRIMOZ [ADALIMUMAB]; MESALAZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20210425; Test Name: blood pressure; Result Unstructured Data: Test Result:210 mmHg; Comments: systolic; Test Date: 20210424; Test Name: blood tests; Result Unstructured Data: Test Result:normal; Comments: with indices of inflammation and fecal Calprotectin within the normal limits; Test Date: 202010; Test Name: colonoscopy; Result Unstructured Data: Test Result:extension of the lesions up to the transversus; Comments: extension of the lesions up to the transversus (Mayo score 1-2); Test Date: 20210425; Test Name: impact on quality of life; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC2021501419

Write-up: Severe headaches and death after 3 days from the administration of the booster of the anti COVID Pfizer vaccine; Insomnia; Blood pressure increased/systolic blood pressure 210 mmHg; Severe headaches and death after 3 days/Cardio-respiratory arrest; This is a spontaneous report received from a contactable consumer and a physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-722091. A 76 years old male patient received the second booster dose BNT162B2 (COVID 19 COMIRNATY VACCINE (PFIZER), lot number EX3599) via intramuscular administration in left shoulder on 22Apr2021 at single dose for COVID-19 immunisation. Medical history included ulcerative colitis since 1990 treated first with mesalazine associated with steroids in the exacerbation phases and with azathioprine in 2008 then suspended: From 2015 to 2020 laboratory clinical remission, in the second half of 2020 disease recurrence; colonoscopy October 2020 showed extension of the lesions up to the transversus (Mayo score 1-2). From November 2020 hospital prescription of Hyrimoz in addition to mesalazine, with subsequent symptomatic remission and normalization of blood tests performed on 24Apr2021 with indices of inflammation and fecal Calprotectin within the normal limits. Concomitant medications included adalimumab (HYRIMOZ) from Nov2020 for ulcerative colitis; mesalazine. The patient received the first dose of comirnaty on 01Apr2021 for covid-19 immunisation with no adverse drug reaction (ADR). Local Center of Pharmacovigilance 28Apr2021: contacted and request sent to the attending physician to prepare clinical report complete with case history; waiting for a reply. Subject not hypertensive, no cardiovascular pathologies, treated with Hyrimoz for ulcerative colitis. At the first dose on 01Apr2021 no ADR; immediately after the second dose initially mild headache then worsened, insomnia. On 25Apr2021 very strong headache all day. In the evening, systolic blood pressure 210 mmHg (blood pressure increased), at 21:30 called emergency, arrived at 21:52. Emergency sheet reports (as far as legible): unconscious patient, cyanotic skin, mydriasis, cardiorespiratory arrest, unblocked airways, manual ventilation and chest compression, administered adrenaline 1 fl intravenous. Declaration of death at 22:30. Severe headaches and death after 3 days from the administration of the booster of the anti COVID Pfizer vaccine. The emergency form and the clinical report of the attending physician will be attached to the National Network of Pharmacovigilance. Relatives are trying to have an autopsy performed. Measures taken (Cardiac massage with telephone assistance from the emergency service of the hospital until their arrival, then resuscitation with defibrillator continued), impact on quality of life (10/10). Local Center of Pharmacovigilance 29Apr2021: attached clinical report received from the general practitioner and intervention of emergency on 25Apr2021. From November 2020 hospital prescription of Hyrimoz in addition to mesalazine, with subsequent symptomatic remission and normalization of blood tests performed on 24Apr2021 with indices of inflammation and fecal Calprotectin within the normal limits. Therefore the patient at the time of vaccination was in good clinical condition in relation to the aforementioned pathology. Local Center of Pharmacovigilance 30Apr2021: Hear from the attending physician, autopsy performed today. The relative autopsy report is awaited. Outcome was fatal. Reporter''s comments: Ulcerative rectal colitis. Azathioprine intolerance.; Reporter''s Comments: Ulcerative rectal colitis. Azathioprine intolerance; Reported Cause(s) of Death: Insomnia; Blood pressure increased/systolic blood pressure 210 mmHg; Severe headaches and death after 3 days/Cardio-respiratory arrest; Severe headaches


VAERS ID: 1304622 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-25
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021501426

Write-up: Administration of the first Pfizer vaccine dose on 10Apr2021. On 25Apr2021 he suddenly fainted and rescuers who intervened within 10 minutes tried to revive him for 30 minutes.; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB [IT-MINISAL02-722534]. A 76-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot#: Ew2246) via intramuscular at 0.3 ml single on 10Apr2021 from 10:00 to 11:00 in right arm for COVID-19 immunisation. Medical history included heart disease. Concomitant medication was not reported. Administration of the first Pfizer vaccine dose on 10Apr2021. On 25Apr2021, Sunday morning, patient suddenly fainted and rescuers who intervened within 10 minutes tried to revive him for 30 minutes. The general practitioner, who had been contacted, excluded that it may have been caused by the vaccine. He hypothesized an ischemia, an embolism or rupture of the aorta. Patient suddenly lost consciousness and rescuers, who intervened within 10 minutes, tried to revive him for 30 Min, even with a defibrillator. Patient died in Apr2021. He took medications regularly and specific tests every 6 months. On 30Apr2021, the emergency report sent by the reporter who contacted communicates: No autopsy was performed because he died at home and the doctor who declared the death did not ask us for anything. The outcome of event was fatal. Reporter comment: heart disease No follow-up attempts possible. No further information expected.; Reporter''s Comments: heart disease; Reported Cause(s) of Death: lost consciousness


VAERS ID: 1304623 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-04-19
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Choledocholithiasis; Decompensation cardiac; Femur fracture; Hypokalaemia; Hypokinesia; IHD; Interstitial lung disease; LBBB; Permanent atrial fibrillation; Pneumonitis
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: SARS-CoV-2 molecular test; Test Result: Negative ; Test Date: 20210412; Test Name: SARS-CoV-2 molecular test; Test Result: Negative ; Test Date: 20210419; Test Name: SARS-CoV-2 molecular test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021501428

Write-up: ischemic and valvular heart disease; ischemic and valvular heart disease; Positive molecular swab in subject vaccinated on 16Jan and 06Feb. Dead.; vaccination failure; This is as spontaneous report received from a contactable Healthcare Professional (HCP) downloaded from the Agency-WEB. The regulatory authority report number is IT-MINISAL02-722826. A 99-year-old female patient received BNT162B2 (COMIRNATY) via intramuscular administered in Arm Left (shoulder) on 06Feb2021 as 2nd dose, 0.3 ml single (Batch/Lot Number: EL0725; Expiration Date: 31Mar2021), via intramuscular administered in Arm Left (shoulder) on 16Jan2021 as 1st dose, 0.3 ml single (Batch/Lot Number: EJ6797; Expiration Date: 30Apr2021) for covid-19 immunisation. Medical history included left bundle branch block (LBBB), femur fracture from 04Nov2020, hypokinesia, ischemic heart disease (IHD), permanent atrial fibrillation, choledocholithiasis from 30Dec2020, hypokalaemia, pneumonitis from 30Dec2020, interstitial lung disease from 01Jan2015, decompensation cardiac. The patient''s concomitant medications were not reported. The patient experienced positive molecular swab on 19Apr2021 in subject vaccinated on 16Jan2021 and 06Feb2021 and died. Reported evident signs of decompensation on the day of death. Most relevant cause of death reported as ischemic and valvular heart disease. The patient underwent SARS-CoV-2 molecular test and revealed negative on 29Mar2021 and on 12Apr2021; revealed positive on 19Apr2021. The patient died on 24Apr2021. It was not reported if an autopsy was performed. The reported cause of death was ischemic and valvular heart disease, positive molecular swab. Outcome of the events was fatal. Reporter comment: Death certificate attached. Most relevant cause of death: ischemic and valvular heart disease.; Reported Cause(s) of Death: Positive molecular swab; Positive molecular swab; ischemic and valvular heart disease; ischemic and valvular heart disease


VAERS ID: 1304624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-03
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Anuria, Asthenia, Decreased appetite, Dehydration, Nervous system disorder, Pneumonia aspiration, Pneumonitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021501425

Write-up: asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; suspected aspiration pneumonia; asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; anuria; dehydration; worsening of neurological conditions; asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is [IT-MINISAL02-723165]. An 81-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Alzheimer''s disease from 30Apr2012 to an unknown date, renal failure from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized on 03Apr2021. Patient received treatment included hydration and antibiotics for the events. The patient died on 20Apr2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. Reporter''s Comment: after the second dose of Pfizer vaccine loss of appetite, dehydration and subsequent appearance of suspected aspiration pneumonia and anuria for which hospitalization was required. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: after the second dose of Pfizer vaccine loss of appetite, dehydration and subsequent appearance of suspected aspiration pneumonia and anuria for which hospitalization was required..; Reported Cause(s) of Death: asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; suspected aspiration pneumonia; asthenia, loss of appetite, worsening of neurological conditions, appe


VAERS ID: 1304784 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pancreatitis acute
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021506944

Write-up: Respiratory arrest / cardiac arrest; Vomiting; This is a spontaneous report from a contactable physician received via Regulatory Authority. A 90-year-old male patient received BNT162B2 (COMIRNATY; Lot number: unknown), dose 1 intramuscular on 06May2021, at 10:30 as single dose for covid-19 immunization. Medical history included pancreatitis acute from an unknown date. The patient''s concomitant medications were not reported. The patient experienced respiratory arrest / cardiac arrest on 06May2021, at 11:45, and vomiting on 06May2021. The reporting physician classified the events as serious as they resulted in death. It was unknown whether the patient received any vaccination within 4 weeks prior to BNT162B2. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was not unknown whether the patient had any allergies to medications, food, or other products. On 06May2021 at 10:30, the patient received the first dose of BNT162b2. On 06May2021 (about 1 hour after the vaccination), the patient experienced vomiting. On 06May2021 at 11:45 (1 hour and 15 minutes after the vaccination), the patient experienced respiratory arrest / cardiac arrest. Therapeutic measures were taken as a result of respiratory arrest / cardiac arrest; the patient received adrenaline administration and resuscitative measure in response to the event. The course of the event was as follows: About 1 hour after vaccination at the short stay (at the nursing home/senior living facility), the patient was transported by emergency to the reporting hospital due to the respiratory arrest/cardiac arrest after vomiting. The event resulted in emergency transport to the reporting hospital. The outcome of the events was fatal. The patient died on 06May2021. An autopsy was not performed and the exact cause of death was unknown. This case was reported because the causality with the vaccine cannot be ruled out completely. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender''s Comments: Based on the close temporal relationship, the association between the fatal events cardiorespiratory arrest and vomiting with BNT162b2 can not 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: unknown cause of death


VAERS ID: 1304785 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Cardio-respiratory arrest, Dyskinesia, Pyrexia, Sputum increased, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslalia; Dysphagia; Hospitalization; Nasogastric tube insertion; Parkinson''s disease (for more than 5 years); Progressive supranuclear palsy
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210430; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: 2 hours after vaccination; Test Date: 20201112; Test Name: CRP; Result Unstructured Data: Test Result:0.37; Test Date: 20201112; Test Name: white blood cell (W); Result Unstructured Data: Test Result:6400
CDC Split Type: JPPFIZER INC2021509322

Write-up: sputum increased; Cardio-respiratory arrest; Pyrexia of 37.5 degrees centigrade; Neck movement from side to side; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21104881. A 70-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 30Apr2021 at 13:37 (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) at 70-years-old as a single dose for COVID-19 immunization. The patient''s medical history included progressive supranuclear palsy from an unknown date and unknown if ongoing, hospitalization from 22Jul2020 to an unknown date, Parkinson symptoms from an unknown date and unknown if ongoing (for more than 5 years), nasogastric tube insertion from 02Sep2020 to an unknown date, dyslalia from an unknown date and unknown if ongoing, and dysphagia from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took influenza vaccine on 10Nov2020 for immunization (at another hospital). On 30Apr2021 at 13:52, the patient experienced neck movement from side to side (non-serious). On 30Apr2021 at 15:37, the patient experienced pyrexia of 37.5 degrees Centigrade (non-serious). On 01May2021 at 02:30, the patient experienced cardio-respiratory arrest (death, medically significant). The clinical course was reported as follows: The patient was a 70-year-old male. Body temperature before vaccination was 36.4 degrees Centigrade. Historical vaccine included influenza vaccine on 10Nov2020 at another hospital. Medical history included progressive supranuclear palsy. Family history and concomitant medications were not reported. On 30Apr2021 at 13:37 (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 30Apr2021 at 13:52 (15 minutes later from the vaccination), the patient was in normal condition except his neck movement from side to side. On 30Apr2021 at around 15:37 (2 hours later form the vaccination), the patient developed pyrexia of 37.5 degrees centigrade. On 01May2021 at 02:30 (1 day after the vaccination), the patient was found in cardio-respiratory arrest. Outcome of the event, cardio-respiratory arrest, was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: The patient had been hospitalized in the reporting hospital (Hospital A) since 22Jul2020. Although the onset time was unclear, the patient had Parkinson symptoms for more than 5 years. The previous physician (Hospital B) diagnosed progressive supranuclear palsy. Around Jun2020, the patient began to gradually have difficulty in oral intake. On 29Jun2020, the patient was admitted to Hospital B for close examination. The patient was confined to bed, needed total assistance, was having swallowing auxiliary food; under this condition, the patient was transferred to the reporting hospital. Pursuit eye movement was possible. The patient had difficulty to move his lips and tongue. The patient had flexion of both elbows and strong muscle tightness and was confined to bed. In the late Aug2020, the patient could not eat anymore. On 02Sep2020, a nasogastric tube was inserted, and tube feeding was started. At another hospital (Hospital C), the patient received an influenza vaccine without experiencing a particular problem on 10Nov2020, and blood test revealed white blood cell (W) 6400 and C-reaction protein (CRP) 0.37 on 12Nov2020. On 30Apr2021 at 13:37, the patient, who was in normal condition, received a coronavirus vaccine (performed by the reporting physician). Thereafter, the patient was observed for 15 minutes and was in normal condition except his neck movement from side to side (on 30Apr2021 at 13:52). However, about 2 hours later, the patient had pyrexia of 37.5 degrees Centigrade without other changes (no change in blood pressure and SO2). On 01May2021, the patient remained unchanged at 01:30, but was found in cardio-respiratory arrest at 02:30. The reporting physician classified the event, cardio-respiratory arrest, as serious (death) and assessed the causality between the event and bnt162b2 as unassessable. As for the events, neck movement from side to side and pyrexia of 37.5 degrees Centigrade, outcome, seriousness classification, and causality assessment were not reported. It was not reported whether there was other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient originally had Parkinson symptoms with dyslalia and dysphagia. The patient did not have cough frequently. He usually had no sputum caught in, but sputum was extracted when suction was performed. This time, the volume of sputum increased due to low-grade fever caused by the vaccine, and the difficulty in sputum discharge might have led to the death. The patient underwent lab tests and procedures which included body temperature: 36.4 Centigrade on 30Apr2021 (before vaccination), body temperature: 37.5 Centigrade on 30Apr2021 (2 hours after vaccination), C-reactive protein (CRP): 0.37 on 12Nov2020, white blood cell (W): 6400 on 12Nov2020. The clinical outcome of the events: dyskinesia and pyrexia, was unknown. The clinical outcome of the event, cardio-respiratory arrest, was fatal. The patient died on 01May2021 due to cardio-respiratory arrest. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1304786 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021509325

Write-up: Cerebral infarction; This is a spontaneous report from a contactable pharmacist. This report was received via a Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cerebral infarction, which was serious for death. The patient died on an unspecified date due to cerebral infarction. It was not reported if an autopsy was performed. Causality assessment for the event were not provided. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: A causal relationship between the event "Cerebral infarction" and suspect product bnt162b2 (COMIRNATY), is possible based on the information provided, safety profile and a temporal association. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1304787 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Cardio-respiratory arrest, Imaging procedure, Ruptured cerebral aneurysm, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Name: autopsy imaging (AI); Result Unstructured Data: Test Result:subarachnoid haemorrhage and basilar artery; Comments: aneurysm rupture
CDC Split Type: JPPFIZER INC2021509396

