National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts.org
Search Results

From the 1/14/2022 release of VAERS data:

Found 22,193 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

This is page 190 out of 222

Result pages: prev   91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222   next


VAERS ID: 1733638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-05
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210944539

Write-up: BODY MALAISE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300106036] concerned a 79 year old male with 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: 212C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 02-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 05-AUG-2021, the patient experienced body malaise. On an unspecified date, the patient died from body malaise. 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: 20210944539-covid-19 vaccine ad26.cov2.s-body malaise. 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


VAERS ID: 1733639 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-05
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210944713

Write-up: DIFFICULTY OF BREATHING; VOMITING; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300105712] concerned a 54 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 (suspension for injection, intramuscular, batch number: 212C21A, and expiry: unknown) dose was not reported, 1 total administered on 04-AUG-2021 for an unknown indication. No concomitant medications were reported. On 05-AUG-2021 at 18:17, the patient experienced difficulty of breathing and vomiting. On an unspecified date, the patient died from difficulty of breathing, and vomiting. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210944713- JANSSEN COVID-19 VACCINE Difficulty of breathing, 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).; Reported Cause(s) of Death: DIFFICULTY OF BREATHING; VOMITING


VAERS ID: 1733641 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament 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: PHJNJFOC20210944978

Write-up: MUSCLE PAIN; DIFFICULTY BREATHING; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300106138] concerned an 81 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 27-JUL-2021 for an unspecified indication. The batch number was not reported. per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 04-AUG-2021 18:00, the patient experienced muscle pain, difficulty breathing. It was unknown if autopsy was performed. On an unspecified date, the patient died from muscle pain, and difficulty breathing. The action taken with covid-19 vaccine was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210944978-COVID-19 Vaccine Muscle Pain( fatal), Difficulty Breathing( fatal). This event(s) is considered un-assessable. 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: MUSCLE PAIN; DIFFICULTY BREATHING


VAERS ID: 1733643 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210945095

Write-up: DIARRHOEA; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300106554] concerned an 18 year old male of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, intramuscular and batch number: 213C21A expiry: Unknown) dose was not reported, 1 total administered on 30-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 07-SEP-2021, the patient experienced fever, and on 12-SEP-2021, the patient experienced diarrhoea. The patient was hospitalized (date unspecified). In SEP-2021, the patient died from fever, and diarrhoea. It was unspecified if an autopsy was performed. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine was not applicable. The outcome of event fever and diarrhoea was fatal. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210945095-covid-19 vaccine Fever, Diarrhoea. 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; DIARRHOEA


VAERS ID: 1733649 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834/PAAW599 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac arrest, Drug ineffective, Renal failure, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (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: 2021-09-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORVASC; OLMESARTAN; DILZEM; LIPITOR; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; Hypertensive; Stroke
Allergies:
Diagnostic Lab Data: Test Name: swab test; Test Result: Positive
CDC Split Type: PHPFIZER INC202101236591

Write-up: cardiac arrest; renal failure; swab test come out positive/MILD to moderate COVID; swab test come out positive/MILD to moderate COVID; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received bnt162b2 (Batch/Lot Number: EY4834/PAAW599), first dose intramuscular, administered in left arm on 10Jun2021 at the age of 86-year-old as single dose for covid-19 immunization. Medical history included asthmatic, hypertensive, post mild post stroke with no deficiency or paralysis, all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine besilate (NORVASC); olmesartan medoxomil; diltiazem hydrochloride (DILZEM); atorvastatin calcium (LIPITOR); clopidogrel taken for hypertensive, start and stop date were not reported. The patient experienced cardiac arrest, renal failure, swab test come out positive/mild to moderate covid all on an unspecified date. Therapeutic measures were taken as a result of swab test come out positive/ mild to moderate covid. The patient was admitted last Sept 19 due to chest pains and difficulty of breathing- swab test come out positive, although patient was treated with mild to moderate COVID and advise to take favipiravir. The outcome of events for swab test come out positive/mild to moderate covid was unknown, for other events was death. The patient died on 20Sep2021. An autopsy was not performed. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn''t diagnosed with COVID-19. Since the vaccination, the patient hasn''t been tested for COVID-19. Investigation Results: 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 5992857. The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EY4834. 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. Regulatory Authority 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.; Reported Cause(s) of Death: cardiac arrest; renal failure


