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 170 out of 196

Result pages: prev   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: 1666988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-13
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Vertebral artery dissection
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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: INFLUVAC TETRA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101103500

Write-up: Cerebrovascular accident; Vertebral artery dissection; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 605823. A 45-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of unknown) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included influenza vaccine inact sag 4v (INFLUVAC TETRA). The patient previously received bnt162b2 (COMIRNATY), dose 1 on an unspecified date (at the age of unknown) for COVID-19 immunisation. The patient experienced cerebrovascular accident and vertebral artery dissection on 13Aug2021. The patient died in Aug2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident; Vertebral artery dissection


VAERS ID: 1666989 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Delirium, Pneumonia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101103501

Write-up: Delirium; Pneumonia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 606241. A 93-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of unknown as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced delirium and pneumonia. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Delirium; Pneumonia


VAERS ID: 1666990 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101103502

Write-up: Adverse event following immunisation, outcome: Fatal; This is a spontaneous report from a contactable other health professional via the Regulatory Authority (RA). Regulatory authority report number is 608051. A 95-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of unknown as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Adverse event following immunisation, outcome: Fatal was reported. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation, outcome: Fatal


VAERS ID: 1667049 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101100623

Write-up: Death; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died on an unspecified date. The cause of death was not reported. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1667162 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-08-23
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lip and/or oral cavity cancer, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Oropharyngeal neoplasms (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   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: Celiac disease; Discomfort in mouth (she began to treat with the help of a health professional, the problem does not improve.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC202101132748

Write-up: heart attack; a type of cancer in her mouth; This is a spontaneous report from a non-contactable pharmacist received by a Pfizer Colleague through COVAES. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) in 2021 and the second dose of BNT162B2 (lot number: unknown) in Apr2021, both at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included mouth injury from Nov2020 and celiac disease. Prior to vaccination, it was unknown that the patient was diagnosed with COVID-19. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient''s concomitant medications were not reported. Patient had presented a problem in the mouth since about Nov2020 that she began to treat with the help of a health professional, the problem does not improve. Months after having applied both doses of the Pfizer vaccine against COVID-19, in a non-specific month in 2021, she was diagnosed with a type of cancer in her mouth. She began curative chemotherapy in the month of Aug2021, dying on 23Aug2021, apparently due to a heart attack, there was no autopsy. Cardiopulmonary resuscitation was received. It was not known whether the patient died from cancer or from adverse effects of chemotherapy. The reporter did not believe that there was a possible relationship between cancer and death with the Pfizer vaccines against COVID, however the case was reported in any way to be analyzed and registered. The reporter was a relative of the patient, so she, due to grief, did not wish to be contacted. Since the vaccination, it was unknown that the patient had been tested for COVID-19. The patient died on 23Aug2021. An autopsy was not performed. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information available in the case , a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: a type of cancer in her mouth; heart attack


VAERS ID: 1667207 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Haemoptysis, Pneumonia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart valve insufficiency (from childhood); Heart valve operation
Allergies:
Diagnostic Lab Data: Test Date: 20210128; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: CZPFIZER INC202101095140

Write-up: COVID-19 infection; Pneumonia; Hemoptysis; Difficulty breathing; This is a spontaneous report received from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB. The regulatory authority report number is CZ-CZSUKL-21009672. An 85-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 18Jan2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. Medical history included had problems with insufficiency of valves from childhood and had an operation of heart valves stopped in 2017. The patient''s concomitant medications were not reported. The patient previously took influenza vaccine on 12Oct2020 for immunisation. The reactions started on Day 7 after the first dose (24Jan2021), this is when the difficulties breathing and occasional hemoptysis began. The day before he went on a hike with his wife. During the whole time period of higher risk of infection (11 months) he was fully mobile, autarkic, was driving a car, and was socially distancing himself and his wife from the rest of his family. On the 28Jan2021 (Day 11), he was admitted to the infectious disease unit. Here COVID-19 and pneumonia were diagnosed. Treated with corticoids and oxygen therapy. On the 06Feb2021, he was transmitted to the intensive care unit. Treated with more intensive oxygen therapy. On the 11Feb2021, the patient died. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jan2021. Therapeutic measures were taken as a result of covid-19 infection, pneumonia, hemoptysis, difficulty breathing. The patient died on 11Feb2021. An autopsy was not performed. The outcome of COVID-19 and pneumonia was fatal. The outcome of other events were not recovered. The reporter does not wish to contact the physician. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pneumonia; COVID-19


VAERS ID: 1667212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 26
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: Disseminated sclerosis (chronic-progredient); Osteoporosis
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZJNJFOC20210857355

Write-up: Embolism lung; Thrombosis; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, CZ-CZSUKL-21009803) on 27-AUG-2021 concerned a 70 year old female of unspecified race and ethnic origin. The patient''s weight was 45 kilograms and height was 154 centimeters. The patient''s concurrent conditions included that she had disseminated sclerosis and osteoporosis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD986, expiry: unknown) 0.5 ml, 1 total administered on 10-JUN-2021 for covid-19 immunization. No concomitant medications were reported. On JUN-2021, the patient experienced embolism lung and thrombosis. On an unspecified date she was hospitalized. The number of days hospitalized was not reported. On 27-JUN-2021, the patient died from embolism lung. An autopsy was not performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of thrombosis on 27-JUN-2021. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Reported Cause(s) of Death: EMBOLISM LUNG


VAERS ID: 1667223 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Dizziness, Loss of consciousness, Somnolence
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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: MORPHINE
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20210

Write-up: Death; This case was initially received via Regulatory Authority (Reference number: 202100027838) on 09-Apr-2021. The most recent information was received on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), LOSS OF CONSCIOUSNESS, SOMNOLENCE and DIZZINESS in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included MORPHINE for an unknown indication. On 24-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEATH (Death) (seriousness criterion death), LOSS OF CONSCIOUSNESS (seriousness criteria death and medically significant), SOMNOLENCE (seriousness criteria death and medically significant) and DIZZINESS (seriousness criteria death and medically significant). The patient died on 24-Jan-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. Action taken with mRNA-1273 in response to the events was not applicable. Within two hours of the vaccination, the patient was no longer normal and was delirious. He kept losing consciousness and gradually became colder and colder until he no longer woke up. No treatment information was provided. Company Comment: This is a case of sudden death in a 81-year-old male subject with no known hx of any medical illness who died after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Translation received on 16-Apr-2021 contains no new information.. On 25-Aug-2021: Follow up received contains seriousness for all events as medically significant in narrative (previously missed to generate narrative); Sender''s Comments: This is a case of sudden death in a 81-year-old male subject with no known hx of any medical illness who died after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1667224 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-04-17
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Decreased appetite, Fatigue, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210417; Test Name: COVID-19 PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC202101094973

Write-up: COVID-19; COVID-19; Coughing/cough; Pyrexia/fever; loss of appetite; exhaustion; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100066836. A 84-year-old male patient received BNT162B2 (COMIRNATY, strength: 0.3ml), first dose via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: ER2659, at the age of 84-year-old) as single dose, second dose via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EJ6789, at the age of 84-year-old) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021, the patient experienced COVID-19, pyrexia/fever, coughing/cough, loss of appetite, exhaustion. The Subject died on the 26Apr2021 01:00 in Hospital. COVID-19 polymerase chain reaction (PCR) test Smear on 17Apr2021 was positive. The outcome of the events "COVID-19" was fatal, for other events was unknown. The patient died on 26Apr2021 01:00. It was not reported if an autopsy was performed. Sender Comment: Vaccination breakthrough Symptom onset: 17Apr2021 (fever, cough, loss of appetite, exhaustion). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19; COVID-19


VAERS ID: 1667227 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101124793

Write-up: Decompensation cardiac; Pyrexia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB (regulatory authority number DE-PEI-202100130785). A 60 years old male patient received BNT162B2 (COMIRNATY; lot number FD7958) on 23Jun2021, at the age of 60 years, as the second single dose, for COVID-19 immunisation. The patient received the first dose of Comirnaty on 26May2021. Medical history and concomitant medications were not reported. On 24Jun2021 the patient experienced pyrexia and decompensation cardiac. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. The patient''s outcome was fatal for pyrexia and fatal for decompensation cardiac. Relatedness of drug to reaction(s)/event(s), all events Source of assessment: Regulatory Authority. Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pyrexia; Decompensation cardiac


VAERS ID: 1667447 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101095217

Write-up: Infarct myocardial/heart attack; second dose on 22Jul2021 , first dose on 10Jun2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority DE-PEI-202100171725. This is the first of two reports. A 63-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Jul2021 (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), on 10Jun2021 as single dose for COVID-19 immunisation had Circulatory collapse. On 22Jul2021 he received his 2nd vaccination, also with COMIRNATY, on 07Aug2021 he suffered a heart attack and had to be resuscitated. On 15Aug2021 he died of the severe infarction in the hospital. This report is serious-death, hospitalization. On 07Aug2021 the patient experienced Infarct myocardial. The patient''s outcome was fatal for Infarct myocardial. An autopsy was to be performed at the hospital. Source of assessment: This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority DE-PEI-202100171725. This is the first of two reports. A 63-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Jul2021 (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), on 10Jun2021 as single dose for COVID-19 immunisation had Circulatory collapse. On 22Jul2021 he received his 2nd vaccination, also with COMIRNATY, on 07Aug2021 he suffered a heart attack and had to be resuscitated. On 15Aug2021 he died of the severe infarction in the hospital. This report is serious-death, hospitalization. On 07Aug2021 the patient experienced Infarct myocardial. The patient''s outcome was fatal for Infarct myocardial. An autopsy was to be performed at the hospital. Source of assessment: Regulatory Authority. Result of Assessment D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender''s Comments: Linked Report(s): DE-PFIZER INC-202101108690 same patient, different events/ different doses; Reported Cause(s) of Death: Infarct myocardial/heart attack.. Result of Assessment D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101108690 same patient, different events/ different doses; Reported Cause(s) of Death: Infarct myocardial/heart attack


VAERS ID: 1667470 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-08-03
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101124863

Write-up: Deep vein thrombosis leg; Thrombosis of venous sinuses; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100176620. A 48-year-old male patient received a dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number was not reported) (at the age of 48-year-old) as 0.3 mL, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Aug2021, the patient experienced deep vein thrombosis leg and thrombosis of venous sinuses. The events were serious, fatal. The patient died on 03Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Deep vein thrombosis leg; Thrombosis of venous sinuses


VAERS ID: 1667601 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET 3045 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, 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), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma bronchial; COPD; Dementia; Diabetes; Heart disease, unspecified; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101094978

Write-up: Cardiac arrest; weakness / powerlessness; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021162579 , Safety Report Unique Identifier DE-PEI-202100167242. A 76-year-old male patient received an unknown does of BNT162B2 (COMIRNATY, 0.3 ml) via an unspecified route of administration on 13Apr2021 (Lot Number: ET 3045) at the age of 76-year-old as single dose for COVID-19 immunization. Medical history included ongoing asthma bronchial, ongoing COPD, ongoing parkinson''s disease, ongoing heart disease, ongoing dementia and ongoing diabetes. Concomitant medication was not reported. On 13Apr2021 weakness symptom cardiac arrest. On 14Apr2021, the patient experienced cardiac arrest. Care level 3 / Increasing weakness and powerlessness after vaccination. Immediate resuscitation initiated. Resuscitated by the emergency doctor for another 20 minutes without success. The patient died on 14Apr2021. Autopsy was unknown. The cause of death was cardiac arrest. The outcome of arrest cardiac was fatal. The outcome of weakness was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1667602 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX 7823 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myeloid leukaemia, Asthenia, Fatigue, Feeling abnormal, Muscle twitching, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 55
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN CILEXETIL; ACETYLSALICYLIC ACID
Current Illness: Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (had been treated with candesartan for years, in addition, intake of ASA)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101094953

Write-up: After the 2nd Biontech, short syncope with an arm twitching, then 4 weeks of tiredness, after 4 weeks diagnosis of acute myeloid leukaemia. After another 4 weeks she died from the AML.; After the 2nd Biontech, short syncope with an arm twitching, then 4 weeks of tiredness, after 4 weeks diagnosis of acute myeloid leukaemia. After another 4 weeks she died from the AML.; After the 2nd Biontech, short syncope with an arm twitching, then 4 weeks of tiredness, after 4 weeks diagnosis of acute myeloid leukaemia. After another 4 weeks she died from the AML.; After the 2nd Biontech, short syncope with an arm twitching, then 4 weeks of tiredness, after 4 weeks diagnosis of acute myeloid leukaemia. After another 4 weeks she died from the AML.; felt "funny"/got "weird"; felt weak; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021162625, Safety Report Unique Identifier DE-PEI-202100167365. A 77-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, Lot Number: EX 7823), via an unspecified route of administration on 21May2021 at 0.3 ml, single dose for COVID-19 immunisation. Medical history included ongoing mild dementia, High blood pressure had been treated with candesartan for years, in addition, intake of ASA. Concomitant medications included candesartan cilexetil and acetylsalicylic acid, both for high blood pressure. The patient previously received 1st single dose of BNT162B2 (COMIRNATY) on 09Apr2021 for COVID-19 immunisation, and no problems/vaccine reactions were observed. On 21May2021, the 2nd Biontech was administered. The day after, 22May2021 in the morning in the bathroom he felt "funny", one arm twitched uncontrollably. Afterwards, fatigue began, which caused the vaccinated person to lie down in bed for hours several times a day in order to sleep. In general, he felt weak and tired. He was then diagnosed with acute myeloid leukaemia after 4 weeks and died on 16Jul2021. It was also reported that after the 2nd Biontech, short syncope with an arm twitching, then 4 weeks of tiredness, after 4 weeks diagnosis of acute myeloid leukaemia. After another 4 weeks she died from the AML. The outcome of the events Syncope, Twitching of limbs, Tiredness, Feeling abnormal and Weakness was unknown. The patient died due to acute myeloid leukaemia on 16Jul2021. It was unknown if an autopsy was performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no Information on risk factors or previous illnesses, No risk factors, Mild dementia, High blood pressure had been treated with candesartan for years, in addition, intake of ASA. No further medication was taken/ The 2nd Biontech was administered on May 21, 2021. The day after, the morning of 22May2021 in the bathroom, he got "weird", an arm twitched uncontrollably. After that, a tiredness began, which led to the vaccinated person lying in bed for hours several times a day to sleep. In general, he felt limp and tired. After 4 weeks the diagnosis of acute myeloid leukemia was made. On July 16, 2021, the vaccinated person died of the AML. (After the 1st Biontech on April 9th, 2021 no problems / vaccination reactions were found). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: After the 2nd Biontech, short syncope with an arm twitching, then 4 weeks of tiredness, after 4 weeks diagnosis of acute myeloid leukaemia. After another 4 weeks she died from the AML.


VAERS ID: 1667609 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E029A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary fibrosis, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Chronic kidney disease (narrow), Tumour lysis syndrome (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: 2021-08-07
   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: Medical History/Concurrent Conditions: Blood pressure high; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101088413

Write-up: pulmonary fibrosis; Kidney failure; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021164607, Safety report unique identifier DE-PEI-202100169120. An 82-year-old male patient received BNT162B2 (COMIRNATY) (Lot Number: 1E029A) via unspecified route single dose for COVID-19 immunisation on 08Jul2021. Medical history included age-related diabetes and high blood pressure. The patient''s concomitant medications were not reported. On 18Jul2021, the patient experienced renal failure, pulmonary fibrosis (death). Therapeutic measures were taken as a result. The patient died on 07Aug2021. It was unknown if an autopsy was performed. Relatedness of BNT162B2 to events was reported as unclassifiable (Source of assessment: Regulatory Authority). Sender Comment: Information on risk factors or previous illnesses Age-related diabetes and high blood pressure are all well adjusted. The deceased was fit and mobile by the day he was admitted to the intensive care unit, drove the car, did the shopping, took care of all the errands himself, lived on the 2nd floor, climbing stairs was no problem, even with shopping! / 10 days after vaccination acute kidney failure, admission to intensive care unit, increasing deterioration, signs of pneumonia / water in the lungs (according to doctor), increasing oxygen supply with a breathing mask necessary, final diagnosis of kidney failure and pulmonary fibrosis No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Pulmonary fibrosis; Kidney failure


VAERS ID: 1667610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH CN:EX8679 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Arterial hypertension; Coronary heart disease; Essential thrombocythaemia; Ischaemic stroke; Lymphoma; Penicillin allergy; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101094952

Write-up: The patient died the next day after the vaccination.; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority -WEB, regulatory authority number DE-PEI-CADR2021164700. A 74-years-old female patient received bnt162b2 (COMIRNATY), second dose via an unspecified route of administration on 04May2021 (Batch/Lot Number: CN:EX8679) as single dose for covid-19 immunisation. Medical history included coronary artery disease, rheumatoid arthritis, hypertension, essential thrombocythaemia, Cell lymphoma, anticoagulant therapy, ischaemic stroke, Penicillin allergy. The patient''s concomitant medications were not reported. The patient died the next day after the vaccination on 05May2021. This report was serious - death. It was not reported if an autopsy was performed. The patient''s outcome was fatal. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? Penicillin allergy. Information on risk factors or previous illnesses: CHD [coronary heart disease] (I25.19+G)Rheumatoid arthritis (M06.99+G)Arterial hypertension (I10.90+G)Essential thrombocythaemia (D47.3+G)B-cell lymphoma a.n.k. (C85.1+G)Anticoagulant therapy (Z92.1+G)Ischaemic insult (I63.9+G) / on 04May21 2nd dose of COMIRNATY, by 05May21 she was dead. Batch/lot number CN:EX8679. Stop date for event: Unknown cause of death: 05May2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1667611 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-13
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101088407

Write-up: Acute heart failure; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021164867, Safety report unique identifier DE-PEI-202100169073. A 70-year-old male patient received BNT162B2 (COMIRNATY) (Lot Number: FE8405) via unspecified route single dose for COVID-19 immunisation on 29Jul2021. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced acute heart failure (death) on 13Aug2021. The patient died on 13Aug2021. It was not reported if an autopsy was performed. Relatedness of BNT162B2 to events was reported as unclassifiable (Source of assessment: Regulatory Authority). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1667612 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101094968

Write-up: Dyspnoea; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021165046. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100170086. An 82-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Jul2021 (Lot Number: FE2625) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 09Jul2021 the patient experienced dyspnoea. The patient died on an unspecified date. It was not reported if an autopsy was performed. This report was serious - death. Event outcome was fatal for dyspnoea. It also reported "Stop date: 12Jul2021". Sender Comment: Are you or the person concerned known of any allergies? If yes, which? NO Information on risk factors or previous illnesses none. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dyspnoea


VAERS ID: 1667613 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-24
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Fatigue, Listless, Pneumonia
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101095480

Write-up: stroke; Pneumonia; Fatigue; listlessness; This is a spontaneous report from a non-contactable consumer (patient was reporter father) downloaded from the regulatory authority, regulatory authority number DE-PEI-CADR2021165177, Safety Report Unique Identifier DE-PEI-202100170437. A 93-year-old male patient received bnt162b2 (COMIRNATY, Strength 0.3ml), dose 2 via an unspecified route of administration on 09Jun2021 (Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included renal failure, prostate cancer. The patient''s concomitant medications were not reported. The patient experienced fatigue (death) on 24Jul2021, pneumonia (death) on 10Aug2021, stroke (death, hospitalization) on 24Jul2021, listlessness (non-serious) in 2021 with outcome of unknown. The patient died in 2021. It was not reported if an autopsy was performed. Patient (reporter''s father) did not experience any side effects immediately after the vaccination, but he got more and more tired and listless. Then the stroke followed, he was taken to the hospital, recovered surprisingly well at first, but then developed pneumonia in geriatric rehab, from which he finally died. Events (stroke, fatigue, pneumonia) stop date 12Aug2021; outcome fatal. Sender Comment: Information on risk factors or previous illnesses: Age, prostate cancer, renal failure. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: fatigue; stroke; pneumonia