Write-up: sudden disturbed consciousness; Cardio-respiratory arrest; basilar artery aneurysm rupture; subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21104899. A 63-year and 1-month old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration, on 30Apr2021 at 13:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardio-respiratory arrest on 03May2021 at 10:30 and basilar artery aneurysm rupture and subarachnoid haemorrhage on 03May2021, which were reported as fatal. The patient also experienced sudden disturbed consciousness on 03May2021, which required hospitalization 03May2021. The clinical course was reported as follows: On 30Apr2021 (the day of vaccination), at 13:30, the patient received BNT162B2 vaccination. On 03May2021 (3 days after vaccination), no change was observed in the physical condition, and the patient had no subjective symptoms. The patient was on the night shift on 01May2021, and she was on holiday on 03May2021. On 03May2021, while the patient was doing her shopping in a shopping mall, she experienced sudden disturbed consciousness, and she was emergently transferred to the medical institution which was different from the reporting medical institution. On 03May2021 at around 10:30 (2 days 10 hours 30 minutes after the vaccination), when the patient arrived in the medical institution, she had cardio-respiratory arrest, and cardiopulmonary resuscitation was performed. However, return of spontaneous circulation was not achieved, and the patient was confirmed to be dead. The diagnoses of subarachnoid haemorrhage and basilar artery aneurysm rupture were made with autopsy imaging (AI) on an unspecified date, and these events were considered as the causes of death. No autopsy was performed based on the patient''s family''s wishes. The patient underwent lab tests and procedures which included body temperature: 36.6 centigrade on 30Apr2021 (before vaccination). Therapeutic measures were taken as a result of cardio-respiratory arrest as aforementioned. The clinical outcome of sudden disturbed consciousness was unknown. The patient died on 03May2021. The causes of death were reported as cardio-respiratory arrest, basilar artery aneurysm rupture, and subarachnoid haemorrhage. An autopsy was not performed. The brain surgeon who confirmed death reported that the event was unrelated to BNT162B2 vaccination. The reporting physician assessed the causality between the events and BNT162B2 as unassessable (since the causality between the event and BNT162b2 was unknown).; Reported Cause(s) of Death: basilar artery aneurysm rupture; subarachnoid haemorrhage; Cardio-respiratory arrest


VAERS ID: 1304788 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Body temperature, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Cardiac failure
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210501; Test Name: Body temperature; Result Unstructured Data: Test Result:37s Centigrade; Comments: continued
CDC Split Type: JPPFIZER INC2021510219

Write-up: Angina pectoris; Pyrexia of 37s degrees C; This is a spontaneous report from a contactable physician (internist) received from the regulatory authority. Regulatory authority report number is v21104906 via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A patient of 95-year-old female (non-pregnant) received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021) via intramuscularly on 30Apr2021 at 14:15 (at 95-years-old) in the left arm for COVID-19 immunization. The patient had medical history of cardiac failure and angina pectoris. The patient family history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received antihypertensive (not specified) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01May2021 (1 day after the vaccination), pyrexia of 37s degrees C was continued from the next day of the vaccination. On 05May2021 at 02:50 (5 days after the vaccination), chest pain developed, and the patient experienced suspected angina pectoris. On 05May2021 at 04:50 (5 days after the vaccination), cardiac arrest was confirmed. The event angina pectoris resulted in death. The course of the events was as follows: Although the patient had cardiac failure, the patient was doing well with only oral medication. On 05May2021 at 02:50 (5 days after the vaccination), chest pain developed, for which sublingual nitro was administered. However, the symptom did not improve. An autopsy was not performed. Reported cause of death was angina pectoris. Body temperature before vaccination was 36.7 degrees Centigrade. Outcome of pyrexia of 37s degrees C were not reported. The reporting physician classified the event angina pectoris as serious (caused death) and assessed that the causality between the event and BNT162b2 as unassessable. Seriousness classification and causality assessment for pyrexia of 37s degrees C were not reported. Other possible causes of the event such as any other diseases were myocardial infarction and cardiac failure. Follow-up (07May2021): This is a follow-up spontaneous report from a same contactable physician received from the regulatory authority. Regulatory authority report number is v21104906. New information included reporter assessment, clinical information, lab data. The reporting physician commented as follows: She originally had a heart disease, but since she has been suffering from fever since the vaccination, a causal relationship cannot be denied.; Reported Cause(s) of Death: Angina pectoris


VAERS ID: 1304789 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-02
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac disorder, Electrocardiogram
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cellulitis (dorsum of the right hand, improving); Dementia Alzheimer''s type (Hospitalized on 03Dec2020); Syncopal attack; Ventricular fibrillation; Ventricular tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: Body temperature; Result Unstructured Data: Test Result:35.5 Centigrade; Comments: Before vaccination; Test Date: 20201219; Test Name: electrocardiogram; Result Unstructured Data: Test Result:ventricular tachycardia was suspected
CDC Split Type: JPPFIZER INC2021517181

Write-up: Death due to heart disorder; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21105215. A 75-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: ET9096; Expiration Date: 31Jul2021), via an unspecified route of administration on 20Apr2021 at 10:19 at a single dose for covid-19 immunisation. Medical history included dementia Alzheimer''s type (hospitalized on 03Dec2020), ventricular fibrillation, cellulitis (dorsum of the right hand, improving), syncopal attack in Nov2020, and ventricular tachycardia from 19Dec2020 to an unknown date. The patient had no significant family history. The patient''s concomitant medications were not reported. On 02May2021, the patient died due to heart disorder, which was serious for death. The course of the event was as follows: on 26Jan2018, the patient regularly visited the reporter''s hospital as an outpatient for the treatment of Alzheimer''s type dementia. In Nov2020, syncopal attack repeatedly occurred. On 03Dec2020, the patient was admitted to the department of psychiatry of the reporter''s hospital for symptoms (unspecified) due to dementia. On 18Dec2020 and 19Dec2020, the patient developed syncope. On 19Dec2020, based on the results of an electrocardiogram, as ventricular tachycardia was suspected, the patient visited the emergency department of a different hospital as an outpatient where the treatment with ICD (implantable cardioverter defibrillator) was suggested by the physician, but his family did not want him to do and the patient was transferred back to the reporter''s hospital. On 01Apr2021 and 13Apr2021, the patient developed syncope. On 23Apr2021, he was slow to respond to the treatment and developed symptoms (unspecified) accompanied by disturbed consciousness. On 02May2021, the patient''s death was confirmed by the caretakers. The patient underwent lab tests and procedures which included body temperature: 35.5 degrees Centigrade on 20Apr2021 before vaccination. The clinical outcome of the event, death due to heart disorder, was fatal. The patient died on 02May2021 due to heart disorder. It was not reported if an autopsy was performed. The reporting physician considered that he died because of heart disorder. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: it was considered that he died because of cardiac disorder.; Sender''s Comments: Based on the current available information, the event Heart disorder is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of ventricular fibrillation may provide an explanation for the event.; Reported Cause(s) of Death: Heart disorder


VAERS ID: 1304790 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood pressure measurement, Blood test, Body temperature, Cardiac failure acute, Electrocardiogram, Heart rate, Oxygen saturation, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis (on oral treatment with anticoagulant agents); Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: BP; Result Unstructured Data: Test Result:64/46 mmHg; Test Date: 20210426; Test Name: BP; Result Unstructured Data: Test Result:80-90 mmHg; Test Date: 20210424; Test Name: Blood sample; Result Unstructured Data: Test Result:positive to troponin T and CK-MB; Test Date: 20210422; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210423; Test Name: ECG; Result Unstructured Data: Test Result:revealed ST elevation in II, III, and aVF leads; Comments: and T wave abnormalities in anterior wall leads; Test Date: 20210426; Test Name: HR; Result Unstructured Data: Test Result:fluctuated in 100-110 bpm; Test Date: 20210423; Test Name: SpO2; Test Result: 88 %; Test Date: 20210426; Test Name: SpO2; Result Unstructured Data: Test Result:fluctuated in 80-90 %
CDC Split Type: JPPFIZER INC2021517250

Write-up: Acute myocardial infarction; Cardiac failure acute; respiratory failure; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21105121. A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: ET9096; Expiration Date: 31Jul2021), via an unspecified route of administration, on 22Apr2021 at 10:25 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and deep vein thrombosis (on oral treatment with anticoagulant agents). Concomitant medications included unspecified anticoagulant agents. The patient experienced acute myocardial infarction, cardiac failure acute, and respiratory failure on 23Apr2021 at 14:00, which required hospitalization on 23Apr2021 and were reported as fatal. The clinical course was reported as follows: On 22Apr2021 (the day of vaccination), the patient received the vaccination. On 23Apr2021 around 14:00 (1 day after the vaccination), the patient experienced vomiting and subsequently had blood pressure decreased and poor oxygenation (blood pressure (BP): 64/46 mmHg and oxygen saturation (SpO2): 88%). The patient visited the outpatient department of the reporting hospital and was admitted there for respiratory failure. On 24Apr2021, the patient received furosemide (MANUFACTURER UNKNOWN) 10 mg for low urine output; even after this, she did not pass urine. Electrocardiogram (ECG) recorded on admission revealed ST elevation in II, III, and aVF leads and T wave abnormalities in anterior wall leads on 23Apr2021. Later, the blood sample was positive to troponin T and creatine kinase-myocardial band (CK-MB) on 24Apr2021. The patient would receive inpatient unspecified treatment as much as possible for acute coronary syndrome. Continuous infusion of heparin (MANUFACTURER UNKNOWN) 8000 unit (U) and isosorbide dinitrate (NITOROL) was started. Because of no urination and low blood pressure, carperitide (genetical recombination) human atrial natriuretic peptide (HANP) 0.025 gamma was administered. On 26Apr2021, oxygen 15 liters (via reservoir mask) was administered, after which the SpO2 had fluctuated in 80-90%, and heart rate (HR) in 100-110 beats per minute (bpm). Dopamine (MANUFACTURER UNKNOWN) 3.0 mL/hour was administered, and the blood pressure was in 80-90 mmHg; respiratory distress was noted. On 26Apr2021 at 12:15, the patient was confirmed dead. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 26Apr2021 at 12:15. The causes of death were reported as acute myocardial infarction, cardiac failure acute, and respiratory failure. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the events and BNT162B2 as unassessable. There was no other possible cause of the events such as any other diseases.; Reported Cause(s) of Death: Cardiac failure acute; Acute myocardial infarction; respiratory failure


VAERS ID: 1304884 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021496800

Write-up: Sudden death; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00524561. A 69-year-old male patient received the BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on 26Apr2021, at 0.3 mL single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. No previous COVID-19 infection. The patient experienced sudden death on 29Apr2021, no symptoms prior to death. The outcome of the event was fatal. The cause of death was not reported. Autopsy was performed and no results available. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sudden death


VAERS ID: 1304892 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-03-15
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, COVID-19, Death, Drug ineffective, Exposure to SARS-CoV-2, Nausea, Oxygen saturation, SARS-CoV-2 test, Transient ischaemic attack, Vaccination failure
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SOBRIL; OMNIC; ZANIDIP; SELO-ZOK; EXELON [RIVASTIGMINE]; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic ischemic heart disease, unspecified; Hyperplasia of prostate; Living in nursing home; Uncomplicated hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Body temperature; Result Unstructured Data: Test Result:Normal; Comments: Normal (value not specified) on 11Apr2021 14: 30; Test Date: 20210411; Test Name: C-reactive protein; Result Unstructured Data: Test Result:6 mg/l; Comments: 14: 30; Test Date: 20210411; Test Name: Oxygen saturation; Test Result: 96 %; Comments: 14: 30; Test Date: 20210405; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive ; Comments: Result: Positive. B.1.351 lineage. Low Ct value.
CDC Split Type: NOPFIZER INC2021496824

Write-up: NAUSEA; died/Cause of death was unknown; covid19 detected/vaccination failure; covid19 detected/lack of drug effect; covid19 detected/asymptomatic covid-19; exposure to covid-19/Infection exposed; TIA; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uqwd1x. Safety Report Unique Identifier [NO-NOMAADVRE-E2B_00026428]. An 88-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular on 26Jan2021 14:15 (Lot Number: EJ6134) as single dose, dose 1 intramuscular on 05Jan2021 16:15 (Lot Number: EJ6795) as single dose, for covid-19 immunisation. Medical history included Living in nursing home; Chronic ischemic heart disease, unspecified; Hyperplasia of prostate; Uncomplicated hypertension. Concomitant medications included oxazepam (SOBRIL); tamsulosin hydrochloride (OMNIC); lercanidipine hydrochloride (ZANIDIP); metoprolol succinate (SELO-ZOK); rivastigmine (EXELON [RIVASTIGMINE]); apixaban (ELIQUIS). The patient experienced TIA (Transient ischaemic attack) on 15Mar2021, asymptomatic covid-19 on 05Apr2021; exposure to covid-19 from 27Mar2021 - 28Mar2021) (B.1.351 lineage); Infection exposed 27Mar2021-28Mar2021 - possibly also 01Apr2021-02Apr2021. On 05Apr2021, the patient developed vaccination failure, lack of drug effect, COVID-19. Relevant laboratory findings and investigations included in the report: SARS-COV-2 RT-PCR TEST on 05Apr2021, Result: Positive. B.1.351 lineage. Low Ct value). COVID-19 detected as part of infection tracing 05Apr2021 - asymptomatic at the time. Little affected in subsequent days. On 11Apr2021 at 14: 30, the patient developed a little nausea but otherwise in good shape. Relevant laboratory findings and investigations included in the report: C-reactive protein on 11Apr2021 14: 30: 6 mg/l; oxygen saturation on 11Apr2021 14: 30: 96%; body temperature on 11Apr2021 14: 30: Normal (value not specified). On the basis of findings stated above and after conversation with the hospital, the patient started treatment with prednisolone 40 mg. The patient was found dead in bed on 11Apr2021 just before midnight. An autopsy was not performed. The reporter suspected that the patient died with and not because of COVID-19. Cause of death was unknown to the reporter. The patient''s outcome was fatal. The case was considered to be Serious. The outcome of the event died/Cause of death was unknown was fatal, of exposure to covid-19/Infection exposed was recovered on 02Apr2021, of the other events was unknown. Health Authority Comment: Since the vaccine is new, it will be subject to special monitoring to identify any new safety information as soon as possible. It is especially important that serious and/or unusual side effects be reported. Your message is therefore important to expand knowledge about adverse reactions that were not discovered in the studies, and it is an important contribution to international cooperation to maintain safe vaccination worldwide. Causality assessment (Relatedness of drug to reaction(s)/event(s)): Vaccination failure: Source of assessment: Center. Result of Assessment: Possible; Drug ineffective: Source of assessment: Center. Result of Assessment: Possible; COVID-19: Source of assessment: Center. Result of Assessment: No relationship; Nausea: Source of assessment: Center. Result of Assessment: Possible.; Reported Cause(s) of Death: died/Cause of death was unknown


VAERS ID: 1304902 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:POSITIVE
CDC Split Type: PLPFIZER INC2021505723

Write-up: COVID-19; Drug ineffective; This is a spontaneous report from a contactable nurse forwarded by company representative. The patient (unknown age and gender) completed two doses of BNT162B2 (COMIRNATY) for COVID-19 immunisation, both unknown lot number at single dose, on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced death from COVID despite previous vaccination with two doses of Comirnaty. It was unknown if autopsy was performed or not. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of fatal Covid19 and Drug ineffectively cannot be assessed. The case will be reassessed if additional information becomes available on patient''s medical history, concomitant medications, risk factors if any. 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: COVID-19; Drug ineffective


VAERS ID: 1304903 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), 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 (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021505757

Write-up: shortness of breath; cardiac arrest; fever; This is a spontaneous report from a contactable consumer received by e-mail. A male patient of an unspecified age received BNT162B2 (COMIRNATY, reported as "Pfizer vaccine") via an unspecified route of administration on 12Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient wanted to report an adverse reaction after Pfizer vaccine. On 12Mar2021, the patient (reporter''s grandfather) received a vaccine from the Pfizer company, after two days (14Mar2021) he got a fever that lasted until 01Apr2021. That day (01Apr2021) he was also taken to hospital by an ambulance due to shortness of breath (onset date unknown). On 03Apr2021, he died as a result of cardiac arrest. It was not reported if an autopsy was performed. The patient had no idea how this would be recognized- whether it would be an adverse reaction or it would be added to the statistics because of the effects, but the reporter convinced that it was the vaccine that contributed to the death. The outcome of event fever was recovered on 01Apr2021, the outcome of event "shortness of breath" was unknown, and the outcome of "cardiac arrest" was fatal.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1304905 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Circulatory failure; Dementia (Dementia syndrome); Depressive disorder; Hypertension (hypertensive disease with heart involvement); Ischemic heart disease; Mitral valve insufficiency (Second / third mitral valve insufficience); Tricuspid regurgitation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021491352

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority, Regulatory authority report number PL-URPL-3-594-2021. The reporter is contactable to Health Authority only. An 86-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EW2243; Expiration Date: 31Jul2021), intramuscular, administered in Arm Left on 14Apr2021 16:17 (at the age of 86years) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included treated chronically for hypertensive disease with heart involvement, permanent atrial fibrillation, chronic circulatory failure, ischemic heart disease, mitral valve insufficiency II degree/III degree and tricuspid valve regurgitation, depressive disorder with dementia syndrome; all ongoing. The patient''s concomitant medications were not reported. It was reported that on April 15, 2021 at 15:35, the patient died of cardiac arrest after the resuscitation action of the Emergency Medical Service. The patient died on 15Apr2021. It was unknown if an autopsy was performed. Causality assessment between the (Product Name) COMIRNATY and Reaction/Event: Cardiac arrest was Unlikely. (Source of assessment Regulatory Authority; Method of assessment WHO-UMC; Result of Assessment Unlikely) Sender''s comment: Cardiac arrest is unexpected symptom after vaccination with Comirnaty. Until April 22, 2021, 119 cases of cardiac arrest were reported in the pharmacovigilance database. There is a time relationship between the administration of the vaccine and the occurrence of the side effect. However, taking into account the patient''s medical history (e.g. ischemic heart disease, circulatory failure, hypertension), the Regulatory Authority believes that the cardiac arrest occurred in a temporary coincidence and that the vaccine administration was unlikely. The person reporting post vaccination adverse reaction qualified it as serious. Due to the health result: death, the Regulatory Authority assessed the post vaccination adverse reaction as serious. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1304913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERENAL [OXAZEPAM]; FLUVOXAMINE; IVABRADINE; LISINOPRIL; MEMANTINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021501427