VAERS ID: 1733653 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-25
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: 2021-09-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101240372

Write-up: death; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (CEP number 160479) Covid-19 vaccine Infoline, Number: 1320. A female patient of unspecified age received the first dose of bnt162b2 (COMIRNATY) on 09Sep2021 as single dose for covid-19 immunisation. It was unknown if the patient was pregnant. Medical history and concomitant medications were not reported. Reporter called on behalf of her brother. Brother and sister-in-law on 09Sep2021 received the vaccine against Covid 19 - the second date is set for 30Sep. Unfortunately, yesterday my sister-in-law died (the doctor informed that it was probably due to vaccination). Brother does not want to vaccinate anymore. Reporter asked if we can find the number of a mobile unit where reporter can call and refuse vaccination. The adverse reaction report has been identified. It was not reported if Autopsy Done. The outcome of the event was fatal.; Reported Cause(s) of Death: died


VAERS ID: 1733693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-08-31
   Days after vaccination:217
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-16
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (under treatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: Sars-Cov-2; Result Unstructured Data: Test Result:positively
CDC Split Type: ROPFIZER INC202101238046

Write-up: positively diagnosed with Sars-Cov-2; positively diagnosed with Sars-Cov-2; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 66-year-old female patient received bnt162b2 (COMIRNATY), dose 1 on 05Jan2021 and dose 2 on 26Jan2021, both via an unspecified route of administration (batch/lot number was not reported) as single dose for covid-19 immunisation. Medical history included arterial hypertension under treatment. The patient''s concomitant medications were none. The patient was positively diagnosed with Sars-Cov-2 on 31Aug2021. The patient died on 16Sep2021. It was not reported if an autopsy was performed. It was not known if she had other comorbidities. Outcome of event 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 currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.; Reported Cause(s) of Death: positively diagnosed with Sars-Cov-2; positively diagnosed with Sars-Cov-2


VAERS ID: 1733697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA 5833 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101228439

Write-up: General malaise; myocarditis; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, Regulatory authority report number SE-MPA-2021-082181. Safety Report Unique Identifier is SE-VISMA-1631014695352. A 65-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FA 5833) at single dose via an unknown route on an unknown date in Jun2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. Reported suspect adverse events were general malaise with onset date of Jun2021 and seriousness criteria of death. The clinical course was reported as follows: The man suffered from general malaise the day after receiving dose 2 of Comirnaty, died 3 days later of myocarditis. The report was assessed as serious due to death. Cause of death was myocarditis. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General malaise; Myocarditis


VAERS ID: 1733719 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC202101229508

Write-up: Subarachnoid hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SI-JAZMP-NCPHV-2021SI0885_0885. A 38-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FD8274; Expiration Date: 31Oct2021), intramuscular on 22Jul2021 (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Jul2021, the patient experienced Subarachnoid hemorrhage (lasted one day). The patient was hospitalized. The patient died in 2021. This case report was assessed as medically significant. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Subarachnoid hemorrhage


VAERS ID: 1733720 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: SIJNJFOC20210939656

Write-up: THROMBOSIS; THROMBOCYTOPENIA; This spontaneous report received from a company representative via an article (social media) concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number and expiry were Unknown) 1 total administered, dose and start therapy date were not reported 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 per the reporter "from the starting of vaccination in last week of APR-2021 to 12-SEP-2021, a total of 387 people had one or more side effects after vaccination with the Janssen vaccine, which they contained an adverse event classified as serious". In this case, it was reported that, a patient died of thrombosis, and thrombocytopenia after vaccination. The date of death was not reported. It was not reported whether an autopsy was performed or not. It was considered that the link with vaccination was certain. The action taken with covid-19 vaccine was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210934498 and 20210942206.; Sender''s Comments: V0: 20210939656-COVID-19 VACCINE thrombosis and thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: THROMBOSIS; THROMBOCYTOPENIA