VAERS ID: 1667614 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Cough, Dyspnoea, Inappropriate schedule of product administration, Off label use
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: Medical History/Concurrent Conditions: Cataract operation (in January); Knee osteoarthritis; Pacemaker insertion (cardiac) ("prophylactic")
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101095114

Write-up: Circulatory collapse; Dyspnoea; Cough; 1st vaccination on 28Apr2021, 2nd dose on 23Jul2021; 1st vaccination on 28Apr2021, 2nd dose on 23Jul2021; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB regulatory authority number DE-PEI-CADR2021165476, Safety Report Unique Identifier DE-PEI-202100170314. An 89-year-old male patient received second dose of BNT162B2 (COMIRNATY, strength 0.3 mL), via an unspecified route of administration on 23Jul2021 at the age of 89 years old as single dose for COVID-19 immunization. Medical history included Knee joint osteoarthritis, pacemaker ("prophylactic"), cataract surgery. Concomitant medications were not reported. Historical Vaccine included first dose of Comirnaty on 28Apr2021 for COVID-19 immunization and exprienced weakness, weight loss, fatigue, joint pain. On 23Jul2021 the patient experienced Circulatory collapse, Dyspnoea, Cough. The patient died on 02Aug2021. The cause of death was Circulatory collapse. It was unknown if autopsy was done. The outcome of event Circulatory collapse was fatal, outcome of other events were unknown. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Circulatory collapse


VAERS ID: 1667615 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Blood test, Cough, Decreased appetite, Dizziness, Immune system disorder, Malaise, Nausea, Neoplasm progression, Somnolence, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Malignancy related conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 136
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: Bladder carcinoma (surgery 10 years ago for a bladder tumour without metastases)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:normal; Comments: the blood values were in normal range
CDC Split Type: DEPFIZER INC202101095112

Write-up: severe dry cough; Arrhythmia; Appetite absent; Weakness; Nausea; Loss of weight; Light headedness; malaise; increased need for sleep; immune system was weakened after the vaccination so that the tumour could progress so rapidly and finally lead to the rapid death; immune system was weakened after the vaccination so that the tumour could progress so rapidly and finally lead to the rapid death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021165870], Safety Report Unique Identifier [DE-PEI-202100171374]. A 85-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Mar2021 (Lot Number: EP9598) as dose 2, single for covid-19 immunisation. Medical history included ongoing bladder carcinoma as surgery 10 years ago for a bladder tumour without metastases. The patient''s concomitant medications were not reported. The patient experienced neoplasm progression and immune system was weakened both on an unknown date with fatal outcome; arrhythmia (heart rhythm disturbances and a too high pulse), light headedness, general weakness, nausea without vomiting, loss of appetite, malaise, rapid weight loss, increased need for sleep, all on 28Mar2021 with outcome of not recovered; severe dry cough on Jun2021 with outcome of unknown. Events arrhythmia, dizziness, general weakness, nausea without vomiting, loss of appetite, malaise, rapid weight loss, increased need for sleep, dry cough, all were considered as serious with hospitalization from 29Jul2021 to an unknown date. The patient underwent lab tests and procedures which included blood test: normal as the blood values were in normal range on an unknown date. The patient died on 11Aug2021. It was not reported if an autopsy was performed. Sender Comment: Do you or the person concerned hae any known allergies? If yes, which ones? No. Information on risk factors or previous illnesses: Surgery 10 years ago for a bladder tumour without metastases. After the 2nd vaccination, the state of health began to deteriorate daily. It started at the end of March with malaise and rapid weight loss (approximately 5 kg in 4 weeks). weeks). Heart rhythm disturbances and a too high pulse. General weakness increased daily. Increased need for sleep. The physical resilience became daily less every day. From the middle of June there was a severe dry cough. DIV. Examinations showed nothing. The blood values were all in the normal range. Neither the family doctor nor an internist nor a cardiologist could find the cause of the worsening deteriorating general condition. On 29Jul2021, the patient was admitted to hospital, where on 11Aug2021 he died. death occurred. The assumption that the rapid deterioration of the condition could be related to the vaccination against COVID was also suggested here. Both the family doctor and the doctor at the hospital cannot rule out the possibility that the immune system was fighting a tumour before the vaccination and that the immune system was weakened after the vaccination so that the tumour could progress so rapidly and finally lead to the rapid death. Events assessment: arrhythmia, appetite absent, weakness, nausea, loss of weight, light headedness, unknown cause of death/Regulatory Authority: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: immune system was weakened after the vaccination so that the tumour could progress so rapidly and finally lead to the rapid death; immune system was weakened after the vaccination so that the tumour could progress so rapidly and finally lead to the r


VAERS ID: 1667616 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-07-11
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain death, Cerebral haemorrhage, Computerised tomogram, Magnetic resonance imaging
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (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: Thrombosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:unknown; Test Name: MRI; Result Unstructured Data: Test Result:unknown
CDC Split Type: DEPFIZER INC202101095028

Write-up: brain death; Extremely severe headache and dizziness, emergency surgery two after finding bleeding, death from ICB; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB number DE-PEI-CADR2021165903, Safety Report Unique Identifier DE-PEI-202100171520. A 62-year-old female patient received an unknown dose of BNT162B2 (COMIRNAYT, 0.3 ml) via an unspecified route of administration on 08Jun2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included ongoing thrombosis. Concomitant medication was not reported. On 11Jul2021, there were unbearably severe headaches in connection with dizziness, an emergency doctor was called, admission to the hospital, then many examinations followed until the bleeding was finally determined in a CT or MRI and the first emergency operation initiated, then the first bleeding was stopped, followed by another which was also stopped, with the third bleeding a third operation could not be justified, on 15Jul2021 brain death was declared. The patient died on an unspecified date. Autopsy was unknown. The outcome of hemorrhage intracerebral was fatal. The outcome of brain death was unknown. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: unknown


VAERS ID: 1667637 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101101008

Write-up: Pulmonary embolism; This is a spontaneous report from a non-contactable physician (patient). A 52-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient was stated to be a non-smoker and slim. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 Immunization. The patient experienced pulmonary embolism weeks after the second vaccination on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events pulmonary embolism cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1667787 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-07-14
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Amylase, Anion gap, Blood beryllium, Blood bicarbonate, Blood bilirubin, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, COVID-19 pneumonia, Carbon dioxide, Chest X-ray, Fibrin D dimer, Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Heart rate, Investigation, Lipaemic index score, Mean cell haemoglobin, Mean platelet volume, Multiple organ dysfunction syndrome, Neutrophil count, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Platelet distribution width, Polymerase chain reaction, Procalcitonin, Protein total, Prothrombin time ratio, Respiratory rate, SARS-CoV-2 test, Serum ferritin, Troponin T, Vaccination failure, White blood cell count, pH urine
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Thromboplastin Time; Result Unstructured Data: Test Result:1.29; Comments: ratio; Test Date: 20210715; Test Name: Thromboplastin Time; Test Result: 40.1 s; Test Date: 20210715; Test Name: GPT; Result Unstructured Data: Test Result:15; Comments: U/I; Test Date: 20210715; Test Name: Amylase; Result Unstructured Data: Test Result:61; Comments: U/I; Test Date: 20210715; Test Name: Anion Gap; Result Unstructured Data: Test Result:9.00 mmol/L; Test Date: 20210715; Test Name: Beryllium; Result Unstructured Data: Test Result:1.10 mmol/L; Comments: BE (ecf) -1.20mmol/L; Test Date: 20210715; Test Name: HCO3; Result Unstructured Data: Test Result:23.50 mmol/L; Test Date: 20210715; Test Name: HCO3; Result Unstructured Data: Test Result:23.90 mmol/L; Test Date: 20210715; Test Name: Bilirrubine; Test Result: 0.37 mg/dl; Test Date: 20210715; Test Name: Ca+; Result Unstructured Data: Test Result:1.19 mmol/L; Test Date: 20210715; Test Name: calcium; Test Result: 9.1 mg/dl; Test Date: 20210715; Test Name: Cl; Result Unstructured Data: Test Result:106.00 mmol/L; Test Date: 20210715; Test Name: CPK; Result Unstructured Data: Test Result:73; Comments: U/I; Test Date: 20210715; Test Name: Creatinine; Test Result: 0.93 mg/dl; Test Date: 20210715; Test Name: Fibrinogen; Test Result: 427.00 mg/dl; Test Date: 20210715; Test Name: Glucose; Test Result: 159 mg/dl; Test Date: 20210715; Test Name: LDH; Result Unstructured Data: Test Result:191; Comments: U/I; Test Date: 20210715; Test Name: Lactate; Test Result: 8.00 mg/dl; Test Date: 20210715; Test Name: K+; Result Unstructured Data: Test Result:4.20 mmol/L; Test Date: 20210715; Test Name: Potassium; Result Unstructured Data: Test Result:4.6 mmol/L; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/60 mmHg; Test Date: 20210715; Test Name: NA+; Result Unstructured Data: Test Result:139.00 mmol/L; Test Date: 20210715; Test Name: sodium; Result Unstructured Data: Test Result:136 mmol/L; Test Date: 20210715; Test Name: Urea; Test Result: 91 mg/dl; Test Name: Temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210715; Test Name: CO2 concentration; Result Unstructured Data: Test Result:25.20 mmol/L; Test Date: 20210815; Test Name: Chest rx; Result Unstructured Data: Test Result:Bilateral pneumonia chest X-ray; Comments: in context appears to be covid infection.; Test Date: 20210715; Test Name: D-dimer; Result Unstructured Data: Test Result:1138.00 ng/ml; Test Date: 20210715; Test Name: Gamma; Result Unstructured Data: Test Result:13; Comments: U/I; Test Date: 20210815; Test Name: Hematocrit; Test Result: 34.00 %; Test Date: 20210815; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.00 g/dl; Test Name: Heart rate; Result Unstructured Data: Test Result:100; Comments: bpm without murmurs; Test Date: 20210715; Test Name: chlorine; Result Unstructured Data: Test Result:102 mmol/L; Test Date: 20210715; Test Name: GOT; Result Unstructured Data: Test Result:29; Comments: U/I; Test Date: 20210715; Test Name: Hemolytic index; Result Unstructured Data: Test Result:3; Test Date: 20210715; Test Name: Investigation; Result Unstructured Data: Test Result:7.38; Comments: pH; Test Date: 20210715; Test Name: Jaundice index; Result Unstructured Data: Test Result:1; Test Date: 20210815; Test Name: mean corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:32.40; Test Date: 20210815; Test Name: medium corpuscular volume; Result Unstructured Data: Test Result:94.70; Comments: Fl; Test Date: 20210715; Test Name: PRO-BNP; Result Unstructured Data: Test Result:1574.00 pg/mL; Test Date: 20210715; Test Name: Lipaemic index; Result Unstructured Data: Test Result:9; Test Date: 20210815; Test Name: Mean Corpuscular Hemoglobin; Test Result: 30.60 pg; Test Date: 20210815; Test Name: Mean platelet volume; Result Unstructured Data: Test Result:11.60; Comments: fl.; Test Date: 20210815; Test Name: Neutrophil count; Result Unstructured Data: Test Result:1.58; Comments: (10x3/uL); Test Date: 20210715; Test Name: O2 saturatiuon; Test Result: 96.70 %; Test Name: saturation; Test Result: 84 %; Test Name: Saturation; Test Result: 88 %; Test Date: 20210715; Test Name: PCO2; Result Unstructured Data: Test Result:40.30 mmHg; Test Date: 20210715; Test Name: pH urine; Result Unstructured Data: Test Result:7.38; Test Date: 20210715; Test Name: Physical Examination; Result Unstructured Data: Test Result:Sarcopexy. Saturation O2 88%, temperature (t) 37.5; Comments: cardiac auscultation: rhythmic, no apparent murmurs; pulmonary auscultation: Scattered Roncus, little collaboration; Abdomen: rha+, soft and depressible, not painful, bloodless liquid stool in diaper; lower limbs: No edema in plant; Arterial pressure 150/60mmHg, Cardiac frequency 83 Saturation O2 84 reservoir 15 lpm++. Disconnected from the medium, magnetoencephalography. Dry skin and mucous membranes. Tachypnea with important respiratory work. Respiratory frequency 28 rpm. cardiac auscultation: Rhythmic 100 b.p.m without murmurs. pulmonary auscultation: Roncus and biblical crackles in both pulmonary hemifields. lower limbs: No edemas.; Test Date: 20210815; Test Name: Platelets; Result Unstructured Data: Test Result:112.00; Comments: 10x3/uL; Test Date: 20210815; Test Name: PDW; Result Unstructured Data: Test Result:13.30; Test Date: 20210715; Test Name: PO2; Result Unstructured Data: Test Result:114.00 mmHg; Test Date: 20210715; Test Name: PCR; Test Result: 2.36 mg/dl; Test Date: 20210715; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.42 ng/ml; Test Date: 20210715; Test Name: Total protein; Result Unstructured Data: Test Result:7.6 g/dl; Test Date: 20210715; Test Name: Prothrombin time ratio; Result Unstructured Data: Test Result:1.69; Test Date: 20210715; Test Name: Prothrombin time ratio; Test Result: 48.00 %; Test Name: Respiratory rate; Result Unstructured Data: Test Result:28; Comments: breaths per minute; Test Date: 20210815; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210815; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210815; Test Name: Ferritin; Result Unstructured Data: Test Result:282 ng/ml; Test Date: 20210815; Test Name: Troponin T; Result Unstructured Data: Test Result:33.50 ng/L; Test Date: 20210815; Test Name: Leucocytes; Result Unstructured Data: Test Result:2.29; Comments: (10x3/uL)
CDC Split Type: ESPFIZER INC202101114655

Write-up: Drug ineffective; COVID-19 pneumonia; Multiorgan failure; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-982270. A 93-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 (Batch/Lot Number: EM0477, expiration date: 31May2021) as single dose for covid-19 immunisation; the second dose of bnt162b2 (COMIRNATY) intramuscularly on 03Feb2021 (Batch/Lot Number: EL8723) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced drug ineffective (death, hospitalization) on 14Jul2021, covid-19 pneumonia (death, hospitalization) on 14Jul2021, multiorgan failure (death, hospitalization) on 14Jul2021. The patient was hospitalized for drug ineffective, covid-19 pneumonia, multiorgan failure from 15Jul2021 to 18Jul2021. Patient was not pregnant at vaccination time. It was not reported whether patient had Covid-19. Patient did not receive the same vaccine. Lack of Efficacy Reported in COVID Vaccinated Patient with Full Schedule. Woman referred for close contact with COVID-19 patient, and clinic of productive cough, general malaise, liquid depositions, at residence saturation O2 85 %. Antigen test is performed being this positive (Dx 15Jul21). The patient had been fully vaccinated (Pfeizer) 3-4 months ago. Physical Examination: Sarcopexy. Saturation O2 88%, temperature (t) 37.5; cardiac auscultation: rhythmic, no apparent murmurs; pulmonary auscultation: Scattered Roncus, little collaboration; Abdomen: rha+, soft and depressible, not painful, bloodless liquid stool in diaper; lower limbs: No edema in plant; Arterial pressure 150/60mmHg, Cardiac frequency 83 Saturation O2 84 reservoir 15 lpm++. Disconnected from the medium, magnetoencephalography. Dry skin and mucous membranes. Tachypnea with important respiratory work. Respiratory frequency 28 rpm. cardiac auscultation: Rhythmic 100 b.p.m without murmurs. pulmonary auscultation: Roncus and biblical crackles in both pulmonary hemifields. lower limbs: No edemas. COVID-19 antigen test: positive. COVID-19 PCR test: positive. GART (unknown FiO2): HCO3-std 23.50 mmol/L, pH Srm 7.38, pCO2 40.30 mmHg, pO2 Srm 114.00 mmHg, HCO3-real 23.90 (mmol/l) mEq/l, ctCO2 25.20 mmol/L, BE(B) -1.10 (mmol/l) mEq/l, BE(ecf) -1.20 mmol/L, O2SAT 96.70 %, Na+ 139.00 mmol/L, K+ 4.20 mmol/L, Ca++ 1.19 mmol/L, Cl- 106.00 mmol/L, Anion Gap 9.00 mmol/L, Lactate 8.00 mg/dl; GLUCOSA Srm 159 mg/dl, UREA Srm 91 mg/dl, Creatinine Srm 0.93 mg/dl, glutamate oxaloacetate (GOT) 29 U/l, Alanine aminotransferase (GPT) 15 U/l, bilirrubina TOTAL 0.37 mg/dl, LDH Srm 191 U/l, CPK 73 U/l, Amylase Srm 61 U/l, Total protein 7.6 g/dl, Calcium Srm 9.1 mg/dl, Sodium Srm 136 mmol/L, Potassium Srm 4.6 mmol/L, GAMMA GLUTAMILTRANSFERASA 13 U/l, PRO-BNP 1574.00 pg/mL, TROPONIN T US 33.50 ng/l, Lipaemic index 9, Hemolytic index 3, Jaundice index 1, CHLORINE Srm 102 (mmol/l), Procalcitonin 0.42 ng/ml, PCR 2.36 mg/dl, Ferritin 282 ng/ml; Urine: DENSITY Sample not received, pH Srm 7.38. Coagulation. Thromboplastin Time: P.A.Ratio 1.29 ratio, PROTHROMBIN TIME (INR) 1.69 ratio, PROTHROMBIN TIME (%) 48.00 %, trombloplastin time P.A. 40.1 SEC, FIBRINOGEN 427.00 mg/dl, D-DIMER 1138.00 ng/mL; Coagulation: Leucocytes Srm 2.29 10x3/uL, (FN 69.00 %), Neutrophil count 1.58 (10x3/uL) 10e3/uL HEMOGLOBIN 11.00 g/dl, HEMATOCRIT 34.00 %, VCM 94.70 f l, Mean Corpuscular Hemoglobin 30.60 pg, mean corpuscular hemoglobin concentration 32.40 g/dl, Platelets Srm 112.00 (10x3/uL) 10e3/mm3, Mean platelet volume 11.60 fl, PDW 13.30 f. Chest bilateral pneumonia in context appears to covid infection. Evolution included Patient admitted for severe covid19 pneumonia, disconnected from the environment and secondary multi-organ failure. Supportive treatment was initiated when the patient died on 17Jul2021. Clinical Judgment included Death, COVID-19 pneumonia, Secondary global respiratory failure, Fragile old woman, Previous. The outcome of the events was fatal. It was not reported if an autopsy was performed. Later investigational results from product quality complaint team regarding consumer''s complaint about Comirnaty (BNT162B2, lot: EL8723, expiration date: 31May2021). Investigational report conclusion from Pfizer division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5595397 (see File attachment in this investigation record) The complaint for a cardiac arrest after vaccination of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Pfizer concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or corrective and preventative actions were identified as the complaint was not confirmed. No follow-up attempts are possible, No further information is expected.; Reported Cause(s) of Death: Drug ineffective; COVID-19 pneumonia; Multiorgan failure