Write-up: The patient died suddenly the next morning, about 21 hours after the vaccine was administered without immediate complications.; This is a spontaneous report from a contactable Physician downloaded from a regulatory authority-WEB PT-INFARMED-J202104-1799. A 76 years old female patient received 1st dose of BNT162B2 (COMIRNATY, lot EW9127) intramuscular on 15Apr2021 12:15 for COVID-19 immunisation at the patient''s usual home, after obtaining her oral consent. Medical history was not provided. Concomitant drugs included oxazepam (SERENAL), Fluvoxamine, Ivabradine, Memantine, Lisinopril. The patient experienced sudden death associated with the use of BNT162B2 on 16Apr2021. The adverse reaction (ADR) occurred about 21 hours after administration of the suspected vaccine. A history of adverse reaction for any drug was unknown. There was no medication error. The outcome of the event was fatal. Result of Assessment: Possible. No follow-up attempts possible. No information expected. ; Reported Cause(s) of Death: Sudden death


VAERS ID: 1304921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Arthralgia, Blood pressure increased, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Cerebrovascular accident, Chills, Dehydration, Diarrhoea, Dizziness, Heart rate, Insomnia, Lymphadenopathy, Malaise, Myalgia, Nausea, Pyrexia, Swelling, Swelling face, Thirst, Tremor, Ventricular arrhythmia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Artificial cardiac pacemaker user; Atrial fibrillation; Atrophy; Hemiparesis; Ischemic stroke (Pacemaker and stroke a year and 2 months ago. Left sequelae ischemic stroke recovered); Lacunar infarction; Type 2 diabetes mellitus (insulin-necesitant); Comments: Pacemaker and stroke a year and 2 months ago.
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:11.5/5.7-14.8/7 mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result:17.8/8 mmHg; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Name: pulse; Result Unstructured Data: Test Result:60-65; Test Name: pulse; Result Unstructured Data: Test Result:98
CDC Split Type: ROPFIZER INC2021479601

Write-up: Muscle pain; Severe nausea; Malaise; Swelling of the face and neck; Swelling of the face and neck; Diarrhea; Fever/38 centigrade; Enlarged lymph nodes at the base of the neck; Vomiting; Strong thirst; Strong chills; dehydration; blood pressure increased; Tremor of the chin; Joint pain; Tremor of the fingers; Dizziness; Insomnia; Irreversible cardio-respiratory arrest; Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia; Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia; Recent recurrent stroke with right hemiparesis and mixed aphasia. Permanent pacemaker; This is a spontaneous report from a contactable consumer (patient''s son) and physician downloaded from the regulatory authority, regulatory authority number RO-NMA-2021-SPCOV7038. An 81-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Mar2021 (Lot Number: ET7205) as single dose for COVID-19 immunisation. Medical history included stroke from 2020 to an unknown date (pacemaker and stroke a year and 2 months ago. Left sequelae ischemic stroke), arterial hypertension, atrial fibrillation, hemiparesis, type 2 diabetes mellitus (insulin-necesitant), lacunarism cerebral and cortical atrophy. The patient''s concomitant medications includes unspecified NOACs and oral antidiabetic drugs. The patient previously received 1st dose of bnt162b2 (COMIRNATY, lot: EP2166) on 06Mar2021 for COVID-19 immunization and experienced dizziness, fatigue, headache, and administration site pain. On 28Mar2021, twenty-four hours after vaccination, there was a slight tremor of the fingers, dizziness, insomnia, joint pain. The tremor of the fingers becomes stronger in the next 2-4 days and fever also appears (38 centigrade), very strong joint pain, muscle pain, enlarged lymph nodes at the base of the neck, malaise, strong chills, swelling of the face and neck, very strong tremor of the chin leading to inability to speak, diarrhea, severe nausea and vomiting. Blood pressure was between 11.5/5.7 mm Hg - 14.8/7 mm Hg and pulse was between 60-65 in the first days after booster and in time blood pressure increased to 17.8/8 mm Hg and pulse to 98. There was a strong thirst, but after hydration vomiting followed leading to a strong dehydration. As a treatment, the rapporteur specified that infusions were made in the hospital, but he does not know details. The rapporteur''s comments: On the night of 01 April 2021 at 11:00 p.m., 5 days after the booster, it was necessary to be hospitalized due to numerous side effects. On 02 April 2021, the doctor spoke with my sister and said she was stable and in good condition. On the evening of 03 April 2021, I spoke to my mother on the phone and she told me that she no longer had a fever, nausea and those severe symptoms, being optimistic, but that she still had trembling hands. Unfortunately, on the morning of 04 April 2021 we were informed that she had died. In the reporter''s opinion the events were related to Comirnaty. On 05 April 2021, the medical certificate confirming the death was completed. Actual causes of death: Irreversible cardio-respiratory arrest, Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia and Recent recurrent stroke with right hemiparesis and mixed aphasia. Permanent pacemaker. Other important morbid condition: Chronic atrial fibrillation in treatment with NOACs, type 2 diabetes mellitus insulin-necesitant + oral antidiabetic drugs, arterial hypertension, left sequelae of ischemic stroke, lacunarism cerebral, cortical atrophy, hemiparesis. Following investigation of the case by the regulatory authority the conclusions were: case infirmed regarding a relationship of death with vaccination. Outcome of dehydration and blood pressure increased was unknown, for tremor of the fingers was not recovered; for other non-fatal events was recovered on 03Apr2021. It was unknown if an autopsy was performed. Sender Comment: We don''t know if an autopsy was done. We have no details which of the adverse reactions would have caused the death. We don''t know the diagnosis. The rapporteur was contacted on the reporting email address, but we did not receive any response. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia; Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia; Recent recurrent stroke with right hemiparesis and mixed aphasia. Permanent pacema


VAERS ID: 1304946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Death
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021506444

Write-up: Death, spontaneous; Some sensations were in the chest; This is a spontaneous report from a contactable consumer reporting on somebody else. A 68-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 22Apr2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma. Concomitant medications included asthma medication. The patient experienced death, spontaneous on 01May2021 and some sensations were in the chest in Apr2021. The outcome of some sensations were in the chest was recovered. The patient died on 01May2021. 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: Death, spontaneous


VAERS ID: 1306269 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001653 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Bipolar disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Haemorrhagic stroke; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC STROKE (Haemorrhagic stroke) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001653) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension and Bipolar disorder. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGIC STROKE (Haemorrhagic stroke) (seriousness criterion death). The patient died on 22-Apr-2021. The reported cause of death was Haemorrhagic stroke. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications and treatment information were provided.; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1306415 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-04-19
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Loss of consciousness, Pulse absent
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: Arterial hypertension; Blood pressure high; Treatment noncompliance
Preexisting Conditions: Medical History/Concurrent Conditions: Cranioencephalic trauma; Hernia repair (scrotal hernia surgery); Scrotal hernia; Traumatic brain injury; Comments: art. Hypertonie, OPS bei SHT, Z.n. Skrotalhernie operat. Noncompliance
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Pulse rate; Test Result: Negative ; Result Unstructured Data: Pulse absent
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS and PULSE ABSENT in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. art. Hypertonie, OPS bei SHT, Z.n. Skrotalhernie operat. Noncompliance. The patient''s past medical history included Scrotal hernia, Cranioencephalic trauma, Traumatic brain injury and Hernia repair (scrotal hernia surgery). Concurrent medical conditions included Arterial hypertension, Blood pressure high and Treatment noncompliance. On 12-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion death) and PULSE ABSENT (seriousness criterion death). The patient died on 19-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Heart rate: pulse absent (Negative) Pulse absent. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Company Comment: This is a case of death in a 54-year-old male subject with unknown medical history of HTN, and Traumatic brain injury, who died 10 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Translation received. On 05-May-2021: Dose 1 added.; Sender''s Comments: This is a case of death in a 54-year-old male subject with unknown medical history of HTN, and Traumatic brain injury, who died 10 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1306420 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal failure; Chronic renal failure anaemia (anemia (renal)); Coronary artery disease; Insulin-requiring type 2 diabetes mellitus (DM type 2 (insulin dependent)); Peripheral arterial disease; Subclavian steal syndrome (subclavian steal syndrome left)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021512158

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB (Regulatory Authority number AT-BASGAGES-2021-25045). A 94-year-old female patient received the first single dose of BNT162B2 (COMIRNATY; lot/batch J07BX03) intramuscular, on 03Feb2021, for COVID-19 immunisation. Medical history included multiple, severe previous illnesses: ongoing subclavian steal syndrome left, ongoing coronary artery disease, ongoing chronic renal failure, ongoing peripheral artery disease, ongoing anemia renal (chronic renal failure anaemia), ongoing DM type 2 (insulin dependent). Concomitant medications were not reported. The patient died in the presence of nursing staff in the nursing home on 05Feb2021 morning. Due to the pre-existing diseases and the old age, no doctor was consulted. A post-mortem examination was not performed, the exact cause of death was unclear. The patient''s outcome was: fatal for death NOS. Sender Comment: BASGAGES-comment: Follow-up information requested. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1306421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Condition aggravated, Cough, Dyspnoea, Ischaemic cardiomyopathy, Pyrexia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Ischaemic cardiomyopathy (Multimorbid patient with ischemic cardiomyopathy.); Multimorbidity (Multimorbid patient with ischemic cardiomyopathy.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021506075

Write-up: Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Dyspnea; Cough; Fever; This is a spontaneous report received from the regulatory authority. The regulatory authority report number is AT-BASGAGES-2021-25098. An 87-year-old male patient received bnt162b2 (COMIRNATY) unknown dose number, intramuscular on 28Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included multimorbid patient with ischemic cardiomyopathy, ongoing. The patient''s concomitant medications were not reported. On 29Apr2021, the patient experienced decompensated ischemic cardiomyopathy with new-onset atrial fibrillation, dyspnea, cough, and fever. The events decompensated ischemic cardiomyopathy with new-onset atrial fibrillation were reported as serious (death); events dyspnea, cough, and fever were reported as serious (medically significant). Clinical course details were reported as follows. On 29Apr2021, the patient had complained of fever, cough, and shortness of breath 24h after vaccination. The patient died 48 h after vaccination due to consequences of decompensated ischemic cardiomyopathy with new onset atrial fibrillation. Outcome of the events fever, cough, and dyspnea were not recovered; while fatal for decompensation myocardial, atrial fibrillation, exacerbation of disease. The patient died on 29Apr2021. It was not reported if an autopsy was performed. Reporter''s comment: A causal relationship with the vaccination seems unlikely to us. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: A causal relationship with the vaccination seems unlikely to us.; Sender''s Comments: Apart from a temporal association, there is not a reasonable possibility that the reported events (decompensated ischemic cardiomyopathy, atrial fibrillation, dyspnea, cough, and fever ) are related to BNT162B2 vaccine. The ongoing ischemic cardiomyopathy may provide a plausible explanation.in this multimorbid patient.; Reported Cause(s) of Death: Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardi


VAERS ID: 1306453 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOL [PANTOPRAZOLE]; SOLIAN; D-CURE; GLUCOPHAGE; APOCARD RETARD; BISOPROLOL [BISOPROLOL FUMARATE]; ZYPREXA VELOTAB; FOLAVIT; L-THYROXINE [LEVOTHYROXINE]; PROTHIADEN
Current Illness: Cardiac failure; Diabetes; Psychiatric disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Sudden death; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN DEATH (Sudden death) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001413) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Cardiac failure and Psychiatric disorder NOS. Concomitant products included PANTOPRAZOL [PANTOPRAZOLE], AMISULPRIDE (SOLIAN), COLECALCIFEROL (D-CURE), METFORMIN HYDROCHLORIDE (GLUCOPHAGE), FLECAINIDE ACETATE (APOCARD RETARD), BISOPROLOL FUMARATE (BISOPROLOL [BISOPROLOL FUMARATE]), OLANZAPINE (ZYPREXA VELOTAB), FOLIC ACID (FOLAVIT), L-THYROXINE [LEVOTHYROXINE] and DOSULEPIN HYDROCHLORIDE (PROTHIADEN) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient died on 08-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other concomitant medications included MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE Description: The patient had not reported any complaints during the day or signs after vaccination. The patient fell down in her room and must have died right away. She was hanging stockings on a heater, the position of the body clearly showed that she had fallen down and had not moved. The patient did not receive any treatment. Action taken with the drug in response to events was not applicable. Company comment:This is a case of death in a 56-year-old female subject with a medical history of Diabetes, Cardiac failure and Psychiatric disorder NOS, who died 7 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Translation received included medical history information.; Sender''s Comments: This is a case of death in a 56-year-old female subject with a medical history of Diabetes, Cardiac failure and Psychiatric disorder NOS, who died 7 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1306499 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Death, Dyspnoea, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), 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: 2021-04-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dialysis; Thrombotic microangiopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:low
CDC Split Type: DEPFIZER INC2021506083

Write-up: Unknown cause of death; Oxygen saturation low; Acute respiratory distress syndrome; Dyspnoea; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority DE-PEI-202100053684. A 69-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: Unknown) as UNKNOWN, 0.3ML SINGLE for COVID-19 immunization. Medical history included dialysis from Jun2005 and ongoing , thrombotic microangiopathy from Jun2005 and ongoing. The patient''s concomitant medications were not reported. On 19Apr2021, the patient experienced acute respiratory distress syndrome, dyspnoea, oxygen saturation low. On 23Apr2021, unknown cause of death was reported. The patient died on 23Apr2021. The outcome of the events was fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Oxygen saturation low; Acute respiratory distress syndrome; Dyspnoea; Unknown cause of death


VAERS ID: 1306501 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 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: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506138

Write-up: Asystolia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100054632. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: ER9480) as UNKNOWN, 0.3 mL, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Apr2021, the patient experienced asystolia. The patient died on 06Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reported Cause(s) of Death: Asystolia


VAERS ID: 1306502 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 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: 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: Hypertensive heart disease; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506141

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable physician reporting for a patient downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100054649. A 90-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EW8904) as UNKNOWN, 0.3 ML SINGLE for covid-19 immunisation, age at vaccination unknown. Medical history included ongoing hypertensive heart disease and ongoing hypothyroidism from an unspecified date. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on 12Apr2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events: Source of assessment: Regulatory Authority Result of Assessment: C. Inconsistent causal association to immunization. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1306503 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: Arterial hypertension; COPD; Dementia; Pleuritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506140

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB, regulatory authority number is DE-PEI-202100054650. An 86-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 07Jan2021 (Batch/Lot Number: Unknown) as unknown, 0.3 mL single (at the age of 86 years old) for COVID-19 immunisation. Medical history included ongoing pleuritis, arterial hypertension, COPD and dementia. The patient''s concomitant medications were not reported. On 15Jan2021, the patient experienced sudden cardiac death. The patient died on 15Jan2021. Death cause: pathologically-anatomically not ascertainable beyond doubt, conceivably most likely sudden cardiac death in high -grade 3-vessel coronary artery disease, mitral and aortic valve vitium, and chronic obstructive pulmonary disease; no meaningful association between vaccination and death. An autopsy was performed, and results were not provided. Relatedness of drug to reactions/events per PEI was D (Unclassifiable). No follow-up attempts are possible; Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1306504 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Ileus paralytic, Large intestine perforation
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Ischaemic colitis (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; General physical condition decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506134

Write-up: Acute heart failure/Toxic-resorptive cardiovascular failure; sigma perforation after massive stooling of the large intestine with suspected paralytic intestine / ileus; sigma perforation after massive stooling of the large intestine with suspected paralytic intestine / ileus; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100054651. An 85-year-old female patient received bnt162b2 (COMIRNATY, lot number was not reported), via an unspecified route of administration on 19Mar2021 (at the age of 85-years-old) as unknown, 0.3 mL single for covid-19 immunisation. The patient medical history included ongoing arterial hypertension, and ongoing general physical condition decreased from Jan2021. The patient''s concomitant medications were not reported. The patient experienced acute heart failure. Also, toxic - resorptive cardiovascular failure with sigma perforation after massive stooling of the large intestine with suspected paralytic intestine/ileus. The outcome of the events was fatal. The cause of death was acute heart failure and also reported as toxic - resorptive cardiovascular failure with sigma perforation after massive stooling of the large intestine with suspected paralytic intestine / ileus. The patient died on 20Mar2021. An autopsy was performed and results were not provided. This report is serious - death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Acute heart failure/Toxic-resorptive cardiovascular failure; Dead cause: Toxic-resorptive cardiovascular failure with sigma perforation after massive stooling of the large intestine with suspected paralytic intestine / ileus; Dead cause: Toxic-resorp