VAERS ID: 1733722 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-08-31
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Myocardial infarction
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Hypertension (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-19
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TNPFIZER INC202101240144

Write-up: heart attack; Blood pressure; This is a spontaneous report from a contactable other HCP (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 11Sep2021 (Batch/Lot Number: Unknown) at age of 54-year-old as DOSE 2, SINGLE, dose 1 intramuscular administered in Arm Left on 11Aug2021 (Batch/Lot Number: Unknown) at age of 54-year-old as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced heart attack on 31Aug2021, blood pressure on 31Aug2021. The patient died on 19Sep2021. An autopsy was performed that revealed blood clot.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events Myocardial Infraction, Blood pressure abnormal and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Blood pressure; heart attack; Autopsy-determined Cause(s) of Death: Blood clot


VAERS ID: 1733730 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-21
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain lower, Anaemia, Asthenia, Body temperature, Death, Diarrhoea, Haemoglobin, Hypokalaemia, Pneumonia, Septic shock, Somnolence
SMQs:, Haematopoietic erythropenia (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Toxic-septic shock conditions (narrow), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma; Brain cancer metastatic; Brain metastases (stage IVB with brain metastasis); CVA (Plavix); EGFR exon 19 deletion; Epilepsy (Keppra 500 BID); Lung cancer; Malignant neoplasm of upper lobe, bronchus or lung, in situ; Seizure grand mal (bilateral upper limbs clonic movement); Stroke (Acute ischemic stroke over right corona radiata,r/o lacunar type, with no IA or TPA, s/p plavix (4/8-).)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: High (37.9 degree Celsius); Test Name: heamoglobin; Result Unstructured Data: Anemia-(baseline Hb: 9-11-$g6.8-$g2U
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: general weakness; consciousness sleepy; Lower abdominal pain; Pneumonia; Septic shock; Anaemia; Hypokalemia; Diarrhea; Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), ASTHENIA (general weakness), SOMNOLENCE (consciousness sleepy), ABDOMINAL PAIN LOWER (Lower abdominal pain), PNEUMONIA (Pneumonia), SEPTIC SHOCK (Septic shock), ANAEMIA (Anaemia), HYPOKALAEMIA (Hypokalemia) and DIARRHEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Epilepsy (Keppra 500 BID), CVA (Plavix), Brain cancer metastatic, Malignant neoplasm of upper lobe, bronchus or lung, in situ on 06-Sep-2021, Lung cancer, Adenocarcinoma, Brain metastases (stage IVB with brain metastasis), EGFR exon 19 deletion, Stroke (Acute ischemic stroke over right corona radiata,r/o lacunar type, with no IA or TPA, s/p plavix (4/8-).) and Seizure grand mal (bilateral upper limbs clonic movement) on 15-Aug-2020. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (general weakness) (seriousness criterion medically significant), SOMNOLENCE (consciousness sleepy) (seriousness criterion medically significant), ABDOMINAL PAIN LOWER (Lower abdominal pain) (seriousness criterion medically significant), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), SEPTIC SHOCK (Septic shock) (seriousness criterion medically significant), ANAEMIA (Anaemia) (seriousness criterion medically significant), HYPOKALAEMIA (Hypokalemia) (seriousness criterion medically significant) and DIARRHEA (Diarrhea) (seriousness criterion medically significant). The patient was treated with LEVETIRACETAM (KEPPRA XR) for Epilepsy, at a dose of 500; CLOPIDOGREL BISULFATE (PLAVIX) for CVA, at an unspecified dose and frequency; PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (TAZOCIN) at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency. The patient died on an unknown date. It is unknown if an autopsy was performed. At the time of death, ASTHENIA (general weakness), SOMNOLENCE (consciousness sleepy), ABDOMINAL PAIN LOWER (Lower abdominal pain), PNEUMONIA (Pneumonia), SEPTIC SHOCK (Septic shock), ANAEMIA (Anaemia), HYPOKALAEMIA (Hypokalemia) and DIARRHEA (Diarrhea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 37.9 (High) High (37.9 degree Celsius). On an unknown date, Haemoglobin: 6.8 (Low) Anemia-(baseline Hb: 9-11-$g6.8-$g2U. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. This case concerns a 82 year-old-female, with medical history of lung cancer with brain metastasis, epilepsy and acute ischemic stroke, who experienced the unexpected events of PNEUMONIA, SEPTIC SHOCK, ANEMIA, HYPOKALEMIA, DIARRHEA, ABDOMINAL PAIN LOWER, ASTHENIA, SOMNOLENCE and DEATH. Patient died 17 days after receiving the reported dose of Spikevax, which it is unknown if it is the first or second dose according to available information. Rechallenge is unknown due to lack of information on doses and dates. No autopsy information was provided. History of lung cancer with brain metastasis and patient''s advanced age remain as confounders for the reported events. The benefit � risk relation of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 82 year-old-female, with medical history of lung cancer with brain metastasis, epilepsy and acute ischemic stroke, who experienced the unexpected events of PNEUMONIA, SEPTIC SHOCK, ANEMIA, HYPOKALEMIA, DIARRHEA, ABDOMINAL PAIN LOWER, ASTHENIA, SOMNOLENCE and DEATH. Patient died 17 days after receiving the reported dose of Spikevax, which it is unknown if it is the first or second dose according to available information. Rechallenge is unknown due to lack of information on doses and dates. No autopsy information was provided. History of lung cancer with brain metastasis and patient''s advanced age remain as confounders for the reported events. The benefit � risk relation of Spikevax is not affected by this report.