VAERS ID: 1667798 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery occlusion, Coronary artery thrombosis, Loss of consciousness, Pneumonia, Tuberculosis
SMQs:, Torsade de pointes/QT prolongation (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101088687

Write-up: suspected tuberculosis; Pneumonia; Coronary artery thrombosis; coronary occlusion; Loss of consciousness; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority -WEB, regulatory authority number FI-FIMEA-20213855. An 85-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: unknown) as dose number unknown, single at the age of 85-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced suspected tuberculosis, pneumonia, coronary artery thrombosis, coronary occlusion, and loss of consciousness on 25Feb2021. Several underlying diseases and general condition very fragile at the time of vaccination. Symptoms appeared immediately after vaccination (25Feb2021). At first, fever and pain. Was taken by ambulance 2 days after vaccination. No diagnosis. After 2 weeks, the fever rose again. In the ambulance to the hospital, pneumonia was diagnosed. After less than 2 weeks, fever and loss of consciousness. Was taken by ambulance to the hospital, from which to intensive care unit, suspected tuberculosis. Transferred to a rehabilitation hospital due to lack of space on 30Mar2021. Died 03Apr2021, cause of death coronary occlusion (as reported). It was not reported if an autopsy was performed. The event outcome was fatal. Seriousness reported as death and hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Coronary artery thrombosis; coronary occlusion; suspected tuberculosis; Pneumonia; Loss of consciousness


VAERS ID: 1667826 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-20
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pancreatic carcinoma
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 78
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
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101095062

Write-up: Pancreatic cancer; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021059170, Safety Report Unique Identifier FR-AFSSAPS-NY20211209. An 84-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via intramuscular on 30Mar2021 (at the age of 84-year-old) as single dose for COVID-19 immunisation. Medical history included arterial hypertension. Concomitant medications were not reported. No history of COVID-19. On 20Feb2021, patient had seen in consultation for a renewal of treatment, no abnormality noted. On 20Apr2021, patient experienced pancreatic cancer, occurring a few weeks after a second injection of vaccine. It was unknown if the patient received a corrective treatment. During Apr2021, onset of pancreatic cancer, patient was hospitalized. The patient died on 07Jul2021 due to pancreas cancer. It was unknown if an autopsy was performed. Reporter''s comments: Pancreatic cancer in an 84-year-old female patient, which occurred a few weeks after a second injection of the COMIRNATY vaccine (batch not specified). Death of the patient as a result of her cancer. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reporter''s Comments: Pancreatic cancer in an 84-year-old female patient, which occurred a few weeks after a second injection of the COMIRNATY vaccine (batch not specified). Death of the patient as a result of her cancer.; Reported Cause(s) of Death: Pancreas cancer


VAERS ID: 1667851 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body mass index, Chest X-ray, Computerised tomogram, Dizziness, General physical health deterioration, Hyponatraemia, Inappropriate antidiuretic hormone secretion, Myasthenia gravis, Mycobacterium tuberculosis complex test, Pulmonary sepsis, SARS-CoV-2 test, Sarcopenia, Urinary retention
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Hyponatraemia/SIADH (narrow), Vestibular disorders (broad), Chronic kidney disease (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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:
Current Illness: Lung neoplasm; Pneumothorax; Urothelial carcinoma (operated on in 2018)
Preexisting Conditions: Medical History/Concurrent Conditions: Metastasis; Pancreatitis
Allergies:
Diagnostic Lab Data: Test Name: Body mass index; Result Unstructured Data: Test Result:16.9; Comments: 16.9 kg/m2; Test Date: 20210513; Test Name: chest X-ray; Result Unstructured Data: Test Result:Pulmonary starting sepsis with diffuse right chest; Comments: Pulmonary starting sepsis with diffuse right chest X-ray (CXR) opacities; Test Name: chest CT scan; Result Unstructured Data: Test Result:cavern in the right upper lobe; Test Name: test for Mycobacterium tuberculosis (M. tb); Test Result: Negative ; Test Date: 20210327; Test Name: COVID Status; Test Result: Negative ; Test Date: 20210513; Test Name: COVID Status; Test Result: Negative ; Test Date: 20210525; Test Name: COVID Status; Test Result: Negative ; Test Date: 20210601; Test Name: COVID Status; Test Result: Negative
CDC Split Type: FRPFIZER INC202101088755

Write-up: General physical health deterioration; lumbar pain; dizziness; Acute urine retention; Hyponatremia; Syndrome of inappropriate antidiuretic hormone secretion (SIADH); sarcopenia; suspicion of myasthenia gravis; Pulmonary starting sepsis; This is a spontaneous report from a contactable consumer and a contactable Other Health Professional downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BS20211596. A 72-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 12May2021 (Batch/Lot Number: FA5831) as single dose for COVID-19 immunisation. Medical history included non-alcoholic pancreatitis, pulmonary neoplasia in 2018 treated by radiotherapy, chemotherapy and immunotherapy and complicated by recurrent pneumothorax, urothelial carcinoma operated on in 2018. Surgical history: urothelial carcinoma, left frontal cerebral metastasis discovered in Feb2021 on right partial motor seizures and operated on 26Mar2021: anatomopathology concluding in a metastasis from a poorly differentiated non-small cell carcinoma rather reminiscent of an adenocarcinoma and whose immunohistochemical profile n is not incompatible with a primary bronchopulmonary origin. Hospitalization is marked by the discovery of a cavern in the right upper lobe on a chest CT scan and diffuse centrilobular and para-septal mixed emphysema. Sputum test for Mycobacterium tuberculosis (M. tb) is negative. The patient''s concomitant medications were not reported. On day 1 (13May2021): the patient was admitted to the emergency room for dizziness and lumbar pain then hospitalized in the neurology department. It was noted in the hospitalization report that since the operation for the brain metastasis in Mar2021, relatives had noted a deterioration in their general condition making it difficult to stay at home. This deterioration in the general condition worsened following the Second vaccine dose according to the patient''s partner. Hospitalization was marked by several facts: acute urine retention requiring probing; hyponatremia, the etiological assessment of which was in favor of a syndrome of inappropriate antidiuretic hormone secretion (SIADH); A grabatisation with discomfort with orthostatism and sarcopenia worsening despite protein supplementation; A suspicion of myasthenia gravis: Electromyography (EMG) with needles not performed; Pulmonary starting sepsis with diffuse right chest X-ray (CXR) opacities and hypoxia not improved by oxygen, corticosteroid and broad-spectrum antibiotics. On Day 33, on 04Jun2021: patient death. No autopsy was performed. Conclusion: deterioration of the general condition and death on D33 of a complete vaccination schedule with COMIRNATY vaccine in a patient operated on for a cerebral metastasis possibly of bronchopulmonary origin.; Reported Cause(s) of Death: Syndrome of inappropriate antidiuretic hormone secretion (SIADH); sarcopenia; suspicion of myasthenia gravis; Pulmonary starting sepsis; General physical health deterioration; lumbar pain; dizziness; Acute urine retention; Hyponatremia


VAERS ID: 1667863 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-08-04
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardio-respiratory arrest, Death, Vaccination failure
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), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: PCR positive for COVID; Test Result: Positive ; Comments: L452R =$g associated Delta variant
CDC Split Type: FRPFIZER INC202101088725

Write-up: Death NOS; Cardio-respiratory arrest; Vaccination failure; COVID-19 aggravated; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB, regulatory authority number FR-AFSSAPS-CF20212425. A 77-years-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EM6950, and Expiration date: Unknown), via intramuscular, administered in arm on 19Feb2021 as dose 2, single, the patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6788, and Expiration date: Unknown), via intramuscular, administered in arm on 29Jan2021 as dose 1, single both for COVID-19 immunization. The patient medical history included cardiac disorder, diabetes, and long term treatment (not specified). The concomitant medications for patient were not reported. It was reported that on 04Aug2021, the patient experienced COVID-19 aggravated with RT-PCR test positive for COVID (L452R =$g associated Delta variant), Vaccination failure on temperature and rhinitis. The patient had altered influenza state, very significant deterioration (context with comorbidities). On 11Aug2021 at 19:30, the patient died by cardio-respiratory arrest (cardiopulmonary arrest). Confirmed Vaccine Failure was reported. The patient was supported with consultation, urgent medical intervention, risk of death, death, and evolution. The patient underwent lab tests and procedures which included COVID-19: positive (L452R =$g associated Delta variant) on 04Aug2021. It was not reported if an autopsy was performed (NOT informed to date). The outcome of events was Fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest; Covid-19 infection =$g VACCINE FAILURE


VAERS ID: 1667864 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-25
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6997 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram, Confusional state, Interstitial lung disease, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   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: Ischaemic heart disease (2 stents)
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:interstitial pneumonia; Comments: interstitial pneumonia on less than 10% of the lung volume; Test Date: 20210725; Test Name: RT-PCR test; Test Result: Positive ; Comments: variant delta
CDC Split Type: FRPFIZER INC202101088720

Write-up: Confusional state; Interstitial pneumonitis; COVID-19 aggravated; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-CF20212436. A 90-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 01Jun2021 (lot number: FC6997) Intramuscularly at single dose for COVID-19 immunisation; the first dose of bnt162b2 (COMIRNATY) on 26Apr2021 (lot number: ET6956) Intramuscularly at single dose for COVID-19 immunisation. Medical history included Ischaemic heart disease (2 stents). Concomitant medications were not reported. Patient experienced Confusional state on 26Jul2021, Interstitial pneumonitis on 26Jul2021, Vaccination failure on 25Jul2021, COVID-19 aggravated on 26Jul2021. This patient, was hospitalized following an operation for a fractured femoral neck on July 15, 2021. With a view to his transfer to SSR, an RT-PCR test was carried out on 25Jul2021. Following this test, the patient was diagnosed with COVID positive (Variant Delta). Vaccine failure confirmed. The patient quickly became symptomatic at the respiratory level, without significant damage on the CT scan (interstitial pneumonia on less than 10% of the lung volume), and especially the appearance of confusion, significant asthenia leading to a deterioration in his general condition. Patient died on 31Jul2021. Autopsy not requested by the family. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Interstitial pneumonitis; Vaccination failure; COVID-19 aggravated; Confusional state


VAERS ID: 1667866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: HYDROXYZINE; KARDEGIC; BISOCE; DIFFU K; ZYMAD; CALCIDOSE VITAMINE D; PANTOPRAZOLE; FUROSEMIDE; MODOPAR; TRIATEC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COVID-19 (PCR test history: yes); Extrapyramidal syndrome; Heart disease, unspecified; Mitral regurgitation
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: Test Result:39.3 Centigrade; Test Date: 202104; Test Name: left ventricular ejection fraction; Test Result: 42 %; Test Name: ECG; Result Unstructured Data: Test Result:extreme bradycardia, pulse recovered temporarily a; Comments: extreme bradycardia, pulse recovered temporarily after two injections of adrenaline followed by twice a stop, discontinuation of resuscitation; Test Date: 202104; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101095398

Write-up: Cardio-respiratory arrest; fever (39.3); This is a spontaneous report received from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-CN20212692. A 69-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 09Aug2021 (Lot Number: FF4213) as dose 2, single at left arm for covid-19 immunisation. Medical history included covid-19 from Apr2021 to Apr2021, arterial hypertension, Grade 1 mitral regurgitation, Extrapyramidal syndrome, Dilated heart disease with major decompensation in April 2021, cause not identified (coronary angiography scheduled for fall). Concomitant medications included hydroxyzine; acetylsalicylate lysine (KARDEGIC); bisoprolol fumarate (BISOCE); potassium chloride (DIFFU K); colecalciferol (ZYMAD); calcium carbonate, colecalciferol (CALCIDOSE VITAMINE D); pantoprazole; furosemide; benserazide hydrochloride, levodopa (MODOPAR); ramipril (TRIATEC), all taken for an unspecified indication, start and stop date were not reported. The patient experienced cardio-respiratory arrest (death) on 10Aug2021, fever (39.3) (non-serious) on 10Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 39.3 centigrade on 10Aug2021, left ventricular ejection fraction: 42 % on Apr2021, electrocardiogram: extreme bradycardia, pulse recovered temporarily after two injections of adrenaline followed by twice a stop, discontinuation of resuscitation on an unknown date, sars-cov-2 test: positive on Apr2021. Cardiopulmonary arrest in a context of fever the day after vaccination with Comirnaty. Access of fever (39.3) the day after vaccination treated with doliprane and ice pack, then cardio-respiratory arrest not recovered. Self-filling balloon with unidirectional O2, cardiac massage, no shock advised by the defibrillator, ECG with extreme bradycardia, pulse recovered temporarily after two injections of adrenaline followed by twice a stop, discontinuation of resuscitation. Death noted by the doctor of the emergency medical service and resuscitation despite the team''s resuscitation. The patient died in Aug2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1667887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-26
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Obstructive pancreatitis
SMQs:, Biliary tract disorders (narrow), Gallstone related disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   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: Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Eventration repair; Herpes zoster; Inguinal hernia repair (2 times)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210902166

Write-up: CALCULUS PANCREATITIS; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-DJ20213313) on 31-AUG-2021 concerned an 86 year old female of unspecified race and ethnic origin. The patient''s weight was 56 kilograms, and height was 155 centimeters. The patient''s past medical history included: herpes zoster, eventration repair, and inguinal hernia repair, and concurrent conditions included: penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-02 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 23-JUN-2021 for covid-19 vaccination. Drug start period was 4 days, drug last period was 4 days and duration of drug administered is 1 days. No concomitant medications were reported. On 26-JUN-2021, the patient experienced calculus pancreatitis. On 05-JUL-2021, the patient died from calculus pancreatitis. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: CALCULUS PANCREATITIS


VAERS ID: 1667948 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-08-01
   Days after vaccination:115
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood uric acid, C-reactive protein, COVID-19 pneumonia, Calcium phosphate product, Computerised tomogram, Drug ineffective, Fibrin D dimer, Gamma-glutamyltransferase, Haemoglobin, Interleukin level, International normalised ratio, Liver function test, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Platelet count, SARS-CoV-2 test, Serum ferritin, Troponin, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; KARDEGIC; COUMADINE; URAPIDIL; EZETROL; NEBIVOLOL; SERESTA; PRINCI B [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE MONONITRATE]; LANTUS; NOVORAPID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy (arterial disease of the lower limbs with femoropopliteal bypass in 1993, right iliofemoral in 1999, aorto-bifemoral, right brachiocephalic bypass in 2001); Carotid endarterectomy; Chronic renal insufficiency; Cognitive disorders; COVID-19; Diverticulosis (left); Dyslipidemia; Ex-tobacco user; Femoropopliteal artery bypass; Insulin-dependent diabetes mellitus; Ischemic cardiomyopathy (with stent in 1990, 2011 and 2014); Ketosis-prone diabetes mellitus; Left ventricular hypertrophy (pacemaker); Mitral stenosis; Prolapsed disc repair; Prostatitis; Pyelonephritis acute (right); Right hemicolectomy; Stent placement (ischemic cardiomyopathy with stent in 1990, 2011 and 2014)
Allergies:
Diagnostic Lab Data: Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:74; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:52; Test Name: blood alkaline phosphatase; Result Unstructured Data: Test Result:266; Test Name: reserve alkaline; Result Unstructured Data: Test Result:16; Comments: acidosis; Test Name: bilirubinemia; Result Unstructured Data: Test Result:normal; Comments: normal bilirubinemia; Test Name: creatinine; Result Unstructured Data: Test Result:300; Test Name: creatinine; Result Unstructured Data: Test Result:470; Comments: Decreased renal function; Test Name: Blood lactate dehydrogenase; Result Unstructured Data: Test Result:810; Comments: increase; Test Name: hyperkalaemia; Result Unstructured Data: Test Result:5.6 mmol/L; Comments: ionogram showing a tendency to hyperkalaemia; Test Name: sodium; Result Unstructured Data: Test Result:151; Test Name: hyperuricaemia; Result Unstructured Data: Test Result:800; Comments: hyperuricaemia; Test Name: phosphocalcic balance; Result Unstructured Data: Test Result:normal; Test Name: on-injected computed tomography scan; Result Unstructured Data: Test Result:frosted perihilar glass with base condensations, b; Comments: frosted perihilar glass with base condensations, bilateral pleural blade, mediastinal lymphadenopathy.; Test Name: C-reactive protein; Result Unstructured Data: Test Result:81 mg/l; Test Name: C-reactive protein; Result Unstructured Data: Test Result:130 mg/l; Comments: Increased; Test Name: D-dimers; Result Unstructured Data: Test Result:3000; Test Name: Gamma-glutamyl transferase; Result Unstructured Data: Test Result:376; Test Name: haemoglobin; Result Unstructured Data: Test Result:12.3 g/l; Test Name: Interleukin-6; Result Unstructured Data: Test Result:57; Test Name: International Normalized Ratio; Result Unstructured Data: Test Result:2.08; Test Name: Hepatic laboratory test; Result Unstructured Data: Test Result:disturbance with worsening of cytolysis to 4 times; Test Name: N-terminal prohormone brain natriuretic peptide; Result Unstructured Data: Test Result:24000; Test Name: oxygen saturation; Test Result: 93 %; Comments: under 4L of oxygen; Test Date: 20210801; Test Name: oxygen saturation; Test Result: 85 %; Test Name: platelets; Result Unstructured Data: Test Result:210; Comments: G/L; Test Date: 20210801; Test Name: PCR test COVID-19; Test Result: Positive ; Comments: mutation L452R (delta variant); Test Name: ferritin; Result Unstructured Data: Test Result:3500; Comments: increase; Test Name: troponin; Result Unstructured Data: Test Result:114; Test Name: leukocytes; Result Unstructured Data: Test Result:6.3; Comments: G/L
CDC Split Type: FRPFIZER INC202101086777