VAERS ID: 1306505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated
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: DEPFIZER INC2021506126

Write-up: Condition worsened; This is a spontaneous report from a non-contactable other healthcare professional downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100054652. A female patient of an unspecified age received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 14Jan2021 as unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced condition worsened with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Condition worsened


VAERS ID: 1306506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Dyspnoea, Fatigue, Retching
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506136

Write-up: Dyspnoea; Gagging; Condition worsened; Tiredness; This is a spontaneous report from a non-contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100054653. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: Unknown) as UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced condition worsened on 31Jan2021, tiredness on 26Jan2021, dyspnoea and gagging on 06Feb2021. The patient died on 15Feb2021. Outcome of the events was fatal. 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: Tiredness; Dyspnoea; Gagging; Condition worsened


VAERS ID: 1306512 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

Administered by: Unknown       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: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Coronary heart disease; Dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. Concurrent medical conditions included Dialysis, Cardiac failure and Coronary heart disease. On 24-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MYOCARDIAL INFARCTION seriousness criterion death). The patient died on 31-Mar-2021. The reported cause of death was Infarct myocardial. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION to be unlikely related. The concomitant medications were not reported. The patient was resuscitated and later died at the hospital. The relationship to the vaccine was considered unlikely because the patient had severe heart disease. The action taken with mRNA 1273 with the event was not applicable. Company comment: This is a case of death in a 63-year-old male subject with a medical history of Dialysis, Cardiac failure and Coronary heart disease, who died 7 days after receiving the first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Translation received. Narrative updated.; Sender''s Comments: This is a case of death in a 63-year-old male subject with a medical history of Dialysis, Cardiac failure and Coronary heart disease, who died 7 days after receiving the first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1308160 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Investigation, Pyrexia
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: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Investigations; Result Unstructured Data: Test Result:Apart from the vaccine, no other causes were clear; Comments: identified
CDC Split Type: FIPFIZER INC2021506113

Write-up: Pyrexia; Confusional state; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20212186. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 14Apr2021 (Batch/Lot Number: UNKNOWN) as 2ND DOSE single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received first dose of the vaccine COMIRNATY on 20Jan2021 for COVID-19 immunization (First vaccine dose). On April 16, 2021 at 1 p.m., a severe fever and confusion began. The patient''s condition collapsed at a rapid pace and he died on 16Apr2021 in the hospital emergency room. Apart from the vaccine, no other causes were clearly identified in the performed investigations. The patient underwent lab tests and procedures which included investigation: apart from the vaccine, no other causes were clear on an unspecified date identified. The patient died on 16Apr2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pyrexia; Confusional state


VAERS ID: 1308162 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congenital heart disease NOS (Congenital heart defect fixed); Obesity; Sleep apnea; Tetralogy of Fallot
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021506764

Write-up: pulmonary embolism; This is a spontaneous report from a contactable consumer. A 43-years-old non-pregnant female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Apr2021 10:00 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. Medical history included congenital heart defect fixed, Tetralogy of Fallot, sleep apnea and obesity. The patient''s concomitant medications were not reported. The patient had no other vaccine in four weeks, and no other medications in two weeks. The patient has no Covid prior vaccination and it was unknown if the patient tested for Covid post vaccination. The patient died within 24 hours from receiving the vaccination, most probably due to pulmonary embolism. The patient died on 23Apr2021. Autopsy was performed, and autopsy investigation results are pending. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1308178 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-13
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021506254

Write-up: Vaccination failure/COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from contactable physician downloaded from the regulatory authority-WEB regulatory authority or other manufacturer number FR-AFSSAPS-BX20213928, Safety Report Unique Identifier FR-AFSSAPS-2021046483. A 89-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 23Feb2021 (Batch/Lot Number: EM6950) as 2nd dose, single; via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included dementia (Unlabeled dementia) and Unwanted effect. Patient living in nursing home. The patient''s concomitant medications were not reported. COVID infection with progression towards the death of patient, despite complete diagram bnt162b2. COVID infection at 49 days of the 2nd dose of the vaccine, Positive Covid-19 PCR test on 13Apr2021, progressive asthenia and hypoxia (desaturation) on 23apr2021 with fatal evolution (without more precision). The patient experienced vaccination failure and covid-19 confirmed by positive covid-19 test on 13Apr2021. The patient died on Apr2021. It was not reported if an autopsy was performed. N.B.: Imputation made without prejudice to the elements of investigations which could be carried out in the framework of legal or amicable compensation procedures. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Vaccination failure/COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1308338 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (with left cardiac decompensation (2019)); Basedow''s disease (treated with ATS); Breast cancer (CANCER of the left breast (mastectomy in 2007, prosthesis), treated by FEMARA until 2011.); Cushing''s syndrome ((bilateral nodular hyperplasia of the adrenals with moderate ACTH-independent hypercortisolemia)); Dyslipidaemia; Hypertension arterial; Mastectomy (prosthesis); Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20190531; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:good LV function, moderate mitral leakage with di; Comments: good LV function, moderate mitral leakage with dilated left atrium, moderate aortic leak, dry pericardium, systolic pulmonary artery pressure (sPAP) not evaluable.
CDC Split Type: FRPFIZER INC2021506195

Write-up: Sudden death unexplained/ died the next day at 3:15 p.m. without clinical symptoms; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PB20212451 Safety Report Unique Identifier FR-AFSSAPS-2021044883. An 82-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: EW4815), intramuscular on 23Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included parkinson''s disease, breast cancer treated by FEMARA until 2011, Cushing''s syndrome (bilateral nodular hyperplasia of the adrenals with moderate ACTH-independent hypercortisolemia), atrial fibrillation with left cardiac decompensation (2019), Basedow''s disease from 1980 to an unknown date treated with ATS, dyslipidaemia, hypertension, mastectomy from 2007 to an unknown date prosthesis. The patient''s concomitant medications were not reported. The patient died the next day (24Apr2021) at 3:15 p.m. without clinical symptoms. The patient underwent lab tests and procedures which included echocardiogram on 31May2019 with good LV function, moderate mitral leakage with dilated left atrium, moderate aortic leak, dry pericardium, systolic pulmonary artery pressure (sPAP) not evaluable. The patient died on 24Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: She died the next day at 3:15 p.m. without clinical symptoms


VAERS ID: 1308353 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 24
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: AFib (complete arrhythmia due to atrial fibrillation); Arrhythmia; Arterial hypertension (history of high blood pressure); Diabetes; Heart failure; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: computerised tomography scan; Result Unstructured Data: Test Result:no lesion and it was considered to be located in t; Comments: no lesion and it was considered to be located in the brainstem
CDC Split Type: FRPFIZER INC2021506214

Write-up: CVA/stroke; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB FR-AFSSAPS-RN20211134, Safety Report Unique Identifier FR-AFSSAPS-2021042271. This is a report received from the Regulatory Authority. A 79-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 15Mar2021 (Batch/Lot Number: EP9605) as 2nd dose, single (1 injection D2) for covid-19 immunisation. Medical history included diabetes, obesity, heart failure, complete arrhythmia due to atrial fibrillation and arterial hypertension (history of high blood pressure). The patient has no allergies. The patient is treated long term with an anticoagulant (not specified). Living quarters not specified. The patient has no history of COVID-19 and was not tested for COVID-19. The patient''s concomitant medications were not reported. The patient experienced CVA on 26Mar2021. The patient was vaccinated on 15Mar2021 with COMIRNATY with immediate good tolerance. On 26Mar2021, 11 days after the vaccination, he presented with a stroke in a comatose state and with massive left haemiplegia initially, with no lesion on the computerised tomography scan and it was considered to be located in the brainstem. The patient was hospitalized and died on Mar2021. An autopsy was not performed. Subject to further investigations that could be carried out as part of legal or amicable compensation procedures. Reported Cause(s) of Death: CVA/stroke


VAERS ID: 1308370 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral amyloid angiopathy, Computerised tomogram, Haemorrhagic stroke, Investigation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 22
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: OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion (pace maker for sinoatrial rhythm disorder since the age of 45); Cardiovascular disorder (pace maker for sinoatrial rhythm disorder since the age of 45); GERD (treated with omeprazole)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: CT scan; Result Unstructured Data: Test Result:parenchymal hemorrhage; Comments: this parenchymal hemorrhage presented features consistent with the diagnosis of cerebral amyloid angiopathy; Test Date: 202104; Test Name: Imaging analysis; Result Unstructured Data: Test Result:2-stage frontal cerebral hemorrhage; Test Date: 202103; Test Name: Rhythmology; Result Unstructured Data: Test Result:without anomaly, no hypertension
CDC Split Type: FRPFIZER INC2021506180

Write-up: Hemorrhagic stroke/spontaneous, lobar, left fronto-parietal intracerebral hemorrhage/cerebral hematoma; cerebral amyloid angiopathy; This is as spontaneous report downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-TO20213024 , Safety report unique identifier FR-AFSSAPS-2021045530. A contactable physician reported that a 74-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: ER9470), intramuscular, administered in the left arm on 03Apr2021 as a single dose for COVID-19 vaccination. Medical history included cardiac pacemaker insertion for sinoatrial rhythm disorder from an unspecified date, since the age of 45 and GERD from an unknown date treated with omeprazole. Rhythmology assessment in Mar2021 was without anomaly, no hypertension. Concomitant medication included omeprazole (manufacturer unknown) taken for GERD, start and stop date were not reported. The patient had a hemorrhagic stroke on 20Apr2021, (also reported as 20 days after the first COVID-19 injection with the Pfizer vaccine). The patient underwent Emergency admission on 20Apr2021 then hospitalization in the intensive care of the neurovascular service on 23Apr2021 at 22:00 for a spontaneous, lobar, left fronto-parietal intracerebral hemorrhage, centered on the Rolando. Imaging analysis is consistent with a 2-stage frontal cerebral hemorrhage. On CT scan, this parenchymal hemorrhage presented features consistent with the diagnosis of cerebral amyloid angiopathy. This was the first hemorrhagic event in this patient who until now had perfect cognitive and physical autonomy and had no particular pathology. It was also reported that in retrospect, the patient''s husband reports headaches 10 days before the stroke he There was no PSA monitoring performed. The patient died on 23Apr2021 as a result of this alertness disorder and cerebral hematoma, under analgesic and comfort treatment. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhagic stroke/spontaneous, lobar, left fronto-parietal intracerebral hemorrhage/cerebral hematoma


VAERS ID: 1308386 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-27
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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: 2021-05-06
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ARICEPT; TOCO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Peritoneal fibrosis
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Nasal Swab - Covid-19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021518031

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer or other non HCP. An 88-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration at the age of 88-year-old, administered in arm left on 26Feb2021 16:30 (Batch/Lot Number: EP2166) as single dose; dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot Number: Unknown) as single dose; for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included peritoneal fibrosis. Concomitant medications included donepezil hydrochloride (ARICEPT); tocopheryl acetate (TOCO, strength 500 with no unit). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced drug ineffective, covid-19 on 27Apr2021 12:00. On 27Apr2021, nasal swab was positive to Covid-19. The events required emergency room visit, then hospitalization for 6 days. Therapeutic measures included oxygen therapy (60 liters). The patient died on 06May2021 due to Covid-19. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Covid-19


VAERS ID: 1308425 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Fall, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: Coronary artery bypass graft; Ischemic heart disease; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021469012

Write-up: Myocardial infarction; Myocardial infarction; Fall; This is a spontaneous report from a contactable other healthcare professional. This is a report received from a regulatory authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202104261015540100-S1XDE, Safety Report Unique Identifier GB-MHRA-ADR 25196416. An 84-year-old male patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration at 1st dose, single on 31Mar2021 for COVID-19 immunization. Medical history included coronary artery bypass graft (CABG), ischemic heart disease (IHD) and myocardial infarction (MI). Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced myocardial infarction; fall on 04Apr2021. The patient died on 13Apr2021 with myocardial infarction. Patient has not tested positive for COVID-19 since having the vaccine.The cause of death was myocardial infarction. The outcome of event fall was recovered on an unspecified date; myocardial infarction was fatal. It was unknown if an autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: myocardial infarction


VAERS ID: 1308588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-03-24
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute aortic syndrome, COVID-19, Chronic obstructive pulmonary disease, Drug ineffective, SARS-CoV-2 test, Wrong product administered
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute aortic syndrome; COPD
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021492612

Write-up: Acute aortic syndrome; exacerbation of COPD; SARS-CoV-2 infection; SARS-CoV-2 infection; first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose COVID-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA; This is a spontaneous report from a contactable Physician. This is a report received from a regulatory authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202104300946529940-PEXZK, Safety Report Unique Identifier is GB-MHRA-ADR 25223208. An 89-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on 13Jan2021 as single dose and second dose of COVID-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA, lot number and expiration date unknown) via an unspecified route of administration on 24Mar2021 as single dose both for COVID-19 immunization. Medical history included acute aortic syndrome and chronic obstructive pulmonary disease (COPD). Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced acute aortic syndrome on an unspecified date and SARS-COV-2 infection on 22Apr2021. The patient was hospitalized for acute aortic syndrome from 21Apr2021 to an unknown date. Positive RT-PCR (Cepheid) on 22Apr2021 was positive. Patient required steroids for exacerbation of COPD (unspecified date). It was reported that the patient died as a consequence of acute aortic syndrome, not COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test with yes - positive COVID-19 test result on 22Apr2021. The patient died on an unspecified date. The patient not recovered from SARS-COV-2 infection while the outcome for exacerbation of COPD was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Acute aortic syndrome


VAERS ID: 1308607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diplegia, Dizziness, Laboratory test, Loss of consciousness, Monoplegia, Myocardial infarction, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder NOS (had to undergo a coronary angioplasty, but she had postponed it for unknown reasons)
Allergies:
Diagnostic Lab Data: Test Name: laboratory examination; Result Unstructured Data: Test Result:nothing shown
CDC Split Type: GRPFIZER INC2021520736

Write-up: fever; loss consciousness/blackout; vomiting; dizziness; paralysis at the arms and legs; paralysis at the arms and legs; unknown cause of death; myocardial infarction/symptoms of myocardial infarction.; This is a spontaneous report from a contactable consumer and from a contactable physician via a sales representative also reported from a non-contactable consumer. A 68-years-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 04May2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation . Medical history included Cardiac problems from an unknown date and unknown if ongoing (''had to undergo a coronary angioplasty, but she had postponed it for unknown reasons'') The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on an unspecified date , myocardial infarction on 05May2021 , loss consciousness/blackout, vomiting, dizziness, paralysis at the arms and legs on 04May2021, fever on an unspecified date . The patient underwent lab tests and procedures which included laboratory test: nothing shown on an unspecified date. The patient died on 05May2021. It was not reported if an autopsy was performed. ''It was mentioned on the media'': Coronovirus: 68-year-old dies a few hours after second dose of Covid vaccine. Lawsuit against anyone responsible from the children of the unfortunate 68-year-old - She was vaccinated with Pfizer. According to her family, the woman had no underlying disease. According to the lawsuit that has been filed, the 68-year-old received the first dose of the Pfizer vaccine on April 14, while the second was scheduled for May 4. After the second dose, the woman stayed for half an hour at the Health Center where she was vaccinated and left, with her daughter, who had accompanied her. A few hours later, on the night of May 4, the 68-year-old began to feel blackout, dizziness, vomiting and paralysis of her arms and legs. Her children took her to the hospital where she described to the doctor on duty her symptoms. There, they did some tests (details not provided) without finding anything, while according to the patient''s children, the doctors from the hospital said that they were adverse events of the second dose of the vaccine and that it would not happen again, giving the woman discharge. According to the lawsuit of the family of the 68-year-old, a few hours later (according to another article next day) the woman developed fever, while she had the same symptoms with vomiting and paralysis of the limbs. Her children took her to the hospital in their car as there was no free ambulance. Arriving at the hospital, the 68-year-old had lost consciousness, but remained alive with a low pulse. The doctors proceeded to intubation, but after about half an hour, she died. According to her family, the woman had no underlying disease and was in excellent physical condition. The lawyer of the family, [Privacy] filed a lawsuit against anyone responsible to investigate the possibility of committing criminal acts in any way. The family also appointed a medical examiner as a technical consultant and thus blocked the burial. The necropsy will take place on Tuesday and the findings of the forensic examination are awaited.'' It was also reported: The same report was received from a contactable physician through a sales representative. A pediatrician reported that this 68 year old female was administered the 2nd dose of Comirnaty on 04May2021 at the Health Center. After the vaccination, the patient was fine and left the Health Center without any problem. The following day the physician heard that the patient came to the Hospitals Emergency Room with symptoms of myocardial infarction. The physician reported that according to information the patient had cardiac problems and had to undergo a coronary angioplasty, but she had postponed it for unknown reasons. The clinical outcome of the events Vomiting, Dizziness, Monoplegia, Diplegia, Pyrexia, loss consciousness/blackout were unknown., While myocardial infarction and unknown cause of death was fatal.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1308621 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NOACID; THIOGAMMA; FURON [FUROSEMIDE SODIUM]; GLURENORM; TANYDON; KALDYUM; MODUXIN MR; ALFUZOSIN; ASACTAL; NEBILET
Current Illness: Cardiac insufficiency; Cerebral arteriosclerosis; Diabetes mellitus; Hypertension; Myocardial ischaemia; Polyneuropathy; Prostatic hypertrophy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021480830