VAERS ID: 1734354 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH CM3H3 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood pressure increased, Blood pressure measurement, Heart rate, Local reaction, Oxygen saturation, Renal failure, Respiratory rate, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: bp; Result Unstructured Data: Test Result:123/74; Test Date: 20210721; Test Name: bp; Result Unstructured Data: Test Result:184/109; Test Date: 20210713; Test Name: heart rate; Result Unstructured Data: Test Result:78; Test Date: 20210721; Test Name: pulse; Result Unstructured Data: Test Result:95; Test Date: 20210713; Test Name: SATS; Test Result: 99 %; Test Date: 20210721; Test Name: SATS; Test Result: 97 %; Test Date: 20210713; Test Name: resp rate; Result Unstructured Data: Test Result:16
CDC Split Type: ZAPFIZER INC202101230831

Write-up: Kidney failure; Blood pressure 184/109; Severe local reaction; Vomiting; Abdominal pain; This is a spontaneous report from a contactable other health professional. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 31May2021 (Batch/Lot Number: CM3H3) at the age of 65-year-old as single dose for covid-19 immunization. The patient medical history included hypertension and diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced kidney failure on 05Jun2021. This event was serious-death, hospitalization. The patient presented with severe local reaction, vomiting and abdominal pain in 2021; blood pressure 184/109 on 21Jul2021. The patient was hospitalized for kidney failure from 21Jul2021. The patient underwent lab tests and procedures which included blood pressure (BP): 184/109 21Jul2021, blood pressure: 123/74 on 13Jul2021, pulse: 95 on 21Jul2021, SATS: 97 % on 21Jul2021, SATS: 99 % on 13Jul2021, heart rate: 78 on 13Jul2021, respiratory rate: 16 on 13Jul2021. Therapeutic measures were taken as a result of kidney failure, vomiting, blood pressure 184/109 and abdominal pain. The patient was reported to have died on 22Jul2021 due to kidney failure. Autopsy was not performed. Outcome of kidney failure was fatal, of other events was unknown.; Reported Cause(s) of Death: kidney failure