Write-up: drug ineffective; COVID-19 pneumonitis; This is a spontaneous report from a contactable physician received from regulatory authority downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MA20213195. An 83-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via intramuscular on 08Apr2021 (83-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history included COVID-19, ketosis-prone diabetes mellitus, right hemicolectomy from 1983, stent placement from 1990 (ischemic cardiomyopathy with stent in 1990, 2011 and 2014) , pyelonephritis acute from 2018 (right), ischaemic cardiomyopathy (with stent in 1990, 2011 and 2014), chronic renal insufficiency, ex-tobacco user, diverticulosis (left), cognitive disorder, dyslipidemia, arteriopathy (arterial disease of the lower limbs with femoropopliteal bypass in 1993, right iliofemoral in 1999, aorto-bifemoral, right brachiocephalic bypass in 2001), femoropopliteal bypass in 1993, insulin-dependent diabetes, mitral aortic stenosis and left ventricular hypertrophy (pacemaker), carotid endarterectomy in 2001 (left), prostatitis from 2012, herniated disc surgery from 2015. Concomitant medications included pantoprazole (PANTOPRAZOLE); acetylsalicylate lysine (KARDEGIC); warfarin sodium (COUMADINE); urapidil (URAPIDIL); ezetimibe (EZETROL); nebivolol (NEBIVOLOL); oxazepam (SERESTA); cyanocobalamin, pyridoxine hydrochloride, thiamine mononitrate (PRINCI B); insulin glargine (LANTUS); insulin aspart (NOVORAPID). The patient experienced drug ineffective and COVID-19 pneumonitis on 01Aug2021. The events were assessed as serious with criteria of death, hospitalization, and life threatening. Case Summary: The patient presented COVID-19 pneumonia, L452R mutation (delta variant), leading to his death at Day 116 of his dose 2 Comirnaty (no information about dose 1). 01Aug2021: the patient presents fever with dysponea, PCR test COVID-19 positive mutation L452R (delta variant), SaO2 85%, oxygen therapy implemented. Emergency transfer: oxygen saturation 93% under 4L of oxygen, non-injected computed tomography scan showing frosted perihilar glass with base condensations, bilateral pleural blade, mediastinal lymphadenopathy. Blood test: leukocytes 6.3 G/L, platelets 210 G/L, haemoglobin 12.3 g/l, ionogram showing a tendency to hyperkalaemia at 5.6 mmol / L, creatinine 300, normal phosphocalcic balance, hyperuricaemia at 800, N-terminal prohormone brain natriuretic peptide 24000, troponin 114, C-reactive protein 81 mg/L. Hepatic laboratory test: aspartate aminotransferase 52, alanine aminotransferase 74, blood alkaline phosphatase 266, gamma-glutamyl transferase 376, normal bilirubinemia. International Normalized Ratio 2.08, D-dimer 3000. The patient receives DEXAMETHASON and concurrently FUROSEMID for suspected cardiac decompensation. Despite a transient improvement with a slight decrease in oxygen requirements, further clinical worsening with desaturation and disturbance of consciousness. Increased C-reactive protein to 130mg / L, Interleukin-6 to 57. Hepatic laboratory test disturbance with worsening of cytolysis to 4 times normal, increase in Blood lactate dehydrogenase to 810 and ferritin to 3500. Decreased renal function with creatinine at 470, acidosis with reserve alkaline at 16 and sodium at 151. Patient died on 09Aug2021. Therapeutic measures were taken as a result of the events. The outcome of the events was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: drug ineffective; COVID-19 pneumonitis


VAERS ID: 1667956 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Unknown cause of death; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-MP20216135) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No medical history was reported. Concurrent medical conditions included Hypertension. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 15-Jun-2021 The patient died on 15-Jun-2021. The reported cause of death was avc. An autopsy was not performed. No concomitant medication was mentioned. No treatment medication was mentioned. Company Comment Very limited information regarding this event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: AVC


VAERS ID: 1667971 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-20
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pneumonia aspiration, 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: 2021-07-27
   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: Diabetes mellitus; Dysphagia; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Choking; Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101095091

Write-up: Drug ineffective; COVID-19 respiratory infection; aspiration pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-MP20216620. A 73-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 28Apr2021 (Lot Number: Unknown) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes mellitus, pulmonary embolism, not ongoing, ongoing dysphagia, ongoing hypertension, repeatedly choking. The patient''s concomitant medications were not reported. The patient experienced drug ineffective (death, hospitalization) on 20Jul2021, covid-19 respiratory infection (death, hospitalization) on 20Jul2021, aspiration pneumonia (death, hospitalization) in 2021. Patient had a hypoxemic covid and aspiration pneumonia. Positive PCR test on 20Jul2021. Died of his covid on 27Jul2021. The patient died on 27Jul2021. An autopsy was not performed. Reporter''s Comments: Record of inefficiency. Person vaccinated against SarsCov2. Vaccination by (Comirnaty) 2nd dose vaccination on 28Apr2021. Person without risk factor of inefficiency but very heavy history and especially repeatedly choking. Therefore had a hypoxemic covid and aspiration pneumonia. Positive PCR test on 20Jul2021. Died of his covid on 27Jul2021. Characterization of the virus: not reported. Complete file, no further information. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reporter''s Comments: Record of inefficiency. Person vaccinated against SarsCov2. Vaccination by (Comirnaty) 2nd dose vaccination on 28Apr2021. Person without risk factor of inefficiency but very heavy history and especially repeatedly choking. Therefore had a hypoxemic covid and aspiration pneumonia. Positive PCR test on 20Jul2021. Died of his covid on 27Jul2021. Characterization of the virus: not reported. Complete file, no further information.; Reported Cause(s) of Death: COVID-19 respiratory infection; aspiration pneumonia; Drug ineffective


VAERS ID: 1668040 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004233 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   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: Congestive (dilated) cardiomyopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: MORT INEXPLIQUEE; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-RN20212564) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (MORT INEXPLIQUEE) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004233) for COVID-19 vaccination. Concurrent medical conditions included Congestive (dilated) cardiomyopathy. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on 16-Aug-2021 The patient died on 16-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant drug was not reported. Treatment medication was not reported. Company Comment: Although a temporal association exist between the fatal outcome and the administration of mRNA-1273 vaccine, critical details such as the actual cause of death was not provided. No further information is expected.; Sender''s Comments: Although a temporal association exist between the fatal outcome and the administration of mRNA-1273 vaccine, critical details such as the actual cause of death was not provided. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1668044 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Intracardiac thrombus, Musculoskeletal discomfort, Neck pain, SARS-CoV-2 test, Specialist consultation
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asymptomatic COVID-19; Factor V Leiden mutation; Sprained ankle; Thrombosis venous deep (following a sprain)
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 202011; Test Name: cardiological monitoring; Result Unstructured Data: Test Result:nothing in particular
CDC Split Type: FRPFIZER INC202101095453

Write-up: Intracardiac thrombus; cardiac arrest; blocked upper back; neck pain; This is a spontaneous report from a contactable consumer or other non hcp and physician downloaded from the Regulatory Authority -WEB FR-AFSSAPS-RS20212715. A 50-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 22Jul2021 (Batch/Lot Number: FF0680) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Factor V Leiden mutation heterozygous; deep vein thrombosis in 2003 in the context of a sprained ankle. History COVID was yes; PCR + test on 23Apr2021; His sister, a carrier of the same mutation, was found dead at the age of 44, with no identified cause. For this reason, the patient benefited from cardiological monitoring; the last consultation in November 2020 found nothing in particular. Patient tested positive for Sars-Cov2 on 23Apr2021 following the demonstration of symptoms in his mother. The patient remained asymptomatic. The patient''s concomitant medications were not reported. Patient experienced neck pain and "blocked upper back" following vaccination, favorable outcome after 2 doses of paracetamol. 13 days later, on 04Aug in the morning, the patient was found dead in his office by his wife. He had not complained of any symptoms in the previous hours. An autopsy was performed at the request of his wife. She specifies that "the death was caused by a thrombosis, a clot formed a priori inside the right ventricle, causing the cardiac arrest. Additional examinations are still in progress insofar as the causes of the formation of the clot are still undetermined (no shock, no plane trip, etc.) Awaiting the report of anatomopathological examinations carried out on the heart. In total, a 50-year-old patient, carrier of a heterozygous mutation of factor V of Leiden, died suddenly 13 days after D1 COMIRNATY, with evidence of a thrombus in the right ventricle at autopsy. It is noted that his sister, who carried the same mutation, also died suddenly, at the age of 44. Autopsy Results was not available. Outcome of events neck pain and blocked upper back was recovered on unknown date. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Intracardiac thrombus; cardiac arrest


VAERS ID: 1668076 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Bradycardia foetal, Foetal growth restriction, Investigation, Maternal exposure during pregnancy, Ultrasound scan vagina
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 40
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: routine blood investigations; Result Unstructured Data: Test Result:unknown result; Test Date: 202108; Test Name: Speculum examination; Result Unstructured Data: Test Result:Fetal bradycardia; Test Date: 202108; Test Name: transvaginal ultrasound; Result Unstructured Data: Test Result:Fetal bradycardia
CDC Split Type: GBPFIZER INC202101111607

Write-up: Bradycardia foetal; Foetal growth restriction; Foetal exposure during pregnancy/exposed to the medicine first-trimester; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number {GB-MHRA-ADR 25847700} Safety Report Unique Identifier {GB-MHRA-ADR 25847700}. The consumer reported for the mother and fetus. This is fetus case. A fetus patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), transplacental on 09Jul2021 (Lot Number: EW3143) as single dose for covid-19 immunisation. The patient medical history was not reported. The mother''s medical history included Folic acid supplementation, First pregnancy in 2017 was successful. The mother''s concomitant medications included folic acid taken for folic acid supplementation; ascorbic acid, betacarotene, biotin, calcium pantothenate, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, nicotinamide, phytomenadione, pyridoxine hydrochloride, riboflavin, selenium, thiamine mononitrate, tocopheryl acid succinate, zinc (PREGNACARE ORIGINAL) from 15Jul2021 to 18Aug2021. The patient experienced foetal exposure during pregnancy/exposed to the medicine first-trimester on 09Jul2021, bradycardia foetal on Aug2021, foetal growth restriction on Aug2021; all reported as serious as medically significant and death. The clinical course was reported as follows: The patient''s mother experienced first bleeding start around 3 weeks post vaccination (end of Jul2021). It was streak of blood and only once. Then following next week (early Aug2021) it bleeds again. One episode. Two weeks later, On 12Aug more bleeding occurred. Went to gynecology emergency unit and get it checked. It was threatened abortion at this stage with fetal bradycardia and small gestational week. The bleeding continues for a week and result in miscarriage on 18Aug2021. Tissue of fetus was expelled. Waiting for scan on 26Aug2021 to determine either it''s completed or incomplete miscarriage. The mother has not tested positive for COVID-19 since having the vaccine. The mother is not enrolled in clinical trial. The mother was exposed to the medicine first-trimester (1-12 weeks). The patient''s mother underwent lab tests and procedures in Aug2021 which included routine blood investigations: unknown result; Speculum examination: Fetal bradycardia; transvaginal ultrasound: Fetal bradycardia. The outcome of the events was fatal. The patient died on 18Aug2021 due to events. 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: Fetal bradycardia; Foetal growth restriction; Foetal exposure during pregnancy/exposed to the medicine first-trimester


VAERS ID: 1668327 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Inappropriate schedule of product administration, Loss of consciousness, Pulmonary embolism
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), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COLECALCIFEROL; ZOLEDRONIC ACID; TAMSULOSIN; ASPIRIN [ACETYLSALICYLIC ACID]; SALBUTAMOL; ESOMEPRAZOLE; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Giant cell arteritis; Hiatus hernia; Immunodeficiency (Has an illness or condition, which reduces the immune response); Unwell
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118652

Write-up: deep vein thrombosis; Pulmonary embolism; collapsed; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108241026054300-93KYX, Safety Report Unique Identifier is GB-MHRA-ADR 25840914. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER1749), via an unspecified route of administration on 31Mar2021 (at the age of 75 years old) at dose 2, single for COVID-19 immunization. Medical history included giant cell arteritis diagnosed in Dec2020, hiatus hernia with stricture, unwell, asthma, and immunodeficiency (has an illness or condition, which reduces the immune response). Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Historical vaccine included first dose of BNT162B2 (Lot: EL0739), received on 16Jan2021 for COVID-19 immunization. Concomitant medications included colecalciferol capsule; zoledronic acid taken from 07Apr2021; tamsulosin; acetylsalicylic acid (ASPIRIN); salbutamol; esomeprazole; and prednisolone. The patient experienced deep vein thrombosis and pulmonary embolism on 17Apr2021. Both events were reported as serious per resulting in death. Additionally, the patient experienced collapsed on 17Apr2021; and inappropriate schedule of vaccine administered as first dose was received on 16Jan2021 and second dose was received on 31Mar2021. The clinical course was reported as follows: The reporter was reporting on behalf of her deceased husband (his GP may also make a report). The patient collapsed and died at home on 17Apr2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events pulmonary embolism and deep vein thrombosis was fatal. The outcome of the remaining events was unknown. The patient died on 17Apr2021. An autopsy (coroner''s investigation/post mortem) was performed. The coroner subsequently reported this was due to pulmonary embolism and deep vein thrombosis. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Deep vein thrombosis; Pulmonary embolism; Autopsy-determined Cause(s) of Death: Deep vein thrombosis; Pulmonary embolism


VAERS ID: 1668376 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Brain oedema, Coagulopathy, SARS-CoV-2 test, Thrombosis
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 31
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: Blood test; Result Unstructured Data: Test Result:clotting disorder; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101118505

Write-up: blooding clots; Brain edema; Clotting disorder; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108260250385580-NTTJF, Safety Report Unique Identifier is GB-MHRA-ADR 25851018. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jul2021 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced clotting disorder on 10Jul2021, blooding clots till death on an unknown date, and brain edema on 07Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood test: clotting disorder due to vaccination and COVID-19 virus test: negative both on an unknown date. The patient has not recovered from the event clotting disorder. The patient died on 10Aug2021 due to brain edema and blooding clots. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Brain oedema; blooding clots


VAERS ID: 1668403 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-08-08
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101126274

Write-up: Death; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number: GB-MHRA-WEBCOVID-202108291356013300-W5YO6, Safety Report Unique Identifier: GB-MHRA-ADR 25865627. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 08Mar2021 (Batch/Lot Number: Not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. The patient experienced death on 08Aug2021. The cause of death was not reported. Autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1668436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-12
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pain, Skin discolouration, Weight, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: weight; Result Unstructured Data: Test Result:lose 4 stone
CDC Split Type: GBPFIZER INC202101108803

Write-up: death; lose 4 stone; unbelievable pain; blue legs; This is a spontaneous report from a non-contactable consumer. A 76 year old male patient (reporter''s father) received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on 12Aug2021, the pfizer/biontech covid-19 vaccine caused the patient to lose 4 stone, unbelievable pain and blue legs on 2021. The outcome of events lose 4 stone, unbelievable pain and blue legs was unknown. The patient died on 12Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1668475 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Laboratory test, Sepsis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 39
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUMYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antidepressant therapy
Allergies:
Diagnostic Lab Data: Test Name: regular laboratory tests every year; Result Unstructured Data: Test Result:without any pathological finding
CDC Split Type: GRPFIZER INC202101127356

Write-up: Death; Breathing difficult/Intense dyspnea; Sepsis; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number and Safety Report Unique Identifier GR-GREOF-20217013. A 68-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 23Jun2021 as dose 2, single for COVID-19 immunization. Medical history included antidepressant therapy. Concomitant medication included fluvoxamine maleate (DUMYROX) taken for antidepressant therapy from 2020. Historical vaccine included first dose of COMIRNATY, received on 31May2021 for COVID-19 immunization. On 26Jun2021, the patient experienced breathing difficult/intense dyspnea. On an unspecified date in 2021, the patient experienced sepsis. On 04Aug2021 (as reported), the patient experienced death. The events were reported as serious per other medically important condition. The clinical course was reported as follows: After the second dose, 2-3 days later he started to have intense dyspnea sometimes during the day. As the days passed, he didn''t have any sign of recession. The patient had a telephone communication with a physician (pathologist) who advised him to stay home, because the dyspnea as the physician said was a result of the high temperature outside and he also advised him to drink a lot of water. Last day of communication with the patient was on 04Aug2021 (Wednesday evening). On Saturday morning, 07Aug2021, the reporter found the patient dead in his house on the floor. The reporter informed that her father was performing regular laboratory tests every year without any pathological finding and that he was very careful about his personal hygiene. The patient died on 04Aug2021. In the death certificate, it was reported that ''Cause of death undetermined/unassessable due to sepsis''. Toxicological tests are pending (autopsy performed). The reporter will send the toxicology tests soon. The outcome of the event death was fatal, while the outcome of the remaining events was unknown. Sender Comment: Initial report with follow-up information. The reporter is relative of the male patient who passed away. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1668617 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Cold sweat, Cyanosis, Feeling cold, Oxygen saturation, Oxygen saturation decreased, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LERCANIDIPINE; FOLIC ACID; LACTULOSE; CLOPIDOGREL; ENSURE PLUS; CITALOPRAM; ALLOPURINOL; ENSURE COMPACT; LANSOPRAZOLE; VIVIOPTAL; ATORVASTATIN; THIAMINE; PARACETAMOL; OXYNORM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain infarction; Depression; Dyspnoea; Folic acid deficiency; Gastrointestinal inflammation; Gout; Hypertension; Lymphoma; Pain; Vitamin B1 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: Blood pressure; Result Unstructured Data: Test Result:BLOOD PRESSURE DROPPED; Test Date: 20210723; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:Oxygen saturation decreased.
CDC Split Type: IEPFIZER INC202101100347

Write-up: ANAPHYLAXIS - COLD AND CLAMMY, BLOOD PRESSURE AND OXYGEN SATURATIONS DROPPED, TACHYCARDIA, PERIPHERAL CYANOSIS; ANAPHYLAXIS - COLD AND CLAMMY, BLOOD PRESSURE AND OXYGEN SATURATIONS DROPPED, TACHYCARDIA, PERIPHERAL CYANOSIS; ANAPHYLAXIS - COLD AND CLAMMY, BLOOD PRESSURE AND OXYGEN SATURATIONS DROPPED, TACHYCARDIA, PERIPHERAL CYANOSIS; ANAPHYLAXIS - COLD AND CLAMMY, BLOOD PRESSURE AND OXYGEN SATURATIONS DROPPED, TACHYCARDIA, PERIPHERAL CYANOSIS; ANAPHYLAXIS - COLD AND CLAMMY, BLOOD PRESSURE AND OXYGEN SATURATIONS DROPPED, TACHYCARDIA, PERIPHERAL CYANOSIS; ANAPHYLAXIS - COLD AND CLAMMY, BLOOD PRESSURE AND OXYGEN SATURATIONS DROPPED, TACHYCARDIA, PERIPHERAL CYANOSIS; peripheral cyanosis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-080978. Sender''s (Case) Safety Report Unique Identifier IE-HPRA-2021-080978. An 84-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 23Jul2021 (Lot Number: FE9174) as single dose for COVID-19 immunisation. Patient age at vaccination was 84-year-old. Medical history included hypertension, gastrointestinal inflammation, gout, vitamin B1 deficiency, brain infarction, folic acid deficiency, depression, lymphoma, dyspnoea and pain. Concomitant medications included lercanidipine taken for hypertension, folic acid (FOLIC ACID) taken for folate deficiency, lactulose taken for an unspecified indication, clopidogrel taken for prophylaxis, carbohydrates nos; electrolytes nos; fatty acids nos; minerals nos; proteins nos; vitamins nos (ENSURE PLUS) taken for an unspecified indication, citalopram taken for depression, allopurinol taken for gout, nutrients nos (ENSURE COMPACT) taken for an unspecified indication, lansoprazole taken for gastrointestinal inflammation, minerals nos; vitamins nos (VIVIOPTAL) taken for an unspecified indication, atorvastatin taken for an unspecified indication, thiamine taken for vitamin b1 deficiency, paracetamol taken for analgesic therapy, oxycodone hydrochloride (OXYNORM) taken for dyspnoea, pain, all with start and stop date were not reported. On 23Jul2021, 5 minutes later, the patient experienced anaphylaxis. It was reported that the patient became cold and clammy, her blood pressure and oxygen saturations dropped, she had tachycardia and peripheral cyanosis. The patient was treated with adrenaline via EPINEPHRINE (EPIPEN), oxygen, and fluids subcutaneously. The patient died approximately 10.5 hours later. It was reported that the patient was in a nursing home for end of life care with a do-not-resuscitate order (DNR) and a family decision in conjunction with hospital that the patient was not for transfer to hospital under any circumstances. The patient died on 23Jul2021. 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: ANAPHYLAXIS - COLD AND CLAMMY, BLOOD PRESSURE AND OXYGEN SATURATIONS DROPPED, TACHYCARDIA, PERIPHERAL CYANOSIS; ANAPHYLAXIS - COLD AND CLAMMY, BLOOD PRESSURE AND OXYGEN SATURATIONS DROPPED, TACHYCARDIA, PERIPHERAL CYANOSIS; ANAPHYLAXIS - COLD AND CLA