Write-up: cardiac insufficiency; myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is HU-OGYI-240921. A 95-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EL0725), intramuscular, administered in left arm on 17Feb2021, at 14:00 as 0.3 mg/m2, single for covid-19 immunisation. Medical history included ongoing hypertension, ongoing polyneuropathy, ongoing diabetes mellitus, ongoing cardiac insufficiency, ongoing prostatic hypertrophy, ongoing myocardial ischaemia, ongoing cerebral arteriosclerosis, all from unspecified dates. Concomitant medications included pantoprazole (NOACID) taken for an unspecified indication, start and stop date were not reported; thioctic acid (THIOGAMMA) taken for an unspecified indication, start and stop date were not reported; furosemide sodium(FURON) taken for an unspecified indication, start and stop date were not reported; gliquidone (GLURENORM) taken for an unspecified indication, start and stop date were not reported; telmisartan (TANYDON) taken for an unspecified indication, start and stop date were not reported; potassium chloride (KALDYUM) taken for an unspecified indication, start and stop date were not reported; trimetazidine hydrochloride (MODUXIN MR) taken for an unspecified indication, start and stop date were not reported; alfuzosin (ALFUZOSIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASACTAL) taken for an unspecified indication, start and stop date were not reported; nebivolol hydrochloride (NEBILET) taken for an unspecified indication, start and stop date were not reported. On 20Feb2021, the patient experienced cardiac insufficiency, which was serious as it involved hospitalization and lead to death. Details were as follows: On 20Mar2021, the patient was submitted to hospital due to worsening cardiac insufficiency and confusion. The patient died on 22Feb2021. An autopsy was performed and results were not provided. Cause of death was myocardial infarction. The physician does not suppose relationship with vaccination. Sender Comment: Cardiac insufficiency is not expected adverse event of COMIRNATY. It might be resulted by the patient''s cardiovascular diseases. TTO was 3 days. Based on the above, relationship between the event and COMIRNATY is unlikely. The case is serious because the patient died. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1308622 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-18
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Chest X-ray, Drug ineffective, SARS-CoV-2 test
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: 2021-04-05
   Days after onset: 18
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: FURON [FUROSEMIDE]; HUMA-PRONOL; JARDIANCE; KALDYUM; PANTOPRAZOLE; RIVOTRIL; TIAPRIDAL; VEROSPIRON
Current Illness: Hospitalization (for alcohol-induced liver cirrhosis)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol dependence syndrome; Ascites; Cirrhosis alcoholic (been decompensated parenchymally and vasculrisically); Decubitus; Hydrothorax; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: Chest X-ray; Result Unstructured Data: Test Result:right lung pneumonia infiltrate and right upper lo; Comments: right lung pneumonia infiltrate and right upper lobe atelectasia; Test Date: 20210318; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021506492

Write-up: COVID-19 PCR test positive; COVID-19 PCR test positive/COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-241221. A 69-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot: EP2163), intramuscular in left arm on 02Mar2021 as 1 st dose, 0.3 ml single for covid-19 immunisation. Medical history included hydrothorax on 22Jan2021, ascites, hypertension, decubitus, Alcohol dependence syndrome and cirrhosis alcoholic (been decompensated parenchymally and vasculrisically), all not ongoing and permanent hospitalization ongoing from Dec2010 (for alcohol-induced liver cirrhosis). Concomitant medications included furosemide (FURON); propranolol hydrochloride (HUMA-PRONOL); empagliflozin (JARDIANCE); potassium chloride (KALDYUM); pantoprazole; clonazepam (RIVOTRIL); tiapride hydrochloride (TIAPRIDAL) and spironolactone (VEROSPIRON). No side effects were observed after vaccination, the patient''s condition was dominated by alcoholic liver cirrhosis for which he was hospitalized. The patient experienced covid-19 pcr test positive (death, hospitalization) on 18Mar2021 and was placed in the hospital''s COVID department. The patient underwent lab tests and procedures which included chest x-ray on 26Mar2021 right lung pneumonia infiltrate and right upper lobe atelectasia. Despite the applied antiviral, antibiotic, steroid, LMWH therapy, the patient''s condition gradually deteriorated and he died on 05Apr2021. The patient died on 05Apr2021 with cause of death was respiratory and circulatory insufficiency on the ground of hydrothorax in consequence of hepatic cirrhosis due to alcohol dependence, next to COVID-19 pneumonia (drug ineffective) according to the death certificate. An autopsy was not performed. Sender Comment: COVID-19 PCR test became positive 16 days after Comirnaty vaccination, the patient died 34 days after vaccination. Autopsy was not done. Cause of death was respiratory and circulatory insufficiency on the ground of hydrothorax in consequence of hepatic cirrhosis due to alcohol dependence, next to COVID-19 pneumonia. Immunity may not be fully developed 2 weeks after the first dose. The case is serious due to fatal outcome. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: respiratory and circulatory insufficiency on the ground of hydrothorax in consequence of hepatic cirrhosis due to alcohol dependence, next to COVID-19 pneumonia; respiratory and circulatory insufficiency on the ground of hydrothorax in consequence of


VAERS ID: 1308623 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-13
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Drug ineffective, Suspected COVID-19
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   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: Benign meningioma; Cholecystectomy; Epilepsy; Stomach cancer; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021506497

Write-up: Vaccination failure; possibility of vaccination failure; cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB, regulatory authority number HU-OGYI-254921. An 85-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EP2166) as 2nd dose, 0.3 ml single for COVID-19 immunization. Medical history included epilepsy, benign meningioma, stomach cancer, stroke and cholecystectomy. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY) on 04Feb2021 (batch number: EP0725) for COVID-19 immunization. On 13Mar2021 at 13:45, the patient passed away. The cause of death was cardiac arrest. It was not reported if an autopsy was performed. The patient died 15 days after the booster shot, therefore there''s a possibility of vaccination failure, however the reporter physician assessed the adverse event as related to the patient''s primary diseases. The events were assessed as serious-fatal. Sender Comment: According to the guidelines of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient died 15 days after the booster shot, therefore there''s a possibility of vaccination failure, however the reporter physician assessed the adverse event as related to the patient''s primary diseases. Based on the above, the causal relationship cannot be excluded between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1308624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-16
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK LA / 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: 2021-03-16
   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: Atherosclerosis of arteries of the extremities; Hyperlipidaemia; Hypertension; Pulmonary embolism (in chronic anticoagulant program)
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021506499

Write-up: Cardiac insufficiency; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-255121. A 80-years-old female patient received the first dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on 25Feb2021 (Lot Number: EP2166) as 0.3 ml single for covid-19 immunisation. Medical history included hyperlipidaemia unknown if ongoing, hypertension unknown if ongoing, peripheral arterial occlusive disease unknown if ongoing, pulmonary embolism from 05Feb2020 to 15Feb2020 (in chronic anticoagulant program). The patient''s concomitant medications were not reported. The patient experienced cardiac insufficiency on 16Mar2021. The patient died on 16Mar2021 at 11:50. The cause of death was cardiac insufficiency. It was not reported if an autopsy was performed. On 16Mar2021 at 11:50 the patient passed away. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse event as the reporter physician assessed the adverse event as related to the patient''s primary diseases. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Based on the information available the event cardiac insufficiency is attributed to patient''s multiple underlying medical conditions and assessed unrelated to BNT162b2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: Cardiac insufficiency


VAERS ID: 1308645 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: CARDIRENE; ENALAPRIL IDROCLOROTIAZIDE EG; COLECALCIFEROL; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Cerebrovascular accident; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021. The most recent information was received on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No medical history was provided by the reporter. On 01-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 08-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criterion death). The patient died on 10-Apr-2021. The reported cause of death was Stroke. 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 treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 83-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, who died 10 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible. Senders case reference number is IT-MINISAL02-714401. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Stop date of the event and date of death was updated.; Sender''s Comments: This is a case of death in a 83-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, who died 10 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: stroke


VAERS ID: 1308648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-04-06
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725_65_008 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   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: Anaemia; Atrial fibrillation; Diabetes; Hypertension; Senile degeneration of brain
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: SARS-CoV-2 molecular test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC2021434348

Write-up: SUSPECTED CLINICAL VACCINE FAILURE AS COVID 19 POSITIVE PATIENT FOLLOWING MOLECULAR SWAB AFTER 2 PFIZER DOSES. ASYMPTOMATIC PATIENT; SUSPECTED CLINICAL VACCINE FAILURE AS COVID 19 POSITIVE PATIENT FOLLOWING MOLECULAR SWAB AFTER 2 PFIZER DOSES. ASYMPTOMATIC PATIENT; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority, number IT-MINISAL02-716222. An 85-year-old female patient received bnt162b2 (COMIRNATY), first dose (lot number: EJ6797_65_003 ) on 21Jan2021, 1st dose, single, unspecified route of administration; second dose (lot number: EL0725_65_008) , intramuscular on 12Feb2021 12:17as 2nd dose, 0.3 mL, single for covid-19 immunisation. Medical history included , atrial fibrillation, diabetes, hypertension, anaemia, senile degeneration of encephalon, all from an unknown date. The patient''s concomitant medications included eight unspecified medicines for atrial fibrillation, diabetes, hypertension, anaemia, senile degeneration of encephalon. The patient experienced asymptomatic covid-19 on 06Apr2021 considered as non-serious by the reporter who described the event as: ''suspected clinical vaccine failure as covid 19 positive patient following molecular swab after 2 pfizer doses. Asymptomatic patient''. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Apr2021. The events was fatal and the patient died on 25Apr2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Asymptomatic COVID-19; Asymptomatic COVID-19


VAERS ID: 1308656 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoptysis, Loss of consciousness, Oesophageal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENTELAN; PALEXIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nephrectomy (NEPHRECTOMY OF THE LEFT KIDNEY BY ETP); Surgery (hernia operation); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: ch
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Oesophageal haemorrhage; Unconsciousness; Haemoptysis; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OESOPHAGEAL HAEMORRHAGE (Oesophageal haemorrhage), LOSS OF CONSCIOUSNESS (Unconsciousness) and HAEMOPTYSIS (Haemoptysis) in a 60-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. Co-suspect products included non-company products CABOZANTINIB S-MALATE (CABOMETYX) for an unknown indication and ENALAPRIL MALEATO (NAPRILENE 20 MG COMPRESSE) for Hypertension. The patient''s past medical history included Surgery (hernia operation) and Nephrectomy (NEPHRECTOMY OF THE LEFT KIDNEY BY ETP). Concomitant products included BETAMETHASONE SODIUM PHOSPHATE (BENTELAN) and TAPENTADOL HYDROCHLORIDE (PALEXIA) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On an unknown date, the patient started CABOZANTINIB S-MALATE (CABOMETYX) (unknown route) dosage form On an unknown date, CABOZANTINIB S-MALATE (CABOMETYX) (unknown route) dosage was changed to at an unspecified dose. and ENALAPRIL MALEATO (NAPRILENE 20 MG COMPRESSE) (unknown route) 20 milligram. On 02-Apr-2021, the patient experienced OESOPHAGEAL HAEMORRHAGE (Oesophageal haemorrhage) (seriousness criterion death), LOSS OF CONSCIOUSNESS (Unconsciousness) (seriousness criterion medically significant) and HAEMOPTYSIS (Haemoptysis) (seriousness criterion medically significant). On 02-Apr-2021, LOSS OF CONSCIOUSNESS (Unconsciousness) and HAEMOPTYSIS (Haemoptysis) outcome was unknown. The patient died on 02-Apr-2021. The reported cause of death was Oesophageal haemorrhage. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. At 7:15 PM, the patient started vomiting blood . The blood came from his oesophagus.and shortly afterwards lost consciousness. Treatment provided included resuscitation and medical observation. No additional treatment was provided. The reporter did not provide any causality assessments. This is a case of death in a 60-year-old male subject with a medical history of Surgery (hernia operation) and Nephrectomy (LEFT KIDNEY), who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Translation provided primary source reaction details. On 03-May-2021: No new information; Sender''s Comments: This is a case of death in a 60-year-old male subject with a medical history of Surgery (hernia operation) and Nephrectomy (LEFT KIDNEY), who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Oesophageal haemorrhage


VAERS ID: 1308765 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW 2246 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (without insulin); Prostate cancer (treated with puncture every 3 months)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021501418

Write-up: Stroke; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-723042. A 79-year-old male patient received the first dose of BNT162B2 (COMIRNATY, COVID 19 COMIRNATY VACCINE, lot number: EW 2246), via an unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunisation. Medical history included mild diabetes (without insulin) and prostate cancer treated with puncture every 3 months. The patient''s concomitant medications were not reported. The patient experienced stroke on 10Apr2021. Patient was hospitalized for this event. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1308987 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Decreased appetite, Feeling abnormal
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), Dementia (broad), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: LEUPLIN PRO; BICALUTAMIDE; OLMESARTAN; BISOPROLOL; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic dissection; Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210429; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210507; Test Name: Postmortem CT examination; Result Unstructured Data: Test Result:Thoracic aortic dissection was found
CDC Split Type: JPPFIZER INC2021510386

Write-up: Thoracic aortic dissection; Cardiopulmonary arrest (CPA); Feels poorly; Appetite impaired; This is a spontaneous report from a contactable physician received via a regulatory authority; and then received from a regulatory authority. Regulatory authority report number is v21105134. A 69-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly, administered in the right arm on 29Apr2021 at 14:30 (Batch/Lot Number: EP2163; Expiration Date: 31May2021) at 69-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included aortic dissection from an unknown date and unknown if ongoing, and prostate cancer from an unknown date and unknown if ongoing. Concomitant medications included leuprorelin acetate (LEUPLIN PRO; 22.5mg, injection); bicalutamide (MANUFACTURER UNKNOWN; 80mg); olmesartan (MANUFACTURER UNKNOWN; 20mg, orodispersible tablet); bisoprolol (MANUFACTURER UNKNOWN; 2.5mg); amlodipine (MANUFACTURER UNKNOWN; 5mg, orodispersible tablet); all within two weeks of vaccination, and taken for an unspecified indication, start and stop date were not reported. On 06May2021, 6 days 9 hrs. 30 min, the patient experienced: feels poorly (non-serious) and appetite impaired (non-serious). On 07May2021 at 09:00, 7 days 18 hrs. 30 min after the vaccination, the patient experienced: thoracic aortic dissection (death, medically significant), and cardiopulmonary arrest (CPA) (death, medically significant). The clinical course was reported as follows: "On 06May2021 (6 days after vaccination), feels poorly and appetite impaired were noted. On 07May2021 at 09:00 (7 days after vaccination), the patient got into the bathroom at home. As the patient did not come out for about 20 minutes, his family checked the bathroom and found him there. On 07May2021 at 9:20 (7days after vaccination), the patient was emergently transferred in cardiopulmonary arrest (CPA). At 10:11, resuscitation was performed, but the patient did not respond, and the patient was confirmed dead. Postmortem CT examination on 07May2021 showed thoracic aortic dissection. The outcome of the event cardiopulmonary arrest was fatal without treatment (as reported). On 07May2021 at 10:11 (7 days 19 hours and 41 minutes after the vaccination), the patient died. An autopsy was not performed." The contactable physician reported to a regulatory authority (Regulatory authority report number is v21105134) the clinical course as follows: The 69-year-7-month old male received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EP2163, Expiration date 31May2021) on 29Apr2021 at 14:30 (the day of vaccination) at the age of 69-year-7-month old. Body temperature before vaccination on 29Apr2021 was 36.7 degrees Celsius. The patient was concomitantly taking leuprorelin acetate (LEUPLIN PRO 22.5MG, injection), oral bicalutamide (80MG), oral olmesartan (20MG, orodispersible tablet), oral bisoprolol (2.5MG), and oral amlodipine (5MG, orodispersible tablet). The reporting physician assessed the causality between the event, thoracic aortic dissection, and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases was thoracic aortic dissection (as reported). The patient underwent lab tests and procedures which included body temperature: 36.4 Centigrade on 29Apr2021 (Before vaccination), computerised tomogram (Postmortem CT examination): thoracic aortic dissection was found on 07May2021. Therapeutic measures were taken as a result of cardiopulmonary arrest (CPA). The clinical outcome of the events feels poorly and appetite impaired, was unknown. The clinical outcome of the events: thoracic aortic dissection (death, medically significant), and cardiopulmonary arrest (CPA), was fatal. The patient died on 07May2021 at 10:11 (7 days 19 hours and 41 minutes after the vaccination) due to thoracic aortic dissection and cardiopulmonary arrest (CPA). An autopsy was not performed.; Reported Cause(s) of Death: Thoracic aortic dissection; cardiopulmonary arrest (CPA)