VAERS ID: 1734355 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4421 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood potassium, Blood sodium, Cellulitis, Dermatitis, Inappropriate schedule of product administration, Investigation, Platelet-large cell ratio, Procalcitonin, Pyrexia, Red blood cell count, Septic rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-15
   Days after onset: 34
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: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (- uncontrolled); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: Blood glucose; Result Unstructured Data: Test Result:5.6; Comments: at 12h50; Test Date: 20210913; Test Name: Blood glucose; Result Unstructured Data: Test Result:1.6; Comments: at 18h00; Test Date: 20210913; Test Name: Blood glucose; Result Unstructured Data: Test Result:3.2; Comments: at 22h; Test Date: 20210913; Test Name: Blood glucose; Result Unstructured Data: Test Result:4.1; Comments: at 22h20; Test Date: 20210915; Test Name: Blood glucose; Result Unstructured Data: Test Result:2.4; Comments: at 6h; Test Date: 20210915; Test Name: Blood glucose; Result Unstructured Data: Test Result:3.1; Comments: at 6h; Test Date: 20210915; Test Name: Blood glucose; Result Unstructured Data: Test Result:14.5; Comments: at 10h00; Test Date: 20210915; Test Name: Blood glucose; Result Unstructured Data: Test Result:15.0; Comments: at 14h00; Test Date: 20210915; Test Name: Blood glucose; Result Unstructured Data: Test Result:13.8; Comments: at 18h00; Test Date: 20210913; Test Name: K-I; Result Unstructured Data: Test Result:7.24 mmol/L; Test Date: 20210913; Test Name: Na-I; Result Unstructured Data: Test Result:133.2 mmol/L; Test Date: 20210913; Test Name: TP2; Result Unstructured Data: Test Result:61.5 g/dl; Test Date: 20210913; Test Name: UREL; Result Unstructured Data: Test Result:32.14 mmol/L; Test Date: 20210913; Test Name: P-LCR; Test Result: 30.3 %; Test Date: 20210913; Test Name: PCT; Test Result: 0.38 %; Test Date: 20210913; Test Name: RBC; Result Unstructured Data: Test Result:Anemia
CDC Split Type: ZAPFIZER INC202101230942

Write-up: septic rash with secondary cellulitis/Dermatitis rash; septic rash with secondary cellulitis; Rash/dermatitis rash; swelling; fever; first dose on on 30Jun2021, second dose on 12Aug2021; This is a spontaneous report from a contactable other HCP. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 on 12Aug2021 15:38 at age of 69-year-old (Lot Number: FG4421; Expiration Date: 12Aug2021) for COVID-19 immunisation. Medical history included hypertension (HPT), diabetes mellitus - uncontrolled (DM). Concomitant medication included insulin. The patient previously received dose 1 bnt162b2 on 30Jun2021 16:30 (Lot Number: FD0927; Expiration Date: 10Jul2021) for COVID-19 immunization. The patient experienced rash, swelling, fever, septic rash with secondary cellulitis on an unspecified date. The patient was hospitalized 13Sep2021. Treatment received from 13Sep2021 to 15Sep2021: Cloxacillin 1g 6 hrly IV, tramadol 50mg bd po, metformin 850mg tds po, enalapril 10mg bd po, aciclovir 400mg tds and panado 1g 6 hrly po. Treatment received from 15Sep2021: Cetirizine 110mg daily po, clotrmazole cream bd topical, hydrocortisone 100mg. The patient underwent lab tests and procedures which included blood glucose: 5.6 on 13Sep2021 at 12h50, blood glucose: 1.6 on 13Sep2021 at 18h00, blood glucose: 3.2 on 13Sep2021 at 22h, blood glucose: 4.1 on 13Sep2021 at 22h20, blood glucose: 2.4 on 15Sep2021 at 6h, blood glucose: 3.1 on 15Sep2021 at 6h, blood glucose: 14.5 on 15Sep2021 at 10h00, blood glucose: 15.0 on 15Sep2021 at 14h00, blood glucose: 13.8 on 15Sep2021 at 18h00, blood potassium: 7.24 mmol/l on 13Sep2021, blood sodium: 133.2 mmol/l on 13Sep2021, investigation (TP2): 61.5 g/dl on 13Sep2021, investigation (UREL): 32.14 mmol/l on 13Sep2021, platelet-large cell ratio: 30.3 % on 13Sep2021, procalcitonin: 0.38 % on 13Sep2021. The patient died on 15Sep2021. It was not reported if an autopsy was performed. Diagnosis reported on death notification form: sepsis, dermatitis rash, DM and HPT. The outcome of events rash/dermatitis rash events septic rash with secondary cellulitis was fatal, outcome of other events was unknown.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events septic rash ,cellulitis , dermatitis is unlikely. A temporal relation between the administration of the vaccine and onset of swelling and pyrexia 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: septic rash; cellulitis; Sepsis; Dermatitis rash; DM; HPT