VAERS ID: 1668728 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Death; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-771719) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death), HYPERPYREXIA and MALAISE in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for COVID-19 immunisation. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 12-Aug-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant) and MALAISE (seriousness criterion medically significant). On 14-Aug-2021, HYPERPYREXIA and MALAISE outcome was unknown. The patient died on 14-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. Company Comment This case concerns a 31-year old male who had adverse events of hyperpyrexia and malaise and died 3 days after receiving first dose of mRNA-1273 (Spikevax). It is unknown if an autopsy was performed. Very limited information regarding this events has been provided at this time.; Reporter''s Comments: Sender''s Comments: This case concerns a 31-year old male who had adverse events of hyperpyrexia and malaise and died 3 days after receiving first dose of mRNA-1273 (Spikevax). It is unknown if an autopsy was performed. Very limited information regarding this events has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1668770 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-07-25
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 16
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: Lymphocytosis
Allergies:
Diagnostic Lab Data: Test Date: 20210725; Test Name: albumin; Result Unstructured Data: Test Result:low; Test Date: 20210728; Test Name: hemochromoticometric test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101100389

Write-up: shortly after completing the vaccination cycle he contracted pneumonia with kidney problems and low albumin; shortly after completing the vaccination cycle he contracted pneumonia with kidney problems and low albumin; shortly after completing the vaccination cycle he contracted pneumonia with kidney problems and low albumin; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-772932. A 79-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly on 13May2021 (Batch/Lot Number: FA5831) as dose 2 at 0.3 ml, single for COVID-19 immunisation. Medical history included lymphomyocytosis from an unspecified date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), on 22Apr2021 (Batch/Lot Number: EX0893) at single dose for COVID-19 immunisation. The patient was suffering from lymphomyocytosis prol. B but never subjected to therapy because it had always remained stable, shortly after completing the vaccination cycle he contracted pneumonia with kidney problems and low albuminon on 25Jul2021. On 28Jul2021 the patient was hospitalized for legionella pneumonia and the death occurred on 10Aug2021 in the resuscitation ward. Actions taken (after two days in medicine he was taken to resuscitation where he died). On 18 August 2021 required to the attending physician clinical report and any autopsy outcome but not available at the moment. The patient died on 10Aug2021. The events were considered serious due to fatal by RA. It was unknown if an autopsy was performed. Reporter comment: The patient is affected by B cell proliferative lymphomonocytosis. The hemochromoticometric test released by the (emergency room) of PRIVACY and dating back to 28Jul2021 is attached to the email. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: The patient is affected by B cell proliferative lymphomonocytosis. The hemochromoticometric test released by the emergency room and dating back to 28Jul2021 is attached to the email; Reported Cause(s) of Death: shortly after completing the vaccination cycle he contracted pneumonia with kidney problems and low albumin; shortly after completing the vaccination cycle he contracted pneumonia with kidney problems and low albumin; shortly after completing the vac


VAERS ID: 1668784 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 58
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]; EUTIROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (mild); Glaucoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101100265

Write-up: elderly vaccinated 1st dose Pfizer 18Apr and 2nd dose 12May died suddenly on 09Jul2021. No disease in progress; administered in Arm Left on 12May2021 as dose 2, 0.5 ml; This is a spontaneous report from a contactable consumer or other non-health care professional downloaded from the Regulatory Authority -WEB, regulatory authority number IT-MINISAL02-773909. An 85-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot number: FA5831) via intramuscular, administered in arm left on 12May2021 (age at vaccination 85-year-old) at 0.5 ml as single dose for COVID-19 immunisation. Medical history included glaucoma, diabetes mellitus mild from an unknown date. Concomitant medication(s) included naphazoline hydrochloride (EYE DROPS NAPHAZOLINE HYDROCHLORIDE) taken for glaucoma and levothyroxine sodium (EUTIROX) for an unspecified indication; both start and stop date were not reported. The patient previously took the first dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot number: EX0893) via an unspecified route of administration on 18Apr2021 (age at vaccination 85-year-old) as single dose for COVID-19 immunisation. On 09Jul2021, the patient suddenly died. It was unknown if an autopsy was performed and no disease in progress. The patient was received treatment for the event included heart massage and adrenaline administration. The outcome of the event was fatal. Reporter''s comment: glaucoma and mild diabetes Taking Eutirox and eye drops for glaucoma. Sender''s comment: 1st DOSE 18Apr2021 lot EX0893 Follow-up performed on 19Aug2021: the reporter reports that he will shortly provide a clinical report. Waiting for a reply. No follow up attempts needed, no further information is expected.; Reported Cause(s) of Death: unknown


VAERS ID: 1668789 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-18
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Body temperature, Investigation, Micturition urgency, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; Heart disease, unspecified (with ICD(Implantable cardioverter defibrillator) implantation); Hypertension; Implantable cardioverter defibrillator insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: fever; Result Unstructured Data: Test Result:39.5 Centigrade; Test Name: Impact on quality of life; Result Unstructured Data: Test Result:10; Comments: 10/10
CDC Split Type: ITPFIZER INC202101100299

Write-up: fever (39.5 C); respiratory failure; imperious urination, cardiac arrhythmia.; fever (39.5 C); respiratory failure; imperious urination, cardiac arrhythmia.; fever (39.5 C); respiratory failure; imperious urination, cardiac arrhythmia.; fever (39.5 C); respiratory failure; imperious urination, cardiac arrhythmia.; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority -WEB IT-MINISAL02-774403 received via regulatory authority. A 76-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number EX7389) at 30 ug single dose on 03May2021 intramuscular in left shoulder for COVID-19 immunisation. Medical history included hypokinetic dilated heart disease with ICD (Implantable cardioverter defibrillator) implantation, hypertension, and Chronic obstructive pulmonary disease. Concomitant drug was not provided. Patient experienced fever (39.5 C); respiratory failure; imperious urination, cardiac arrhythmia on 18May2021, which resulted in hospitalization. Impact on quality of life was 10/10. Outcome of the events was fatal. Sender Comment: The reporter was asked for information about the first dose of vaccine and any concomitant therapies as well as the expiration of the batch of the vaccine administered as the second dose. The detailed clinical report was also requested.; Reported Cause(s) of Death: fever (39.5 C); respiratory failure; imperious urination, cardiac arrhythmia; fever (39.5 C); respiratory failure; imperious urination, cardiac arrhythmia; fever (39.5 C); respiratory failure; imperious urination, cardiac arrhythmia; fever (39.5 C);


VAERS ID: 1668791 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210901995

Write-up: Infection; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, IT-MINISAL02-775448) on 31-AUG-2021 and concerned a 70 year old male of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) 0.5 ml,1 total administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced infection. On 17-AUG-2021, the patient died from infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: INFECTION


VAERS ID: 1668800 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2154 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JOPFIZER INC202101119141

Write-up: Death/passed away; This is a spontaneous report from a contactable consumer or other non HCP (parent, father of patient). A 15-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 09Aug2021 at 09:00 AM (at the age of 15-year-old; lot number: FF2154) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The father reported that the patient (the son) received the dose 1 of the Pfizer vaccine on 09Aug2021 at 9AM on left arm. Unfortunately, patient passed away (death) on Friday 13Aug2021 at 04:30 without any history of illness. The event resulted in Emergency room/department or urgent care. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient did not test for COVID-19. Device date was 29Aug2021. No treatment received. Outcome of the event was fatal. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death/passed away


VAERS ID: 1668945 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Marasmus, Oxygen saturation, Respiratory arrest, Respiratory rate, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyponatraemia; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: blood pressure; Result Unstructured Data: Test Result:112/62; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210716; Test Name: pulse rate; Result Unstructured Data: Test Result:84; Test Date: 20210716; Test Name: SpO2; Test Result: 97 %; Test Date: 20210716; Test Name: respiratory rate; Result Unstructured Data: Test Result:Increased
CDC Split Type: JPPFIZER INC202101099133

Write-up: Geromarasmus; Respiratory arrest; Tachypnoea; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21124623. The patient was a 91-year and 2-month-old male. Body temperature before vaccination was 36.7 degrees centigrade. The patient had no particular family history. The patient had medical history of pneumonia aspiration chronic and hyponatraemia. On 02Jul2021, the patient was discharged from a hospital and came back to his home. Since the patient had pneumonia aspiration, the activity of daily living (ADL) was total assisted on the bed. Since the amount of oral intake was very small, subcutaneous transfusion was performed daily. On 16Jul2021 at 12:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as the first single dose for COVID-19 immunization (at his home). The physician stayed at his home for 15 minutes for confirmation. There were no appreciable changes (blood pressure was 112/62, pulse rate was 84, and SpO2 was 97%). On 16Jul2021 at around 17:00 (4 hours and 45 minutes after vaccination), the respiratory rate increased. On 16Jul2021 at 19:11 (6 hours and 56 minutes after vaccination), the patient had respiratory arrest. On 16Jul2021 at 19:50 (7 hours and 35 minutes after vaccination), the patient was confirmed to die. The reporting physician classified the event, respiratory arrest, as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were geromarasmus and hyponatraemia. The reporting physician commented as follows: Since the patient had pneumonia aspiration, the patient was unable to intake orally. In addition, the patient also had hyponatraemia, and the condition was easy to change. The patient was so called in the end-of-life period considering his age. The effect caused by the vaccination was unknown.; Reported Cause(s) of Death: Respiratory arrest; Geromarasmus


VAERS ID: 1668952 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 27 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210628; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: JPPFIZER INC202101120264

Write-up: Interstitial pneumonia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21125174. A 78-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) on 10Jun2021 (the day of vaccination), via an unspecified route of administration as the first single dose (at 78 years old) for COVID-19 immunization. Body temperature before vaccination was not provided. The family history was not provided. Points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) was not provided. After the patient received the first dose of BNT162b2 vaccination, he had physical deconditioning. On 23Jun2021 (13 days after the vaccination), the patient experienced interstitial pneumonia. The patient had pyrexia of 37 degrees Celsius. On 28Jun2021 (18 days after vaccination), the body temperature was 38 degrees Celsius. The patient visited the reporting hospital. The patient was diagnosed with pneumonia, and he was admitted to the hospital. Although the patient was treated with a general antibiotic, the symptom did not improve. On 05Jul2021 (25 days after vaccination), the respiratory condition was aggravated. Since the patient had acute aggravation of interstitial pneumonia, steroid pulse therapy and cyclophosphamide (ENDOXAN) pulse therapy were performed; however, the improvement was poor. On 25Jul2021 (one month/15 days after vaccination), the patient died. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient originally had no medical history of interstitial pneumonia. CT at an earlier stage of the disease showed that parts of the condition were similar to those of COVID-19. According to the clinical course, the possibility of drug-induced pneumonia could not be ruled out. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Interstitial pneumonia


VAERS ID: 1668976 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-31
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002617 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol dependence syndrome (Suspicion of alcoholism); Spinal stenosis (Suspicion of spinal stenosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP079031

Write-up: Acute cardiac failure; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE ACUTE (Acute cardiac failure) in a 57-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3002617 and 3004229) for COVID-19 vaccination. Concurrent medical conditions included Spinal stenosis (Suspicion of spinal stenosis) and Alcohol dependence syndrome (Suspicion of alcoholism). On 01-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced CARDIAC FAILURE ACUTE (Acute cardiac failure) (seriousness criteria death and medically significant). The patient died on 31-Jul-2021. The reported cause of death was Cardiac failure acute. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC FAILURE ACUTE (Acute cardiac failure) to be possibly related. Reporter''s comments: There is a possibility that the patient had primary hyperaldosteronism and abnormal liver function. Other than the above diseases, spinal canal stenosis and alcoholism are suspected as other factors. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected. However, the patients medical history of Alcohol dependence is a confounder.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1668981 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002540 / 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: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Hyperlipidaemia; Hypertension (Hypertension); Hyperuricaemia; Tachycardia paroxysmal (Paroxysmal tachycardia)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Sudden death; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP082042) on 24-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This case, initially reported to the Regulatory Authority (RA) by a physician, was received via the PMDA (Ref, v21124455). Oral medicine (irbesartan/amlodipine besilate, allopurinol, rivaroxaban, flecainide acetate, triazolam) On an unspecified date, body temperature before vaccination: 36.2 degrees Celsius. On 29-JUN-2021, at 18:50, the patient received 1st dose of Moderna vaccine. The patient did not complain of any symptom at outpatient visit as well as at home. The patient had lived a normal life almost until right before. On 01-JUL-2021, at around 15:00, the patient was presumed suddenly dead. Follow-up investigation will be made. The patient had visited the reporting hospital since 2015 and had been treated with oral medication for the above diseases. The patient was followed up without changing the dosing regimen, and no change was observed in the physical condition. Investigation for the causality, etc. was requested as the patient passed away suddenly after receiving the Moderna vaccine. Ischaemic heart disease is considered as another possible causal factor based on the diagnosis of postmortem certificate. Although the event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273), it is also considered that the event is due to effects from patient background, etc.; Sender''s Comments: This is a case of sudden death in a 55-year old male with a medical history of hypertension, hyperlipidaemia, hyperuricaemia, atrial fibrillation, paroxysmal tachycardia, 1 day after receiving the mRNA-1273. Possible cause was reported as ischemic heart disease per the autopsy. Case causality is confounded by the underlying comorbidities.; Reported Cause(s) of Death: Sudden death; Heart Disease


VAERS ID: 1669014 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myeloid leukaemia, Body temperature, Hyperthermia, Pyrexia, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: General body pain; Sore throat; Sore tongue; Tiredness
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 39.4 degrees Celsius, High; Test Name: white blood cell count; Result Unstructured Data: 125/?L, 20 times more than the previous result; Test Date: 20210522; Test Name: white blood cell count; Result Unstructured Data: 5.9/?L, normal
CDC Split Type: KRMODERNATX, INC.MOD20212

Write-up: Acute myeloid leukemia; Hyperthermia; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE MYELOID LEUKAEMIA (Acute myeloid leukemia), HYPERTHERMIA (Hyperthermia) and PYREXIA (Fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included General body pain, Sore tongue, Sore throat and Tiredness. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE MYELOID LEUKAEMIA (Acute myeloid leukemia) (seriousness criteria death, hospitalization and medically significant). an unknown date, the patient experienced HYPERTHERMIA (Hyperthermia) (seriousness criteria death and hospitalization) and PYREXIA (Fever) (seriousness criteria death and hospitalization). The reported cause of death was Hyperthermia, Acute myeloid leukemia and Fever. It is unknown if an autopsy was performed. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, White blood cell count (4.0-10.8): 5.9/?l (normal) 5.9/?L, normal. On an unknown date, Body temperature: 39.4 degrees celsius (High) 39.4 degrees Celsius, High. On an unknown date, White blood cell count (4.0-10.8): 125/?l (High) 125/?L, 20 times more than the previous result. Concomitant medications were not provided by the reporter. The patient''s wife asked the doctor if the patient could receive a COVID-19 vaccine, and the doctor said without hesitation that he could get vaccine and then strongly recommended to get vaccine on that day. The patient had a fever for all three days after vaccination, and while having fever, took the antipyretics precribed by the hospital. Company Comment : Very limited information regarding these events has been provided at this time. No further follow-up information is expected; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected; Reported Cause(s) of Death: Hyperthermia; Acute myeloid leukemia; Fever


VAERS ID: 1669032 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-19
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Angiocardiogram, Electrocardiogram, Fatigue, Hypotension, SARS-CoV-2 test, Troponin T
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: Atherosclerosis cerebral; Cane user; Cerebral ischaemia (Chronic subcompensated cerebral ischemia); Chronic kidney disease stage 4; Coronary heart disease; Iron deficiency anaemia; Primary hypertension; Spondylosis
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: Troponin T; Result Unstructured Data: 2573 ng/L; Test Date: 20210527; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Negative; Test Date: 20210527; Test Name: Coronary angiogram; Result Unstructured Data: Diffuse atherosclerosis; Test Date: 20210531; Test Name: ECG; Result Unstructured Data: Atrial fibrillation, 94 BPM
CDC Split Type: LVJNJFOC20210844306

Write-up: ACUTE CORONARY SYNDROME; ARTERIAL HYPOTENSION; FATIGUE; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, LV-SAM-2021086440] concerned a 95 year old female. The patient''s weight was 50 kilograms, and height was not reported. The patient''s concurrent conditions included: cane user, spondylosis, chronic kidney disease stage 4, iron deficiency anaemia, cerebral ischaemia, primary hypertension, coronary heart disease, and atherosclerosis cerebral. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-05 expiry: UNKNOWN) .5 ml, 1 total administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the patient experienced fatigue, and was hospitalized (date unspecified). Duration of hospitalization was not reported. On 27-MAY-2021, the patient experienced acute coronary syndrome and arterial hypotension. Laboratory data included: Coronary angiogram (NR: not provided) Diffuse atherosclerosis, SARS-CoV-2 PCR test (NR: not provided) Negative, and Troponin T (NR: not provided) 2573 ng/L. On 31-MAY-2021, Laboratory data included: ECG (NR: not provided) Atrial fibrillation, 94 BPM. On 01-JUN-2021, the patient died from acute heart failure, and arrhythmia. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of acute coronary syndrome and arterial hypotension on 01-JUN-2021, and the outcome of fatigue was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0 20210844306-COVID-19 VACCINE AD26.COV2.S-acute coronary syndrome , arterial hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 20210844306-COVID-19 VACCINE AD26.COV2.S-fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: ACUTE HEART FAILURE; ARRHYTHMIA


VAERS ID: 1669038 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cerebral thrombosis, Chills, Fatigue, Headache, Malaise, Mobility decreased, Myalgia, Nausea, Pneumonia, Scan brain, Thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 96
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: Pneumonia
Allergies:
Diagnostic Lab Data: Test Name: brain scan; Result Unstructured Data: Test Result:Unknown
CDC Split Type: NLPFIZER INC2021237018

Write-up: Pneumonia; Thrombus in brain; thrombus in leg; Pain in joints; Not able to get out of bed due to muscle pain; Muscle pain; headache; Nausea; Malaise; Fatigue; Chills; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority -WEB, regulatory authority number NL-LRB-00439458. A 91-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 05Feb2021 (Batch/Lot Number: EJ6136) as unknown, single dose for covid-19 immunization. Medical history and concomitant medications were not reported.On 06Feb2021, the patient experienced muscle pain, pain in joints and not able to get out of bed due to muscle pain. The patient was recovering from events. No follow up attempts are possible. No further information is expected. Follow-up (14Jun2021) received via the Regulatory Authority. Regulatory Authority report number NL-LRB-00439458: new case identifier added: NL-LRB-00562000. A 91-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 05Feb2021 (Batch/Lot Number: EJ6136) as unknown, single dose for covid-19 immunization. Medical history included pneumonia from an unknown date and unknown if ongoing. Concomitant medication included unspecified blood pressure medication. The patient did not have a previous COVID-19 infection. On 06Feb2021, the patient experienced the non-serious events, headache, nausea, malaise, fatigue, and chills. On an unspecified date, the patient experienced the fatal event, pneumonia, for which she was hospitalized on an unknown date. On 20Apr2021, the patient experienced fatal events, thrombus in brain and thrombus in leg, both for which she was hospitalized on an unknown date. Cerebral thrombosis is treated with unknown drug and/or procedure, pneumonia is treated with antibiotica, diuretics given to reduce the amount of fluid behind the lungs, and thrombosis leg is treated with thrombus removal from leg. The patient died on 14May2021. It was not reported if an autopsy was performed. A cause of death was not reported. The outcome of the events, headache, nausea, malaise, fatigue, and chills was unknown. Health Authority comments: This report replaces NL-LRB-00552547 and NL-LRB-00439458, that have both been nullified. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonia; Thrombus in brain; thrombus in leg