VAERS ID: 1308993 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cerebral infarction, Coma scale, Computerised tomogram, Computerised tomogram head, Diarrhoea, Heart rate, Oxygen saturation
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: ASPARA POTASSIUM; LANSOPRAZOLE; MOSAPRIDE CITRATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deaf mutism; Nutritional supplement; Rehabilitation therapy
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: Blood pressure; Result Unstructured Data: Test Result:128/73 mmHg; Test Date: 20210428; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210507; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Test Date: 20210507; Test Name: JCS; Result Unstructured Data: Test Result:200; Test Date: 20210506; Test Name: Abdominal CT; Result Unstructured Data: Test Result:revealed no clear abnormality; Test Date: 20210507; Test Name: Head CT; Result Unstructured Data: Test Result:no haemorrhage intracranial was found; Test Date: 20210507; Test Name: Pulse; Result Unstructured Data: Test Result:58/min; Test Date: 20210507; Test Name: Peripheral oxygen saturation; Test Result: 97 %
CDC Split Type: JPPFIZER INC2021511530

Write-up: Cerebral infarction (vomiting and consciousness disturbed); Diarrhoea; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is v21105068. A 76-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EW4811, Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 28Apr2021, at 12:00 as single dose for covid-19 immunization. Medical history included deaf mutism, rehabilitation therapy, and nutritional supplementation from an unknown date and unknown if ongoing. Concomitant medications included potassium aspartate (ASPARA POTASSIUM) taken for an unspecified indication, start and stop date were not reported; lansoprazole (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported; mosapride citrate (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebral infarction (vomiting and consciousness disturbed) on 02May2021, at 10:30, which was serious as it lead to death and diarrhoea on 02May2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure: 128/73 mmhg on 07May2021, body temperature: 36.3 Centigrade on 28Apr2021 before vaccination, body temperature: 35.7 Centigrade on 07May2021 Coma Scale: 200 on 07May2021, abdominal computerised tomogram: revealed no clear abnormality on 06May2021, computerised tomogram head: no haemorrhage intracranial was found on 07May2021, pulse: 58/min on 07May2021, Peripheral oxygen saturation: 97 % on 07May2021. Therapeutic measures were taken as a result of cerebral infarction (vomiting and consciousness disturbed). Details were as follows: The patient was a 76-year and 2-month-old female. Body temperature before vaccination was 36.3 degrees centigrade. Family was nothing noteworthy (no alive relatives other than the older brother and younger sister who have adult guardians and are receiving a residential care for intellectual disability). Medical history included deaf mutism, rehabilitation therapy, and nutritional therapy (although the patient was hospitalized over the last 1 month, she mainly received treatments like rehabilitation therapy and nutritional therapy and underwent no medical interventions other than oral drug treatment). On 02May2021 at 10:30 (4 days after the vaccination), the patient experienced cerebral infarction (vomiting and consciousness disturbed). On an unknown date, after the vaccination, the patient''s hospitalization was prolonged, no otherwise specified. On 07May2021 (9 days after the vaccination), the patient was discharged, and the outcome of the event was fatal. The event course of the event was as follows: On 02May2021 (4 days after the vaccination), the patient had several episodes of vomiting and diarrhoea, due to which she received intravenous therapy while fasting temporarily. On 06May2021, abdominal computerised tomography (CT) revealed no clear abnormality, and aggravation of general condition was confirmed to be absent; the patient restarted eating. On the same day, the patient experienced no changes in the consciousness level, had full meals, and felt asleep. On 07May2021 at 5:45, the patient was found to have a sudden onset of consciousness disturbed (200 on coma scale) in the hospital room. Inner downward deviation of both eyes was noted, and the response of the upper extremities to pain stimuli was observed to be different bilaterally. When found, the patient had peripheral oxygen saturation of 97%, blood pressure of 128/73 mmHg, pulse of 58/min, and body temperature of 35.7 degrees Centigrade. Intracranial disease (especially cerebral infarction due to basilar artery occlusion) was suspected; on 07May2021 at 8:45, head CT was performed. No haemorrhage intracranial was found, and a definite diagnosis of cerebral infarction could not be made because of the short time gap from the onset. However, considering that no haemorrhagic lesion was revealed from the symptom''s clinical course and head CT, a disease called cerebral infarction (cerebral infarction due to basilar artery occlusion) was diagnosed. The patient died on 07May2021. An autopsy was not performed. The reporting physician classified the event, Cerebral infarction (vomiting and consciousness disturbed) as serious per 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 commented that as pathological anatomy and other methods could not be suggested considering the familial and social backgrounds, the diagnosis this time was made based on head CT ad the symptoms'' course. The causal relationship between vomiting (4 days after the vaccination) and the symptoms strongly suspected of cerebral infarction (9 days after the vaccination) was unclear. As a Pfizer vaccine was used, considered that the causal relationship between the vaccination and the ensuing cerebral infarction-like symptoms after 9 days was also unclear.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1308996 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Cardio-respiratory arrest, Chest discomfort, Cyanosis, Death, Myocardial ischaemia, Nausea, Oxygen saturation, Pallor, Peripheral vascular disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: cT (AI) blood test; Result Unstructured Data: Test Result:was conducted; Test Date: 20210426; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210426; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: at 18:15; Test Date: 20210426; Test Name: SpO2; Result Unstructured Data: Test Result:85-91 %
CDC Split Type: JPPFIZER INC2021511627

Write-up: Respiratory and cardiac arrest; Circulatory disorder peripheral; Queasy; Cyanosis; pallor facial; Chest tightness; Unknown cause of death; ischaemic heart disease; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21105072. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Apr2021 at 14:45 (Batch/Lot Number: ER7449; Expiration Date: 30Jun2021) at 82-years-old as a single dose for COVID-19 immunisation. The patient''s medical history included Heart disorder from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took influenza vaccine for influenza immunisation and experienced pyrexia on an unspecified date. On 26Apr2021 at 18:15, the patient experienced: cyanosis (hospitalization, life threatening), pallor facial (hospitalization, life threatening), chest tightness (hospitalization, life threatening). On 26Apr2021 at 19:30, the patient experienced: queasy (hospitalization, life threatening). On 27Apr2021 at 08:30, the patient experienced: circulatory disorder peripheral (hospitalization, life threatening). On 27Apr2021 at 08:30, the patient experienced: respiratory and cardiac arrest (hospitalization, medically significant, life threatening). On 27Apr2021 at 11:41, the patient experienced: unknown cause of death and ischaemic heart disease (death, medically significant). The patient was hospitalized for cyanosis, pallor facial, chest tightness, queasy, circulatory disorder peripheral, and cardio-respiratory arrest from 27Apr2021 to 27Apr2021. The clinical course was reported as follows: The patient was an 82-year and 8-month-old male. Body temperature before vaccination was 36.6 degrees Centigrade. Family history was not reported. Medical history included heart disorder. Historical vaccine included influenza vaccine for influenza immunization and reaction included pyrexia. On 26Apr2021 at 14:45 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Apr2021 at 18:15 (3 hours 30 minutes after the vaccination), the patient experienced circulatory disorder peripheral, cyanosis, respiratory and cardiac arrest, chest tightness, and queasy (as reported). On 27Apr2021 (1 day after the vaccination), the patient was admitted to the hospital. On 27Apr2021 (1 day after the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 26Apr2021 (Monday) at 14:45, the patient was vaccinated. At 18:15, the patient developed pallor facial and cyanosis of lip. Body temperature was 37.5 degrees Centigrade and the patient''s chief complaint was "chest tightness". At 19:30, the patient developed queasy. From 23:00 to 04:00 on the following day, SpO2 was 85-91% and the patient had breathing shallow, and mild hyperpnoea. The patient repeatedly had normal breathing and respiratory distress. On 27Apr2021 (Tuesday) at 08:30, the patient had circulatory disorder peripheral, feeling cold, and cyanosis of distal extremities. At 10:30, respiratory and cardiac arrest was confirmed. At 11:05, the patient was transferred to a depressurized room of an emergency room of another hospital. At 11:41, death was confirmed. Due to investigate a cause, cT (AI) blood test was conducted. At 13:35, cause of death could not be identified, and autopsy was initiated (the result of autopsy was not reported). The patient was admitted to the hospital from 27Apr2021 to 27Apr2021. The reporting physician classified the events of circulatory disorder peripheral, cyanosis, respiratory and cardiac arrest, chest tightness, and queasy as serious (life-threatening and hospitalization) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was ischaemic heart disease. The reporting physician commented as follows: Physician of the medical institution where the patient was transferred reported that cause of death could not be identified in postmortem examination; however, ischaemic heart disease was suspected. Causality between the vaccination and the events were unknown. The patient underwent lab tests and procedures which included body temperature: 36.6 Centigrade on 26Apr2021 before vaccination, body temperature: 37.5 Centigrade on 26Apr2021 at 18:15, oxygen saturation (SpO2): 85-91 % on 26Apr2021, cT (AI) blood test: was conducted on 27Apr2021. The clinical outcome of the events: cyanosis, pallor facial, chest tightness, queasy, circulatory disorder peripheral, and cardio-respiratory arrest, was unknown. The clinical outcome of the event, unknown cause of death, was fatal. The patient died on 27Apr2021 due to an unknown cause of death; and the other possible cause of the event such as any other diseases was ischaemic heart disease. An autopsy was performed, and results were not provided. ; Reported Cause(s) of Death: ischaemic heart disease; ischaemic heart disease; Unknown cause of death


VAERS ID: 1309001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Body temperature, Cardiac arrest, Choking, Hypophagia, Irregular breathing, Nausea, Oedema, Pneumonia aspiration, Pyrexia, Respiration abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: BASSAMIN
Current Illness: Hypertension; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hemiplegia
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Body temperature; Result Unstructured Data: Test Result:around 37 Centigrade; Test Date: 20210421; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210422; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Comments: at 00:45 (one day after vaccination); Test Date: 20210423; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: at 19:00 (two days after vaccination)
CDC Split Type: JPPFIZER INC2021513004

Write-up: cardiac arrest; Pneumonia aspiration; Choked on sputum; irregular breathing; respiratory like blew; Vomiting; queasy; Abdominal distension; could no longer be taken orally; Oedema; Pyrexia; This is a spontaneous report from a contactable consumer (patient''s daughter) via medical information team and from a contactable physician received from a regulatory authority(v21105245). An 88-year and 8-month-old male patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 21Apr2021 at 13:30 (Lot Number: ER9480; Expiration Date: 31Jul2021) (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing living in nursing home, non-ongoing cerebral infarction on an unspecified date, hemiplegia, and ongoing hypertension. The patient had no noteworthy family history. Concomitant medication included acetylsalicylic acid, aluminium glycinate, magnesium carbonate (BASSAMIN) taken as antiplatelet agent. The patient experienced pyrexia on 22Apr2021 00:45; could no longer be taken orally and odema on 24Apr2021 12:00; vomiting, queasy, and abdominal distension on 27Apr2021; respiratory like blew on 29Apr2021; irregular breathing on 30Apr2021 at 19:30; choked on sputum, pneumonia aspiration, and cardiac arrest on 01May2021 02:40. All of the events were reported as fatal. The clinical course was reported as follows: On 21Apr2021 at 13:30, the patient received BNT162B2 with a body temperature before vaccination of 36.3 degrees Centigrade on 21Apr2021. On 22Apr2021 at 00:45, pyrexia with body temperature of 38.4 degrees Centigrade (one day after vaccination) was noted and oral acetaminophen (CALONAL) was administered. On 23Apr2021 at 19:00, pyrexia with body temperature of 38.3 degrees Centigrade (two days after vaccination) was noted. On 24Apr2021 at noon, the patient could no longer be taken orally, so unspecified transfusion was initiated, and oedema of extremities developed (as reported). After that, oedema persisted but the body temperature remained around 37 degrees Centigrade in Apr2021. On 27Apr2021, vomiting and queasy were noted. On 28Apr2021, no vomiting and queasy were noted, so oral ingestion was initiated but was discontinued due to queasy. Oedema extremities and abdominal distension were recovering. After that, the amount of oral ingestion was small and queasy sometimes occurred, so oral unspecified injection was repeatedly interrupted. On 29Apr2021, respiratory like blew was noted and there was no pneumonic bruit. On 30Apr2021 at 19:30, the patient had vomiting and irregular breathing. On 01May2021 at 01:30, the patient had jaw breathing and then cardiac arrest. Although cardiac massage was performed, it was not improved. On the same date at 02:40, the patient''s death was confirmed. A diagnosis of pneumonia aspiration was made by a physician. The reporter reported that no pyrexia was evidently noted until 20Apr2021 based on the data (blood pressure, pulse and body temperature) but pyrexia and vomiting were noted after the vaccination, on 20Apr2021. The reporter was told by the physician that although he/she recognized that the patient had febrile symptom, he/she could not state confidently that the death cause was pneumonia aspiration due to the vaccine. Therapeutic measures were taken as a result of all of the events as aforementioned. The patient died on 01May2021. The cause of death was reported as pneumonia aspiration. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the events and BNT162B2 as unassessable. Other possible causes of the events, such as any other diseases, were reported as pneumonia aspiration and suffocation due to sputum. The reporting physician commented as follows: the causal relationship with the vaccine was unknown and it was considered that the association was low. However, the family strongly claimed about the association with the vaccine and requested a report to the country. Therefore, this case was reported.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1309017 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NITROFURANTOINE; RISPERIDON; AZITHROMYCIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200420; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: SARS-CoV-2 test positive
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Fever; Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 20-Apr-2020. Concomitant products included NITROFURANTOINE, RISPERIDONE (RISPERIDON) and AZITHROMYCIN for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). The patient died on 28-Feb-2021. The reported cause of death was Fever. It is unknown if an autopsy was performed. At the time of death, PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2020, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not confirmed; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not confirmed; Reported Cause(s) of Death: Fever


VAERS ID: 1309029 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-04-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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: ALLOPURINOL; FAMOTIDINE ACID REDUCER; TRAMADOL; CLONAZEPAM; ALFACALCIDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident ("5 months ago"); COVID-19; Dialysis; Renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20200402; Test Name: Corona, bevestigd met test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Cardiac arrest; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Renal insufficiency, Dialysis, Cerebrovascular accident ("5 months ago") in December 2020, Renal insufficiency, Dialysis and COVID-19 on 02-Apr-2020. Concomitant products included ALLOPURINOL, FAMOTIDINE (FAMOTIDINE ACID REDUCER), TRAMADOL, CLONAZEPAM and ALFACALCIDOL for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient died on 14-Apr-2021. The reported cause of death was Cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2020, SARS-CoV-2 test positive: positive (Positive) Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: This case concerns death of a 83-year-old male patient 1 day after the administration of the mRNA-1273 vaccine. Patient is reported to have known risk factors such as Renal insufficiency, Dialysis, Cerebrovascular accident4 months prior and COVID-19, 12 days prior to vaccine administration. Although a temporal association exist, based on the current available information a causal relationship between the reported events and mRNA-1273 use is assessed as unlikely. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: The follow-up received has NNI.; Sender''s Comments: This case concerns death of a 83-year-old male patient 1 day after the administration of the mRNA-1273 vaccine. Patient is reported to have known risk factors such as Renal insufficiency, Dialysis, Cerebrovascular accident4 months prior and COVID-19, 12 days prior to vaccine administration. Although a temporal association exist, based on the current available information a causal relationship between the reported events and mRNA-1273 use is assessed as unlikely.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1309030 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: pulmonary embolism; The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis) and PULMONARY EMBOLISM (pulmonary embolism) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced THROMBOSIS (The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis) (seriousness criterion death). On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 07-Apr-2021. The reported cause of death was pulmonary embolism presumably from thrombotic. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities, further information required. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Translation received; The event verbatim changed for both the events and the stop date for the event thrombosis leg updated; Sender''s Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities, further information required.; Reported Cause(s) of Death: Pulmonary embolism presumably from thrombotic


VAERS ID: 1309035 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac tamponade, Electrocardiogram, Myocardial infarction, Ventricular fibrillation, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Myocardial infarction (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL SUCCINATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: ECG; Result Unstructured Data: Test Result:first ventricular fibrillation followed by; Comments: first ventricular fibrillation followed by ventricular tachycardia. Later ventricular fibrillation again after which asystolic.
CDC Split Type: NLPFIZER INC2021506309