VAERS ID: 1736096 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-20
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-20
   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: Asthma; Infarct myocardial
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210948219

Write-up: Arrest cardiac; This spontaneous report received from a pharmacist via a Regulatory Authority (FR-AFSSAPS-TO20218070) on 24-SEP-2021 concerned a 55 year old female with an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: asthma, and infarct myocardial. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: Unknown) 1 dosage forms, 1 total administered on 14-SEP-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 20-SEP-2021, the patient experienced arrest cardiac and on same day the patient died from arrest cardiac. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from arrest cardiac on 20-SEP-2021. This report was serious (Death).; Reported Cause(s) of Death: ARREST CARDIAC


VAERS ID: 1736119 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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: PHJNJFOC20210944754

Write-up: SWELLING OF LEGS AND ABDOMEN; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300105894] concerned a 76 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 was not reported) dose was not reported, 1 total administered on 27-JUL-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced swelling of legs and abdomen. On an unspecified date, the patient died from swelling of legs and abdomen. It was unspecified 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: 20210944754- covid-19 vaccine ad26.cov2.s-Swelling of legs and abdomen. 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: SWELLING OF LEGS AND ABDOMEN


VAERS ID: 1736218 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-31
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE426 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, COVID-19 pneumonia, Death, Dehydration, Dizziness, Gait inability, Glucose urine present, Heart rate, Oxygen saturation, Polymerase chain reaction, SARS-CoV-2 test, Urine analysis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Infective pneumonia (narrow), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-14
   Days after onset: 14
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: ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE
Current Illness: Hypertension; Systemic antiviral treatment
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 virus test positive; GFR decreased; Oral candidiasis; Renal impairment; Comments: The physician was unknown for the following information of the patient like any history of similar event, any previous reaction or adverse event after immunization, any history of allergies (vaccine, food, drugs), any family history of any allergies and any disease (relevant to adverse event after immunization), pre-existing medical condition/ congenital disorder, pre-existing acute illness (30 days) prior to vaccination, suffering from any medical condition currently, history of hospitalization in last 30 days with cause and receiving any herbal and/or traditional medicines.
Allergies:
Diagnostic Lab Data: Test Date: 20200820; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Date: 20210911; Test Name: PCR; Result Unstructured Data: Not reported; Test Date: 20210911; Test Name: Urinalysis; Result Unstructured Data: Color: amber, PH:6.0, Sugar: glucose plus; Test Date: 20210911; Test Name: Heart rate; Result Unstructured Data: 90 {beats}/min; Test Date: 20210911; Test Name: SARS-CoV-2 rapid diagnostic test; Result Unstructured Data: Positive; Test Date: 20210911; Test Name: Blood pressure; Result Unstructured Data: 120/80 mmHg; Test Date: 20210912; Test Name: Urinalysis; Result Unstructured Data: Color: amber, PH:6.0, Sugar: glucose plus; Test Date: 20210912; Test Name: Body temperature; Result Unstructured Data: 36.7 C; Test Date: 20210912; Test Name: Heart rate; Result Unstructured Data: 84 {beats}/min; Test Date: 20210912; Test Name: Blood pressure; Result Unstructured Data: 117/74 mmHg; Test Date: 20210912; Test Name: Oxygen saturation; Result Unstructured Data: 95 %; Test Date: 20210913; Test Name: Urinalysis; Result Unstructured Data: Color: amber, PH:6.0, Sugar: glucose plus; Test Date: 20210914; Test Name: Urinalysis; Result Unstructured Data: Color: amber, PH:6.0, Sugar: glucose plus
CDC Split Type: ZAJNJFOC20210940121