VAERS ID: 1669119 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ELIQUIS
Current Illness: Renal function disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ct scan; Result Unstructured Data: Test Result:results unknown
CDC Split Type: NLPFIZER INC202101095408

Write-up: stroke; This is a spontaneous report from a contactable other health care professional downloaded from the Regulatory Authority -WEB [NL-LRB-00670127]. A 82-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 24Jul2021 as dose 1, single for covid-19 immunisation. Medical history included renal function disorder (ongoing). Patient had no previous COVID-19 infection. Concomitant medication(s) included amlodipine (AMLODIPINE) (10mg) taken for an unspecified indication, from unknown start date; apixaban (ELIQUIS) (5mg) taken for an unspecified indication, from unknown start date. Patient had no past drug therapy. On 02Aug2021, the patient experienced stroke. Cerebral haemorrhage 1 weeks after start. The patient underwent lab tests and procedures which included ct scan: results unknown on an unspecified date. The patient died on 02Aug2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Stroke


VAERS ID: 1669121 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-19
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210900048

Write-up: Aneurysm; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, NL-LRB-00672865) on 31-AUG-2021 and concerned a 79 year old female. The patient''s weight was 75 kilograms, and height was 175 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) 1 dosage forms, 1 total administered on 08-JUL-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-AUG-2021, the patient experienced aneurysm and died from aneurysm. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: ANEURYSM


VAERS ID: 1669165 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Nausea, Pyrexia, Vaccination failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852416

Write-up: COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; COUGH; FEVER; NAUSEA; VOMITING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100968] concerned a 36-year-old female with unspecified unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A, expiry: UNKNOWN) dose was not reported, 1 total was administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the patient experienced cough, fever, nausea and vomiting. On an unspecified date, the patient experienced covid-19, and was hospitalized (duration unspecified).On an unspecified date, the patient had suspected clinical vaccination failure and the patient died from cough, fever, nausea, vomiting, and covid-19. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender''s Comments: V0: 20210852416-covid-19 vaccine ad26.cov2.s-covid-19, cough, fever, nausea, vomiting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210852416- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COUGH; FEVER; NAUSEA; VOMITING; COVID-19


VAERS ID: 1669167 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-05
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19 pneumonia, SARS-CoV-2 test
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210861804

Write-up: ACUTE RESPIRATORY DISTRESS SYNDROME; COVID-19 PNEUMONIA; This spontaneous report received from a consumer concerned a 64 year old male of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 292C21A, expiry: Unknown) dose was not reported, 1 total administered on 04-AUG-2021, 11:01 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced fever and coughs and feeling uneasy or easily getting tired. On 06-AUG-2021, his breathing pattern increased when exerting effort. Then on 07-AUG-2021, patient experienced difficulty of breathing and on same day swab test was performed showing a positive result to COVID. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 07-AUG-2021; 13:46, the patient died due to acute respiratory distress syndrome, pneumonia high risk and covid-19 positive (Covid-19 pneumonia). It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of acute respiratory distress syndrome, pneumonia high risk and covid-19 positive (covid-19 pneumonia) on 07-AUG-2021. This report was serious (Death).; Sender''s Comments: V0:20210861804-Covid-19 vaccine ad26.cov2.s- Acute respiratory distress syndrome, Covid 19 pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ACUTE RESPIRATORY DISTRESS SYNDROME; PNEUMONIA HIGH RISK; COVID POSITIVE


VAERS ID: 1669168 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 42 / UNK - / OT

Administered by: Unknown       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: 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: PHMODERNATX, INC.MOD20212

Write-up: Loss of consciousness; This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 42-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 42) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Aug-2021 at 11:30 AM, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criteria death and medically significant). The reported cause of death was Loss of consciousness. 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 relevant concomitant medications were provided. No treatment information was provided. Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Loss of consciousness


VAERS ID: 1669179 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-18
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G26761A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Diarrhoea, Dyspnoea, Vomiting
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), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Osteoarthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis of arteries of the extremities; Ischemic heart disease; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20212

Write-up: Cardiac arrest; Vomited; Diarrhea; Dyspnea exacerbated; This case was received via Regulatory Authority (Reference number: PL-URPL-3-878-2021) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest), DYSPNOEA (Dyspnea exacerbated), VOMITING (Vomited) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. G26761A) for COVID-19 vaccination. The patient''s past medical history included Obesity, Ischemic heart disease and Atherosclerosis of arteries of the extremities. Concurrent medical conditions included Hypertension and Osteoarthritis. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 18-Mar-2021, after starting mRNA-1273 (Spikevax), the patient experienced DYSPNOEA (Dyspnea exacerbated) (seriousness criterion medically significant). On 21-Mar-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant), VOMITING (Vomited) (seriousness criterion death) and DIARRHOEA (Diarrhea) (seriousness criterion death). The patient died on 21-Mar-2021. The reported cause of death was icd-10-cm diagnosis code i46: cardiac arrest. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (Dyspnea exacerbated) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Company Comment : Very limited information regarding this events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Translated doc received on 30-AUG-2021 includes no new info; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: ICD-10-CM Diagnosis Code I46: Cardiac arrest


VAERS ID: 1669183 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Asthenia, Condition aggravated, Cough, Dyspnoea, Pain, Pneumonia
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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101095502

Write-up: Cough; Weakness; Acute respiratory insufficiency; Dyspnoea; Pneumonia; Pain; Condition aggravated; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the Regulatory Authority -WEB PL-URPL-DML-MLP.4401.2.573.2021. An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular on 01Apr2021 (Lot Number: ET3674) at the age of 82-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 04Apr2021 at 12:00, the patient developed the following adverse reactions: dyspnoea, cough, weakness-lack of power to move, acute respiratory failure, pneumonia, pain, death. The symptoms manifested themselves gradually. The first with malaise and pains immediately after the vaccine. Every day it got worse. Death occurred on 28Apr2021 at 23:40 in hospital. Health outcome: death; Consequences: death, date of death: 28Apr2021, cause: pneumonia (After vaccination Pfizer Series No. ET3674), no autopsy was performed; Hospitalization from 10Apr2021 to 28Apr2021. The reporting person did not specify the severity of the adverse reaction. The outcome of events was fatal. Sender''s comments: Feeling unwell is an expected side effect of Comirnaty in the Summary of Product Characteristics. The location of the pain was not specified in the notification - the Vaccine Summary of Product Characteristics lists the following as expected side effects: muscle pain, joint pain, headache. Other reactions are unexpected adverse reactions. Symptoms: shortness of breath, cough, weakness-lack of power to move, acute respiratory failure, pain, malaise, death can result from pneumonia. Pneumonia is caused by microorganisms, it was not determined which pathogens caused the patient''s illness. Vaccines based on matrix RNA, including the Comirnaty preparation, do not expose the vaccinated person to the virus, hence it is unlikely that the illness was the result of receiving vaccine. It is possible that the administration of the vaccine and any It is possible that the administration of the vaccine, and any adverse reactions that may have occurred, coincided with the appearance of It is possible that the administration of the vaccine and any side effects that may have occurred coincided with the appearance of symptoms of infection. It is possible that the administration of the vaccine and any side effects that may have occurred coincided with the appearance of the infection. The time-course of the vaccination and any adverse events that may have occurred coincide with the appearance of the infection. There is a temporal relationship between the administration of Comirnata and There is a temporal relationship between the administration of Comirnata and the occurrence of the adverse reaction. The reporter did not specify the severity of the adverse reaction, URPL due to the hospitalisation and death of the Patient, considered it as severe. Related notification: RPW/112531/2021 - duplicate. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia (after vaccination with Pfizer, batch no. ET3674)


VAERS ID: 1669373 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Dyskinesia, Musculoskeletal stiffness, SARS-CoV-2 test, Weight
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   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: Blood pressure abnormal (unspecified); Gout; High weight; Hyperlipidemia
Allergies:
Diagnostic Lab Data: Test Name: covid-19 test; Result Unstructured Data: Test Result:negative; Test Name: weight; Test Result: 104 kg
CDC Split Type: THPFIZER INC202101122503

Write-up: tight at his arms and legs; crooked mouth; hands and feet turn green; This is a spontaneous report from a non-contactable consumer (patient''s mother) via online news (Internet source). A 43-year-old male patient received bnt162b2 (COMIRNATY), dose number unknown via an unspecified route of administration on 23Aug2021 (at the age of 43-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hyperlipidaemia, blood pressure (unspecified), gout, weight was 104 kg. The patient''s concomitant medications were not reported. The patient experienced tight at his arms and legs (death) on 23Aug2021, crooked mouth (death) on 23Aug2021, hands and feet turn green (death) on 23Aug2021. The patient died on 23Aug2021. The course of events was as follows: The mother of dead person informed that the patient died mysteriously inside a home after vaccination with Pfizer vaccine on 23Aug2021 at hospital at the province for the conditional of patient who had underlying disease and weighed more than 100 kg. On 23Aug2021, her son received vaccine at hospital and went back to take a rest at home with normal condition. Around 20.00, her son told that he was tight at his arms and legs. After a while, she saw that her son had crooked mouth and hands and feet turn green. When she called him, he did not respond to her. She immediately called emergency car and when emergency team arrived at home and performed CPR, it did not work as her son already died. After that, officer brought his body to perform preliminary autopsy at the hospital. Physician team assumed the that patient died for around 8-18 hours with the unknown cause of death. His body was transferred to perform further autopsy at other hospital and must wait the result for 1-2 months. The COVID-19 test was performed and the result was negative. He had no symptoms of illness or exacerbation symptoms from his underlying diseases at all. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1669383 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arteriosclerosis coronary artery, Chest pain, Head discomfort, Hyperhidrosis, Myocardial infarction, Oral discomfort, Pain in extremity
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (The patient had smoking habits.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: myocardial infarction; Coronary atherosclerosis and severe obstruction; Severe chest pain; Stomach pain; Bed was wet; Mild sore arm; Slight burning in the mouth; Mild heavy-headedness; This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION (myocardial infarction), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary atherosclerosis and severe obstruction), CHEST PAIN (Severe chest pain), ABDOMINAL PAIN UPPER (Stomach pain), ORAL DISCOMFORT (Slight burning in the mouth), HEAD DISCOMFORT (Mild heavy-headedness), PAIN IN EXTREMITY (Mild sore arm) and HYPERHIDROSIS (Bed was wet) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004223-CDC) for COVID-19 vaccination. Concurrent medical conditions included Smoker (The patient had smoking habits.). On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced ORAL DISCOMFORT (Slight burning in the mouth) (seriousness criterion death) and HEAD DISCOMFORT (Mild heavy-headedness) (seriousness criterion death). On 16-Jul-2021, the patient experienced PAIN IN EXTREMITY (Mild sore arm) (seriousness criterion death). On 23-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (myocardial infarction) (seriousness criteria death and medically significant), ARTERIOSCLEROSIS CORONARY ARTERY (Coronary atherosclerosis and severe obstruction) (seriousness criterion death), CHEST PAIN (Severe chest pain) (seriousness criterion death), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion death) and HYPERHIDROSIS (Bed was wet) (seriousness criterion death). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. The patient died on 23-Jul-2021. The reported cause of death was Myocardial infarction and coronary atherosclerosis and severe obstruction. An autopsy was performed, but no results were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was found lying in the kitchen and had died before being admitted to the hospital. On 28-Jul-2021 the judicial autopsy was performed. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event terms, onset dates and seriousness captured per SD Authority reporting. No relevant concomitant medications were reported; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event terms, onset dates and seriousness captured per SD Authority reporting.; Reported Cause(s) of Death: Myocardial infarction; Coronary atherosclerosis and severe obstruction


VAERS ID: 1669384 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Death, Diarrhoea, Fatigue, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; Heart disease, unspecified; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; severe diarrhea; Lethargy; Fatigue; Chills; Fever; This regulatory authority case was reported by an other and describes the occurrence of DEATH (Death) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Heart disease, unspecified and Dementia. On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever). On 05-Jul-2021, the patient experienced LETHARGY (Lethargy). On 15-Jul-2021, the patient experienced DIARRHOEA (severe diarrhea). The patient died on 16-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIARRHOEA (severe diarrhea), LETHARGY (Lethargy), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. No concomitant medication were provided. No treatment medication were provided. The patient visited the emergency room due to onset of fever. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected. Event terms, onset dates and seriousness captured per Regulatory Authority reporting.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected. Event terms, onset dates and seriousness captured per Regulatory Authorityreporting.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1669385 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-20
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, 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: 2021-07-31
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Stroke
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; loss of consciousness; This regulatory authority case was reported by a patient family member or friend and describes the occurrence of DEATH (Death) and LOSS OF CONSCIOUSNESS (loss of consciousness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Stroke. On 14-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (loss of consciousness) (seriousness criterion medically significant). On 31-Jul-2021, LOSS OF CONSCIOUSNESS (loss of consciousness) outcome was unknown. The patient died on 31-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications were reported. The patient had experienced loss of consciousness on 20-JUL-2021 and subsequently death on 31-JUL-2021, after being brought to the hospital. Treatment information was not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected. Event terms, onset dates and seriousness captured per Regulatory Authority reporting.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected. Event terms, onset dates and seriousness captured per Regulatory Authority reporting.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1669386 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Heart disease, unspecified. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 16-Jul-2021 The patient died on 16-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter Lab data was not provided Treatment product was not provided by the reporter This is a case of sudden death in a 69-year-old male subject with hx of Heart Disease, Unspecified, who died 3 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Translated document received on 01-AUG-2021 contained significant information Reporter information, Event information was updated; Sender''s Comments: This is a case of sudden death in a 69-year-old male subject with hx of Heart Disease, Unspecified, who died 3 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1669387 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. Death occurred on 15-Jul-2021 The patient died on 15-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 15-Jul-2021 after receiving vaccination patient suddenly fell to the ground when undressed after returning home, no signs of life and family members called 119 and patient was immediately administered on the spot with Cardiopulmonary Cerebral Resuscitation (CPCR) and 3 ampoules of Bosmin. Patient was unconscious, not breathing, and without pulse when taken to emergency department. Patient received first aid immediately but first aid was failed and patient died. No concomitant medication information was reported. Company Comment: This is a case of sudden death in a 66-year-old male subject with no known medical history, who died after receiving the vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 66-year-old male subject with no known medical history, who died after receiving the vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1669389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; Redness at the vaccination site; Swelling at the vaccination site; Pain at the vaccination site; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the vaccination site), VACCINATION SITE SWELLING (Swelling at the vaccination site) and VACCINATION SITE PAIN (Pain at the vaccination site). The patient died on 14-Jul-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, VACCINATION SITE ERYTHEMA (Redness at the vaccination site), VACCINATION SITE SWELLING (Swelling at the vaccination site) and VACCINATION SITE PAIN (Pain at the vaccination site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication or treatment information was provided. The patient died suddenly on 14-Jul-2021, and the physician who issued the death certificate assessed that the COVID vaccine might be unlikely to be related to the event, but still reported as adverse reactions. Autopsy was not done since family members preferred not to perform an autopsy on the patient. Company Comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Translation received on 01-Sep-2021 as live follow up; Sender''s Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1669391 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Consciousness fluctuating, SARS-CoV-2 test, Troponin I, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: COVID-19 POCT-PCR fast testing negative.; Test Date: 20210720; Test Name: Troponin-I; Result Unstructured Data: Troponin-I: 149.6 pg/ml High Sensitivity
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Changes in consciousness; Vomiting; This regulatory authority case was reported by a pharmacist and describes the occurrence of CONSCIOUSNESS FLUCTUATING (Changes in consciousness) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced CONSCIOUSNESS FLUCTUATING (Changes in consciousness) (seriousness criteria death and medically significant) and VOMITING (Vomiting) (seriousness criterion death). The patient was treated with ADRENALINE [EPINEPHRINE] (intravenous) for Adverse event, at an unspecified dose and frequency. The patient died on 20-Jul-2021. The reported cause of death was changes in consciousness and Vomiting. An autopsy was performed, but no results were provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: negative (Negative) COVID-19 POCT-PCR fast testing negative.. On 20-Jul-2021, Troponin I: 149.6 (High) Troponin-I: 149.6 pg/ml High Sensitivity. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CONSCIOUSNESS FLUCTUATING (Changes in consciousness) and VOMITING (Vomiting) to be possibly related. Concomitant product use was not provided by the reporter. The patient received the Moderna vaccine at on 07/16/2021 and did not report any discomfort. The patient did not develop any symptoms after receiving the vaccine in the morning of 16-Jul-2021. The patient did not report a fever, arm pains, or any other symptoms. In the afternoon of 20-Jul-2021, the patient vomited and returned to her bedroom to rest. On 20-JUL-2021 the patient was administered Cardiopulmonary resuscitation on the way back to emergency room. The patient was accompanied to the room after vomiting at 03:00 p.m. At 5:00 p.m., the patient could not be woken and was not breathing and had no heartbeat. After the ambulance arrived at the scene, the EMTs did not recommend AED and they administered CPR on the way to the emergency room Emergency care administered at 5:19 p.m. Adrenalin 1mg IVP was administered after thumper, CPR, and ventilator. Emergency care was ineffective at 5:47 p.m. The forensic report was issued at 7:08 p.m. and the ambulance service assisted in the returning the patient back home. Laboratory test on 20-Jul-2021 showed K (Potassium) value was 6.8 mmol/L, Creatinine value was 1.12 mg/dL, GOT:Aspartate Aminotransferase value was 54 IU/L, CPK(Creatine phosphokinase test) value was 341 IU/L, Glucose PC(Post Cibum) value was 312 mg/L. The follow-up from the patient''s husband and the family member reported that the patient did not develop any symptoms after receiving the vaccine in the morning of July 16 (the husband drove her to the vaccination station). The patient was unresponsive, so an ambulance was called. The hospital has not issued a death certificate. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Reported Cause(s) of Death: Changes in consciousness; Vomiting