Write-up: Myocardial infarction; Tamponade cardiac; Ventricular fibrillation; Ventricular tachycardia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number NL-LRB-00525909. An 80-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 30Apr2021 as second dose, 0.3 mL, single for COVID-19 immunization. Medical history was not reported. The patient has no previous COVID-19 infection. Concomitant medications included metoprolol succinate taken for an unspecified indication. The patient previously received BNT162B2 (COMIRNATY) on 26Mar2021, as first dose, 0.3 mL, for COVID-19 immunization. On 30Apr2021, the patient experienced myocardial infarction and tamponade cardiac. An ECG by ambulance nurses showed first ventricular fibrillation, followed by ventricular tachycardia, and later ventricular fibrillation again after which the patient was asystolic. The patient died on 30Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Ventricular fibrillation; Ventricular tachycardia; Myocardial infarction with cardiac tamponade; Myocardial infarction with cardiac tamponade


VAERS ID: 1309036 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021506274

Write-up: himself not feeling well; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [NL-LRB-00526430], received from Regulatory Authority. An 82-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Lot number and expiry date were unknown), via an unspecified route of administration on 29Apr2021 as 0.3 mL, single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on unspecified date as a single dose for COVID-19 immunization; there were no side effects were reported. The patient experienced not feeling well/ malaise on 30Apr2021. The patient was found deceased the day after vaccination on 30Apr2021. As a differential diagnosis HA been examined in the patient unexpected death (sudden death) on 30Apr2021. Two (2) hours before death he had indicated that he did not feel well but was walking around. Afterwards found dead. Unclear relation with vaccine. The outcome of malaise was fatal. The patient died on 30Apr2021. Cause of death was not feeling well/ malaise. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: not feeling well/ malaise; unexpected death (sudden death)


VAERS ID: 1309041 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-03-28
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Oxygen saturation decreased, Respiratory failure, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (Sequelae: paresis); Chronic renal failure (Age-related mild renal failure); Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210328; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: B.1.351 lineage
CDC Split Type: NOPFIZER INC2021506306

Write-up: Pulmonary failure; Oxygen saturation decreased; Lack of drug effect; COVID-19 disease/Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable physician, downloaded from the Regulatory Authority (RA)-WEB, Regulatory authority report number: NO-NOMAADVRE-FHI-2021-U2m1wr, Safety Report Unique Identifier: NO-NOMAADVRE-E2B_00026412. An 87-years-old male patient received BNT162b2 (COMIRNATY), intramuscular on 26Jan2021 14:11 (Batch/Lot Number: EJ6134) as 2ND DOSE, SINGLE, and intramuscular on 06Jan2021 08:20 (Batch/Lot Number: EJ6795) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included living in a nursing home in 2014, chronic renal failure (age-related mild renal failure), and apoplexy with paresis sequelae in 2014. The patient''s concomitant medications were not reported. On 28Mar2021, the patient had vaccination failure, lack of drug effect, due to confirmed COVID-19 pneumonia, and oxygen saturation decreased continuously, despite increasing amounts of medical oxygen. On 03Apr2021, the patient died due to COVID-19 pneumonia/pulmonary failure since Apr2021. Relevant laboratory findings and investigations included in the report (SARS-COV-2 PCR TEST on 28Mar2021, Positive, B.1.351 lineage. Cycle threshold not known at the time of the report.). The patient died on 03Apr2021. The outcome of the events was fatal. It was not reported if an autopsy was performed. The Center assessed the causal relationship between BNT162b2 (COMIRNATY) and all the reported events as Possible. The case was considered to be Serious. Sender comment: Since the vaccine is new, it will be subject to special monitoring to identify any new safety information as soon as possible. It is especially important that serious and/or unusual side effects be reported. Your message is therefore important to expand knowledge about adverse reactions that were not discovered in the studies, and it is an important contribution to international cooperation to maintain safe vaccination worldwide.; Reporter''s Comments: Reporters qualification: Physician.; Reported Cause(s) of Death: COVID-19 pneumonia; Pulmonary failure


VAERS ID: 1309043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Incomplete course of vaccination, Infection, Oxygen saturation, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: LIPITOR [ATORVASTATIN]; SOMAC; DEXAMETASON ABCUR; TARGINIQ; AFIPRAN; METOPROLOL MYLAN [METOPROLOL SUCCINATE]; ATACAND; LIXIANA; IMOVANE; HALOPERIDOL; LYRICA; AKYNZEO
Current Illness: Exposure to COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac arrest (Date of event not specified by the reporter.); Chemotherapy induced peripheral neuropathy; Hypertension; Implantable defibrillator user (Since cardiac arrest.); Living in residential institution; Metastatic gastric cancer (Cancer ventriculi with metastases to liver, brain and skeleton.); Overweight
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Oxygen saturation (p02); Result Unstructured Data: Test Result:around 90 %; Test Date: 20210402; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Result: Positive.
CDC Split Type: NOPFIZER INC2021506321

Write-up: Covid 19 lung failure/ COVID-19 PNEUMONIA; Covid 19 lung failure/ PULMONARY FAILURE; Covid 19 lung failure/ INCOMPLETE COURSE OF VACCINATION; Covid 19 lung failure/ BREAKTHROUGH INFECTION; This is a spontaneous report from a contactable physician, downloaded from a regulatory authority-WEB. The regulatory authority number is NO-NOMAADVRE-FHI-2021-U4n1jd with Safety Report Unique Identifier: NO-NOMAADVRE-E2B_00026430. A 71-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscularly, administered in the arm on 24Mar2021 (batch/lot number: ET3674, expiration date: unknown) as the 1st dose, single for COVID-19 immunization. Relevant medical history included cardiac arrest in 2014 (date of event not specified by the reporter); implantable defibrillator user from 2014 since cardiac arrest; and exposure to COVID-19 in 31Mar2021; and overweight, hypertension, living in residential institution, chemotherapy induced peripheral neuropathy, metastatic gastric cancer (cancer ventriculi with metastases to liver, brain and skeleton), and atrial fibrillation; all from an unknown date. Concomitant medications included atorvastatin (LIPITOR, strength: 20 mg); pantoprazole sodium sesquihydrate (SOMAC, strength: 40 mg); dexamethasone (DEXAMETASON ABCUR, strength: 4 mg); naloxone hydrochloride, oxycodone hydrochloride (TARGINIQ, Tablet, strength: naloxone hydrochloride 10 mg, oxycodone hydrochloride 20 mg); metoclopramide hydrochloride (AFIPRAN, strength: 10 mg); metoprolol succinate (METOPROLOL MYLAN, strength: 100 mg); candesartan cilexetil (ATACAND, strength: 32 mg); edoxaban tosilate (LIXIANA, strength: 60 mg); zopiclone (IMOVANE, Tablet, strength: 7.5 mg); haloperidol (strength: 0.5 mg); pregabalin (LYRICA, strength: 150 mg); and netupitant, palonosetron hydrochloride (AKYNZEO, strength: netupitant 300 mg, palonosetron hydrochloride 0.5 mg), all taken for an unspecified indication, start and stop date were not reported. On 02Apr2021, the patient experienced Covid 19 lung failure, further described as COVID-19 pneumonia, pulmonary failure, incomplete course of vaccination, and breakthrough infection, which all led to hospitalization and death. The patient was hospitalized for Covid 19 lung failure/COVID-19 pneumonia, pulmonary failure, incomplete course of vaccination, and breakthrough infection from 07Apr2021 to an unknown date. It was further reported that the patient gradually developed COVID-19 lung disease with increasing oxygen demand and decreasing oxygen saturation with oxygen saturation (p02) around 90 % with 2 L on nasal catheter (date of measurement not specified)] in Apr2021. The patient underwent further lab tests and procedures, which included SARS-CoV-2 PCR test: positive on 02Apr2021 as part of infection tracing. The patient died at the hospital in the evening of 10Apr2021. It was not reported if an autopsy was performed. A regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. Reporters comments: 22Apr2021: Telephone contact with the reporter to obtain additional information regarding the case. Following fields have been updated according to this conversation: Person (Disease), Product, Event. This is a final report. Sender comment: Since the vaccine is new, it will be subject to special monitoring to identify any new safety information as soon as possible. It is especially important that serious and/or unusual side effects be reported. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 22-Apr-2021: Telephone contact with the reporter to obtain additional information regarding the case. Following fields have been updated according to this conversation: Person (Disease), Product, Event. This is a final report.; Reported Cause(s) of Death: Covid 19 lung failure/ COVID-19 PNEUMONIA; Covid 19 lung failure/ PULMONARY FAILURE; Covid 19 lung failure/ INCOMPLETE COURSE OF VACCINATION; Covid 19 lung failure/ BREAKTHROUGH INFECTION


VAERS ID: 1309053 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-12
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021510917

Write-up: death; This is a spontaneous report from a contactable other HCP forwarded by company representative. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 2nd dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient died (death) two days after receiving the first dose of Comirnaty. Information obtained from an acquaintance related to the patient that the patient did not suffer from any serious medical conditions. The patient died on an unspecified date. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1309055 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-14
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure, Haemorrhagic diathesis, Respiratory tract haemorrhage, Thrombocytopenia
SMQs:, Cardiac failure (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: PLMODERNATX, INC.MOD20211

Write-up: Diathesis skin-mucosal; Respiratory tract bleeding; Failure heart; Acute thrombocytopenia; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC DIATHESIS (Diathesis skin-mucosal), RESPIRATORY TRACT HAEMORRHAGE (Respiratory tract bleeding), THROMBOCYTOPENIA (Acute thrombocytopenia) and CARDIAC FAILURE (Failure heart) in an 86-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Mar-2021, the patient experienced THROMBOCYTOPENIA (Acute thrombocytopenia) (seriousness criterion death). On 18-Mar-2021, the patient experienced HAEMORRHAGIC DIATHESIS (Diathesis skin-mucosal) (seriousness criterion death), RESPIRATORY TRACT HAEMORRHAGE (Respiratory tract bleeding) (seriousness criterion death) and CARDIAC FAILURE (Failure heart) (seriousness criterion death). The patient died on 18-Mar-2021. The reported cause of death was Respiratory tract bleeding, Heart failure, acute thrombocytopenia and diathesis skin-mucosal. An autopsy was not performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Cardiac failure, thrombocytopaenia (both immune and toxic thrombocytopaenia) and the associated dermatomucosal diathesis and respiratory tract bleeding are unexpected adverse reactions which are not listed in section 4.8 of the COVID-19 Vaccine Moderna Summary ofProduct Characteristics. A causal relationship between the administration of the Moderna vaccine and the occurrence of immune thrombocytopaenia cannot be ruled out or confirmed at the current stage of development. Based on the information in the report, although acute immune thrombocytopaenia was reported as an adverse reaction, the type of thrombocytopaenia has not been confirmed (immune thrombocytopaenia or toxic thrombocytopaenia was merely suspected). There is a temporal relationship between vaccine administration and the onset of thrombocytopaenia, but due to the reasons listed above, a causal relationship has not been established. No information is available on whether cardiac failure existed before the vaccination (an attempt to obtain information was unsuccessful); therefore, no temporal or causal relationships can be established. The reporting physician assessed the adverse reactions as severe (death). The regulatory authority classified the report as severe. This is a case of death in a 86-year-old female subject with unknown medical history, who died 16 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Translation received. Sender''s comments added.; Sender''s Comments: This is a case of death in a 86-year-old female subject with unknown medical history, who died 16 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Respiratory tract bleeding; Heart failure; Acute thrombocytopenia; Diathesis skin-mucosal


VAERS ID: 1309107 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: NYSTATIN ORIFARM; FOLACIN [FOLIC ACID]; MIRTAZAPIN ACTAVIS; BEHEPAN [CYANOCOBALAMIN]; DUROFERON; CANDESARTAN SANDOZ; SPIRONOLACTONE ACCORD; AMLODIPIN ACCORD; LEVAXIN; IMPUGAN [FUROSEMIDE SODIUM]; ALVEDON; RISPERIDON ACTAVIS
Current Illness: Cardiac failure; Dementia NOS; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021506346

Write-up: CEREBROVASCULAR DISEASE; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is [SE-MPA-2021-032319 ]. A 92-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in Feb2021 (Batch/Lot Number: EJ6136) 2ND DOSE, single for COVID-19 immunisation. Medical history included ongoing hypertension, cardiac failure, and dementia NOS. Concomitant medications included nystatin (NYSTATIN ORIFARM); folacin [folic acid] (FOLACIN [FOLIC ACID]); mirtazapine (MIRTAZAPIN ACTAVIS); cyanocobalamin (BEHEPAN); ferrous sulfate (DUROFERON); candesartan cilexetil (CANDESARTAN SANDOZ); spironolactone (SPIRONOLACTONE ACCORD); amlodipine besilate (AMLODIPIN ACCORD); levothyroxine sodium (LEVAXIN); furosemide sodium (IMPUGAN); paracetamol (ALVEDON); risperidone (RISPERIDON ACTAVIS); all taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebrovascular disease in Mar2021. Time to onset was reported as 28 days. The patient died on an unspecified date. Cause of death: Unspecified cerebrovascular disease. No autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CEREBROVASCULAR DISEASE


VAERS ID: 1309108 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Cardiac failure acute, Cerebrovascular disorder, Decreased appetite, Fatigue
SMQs:, Cardiac failure (narrow), 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), 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: OXASCAND; XARELTO; NYSTATIN ORIFARM; FOLACIN [FOLIC ACID]; ATORBIR; ALVEDON; BEHEPAN [CYANOCOBALAMIN]
Current Illness: Cognitive disturbance; Hypertension; Late effects of cerebral infarction
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021506340

Write-up: CVS (cerebrovascular disease); Acute cardiac failure due to arteriosclerosis; Acute cardiac failure due to arteriosclerosis; tired; stopped eating; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB SE-MPA-2021-032398, other case identifier is SE-VISMA-1619541691170. An 88-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot Number: EJ6136) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included ongoing hypertension, ongoing late effects of cerebral infarction, and ongoing cognitive disturbance. Concomitant medications included oxazepam (OXASCAND; strength: 5 mg); rivaroxaban (XARELTO; strength: 20 mg); nystatin (NYSTATIN ORIFARM; strength: 100000 IU/ml); folacin [folic acid] (FOLACIN [FOLIC ACID]; strength: 1 mg); atorvastatin calcium (ATORBIR; strength: 20 mg); paracetamol (ALVEDON; strength: 500 mg); cyanocobalamin (BEHEPAN [CYANOCOBALAMIN]; strength: 1 mg). On an unspecified date in Feb2021, the patient was tired and stopped eating. The patient had CVS (cerebrovascular disease) and acute cardiac failure due to arteriosclerosis on an unspecified date in Feb2021. The patient died on an unspecified date. An autopsy was performed and results were not provided. The outcome of CVS (cerebrovascular disease), and acute cardiac failure due to arteriosclerosis was fatal while the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute cardiac failure due to arteriosclerosis; Acute cardiac failure due to arteriosclerosis; CVS (cerebrovascular disease)


VAERS ID: 1309109 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: ENALAPRIL COMP; ATENOLOL ACCORD; ATORVASTATIN KRKA; AMLODIPIN SANDOZ [AMLODIPINE MESILATE]; SPIRONOLACTONE ACCORD; ACETYLSALICYLSYRA TEVA; ATENOLOL ORIFARM; BETMIGA; DERMOVATE; FELODIPIN; FINASTERID SANDOZ; KETOCONAZOL ACTAVIS; LACROFARM; L
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021506349

Write-up: saddle embolus pulmonary embolism in lung at autopsy; This is a spontaneous report from a contactable physician downloaded from the regulatory authority SE-MPA-2021-032855. A 69-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on Apr2021 (Batch/Lot Number: Unknown) as UNKNOWN, SINGLE for covid-19 immunisation (Age at vaccination: 69 years). Medical history included ongoing hypertension. Concomitant medications included enalapril maleate, hydrochlorothiazide (ENALAPRIL COMP); atenolol (ATENOLOL ACCORD); atorvastatin calcium (ATORVASTATIN KRKA); amlodipine mesilate (AMLODIPIN SANDOZ [AMLODIPINE MESILATE]); spironolactone (SPIRONOLACTONE ACCORD); acetylsalicylic acid (ACETYLSALICYLSYRA TEVA); atenolol (ATENOLOL ORIFARM); mirabegron (BETMIGA); clobetasol propionate (DERMOVATE); felodipin; finasteride; ketoconazole; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LACROFARM); levocabastine hydrochloride (LIVOSTIN); omeprazole (OMEPRAZOL SANDOZ [OMEPRAZOLE]); oxycodone hydrochloride (OXIKODON ACTAVIS); paracetamol (PARACETAMOL ORIFARM); ramipril (RAMIPRIL HEXAL); simvastatin (SIMVASTATIN SANDOZ); diclofenac sodium (VOLTARENE). The patient experienced saddle embolus pulmonary embolism in lung at autopsy on Apr2021. Outcome of the event was fatal. The patient died on Apr2021. An autopsy was performed that revealed pulmonary embolism . Information on the lot/batch number has been requested.; Autopsy-determined Cause(s) of Death: pulmonary embolism