VAERS ID: 1669392 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Fatigue, Nausea, Pyrexia, Somnolence
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   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: Blood pressure high; Dialysis (Dialysis patient with high blood pressure); End stage renal disease; Foot infection; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: loss of appetite; Nausea; felt weak throughout the body; fever; sleepiness; fatigue; This regulatory authority case was reported by a non-health professional and describes the occurrence of DECREASED APPETITE (loss of appetite), FATIGUE (fatigue), PYREXIA (fever) and NAUSEA (Nausea) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Blood pressure high, Stroke, End stage renal disease, Foot infection and Dialysis (Dialysis patient with high blood pressure). On 09-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion death) and SOMNOLENCE (sleepiness). On 12-Jul-2021, the patient experienced PYREXIA (fever) (seriousness criterion death). On 14-Jul-2021, the patient experienced ASTHENIA (felt weak throughout the body). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite) (seriousness criterion death) and NAUSEA (Nausea) (seriousness criterion death). The patient died on 18-Jul-2021. The reported cause of death was loss of appetite, Fatigue, Fever and Nausea. It is unknown if an autopsy was performed. At the time of death, SOMNOLENCE (sleepiness) and ASTHENIA (felt weak throughout the body) outcome was unknown. Concomitant product was not provided by the reporter. The patient reported that he was a dialysis patient (W2, 4, 6 at Jian Ren Hospital). The patient was hospitalized at Jian Ren Hospital between 29-Jun-2021 to 06-Jul-2021 for a toe infection. The patient developed fatigue and sleepiness after vaccination. The patient developed a fever on 12-Jul-2021 and the fever broke on 13-Jul-2021 after medication. Fatigue continued after 14-Jul-2021 and the patient felt weak throughout the body. However, they were still conscious and able to converse. The patient went to the hospital for dialysis on 17-Jul-2021. The family reported that the patient was still able to converse normally after returning home but developed loss of appetite and nausea within a few days. On 18-Jul-2021, the family found that the patient was not breathing in their sleep. After the ambulance arrived, the patient had no vital signs. Treatment information was not provided. Company comment: This is a case of death in a 84-year-old male patient with medical history of terminal kidney disease undergoing dialysis, stroke and hypertension and recent toe infection who experienced fatal events of fatigue, pyrexia, decreased appetite, nausea and non serious events of sleepiness and weakness. The patient was found dead 11 days after receiving first dose of vaccine. The family found that the patient was not breathing in their sleep. The patient had no vital signs. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 84-year-old male patient with medical history of terminal kidney disease undergoing dialysis, stroke and hypertension and recent toe infection who experienced fatal events of fatigue, pyrexia, decreased appetite, nausea and non serious events of sleepiness and weakness. The patient was found dead 11 days after receiving first dose of vaccine. The family found that the patient was not breathing in their sleep. The patient had no vital signs. Very limited information has been provided at this time.; Reported Cause(s) of Death: loss of appetite; fatigue; fever; Nausea


VAERS ID: 1669397 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cyanosis, Fatigue
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical cancer (Cervical cancer S/P); Heart valve replacement (Last year); Hepatic cancer (Hepatic cancer S/P)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Slight fatigue; Cyanosis; This regulatory authority case was reported by a pharmacist and describes the occurrence of CYANOSIS (Cyanosis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Cervical cancer (Cervical cancer S/P), Hepatic cancer (Hepatic cancer S/P) and Heart valve replacement (Last year) in 2020. Concurrent medical conditions included Heart disease, unspecified. On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced CYANOSIS (Cyanosis) (seriousness criterion death). On an unknown date, the patient experienced FATIGUE (Slight fatigue). The patient died on 20-Jul-2021. The reported cause of death was Cyanosis. It is unknown if an autopsy was performed. At the time of death, FATIGUE (Slight fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medications were not reported. The treatment information was not provided. After vaccination, the son reported that the patient felt slight fatigue but was generally fine. The son said the patient was in generally good spirits and was able to take care of herself during the past few days. At noon, the son returned home to find the patient on the sofa and was cyanosis. At 1:30 p.m. on 07/20/2021, the patient had no heartbeat before arriving at the hospital. CPR was administered from 12:35 p.m. to 1:11 p.m. and the emergency care was ineffective. He called 119. 4. The son reported that due to the sudden nature of events, the family are still contacting funeral parlors. The family has not discussed drug injury relief yet. On 07/22/2021, the daughter applied for administrative examination in the afternoon. Vaccine related reasons have been excluded and the case is closed. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient''s age and med history of heart valve replacement and heart disease are confounding factors.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient''s age and med hx of heart valve replacement and heart disease are confounding factors.; Reported Cause(s) of Death: Cyanosis


VAERS ID: 1669719 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-07-18
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Diarrhoea, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Carcinoma hepatocellular; Chronic pancreatitis; Diabetes mellitus; Ischaemic heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: COVID-19 respiratory infection; Insufficiency renal; Diarrhea; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-MP20216628) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 respiratory infection), RENAL FAILURE (Insufficiency renal) and DIARRHOEA (Diarrhea) in a 94-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Carcinoma hepatocellular, Ischaemic heart disease, Diabetes mellitus and Chronic pancreatitis. In April 2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced COVID-19 (COVID-19 respiratory infection) (seriousness criteria death and hospitalization), RENAL FAILURE (Insufficiency renal) (seriousness criteria death, hospitalization and medically significant) and DIARRHOEA (Diarrhea) (seriousness criteria death and hospitalization). The patient died on 01-Aug-2021. The reported cause of death was pneumopathie, insuffisance r?nale, covid. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication was received by the patient No Treatment information was received by the patient. Company comment: Based on biological implausibility and mechanism of action of the product mRNA-1273, a causal relationship between the reported serious unexpected event of COVID-19 and the administration of mRNA-1273 assessed as unlikely. COVID-19 was more consistent with the increased risk of infections due to environmentally mediated pandemic for COVID-19 and confounded by underlying comorbidities. The serious unexpected events of Renal failure and Diarrhea were more consistent with the possible complications of COVID-19 and confounded by underlying comorbidities.; Sender''s Comments: Based on biological implausibility and mechanism of action of the product mRNA-1273, a causal relationship between the reported serious unexpected event of COVID-19 and the administration of mRNA-1273 assessed as unlikely. COVID-19 was more consistent with the increased risk of infections due to environmentally mediated pandemic for COVID-19 and confounded by underlying comorbidities. The serious unexpected events of Renal failure and Diarrhea were more consistent with the possible complications of COVID-19 and confounded by underlying comorbidities.; Reported Cause(s) of Death: pneumopathie, insuffisance r?nale, covid


VAERS ID: 1669722 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001653 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Vaccination site erythema
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy; Food allergy; House dust mite allergy; Latex allergy; Pollen allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Dyslipidaemia (treated with Pravastatin 20mg); Hyperexcitability (treated with flecaine LP50mg)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death unexplained; Vaccination site erythema; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-RN20212484) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3001653) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Latex allergy since an unknown date, Food allergy since an unknown date, Arrhythmia, House dust mite allergy since an unknown date, Drug allergy since an unknown date, Dyslipidaemia (treated with Pravastatin 20mg), Pollen allergy since an unknown date and Hyperexcitability (treated with flecaine LP50mg). On 20-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Apr-2021, after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient died on 17-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication details were not reported by the reporter.Treatment details were not reported by the reporter. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was not applicable. Company comment: This is a case of death in a 72 -year-old female subject with a hx of Latex allergy, Food allergy, Arrhythmia, House dust mite allergy, Drug allergy, Dyslipidaemia, Pollen allergy, Hyperexcitability, who died 27 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Sender''s Comments: This is a case of death in a 72 -year-old female subject with a hx of Latex allergy, Food allergy, Arrhythmia, House dust mite allergy, Drug allergy, Dyslipidaemia, Pollen allergy, Hyperexcitability, who died 27 days after receiving first dose of vaccine. Very limited information has been provided at this time. No further information has been requested.; Reported Cause(s) of Death:


VAERS ID: 1669791 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002913 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental underdose, Blood pressure diastolic, Blood pressure increased, Blood pressure measurement, Blood pressure systolic, Death, Decreased appetite, Dyspnoea, Fatigue, Hyperhidrosis, Injection site pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   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: METFORMIN - TABLET; AMLODIPINE;BISOPROLOL; ACETYLSALICYLIC ACID; ATORVASTATIN
Current Illness: Heart failure NYHA class II; Primary hypertension (Stage 3); Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: Blood pressure diastolic; Result Unstructured Data: mm[Hg] (millimetre of mercury); Test Date: 20210813; Test Name: Blood pressure; Result Unstructured Data: Increased; Test Date: 20210813; Test Name: Blood pressure systolic; Result Unstructured Data: mm[Hg] (millimetre of mercury)
CDC Split Type: LVMODERNATX, INC.MOD20212

Write-up: Death; Syncope; Sweating increased; Laboured breathing; Blood pressure increased; Accidental underdose; Injection site pain; Fatigue; Appetite lost; This case was received via Regulatory Authority (Reference number: LV-SAM-2021086465) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) and SYNCOPE (Syncope) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002913) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Stroke in 2002. Concurrent medical conditions included Heart failure NYHA class II, Primary hypertension (Stage 3) and Type 2 diabetes mellitus. Concomitant products included AMLODIPINE;BISOPROLOL for Primary hypertension, METFORMIN (METFORMIN - TABLET) for Type 2 diabetes mellitus, ACETYLSALICYLIC ACID and ATORVASTATIN for an unknown indication. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter. On 09-Aug-2021, the patient experienced DECREASED APPETITE (Appetite lost), ACCIDENTAL UNDERDOSE (Accidental underdose), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue). On 13-Aug-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased). On 14-Aug-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating increased) and DYSPNOEA (Laboured breathing). On 09-Aug-2021, ACCIDENTAL UNDERDOSE (Accidental underdose) outcome was unknown. On 13-Aug-2021, BLOOD PRESSURE INCREASED (Blood pressure increased) had resolved. The patient died on 14-Aug-2021. The reported cause of death was Coronary thrombosis and Coronary atherosclerosis. An autopsy was not performed. At the time of death, SYNCOPE (Syncope), HYPERHIDROSIS (Sweating increased), DECREASED APPETITE (Appetite lost), DYSPNOEA (Laboured breathing) and FATIGUE (Fatigue) outcome was unknown and INJECTION SITE PAIN (Injection site pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, Blood pressure diastolic: 109 (High) mm[Hg] (millimetre of mercury). On 13-Aug-2021, Blood pressure measurement: increased (High) Increased. On 13-Aug-2021, Blood pressure systolic: 180 (High) mm[Hg] (millimetre of mercury). For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient concurrent medical conditions of heart failure, primary hypertension and type 2 diabetes mellitus could be contributing factors.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient concurrent medical conditions of heart failure, primary hypertension and type 2 diabetes mellitus could be contributing factors.; Reported Cause(s) of Death: Coronary thrombosis; Coronary atherosclerosis


VAERS ID: 1669805 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210902668

Write-up: DEATH; This spontaneous report received from a consumer via a company representative through social media, concerned a patient of unspecified age, sex, race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, following vaccination, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal. This report was serious (Death).; Sender''s Comments: V0-20210902668-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1669807 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C212 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210903539

Write-up: NAUSEA; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA,PH-PHFDA-300101732] concerned a 75 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213c212, and expiry: unknown) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021 07:30, the patient experienced nausea. On unspecified date, she also had vomiting and hypertension. She died from nausea on unknown date and autopsy details were not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210903539-Covid-19 vaccine ad26.cov2.s-Nausea. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: NAUSEA


VAERS ID: 1669809 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210903722

Write-up: GENERAL MALAISE; COUGH; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300102568] concerned a 39 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. It was unspecified whether autopsy was performed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, and expiry: unknown) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, at 08:00, the patient experienced general malaise, cough and fever. It was unknown if autopsy was performed. On an unspecified date, the patient died from fever, cough, and general malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210903722-covid-19 vaccine ad26.cov2.s -general malaise, Cough, Fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; COUGH; GENERAL MALAISE


VAERS ID: 1669810 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 209C2IA / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Blood pressure; Result Unstructured Data: Decrease
CDC Split Type: PHJNJFOC20210903755

Write-up: BODY WEAKNESS; SOB; DECREASE BP; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300102846] concerned a 76 year old male of an unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 209C2IA expiry: unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021 at 08:00, the patient experienced cough. On 17-AUG-2021 at 09:00, the patient experienced shortness of breath and decrease blood pressure. Laboratory data included: Blood pressure (NR: not provided) Decrease. On an unspecified date, the patient experienced body weakness. On an unknown date in 2021, the patient died from cough, body weakness, shortness of breath, and decrease blood pressure. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events cough, body weakness, shortness of breath, and decrease blood pressure was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210903755-Covid-19 vaccine ad26.cov2.s -Body weakness, Cough, SOB, Decrease BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; BODY WEAKNESS; SOB; DECREASE BP


VAERS ID: 1669812 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-06
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cough, Decreased appetite, Malaise, Musculoskeletal stiffness, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210903812

Write-up: BACK PAIN; BODY MALAISE; COUGH; FEVER; LOSS OF APPETITE; STIFFNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300102497] concerned a 41 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced back pain, body malaise, cough, fever, loss of appetite and stiffness. On an unspecified date, the patient died from back pain, body malaise, cough, fever, loss of appetite, back pain, and stiffness. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210903812-covid-19 vaccine ad26.cov2.s-back pain, body malaise, cough, fever, loss of appetite and stiffness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BODY MALAISE; COUGH; FEVER; LOSS OF APPETITE; BACK PAIN; STIFFNESS


VAERS ID: 1669815 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210904034

Write-up: Dizziness; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300102561] concerned a 67 year old male of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced dizziness. On an unspecified date, the patient died from dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210904034-Covid-19 vaccine ad26.cov2.s-Dizziness. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DIZZINESS


VAERS ID: 1669817 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Haemoptysis, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210904249

Write-up: DYSPNEA; HEMOPTYSIS; GENERAL MALAISE; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300102545] concerned a 57 year old female with an unspecified race and ethnic origin.. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, expiry: UNKNOWN) dose was not reported,1 total administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021 at 07:00, the patient experienced fever. On 11-AUG-2021, the patient experienced general malaise. On 13-AUG-2021, the patient experienced hemoptysis. On 21-AUG-2021 at 08:00, the patient experienced dyspnea. On an unspecified date, the patient died from fever, hemoptysis, general malaise, and dyspnea. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210904249-Covid-19 vaccine ad26.cov2.s-Fever, hemoptysis, general malaise and dyspnea. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; HEMOPTYSIS; GENERAL MALAISE; DYSPNEA


VAERS ID: 1669818 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN B#21210502#205 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210904362

Write-up: HYPERTENSION URGENCY; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA,PH-PHFDA-300102541] concerned a 47 year old female with an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: B#21210502#205, expiry: UNKNOWN) dose was not reported, 1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021 at 08:10, the patient experienced hypertension urgency. On an unspecified date, the patient died from hypertension urgency. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210904362- COVID-19 VACCINE AD26.COV2.S - Hypertension urgency. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: HYPERTENSION URGENCY


VAERS ID: 1670068 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 2 - / OT

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

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

Write-up: recently died two weeks after his second Moderna jab; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (recently died two weeks after his second Moderna jab) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. Concurrent medical conditions included Non-smoker. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No treatment drug information provided. No concomitant drug information provided. Patient did not drink. Gender was not confirmed but patient referred to as his and he. Very limited information regarding this event has been provided at this time. Further information has been requested if possible.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information has been requested if possible.; Reported Cause(s) of Death: unknown


VAERS ID: 1671048 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210902067

Write-up: THROMBOCYTOPENIA; This spontaneous report received from a consumer via news article concerned multiple patients (7 patients). The patient''s weight, height, and medical history were not reported. The patient''s received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. As of 31-JUL-2021, seven patient''s died as a result of thrombocytopenia post vaccination. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210902066.; Sender''s Comments: V0:20210902067-covid-19 vaccine ad26.cov2.s- thrombocytopenia (fatal outcome)- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: THROMBOCYTOPENIA


VAERS ID: 1671327 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-08-05
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101125269

Write-up: Vaccination failure; Covid-19 pneumonia/Covid-19 virus test positive; This is a spontaneous report from a contactable other HCP downloaded from the Regulatory Authority-WEB FR-AFSSAPS-AN20213421 A 93-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 18Feb2021 (Lot Number: EK9788; Expiration Date: 31May2021) as Dose 2, single, dose 1 intramuscular, administered in Arm Left on 27Jan2021 (Lot Number: EJ6595) as Dose 1, single for covid-19 immunisation. Previous Covid-19 was no. Medical history included diabetes mellitus and history of cardio. The patient''s concomitant medications were not reported. The patient experienced vaccination failure (death) on 05Aug2021, covid-19 pneumonia/covid-19 virus test positive (death) on 05Aug2021. Covid-19 PCR test was positive 05Aug2021. Patient experienced Covid-19 pneumonia leading to her death after receiving two doses of COMIRNATY vaccine (fatal symptomatic vaccine failure). The patient developed a cold with cough and fever. Then deterioration of the respiratory situation. Death on 10Aug2021. It was not reported if an autopsy was performed. Product Complaint Team reported the conclusion was the investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Covid-19 pneumonia/Covid-19 virus test positive; Vaccination failure


VAERS ID: 1671416 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-06-01
Onset:2021-08-01
   Days after vaccination:1522
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Biopsy skin, Bone marrow myelogram, Coma, Erythema, Fall, General physical health deterioration, Glomerular filtration rate, Haemoglobin, Hypoalbuminaemia, Multiple organ dysfunction syndrome, Pancytopenia, Platelet count, Skin abrasion, Toxic epidermal necrolysis, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   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? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Arthritis rheumatoid (treated with Methotrexate); Cholecystectomy; Hypertension arterial; IDDM
Allergies:
Diagnostic Lab Data: Test Name: Skin biopsy; Result Unstructured Data: Test Result:Lyell''s syndrome; Test Name: bone marrow count; Result Unstructured Data: Test Result:poor marrow with no sign of malignant cells; Comments: poor marrow with no sign of malignant cells; Test Date: 20210430; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:56 ml/min; Test Date: 20210813; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:19 ml/min; Comments: acute renal failure; Test Date: 20210430; Test Name: haemoglobin; Result Unstructured Data: Test Result:11.4 g/dl; Test Date: 20210813; Test Name: haemoglobin; Result Unstructured Data: Test Result:7.5 g/dl; Test Date: 20210430; Test Name: platelet count; Result Unstructured Data: Test Result:Normal /mm3; Test Date: 20210813; Test Name: platelet count; Result Unstructured Data: Test Result:3000 /mm3; Test Date: 20210430; Test Name: leucocyte; Result Unstructured Data: Test Result:Normal /mm3; Test Date: 20210813; Test Name: leucocyte; Result Unstructured Data: Test Result:200 /mm3
CDC Split Type: FRPFIZER INC202101125345

Write-up: hypoalbuminemia; acute renal failure; coma; Lyell syndrome; Pancytopenia; fall; deterioration in her general condition; erythema of the back with excoriations; erythema of the back with excoriations; multivisceral failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-DJ20213306. A 71-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 06Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation; methotrexate sodium (METOJECT), via an unspecified route of administration from Jun2017 (Batch/Lot number was not reported) to Dec2020, at 20 mg, weekly, subcutaneous from Dec2020 (Batch/Lot Number: Unknown) to 06Aug2021, at 25 mg, weekly, for rheumatoid arthritis. Medical history included type 1 diabetes mellitus, cholecystectomy, Anxiodepressive syndrome, Hypertension arterial, and rheumatoid arthritis treated with Methotrexate. The patient''s concomitant medications were not reported. The patient had been receiving METOJECT since Jun2017 with an increase in dosage from 20 to 25 mg since Dec2020 and a last injection on 06Aug2021, also the date of her second injection of the COMIRNATY vaccine. On the semiological level, the last biological check-up found in her analysis laboratory was dated 30Apr2021, and showed a normal leucocyte and platelet count, a haemoglobin of 11.4 g/dl, and a glomerular filtration rate of 56 ml/min. The patient was admitted to hospital on 10 August 2021, following a fall and a deterioration in her general condition. A state of neglect was reported. The patient presented an erythema of the back with excoriations. The biological work-up revealed acute renal failure with a glomerular filtration rate of 19 ml/min, pancytopenia (haemoglobin 7.5 g/dl, leukocytes 200/mm3 and platelets 3000 mm3 on 13Aug2021), hypoalbuminemia. The patient was transferred to the intensive care unit on 13Aug2021 due to the onset of a coma. Skin biopsy confirmed Lyell''s syndrome. The patient underwent a bone marrow count, which showed poor marrow with no sign of malignant cells, which could point to a toxic cause. The patient''s condition then deteriorated with increasing multivisceral failure. The doctors believe that methotrexate may have played a role in this patient''s condition. The patient died on 20Aug2021. An autopsy was not performed. The outcome of the events Lyell syndrome, Pancytopenia, and multivisceral failure was fatal, of the rest of events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtain. No further information is expected.; Reported Cause(s) of Death: Pancytopenia; Multiple organ failure; Lyell syndrome


VAERS ID: 1671421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   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: XARELTO; CORDARONE
Current Illness: Cognitive disturbance (with temporo-spatial disorientation); Temporospatial disorientation
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery atheroma; Cerebral atrophy (inversion of the day-night-cycle - evidence of corticosteroid subcortical atrophy on CT (TDM)); COVID-19; Decompensation cardiac (right); General physical health deterioration; Hospitalization; Hypertension arterial; Hypotension orthostatic; Paroxysmal atrial fibrillation; Peritonsillar abscess drainage; Prostatic hypertrophy; Retention urinary (Acute)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101125398

Write-up: bilateral pulmonary embolism; cardiac decompensation; bilateral overopopliteal thrombosis; Erysipelas; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LY20218783. A 92-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 21Jul2021 (Batch/Lot Number: FF3318) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history included Hypertension arterial, Paroxysmal atrial fibrillation, Carotid artery atheroma, Right decompensation cardiac in Aug202, Cognitive disturbance since 2014- with temporo-spatial disorientation (ongoing), inversion of the day-night-cycle - evidence of corticosteroid subcortical atrophy on CT (TDM) in Aug2020, Hypotension orthostatic, Acute retention urinary on probable prostatic hypertrophy in 2020, Peritonsillar abscess drainage in 2006, History of COVID infection, Patient hospitalized (date not specified) for deterioration of general condition and context of opposition to care. Concomitant medications included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; amiodarone hydrochloride (CORDARONE) taken for an unspecified indication, start and stop date were not reported. On 26Jul2021, either on Day 6: bilateral pulmonary embolism with cardiac decompensation, presence of bilateral overopopliteal thrombosis, Occurrence of erysipelas. Faced with the entire clinical picture, the major loss of autonomy and severe cognitive disorders, care was oriented towards comfort care. In summary, 92-year-old patient with a cardiovascular history and in particular atrial fibrillation, having presented a pulmonary embolism with cardiac decompensation of fatal evolution (context of comfort care) on day 6 of his first dose of Comirnaty. The patient died on 19Aug2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: bilateral pulmonary embolism; cardiac decompensation; bilateral overopopliteal thrombosis; erysipelas


VAERS ID: 1671422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Coma scale, Coma scale abnormal, 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Haemorrhagic stroke (hemorrhagic stroke 10 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: glasgow; Result Unstructured Data: Test Result:between 4 and 5 at extubation; Test Date: 20210414; Test Name: Ct scan; Result Unstructured Data: Test Result:occlusion of the left carotid artery; Comments: occlusion of the left carotid artery, therefore no possibility of thrombolysis or thrombectomy.
CDC Split Type: FRPFIZER INC202101125363

Write-up: Patient with Glasgow score between 4 and 5 on extubation; The patient, on 14Apr2021, experienced right hemiplegia with aphasia and facial paralysis. Diagnosis of stroke.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LY20218892. An 88-year-old female patient received the first dose of bnt162b2 (COMIRNATY) via intramuscular on 08Apr2021 (Lot Number: ET7205) as dose 1, single for covid-19 immunisation. Medical history included hemorrhagic stroke 10 years ago and atrial fibrillation. Concomitant medications included apixaban. The patient, on 14Apr2021, experienced right hemiplegia with aphasia and facial paralysis. Diagnosis of stroke. CT scan finding an occlusion of the left carotid, so no possibility of thrombolysis or thrombectomy. Patient with Glasgow score between 4 and 5 on extubation. Palliative care decision given the poor prognosis, with the introduction of scopolamine, midazolam, morphine and hydration. The patient died on 18Apr2021. 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: 1671453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-16
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3143 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Fall, Ischaemic stroke, Magnetic resonance imaging head, Neurological examination
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use (Occasional alcohol consumption); Cigarette smoker (Daily smoking (2 or 3 cigarettes / day)); Exercise regular (Non-sedentary patient (3 hours of walking per day))
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: brain MRI; Result Unstructured Data: Test Result:recent massive cerebrovascular accident; Comments: recent massive cerebrovascular accident in the territory of the middle cerebral artery and the left anterior cerebral artery on occlusion of the carotid T.; Test Date: 20210616; Test Name: examination; Result Unstructured Data: Test Result:Right hemiplegia and aphasia; Comments: Right hemiplegia and aphasia
CDC Split Type: FRPFIZER INC202101124850

Write-up: Ischemic stroke; fall; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20216375. A 73-year-old male patient received second dose of BNT162B2(COMIRNATY), intramuscularly in left arm on 10Jun2021, as single dose (Lot Number: FC3143) for covid-19 immunisation. Medical history included daily smoking (2 or 3 cigarettes per day); occasional alcohol consumption; non-sedentary patient (3 hours of walking per day). The patient''s concomitant medications were not reported. The patient had no COVID-19. No person test. The patient was considered to be at risk of developing a severe form of COVID-19 disease. On 16Jun2021, the patient had a fall while walking down the street and was brought by firefighters to the emergency room. The patient experienced massive stroke on 16Jun2021. The patient had emergency room visit and hospitalization for massive stroke and fall. Vigilance disturbances since admission to hospital (as reported). On 19Jun2021, the patient died. The patient underwent lab tests and procedures which included brain MRI(magnetic resonance imaging): recent massive cerebrovascular accident in the territory of the middle cerebral artery and the left anterior cerebral artery on occlusion of the carotid T on 16Jun2021; examination: right hemiplegia and aphasia on 16Jun2021. The outcome of massive stroke was fatal. The outcome of fall was unknown. An autopsy was not performed. The case was reported as serious due to fatal outcome and hospitalization condition. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1671457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101131307

Write-up: Myocardial infarction; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20216882. A 56-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: FC5435), via intramuscular in left arm on 21Jun2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension. The patient was not considered to be at risk of developing a severe form of COVID-19 disease. The patient had no history of COVID-19. The patient had not been tested for COVID-19. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction - immediate death on 25Jun2021. The patient died on25Jun2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1671500 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-08-16
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   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: Test Date: 20210816; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: This is the delta variant
CDC Split Type: FRPFIZER INC202101131012

Write-up: SARS-CoV-2 infection/Vaccination failure; SARS-CoV-2 infection; asthenia; This is a spontaneous report from a contactable Other Health Professional from the Regulatory Authority-WEB FR-AFSSAPS-PC20213161. A 94-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), dose 2 intramuscular, administered in Arm Right on 30Apr2021 (Lot Number: ET6956, at age of 93 years old), dose 1 intramuscular, administered in Arm Right on 09Apr2021 (Lot Number: EM2246, at age of 93 years old), both as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 23Aug2021. It was unknown if an autopsy was performed. On 16Aug2021: Confirmed vaccine failure and SARS-COV2 infection. Symptoms of asthenia. The patient is under infusion. This is the delta variant. Evolution: death on 23Aug2021. In total: infection with SARS-COV2 at 4 months from the second dose of COMIRNATY vaccine. Death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: SARS-CoV-2 infection/Vaccination failure; SARS-CoV-2 infection; asthenia


VAERS ID: 1671526 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine, Blood glucose, Blood potassium, Blood sodium, C-reactive protein, Cardio-respiratory arrest, Coagulation factor V level, Electrocardiogram, Haemoglobin, Lymphocyte count, Myocardial infarction, Platelet count, Prothrombin level, Scan, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity; Sigmoidectomy; Sigmoiditis; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: creat; Result Unstructured Data: Test Result:55 umol/l; Comments: at 03:45; Test Date: 20210802; Test Name: glycemia; Result Unstructured Data: Test Result:7.7 mmol/L; Comments: at 03:45; Test Date: 20210802; Test Name: K+; Result Unstructured Data: Test Result:4.6; Comments: at 03:45; Test Date: 20210802; Test Name: Na+; Result Unstructured Data: Test Result:139; Comments: at 03:45; Test Date: 20210802; Test Name: factor V; Test Result: 68 %; Comments: at 03:45; Test Date: 20210802; Test Name: CRP; Result Unstructured Data: Test Result:1.1 mg/l; Comments: at 03:45; Test Date: 20210802; Test Name: ECG; Result Unstructured Data: Test Result:Trace in ventricular fibrillation; Comments: Trace in ventricular fibrillation, refractory to 5 external cardioversion and 5 ampoules of cordarone.; Test Date: 20210802; Test Name: Hb; Result Unstructured Data: Test Result:16.7 g/dl; Comments: at 03:45; Test Date: 20210802; Test Name: lymphocytes; Result Unstructured Data: Test Result:8.93 g/l; Comments: at 03:45; Test Date: 20210802; Test Name: plateletes; Result Unstructured Data: Test Result:257 g/l; Comments: at 03:45; Test Date: 20210802; Test Name: TP; Test Result: 17 %; Comments: at 03:45; Test Date: 202102; Test Name: ionogram; Result Unstructured Data: Test Result:normal; Test Date: 20210802; Test Name: WBC; Result Unstructured Data: Test Result:16.17 g/l; Comments: at 03:45
CDC Split Type: FRPFIZER INC202101125201

Write-up: Cardio-respiratory arrest; Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-SE20212248. A 47-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: FF4213), via intramuscular in left arm on 27Jul2021 at single dose for COVID-19 immunisation. Medical history included obesity, smoking, outbreak of sigmoiditis in Feb2021 and sigmoidectomy in Mar2021. The patient was at risk of developing a severe form of COVID-19 (obesity and sigmoidectomy). The patient had no COVID-19. The patient had not been tested for COVID-19. Treatment was none. Unemployed patient lived at home alone. She underwent a medical assessment in Feb2021 in the context of an outbreak of sigmoiditis with normal ionogram. No recent ECG. The patient''s concomitant medications were not reported. On 02Aug2021, the patient experienced feeling a discomfort with chest tightness and neck pain, the patient called herself for emergency. At the arrival at the emergency room, cardiopulmonary arrest in the ambulance (at 03:35). Immediate external cardiac massage. Pupils in reactive bilateral mydriasis. corneal reflex preserved. Starting resuscitation unit. IOT Probe 7.5 after aspiration +++ haemorrhage in the trachea. ECG: Trace in ventricular fibrillation, refractory to 5 external cardioversion and 5 ampoules of cordarone. Administration of Mg SO4 2 ampoules and 250cc bicar. Resuscitation notice before intra-hospital heart failure with zero no flow: Time to access the block estimated$g 80min in total, therefore neurological prognosis engaged. No ECMO. Continued resuscitation for 45 min in total, 18 mg of adrenaline without return of spontaneous circulation. No pulse. Stop of reanimation actions stop at 04:25. Biology of 02Aug2021 at 03:45: K + 4.6, Na + 139, creat 55 umol / l, glycemia at 7.7 mmol / l, C-reactive protein (CRP) 1.1mg / l, white blood cell (WBC) 16.17G / l, lymphocytes 8.93G / l, Hb 16.7g / dl, plateletes 257G / l, TP 17%, factor V 68%. The patient died on 02Aug2021. An autopsy was performed. The autopsy examination showed the following significant abnormalities: probable thrombosis in the right coronary artery on atherosclerotic plaque, to be confirmed histologically; an atherosclerotic plaque stenose 90% of the arterial caliber on the anterior interventricular artery; a muscle bridge on the anterior interventricular artery 5 mm long, and 2 mm thick myocardial; diffuse pulmonary congestion lesions, a hepatic congestive patch; a pericardial effusion blade of less than 1 cc. Death from myocardial infarction on day 7 after the second dose of BNT162B2 in a 47-year-old patient with cardiovascular risk factors (smoking, obesity). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; infarct myocardial; Autopsy-determined Cause(s) of Death: atherosclerotic plaque stenosing 90% of the arterial caliber on the anterior interventricular artery; a muscle bridge on the anterior interventricular artery 5 mm long, and 2 mm thick myocardial; diffuse pulmonary congestion lesions; hepatic congesti


VAERS ID: 1671719 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TEGRETOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neurofibromatosis; Seizure
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101131395

Write-up: Intracranial bleed; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-083389. A 33-year-old female patient received first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on 26May2021 (Lot Number: FA7812) (at the ae of 33-year-old) as single dose for COVID-19 immunisation. Medical history included seizure and neurofibromatosis, both from an unknown date and unknown if ongoing. Concomitant medication included carbamazepine (TEGRETOL) at 500 mg twice daily (every 12hrs.) taken for seizure disorder from 01Nov2010 to 26May2021. It was reported that: approximately 90 minutes post vaccination on 26May2021, the patient experienced intracranial bleed. The patient was admitted to ICU (intensive care unit) and passed away on 05Jun2021. The event was serious (death, hospitalization, medically significant). 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: Intracranial bleed


VAERS ID: 1671872 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: blood pressure; Result Unstructured Data: Test Result:78/41; Comments: at 00:20; Test Date: 20210702; Test Name: blood pressure; Result Unstructured Data: Test Result:102/55; Comments: at 07:30; Test Date: 20210630; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Comments: at 00:20; Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: at 07:30; Test Date: 20210702; Test Name: pulse rate; Result Unstructured Data: Test Result:123; Comments: beats/minute at 00:20; Test Date: 20210702; Test Name: pulse rate; Result Unstructured Data: Test Result:120; Comments: beats/minute at 07:30; Test Date: 20210701; Test Name: SpO2; Test Result: 90 %; Comments: room air at 07:00; Test Date: 20210701; Test Name: SpO2; Result Unstructured Data: Test Result:60 to 70 %; Comments: room air at 12:00; Test Date: 20210702; Test Name: SpO2; Result Unstructured Data: Test Result:could not be measured %; Comments: at 00:20; Test Date: 20210702; Test Name: SpO2; Result Unstructured Data: Test Result:could not be measured %; Comments: at 07:30
CDC Split Type: JPPFIZER INC202101119345

Write-up: Acute pneumonia; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 78-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) on 28Jun2021 at 10:45 (the day of vaccination), via an unspecified route of administration as single dosein the unknown site (at 78 years old) for COVID-19 immunization. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Relevant medical history and concomitant medications were not reported. On 02Jul2021 at 12:45 (4 days/2 hours after the vaccination), the event resulted in death. The cause of death was diagnosed as acute pneumonia. The outcome of the event was fatal. The reporting physician assessed the event as serious (resulted in death). Since the vaccination, it was unknown whether the patient has been tested for COVID-19. The reported event was as follows: On 28Jun2021 (the day of vaccination), at 10:45, the patient received the first dose of BNT162b2 vaccination. On 29Jun2021 (one day after vaccination), around at 20:40, there was a large amount of food residue. The patient had also a large amount of diarrheal stools. At around 21:30, the patient had vomiting again. On 30Jun2021 (2 days after vaccination), at 16:45, the fever increased to 37.8 degrees Celsius. The patient had a large amount of vomiting again. The content was food residue. On 01Jul2021 (3 days after vaccination), at 07:00, the SpO2 was 90% (room air). At 12:00, the SpO2 was 60 to 70 % (room air). At round 13:30, wheezing became severe, and laboured breathing was noted. On 02Jul2021 (4 days after vaccination), at 00:20. The vital signs were as follows: The body temperature was 38.1 degrees Celsius, the blood pressure was 78/41, the heart rate was 123 beats/minute, and the SpO2 could not be measured. At 07:30, the vital signs were as follows: The body temperature was 37.5 degrees Celsius, the blood pressure was 102/55, the heart rate was 120 beats/minute, and the SpO2 could not be measured. The patient had laboured breathing, peripheral coldness, and cyanosis on the extremities. At 12:45, the patient was confirmed to die by the physician. The cause of death was diagnosed as acute pneumonia. Unknown if an autopsy was performed. It was considered that the event was unrelated to BNT162b2 vaccination. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the event Acute Pneumonia and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Acute pneumonia


VAERS ID: 1671917 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003190 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Acute subarachnoid hemorrhage; This case was received via Regulatory Authority (Reference number: 2021TJP082034) on 19-Aug-2021 and was forwarded to Moderna on 03-Sep-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0020948). On an unknown date, body temperature before the vaccination: 36.2 degrees Celsius. On 03-Aug-2021, at 09:00, the patient received the 1st dose of the vaccine. On 08-Aug-2021, the patient experienced acute subarachnoid hemorrhage and was urgently transported to a hospital. On 17-Aug-2021, at 01:57, the patient was confirmed dead. The outcome of acute subarachnoid hemorrhage was reported as fatal. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: As there was only a report of death, and details are unknown, it is necessary to check with the hospital where the patient was transported about the details.; Sender''s Comments: This case concerns a 43 year-old male patient with reported fatal subarachnoid haemorrhage. The onset of the event occurred 9 days after receiving the first dose of the mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Acute subarachnoid hemorrhage


VAERS ID: 1671918 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-22
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004228 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Death; This case was received via Regulatory Authority (Reference number: 2021TJP082445) on 26-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This case, initially reported to the Regulatory Authority (RA) by a physician, was received via the RA (Ref, v21124847). On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 05-Aug-2021, at 12:00, the patient received the 1st dose of this vaccine. On 22-Aug-2021, at around 14:00, the patient was presumed dead. Company Comment: Although a temporal association exist, there is not enough information to assess the fatal outcome. Critical details such as the patient''s medical history, clinical details about the event, including cause of death and autopsy report is lacking. No further information is expected; Reporter''s Comments: The police headquarters conducted an autopsy based on a judicial autopsy. Since being a forensic autopsy case, this case is under close examination. Since this case is under the examination, its details are unknown, and its assessment is not possible as of this moment. Sender''s comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) andhere is temporal relationship.; Sender''s Comments: Although a temporal association exist, there is not enough information to assess the fatal outcome. Critical details such as the patient''s medical history, clinical details about the event, including cause of death and autopsy report is lacking. No further information is expected; Reported Cause(s) of Death: Death


VAERS ID: 1672024 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210903583

Write-up: DEATH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300102532] concerned a 73 year old male patient of unspecified race and ethnic origin The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, 1 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient died. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was reported as fatal. This report was serious (Death).; Sender''s Comments: V0:20210903583-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1672026 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dizziness, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210903625

Write-up: BODY MALAISE; COUGH; FEVER; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101933] concerned a 62 year old female of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, at 11:00 the patient experienced body malaise, cough, fever, dizziness. On an unspecified date, the patient died from body malaise, cough, fever, and dizziness. It was unknown if autopsy performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210843590-COVID-19 VACCINE AD26.COV2.S- Body malaise, cough, fever, and dizziness.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BODY MALAISE; COUGH; FEVER; DIZZINESS


Result pages: prev   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=170&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