VAERS ID: 1309784 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular insufficiency, Coronary artery occlusion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAMICRON; SIMVASTATIN; JANUMET; FORXIGA
Current Illness: Hyperlipidaemia (Hyperlipid?mie); NIDDM (NIDDM)
Preexisting Conditions: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIOVASCULAR INSUFFICIENCY and CORONARY ARTERY OCCLUSION in an 81-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported by the reporter. Concurrent medical conditions included NIDDM (NIDDM) and Hyperlipidaemia (Hyperlipid?mie). Concomitant products included GLICLAZIDE (DIAMICRON), SIMVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FORXIGA) for an unknown indication. On 16-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced CARDIOVASCULAR INSUFFICIENCY (seriousness criterion death) and CORONARY ARTERY OCCLUSION (seriousness criterion death). The patient died on 18-Apr-2021. The reported cause of death was Occlusion coronary. An autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment medications were not reported. Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the event was not applicable. Company comment:This is a case of death in a 81-year-old male subject with a medical history of NIDDM and Hyperlipidaemia, who died 2 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient autopsy info, Medical History, and Concomitant medication info added; Sender''s Comments: This is a case of death in a 81-year-old male subject with a medical history of NIDDM and Hyperlipidaemia, who died 2 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible.; Reported Cause(s) of Death: Occlusion coronary


VAERS ID: 1309786 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Asthenia, Cardiac failure, Dyspnoea, Pleural effusion
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 13
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: Anemia (Myelodysplastic syndrome (anemia, thrombocytopenia)); Atrial fibrillation (permanent atrial fibrillation); Chronic renal failure (chronic renal failure KDOQI III); COPD (COPD III); Coronary artery disease (coronary heart disease (condition after 4-fold aortocoronary bypass)); Myelodysplastic syndrome NOS (Myelodysplastic syndrome (anemia, thrombocytopenia)); Thrombocytopenia (Myelodysplastic syndrome (anemia, thrombocytopenia))
Preexisting Conditions: Medical History/Concurrent Conditions: Aortocoronary bypass (coronary heart disease (condition after 4-fold aortocoronary bypass))
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021512163

Write-up: anemia was worsened; increasing shortness of breath; Weakness; bilateral pleural effusions; Global cardiac decompensation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-25042. A 91-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 18Mar2021 (Lot Number: ET1831) at unknown, single for covid-19 immunisation. Medical history included ongoing coronary heart disease (condition after 4-fold aortocoronary bypass - not ongoing), ongoing Myelodysplastic syndrome (anemia, thrombocytopenia), ongoing permanent atrial fibrillation, ongoing chronic obstructive pulmonary disease (COPD) III, and ongoing chronic renal failure KDOQI III. The patient''s concomitant medications were not reported. The patient experienced global cardiac decompensation on 03Apr2021, bilateral pleural effusions on 21Mar2021, and consequently increasing shortness of breath and weakness and blood count deterioration (anemia was worsened and thrombocytopenia was stable, in the presence of a known myelodysplastic syndrome) on unknown date. Outcome of the events increasing shortness of breath, weakness and anemia was worsened was not recovered while unknown for bilateral pleural effusions. The patient died on 03Apr2021. It was not reported if an autopsy was performed. The event global cardiac decompensation was reported as serious, fatal and other events were serious, causing hospitalization from 21Mar2021. Health Authority Comment: Regulatory Authority-comment: Follow-up information requested. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Global cardiac decompensation


VAERS ID: 1309787 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, General physical health deterioration, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal insufficiency (chronic kidney failure); Epilepsy; Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: blood pressure; Result Unstructured Data: Test Result:Drop
CDC Split Type: ATPFIZER INC2021512151

Write-up: Unresponsive to stimuli/Patient no longer responsive; acute deterioration in general condition; Drop in blood pressure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB with regulatory authority number AT-BASGAGES-2021-25044. An 88-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Feb2021 (Lot Number: EJ6790) as second dose, single for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing hypertension arterial, ongoing chronic renal insufficiency/chronic kidney failure, ongoing epilepsy and transient ischaemic attack from 2014 to an unknown date (not ongoing). The patient''s concomitant medications were not reported. On 15Feb2021, the patient experienced general physical condition decreased death, drop of blood pressure and unresponsive to stimuli (patient no longer responsive). The outcome of the events was fatal. The patient died on 19Feb2021. It was not reported if an autopsy was performed. Sender''s comments: regulatory authority -comment: Follow-up information requested. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Unresponsive to stimuli/Patient no longer responsive; acute deterioration in general condition; Drop of blood pressure


VAERS ID: 1309827 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Death, General physical health deterioration, Inflammation, Liver function test, Renal function test, Thyroid function test, Urine analysis, White blood cell count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANOXIN; DONEPEZIL; D-CURE; CALCIUM CITRATE; BISOPROLOL; MAGNESIUM; QUETIAPINE; LIXIANA; HALDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrial fibrillation; Breast cancer (Vinorelbine with Gemcitabine (VG) for breast cancer); Hypercholesterolemia
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: CRP; Test Result: 20.6 mg/dl; Test Date: 20210121; Test Name: Liver; Result Unstructured Data: Test Result:Normal; Test Date: 20210121; Test Name: kidney; Result Unstructured Data: Test Result:Normal; Test Date: 20210121; Test Name: Thyroid; Result Unstructured Data: Test Result:Normal; Test Date: 20210121; Test Name: Urine; Test Result: Negative ; Test Date: 20210121; Test Name: white blood cell count; Result Unstructured Data: Test Result:Normal
CDC Split Type: BEPFIZER INC2021512193

Write-up: inflammatory picture with rapidly progressive deterioration and death; inflammatory picture with rapidly progressive deterioration and death; inflammatory picture with rapidly progressive deterioration and death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-89935. An 83-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: EJ6796) as 1st dose, single for covid-19 immunisation. Medical history included dementia Alzheimer, atrial fibrillation, hypercholesterolaemia, and breast cancer (Vinorelbine with Gemcitabine (VG) for breast cancer). Concomitant medications included digoxin (LANOXIN), donepezil, colecalciferol (D-CURE), calcium citrate, bisoprolol, magnesium, quetiapine, edoxaban tosilate (LIXIANA), haloperidol (HALDOL); all taken for an unspecified indication, start and stop date were not reported. The patient experienced inflammatory picture with rapidly progressive deterioration on 21Jan2021 which resulted in death. No treatment was given for the events. The patient underwent lab tests and procedures which included c-reactive protein: 20.6 mg/dl on 21Jan2021, liver: normal on 21Jan2021,kidney: normal on 21Jan2021, thyroid: normal on 21Jan2021, urine analysis: negative on 21Jan2021, white blood cell count: normal on 21Jan2021. The patient died on 04Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death; inflammatory picture with rapidly progressive deterioration; inflammatory picture with rapidly progressive deterioration


VAERS ID: 1309828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: NOBIRETIC; CARDIOASPIRINE; COVERAM; VEINOFYTOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021512210

Write-up: Death; Pain in the chest; Reaction at the injection site; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB BE-FAMHP-DHH-N2021-90559. An elderly male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: ET9096) as 1st dose, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, nebivolol hydrochloride (NOBIRETIC); acetylsalicylic acid (CARDIOASPIRINE); amlodipine besilate, perindopril arginine (COVERAM) and aesculus hippocastanum extract (VEINOFYTOL) all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced death, pain in the chest and reaction at the injection site on 16Apr2021. The patient died on 19Apr2021 (as reported- pending clarification). It was unknown if an autopsy was performed. Reporter''s comments: Treatment - No Evolution of the ADR - Death; Reporter''s Comments: Treatment - No Evolution of the ADR - Death; Reported Cause(s) of Death: Death


VAERS ID: 1309841 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-13
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acquired haemophilia, Gallbladder rupture, Haemobilia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gallbladder related disorders (narrow), Biliary tract disorders (narrow), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 27
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: ACETYLSALICYLIC ACID; ATORVASTATIN; SPIRONOLACTONE; BISOPROLOL FUMARATE; EZETIMIBE; Aldactone; CONCOR; Fludex; Triatec; ZANIDIP; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute blood loss anemia; Acute on chronic renal failure; Acute renal failure; Chronic renal failure; Coronary artery disease; Coronary artery disorder; Thrombopenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Acquired haemophilia A with anti factor VIII; gall bladder hemorrhage; gallbladder perforation; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACQUIRED HAEMOPHILIA (Acquired haemophilia A with anti factor VIII), HAEMOBILIA (gall bladder hemorrhage) and GALLBLADDER RUPTURE (gallbladder perforation) in an 85-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3000496 and 300042460) for COVID-19 vaccination. The patient''s past medical history included Acute renal failure on 14-Mar-2021, Chronic renal failure, Acute blood loss anemia, Coronary artery disease, Acute on chronic renal failure on 14-Mar-2021, Thrombopenia and Coronary artery disorder. Concomitant products included ACETYLSALICYLIC ACID, ATORVASTATIN, SPIRONOLACTONE, BISOPROLOL FUMARATE, EZETIMIBE, Spironolactone (Aldactone), BISOPROLOL FUMARATE (CONCOR), Indapamide (Fludex), Ramipril (Triatec), LERCANIDIPINE HYDROCHLORIDE (ZANIDIP) and ALLOPURINOL (ZYLORIC) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ACQUIRED HAEMOPHILIA (Acquired haemophilia A with anti factor VIII) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced HAEMOBILIA (gall bladder hemorrhage) (seriousness criterion death) and GALLBLADDER RUPTURE (gallbladder perforation) (seriousness criterion death). The patient died on 10-Apr-2021. The reported cause of death was gallbladder rupture and Gallbladder hemorrhage. It is unknown if an autopsy was performed. At the time of death, ACQUIRED HAEMOPHILIA (Acquired haemophilia A with anti factor VIII) had not resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Based on the current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. This is a case of death in a 85-year-old male subject with a medical history of Chronic renal failure, Acute blood loss anemia, Thrombopenia and Coronary artery disorder., who died 29 days after receiving the second dose of vaccine. Based on information received, death was due to gallbladder hemorrhage and perforation, hence the events and death are assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Translated document received on 08 May 2021.Updated event death, death date and concomitant drug details.; Sender''s Comments: This is a case of death in a 85-year-old male subject with a medical history of Chronic renal failure, Acute blood loss anemia, Thrombopenia and Coronary artery disorder., who died 29 days after receiving the second dose of vaccine. Based on information received, death was due to gallbladder hemorrhage and perforation, hence the events and death are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Gallbladder rupture; Gallbladder hemorrhage


VAERS ID: 1309868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial sepsis, Body temperature, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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: TIAPRIDAL; KALNORMIN; HALOPERIDOL
Current Illness: Hypertension; Ischemic heart disease; Right bundle branch block
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: Body temperature; Result Unstructured Data: Test Result:$g40 Centigrade; Test Date: 20210414; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: CZPFIZER INC2021512359

Write-up: Gram-negative sepsis; Fever over 40 degree Celsius; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is CZ-CZSUKL-21004614. An 82-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: Unknown) as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing ischemic heart disease and ongoing right bundle branch block. Concomitant medications included tiapride hydrochloride (TIAPRIDAL); potassium chloride (KALNORMIN); and haloperidol. On 18Apr2021, the patient experienced gram-negative sepsis and fever. The patient experienced a fever over 40 degree Celsius (C) after the vaccination with COMIRNATY the first dose was on 16Apr2021. The patient was transferred to the hospital on 18Apr2021 and died in the hospital on 22Apr2021. The cause of death was sepsis by other G negative organisms. On 29Apr2021, the nurse of home for the elderly stated that the patient was in normal health condition before and after the vaccination. The fever occurred on 18Apr2021, then was transferred to the hospital. The patient had an antigen test COVID-19 test on 14Apr2021 that provided a negative result. An autopsy was not performed. The outcome of fever was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Gram-negative sepsis


VAERS ID: 1309874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Dyspnoea, Hypotonia, Myocarditis, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021512315

Write-up: Floppy; Stomach discomfort; Vomiting; Nausea; Myocarditis; Dyspnea; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100054953. An 80-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: Unknown), via an unspecified route of administration on 07Apr2021 as UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced floppy, stomach discomfort, vomiting and nausea on an unspecified date, myocarditis and dyspnea on 12Apr2021. Outcome of the events was fatal. The patient died on 22Apr2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Floppy; Stomach discomfort; Vomiting; Myocarditis; Dyspnea; Nausea


VAERS ID: 1309875 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-02-09
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL7491 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021512281

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100054955. A 93-year-old female patient received the second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL7491), via an unspecified route of administration on 24Jan2021 (at the age of 93-year-old) as 0.3 mL, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previous received first dose of BNT162B2 on 08Jan2021 for COVID-19 immunization. The patient experienced unknown cause of death on 09Feb2021. The patient died on 09Feb2021 due to unknown cause of death. An autopsy was not performed. Relatedness of Comirnaty to event Unknown cause of death was assessed as inconsistent causal association to immunization. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309876 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-25
Onset:2021-04-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (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), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021512300

Write-up: Unconsciousness; Fall; Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, company number DE-PEI-202100054957. An 86-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Apr2021 (Lot Number: ET3045) at 2nd dose, 0.3 mL single for covid-19 immunisation. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 01Apr2021 for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On unknown date (also reported as 26Mar2021, pending clarification), the patient experienced unconsciousness and fall, both considered as serious (medically significant). On 30Apr2021, the patient experienced unknown cause of death. The outcome of event unconsciousness was recovered, while unknown for event fall. It was not reported if an autopsy was performed. Relatedness of drug to reactions from regulatory authority was D. Unclassifiable.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309878 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021512311

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100055000. An 81-year-old male patient received second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 29Apr2021 (at age of 81 years old) (Lot Number: ET3045) as 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of Comirnaty on 18Mar2021 also at age of 81 years old as 0.3 ml single for covid-19 immunization. On 30Apr2021, the patient experienced unknown cause of death. The event outcome was fatal. It was not reported if an autopsy was performed. Relatedness of Comirnaty to event unknown cause of death was unclassifiable by Regulatory Authority. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309880 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-20
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021512337

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100055066. An 86-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 08Apr2021 (Lot Number: ER9480) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 20Apr2021. The patient died on 20Apr2021. It was not reported if an autopsy was performed. The reporter''s assessment on the causal relationship between the suspect product Comirnaty and the event death was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309881 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-30
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; CANDESARTAN; ELIQUIS
Current Illness: Asthma bronchial; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Lung embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522053

Write-up: Unknown cause of death; This is a spontaneous report received from a non-contactable physician downloaded from the Medicine Agency (EMA) -WEB DE-PEI-202100056654. A 61-years-old female patient received BNT162B2 (Pfizer vaccine), via an unspecified route of administration at the age of 61-years-old on 07Apr2021 (Lot Number: EW8904) as 0.3mL single for covid-19 immunisation. Medical history included ongoing hypertension, lung embolism, ongoing asthma bronchial. Concomitant medications included amlodipine; candesartan; apixaban (ELIQUIS). The patient experienced unknown cause of death on 30Apr2021. The patient died on 30Apr2021. It was not reported if an autopsy was performed. The reporter''s assessment on the causal relationship between the suspect product Pfizer vaccine and the event death was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Oxygen saturation decreased, Pyrexia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: NOVORAPID; DILIBAN; ADIRO; URSOBILANE; DISTRANEURINE [CLOMETHIAZOLE EDISILATE]; HALOPERIDOL ESTEVE; AMLODIPINE; LEXATIN [BROMAZEPAM]; ORFIDAL; ABASAGLAR; TRAVATAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021506158

Write-up: Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-725200. An 87-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 20Jan2021 (lot number: EK9788) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included hypertension arterial, alzheimer''s disease, and type 2 diabetes mellitus. Concomitant medications included insulin aspart (NOVORAPID); paracetamol, tramadol hydrochloride (DILIBAN); acetylsalicylic acid (ADIRO); ursodeoxycholic acid (URSOBILANE); clomethiazole edisilate (DISTRANEURINE); haloperidol (HALOPERIDOL ESTEVE); amlodipine; bromazepam (LEXATIN); lorazepam (ORFIDAL); insulin glargine (ABASAGLAR); and travoprost (TRAVATAN); all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included first dose of bnt162b2 (COMIRNATY) on 30Dec2020 (Batch/lot number: EJ6796) for COVID-19 immunisation. The patient experienced fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation (unspecified) on 20Jan2021. The patient died on 21Jan2021. An autopsy was not performed. Clinical course: the patient was referred to the hospital the day after administration of the vaccine with death in emergency triage. The family did not wish to perform an autopsy although it was offered. It was unknown if the patient had COVID-19. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: SECOND DOSE. Reasons for patient vaccination: Over 65 years of age Has she passed COVID-19?: Unknown Additional information on ADRs: Resident in residence xxx referred to the hospital the day after administration of the vaccine with death in emergency triage. The family did not wish to perform an autopsy although it was offered.; Reported Cause(s) of Death: Fever; Tremors; Fatigue; low saturation; sweating; dyspnea


Result pages: prev   26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=125&PERPAGE=100&VAX=COVID19&VAXTYPES=COVID-19&DIED=Yes


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