Write-up: DEATH; MILD DEHYDRATION; GLUCOSE POSITIVE; COVID-PNEUMONIA; INABILITY TO WALK; DIZZINESS; This spontaneous report received from a physician concerned a 57 year old female of unspecified race and ethnicity. The patient''s weight was not reported and height was 163 centimeters. The patient''s past medical history included: covid-19 positive (20-AUG-2020),low e-gfr (Estimated glomerular filtration rate), oral candidiasis and renal impairment, and concurrent conditions included: hypertension and the patient was on antiretroviral therapy. The physician was unknown for the following information of the patient like any history of similar event, any previous reaction or adverse event after immunization, any history of allergies (vaccine, food, drugs), any family history of any allergies and any disease (relevant to adverse event after immunization), pre-existing medical condition/ congenital disorder, pre-existing acute illness (30 days) prior to vaccination, suffering from any medical condition currently, history of hospitalization in last 30 days with cause and receiving any herbal and/or traditional medicines. The patient was previously treated with emtricitabine/tenofovir disoproxil fumarate/lamivudine, nevirapine, amphotericin b for oral candidiasis, sulfamethoxazole/trimethoprim; and experienced bad dreams/nightmares when treated with efavirenz. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE426 and expiry: 03-NOV-2021) dose was not reported, 1 total administered on 30-AUG-2021 10:11 for prophylactic vaccination. Consumables used were needles with size 24G (batch: 20181002) and syringes with size 1ml (batch: 20210718). Concomitant medications included abacavir/dolutegravir/lamivudine. On 31-AUG-2021, the patient experienced diarrhea, generalized body pain, weakness, cough, dizziness and inability to walk. On 11-SEP-2021, the patient experienced mild dehydration, glucose positive and was hospitalized, and diagnosed with covid-pneumonia. Laboratory data included: Blood pressure (NR: not provided) 120/80 mmHg, Heart rate (NR: not provided) 90 bpm, PCR (NR: not provided) Not reported, SARS-CoV-2 rapid diagnostic test (NR: not provided) Positive, and Urinalysis (NR: not provided)Color: amber, PH:6.0, Sugar: glucose plus, albumen, pus, blood, acetone, diacetic acid, bile, micro deposit and ketone was NAD (no abnormality detected). On 12-SEP-2021, Laboratory data included: Blood pressure (NR: not provided) 117/74 mmHg, Body temperature (NR: not provided) 36.7 celcius, Heart rate (NR: not provided) 84 bpm, Oxygen saturation (NR: not provided) 95 %, and Urinalysis (NR: not provided) Color: amber, PH:6.0, Sugar: glucose plus, albumen, pus, blood, acetone, diacetic acid, bile, micro deposit and ketone was NAD (no abnormality detected). On 13-SEP-2021, Laboratory data included: Urinalysis (NR: not provided) Color: amber, PH:6.0, Sugar: glucose plus, albumen, pus, blood, acetone, diacetic acid, bile, micro deposit and ketone was NAD (no abnormality detected). On 14-SEP-2021, Laboratory data included: Urinalysis (NR: not provided) Color: amber, PH:6.0, Sugar: glucose plus, albumen, pus, blood, acetone, diacetic acid, bile, micro deposit and ketone was NAD (no abnormality detected). The patient was hospitalized for 3 days. On 14-SEP-2021, the patient died from unknown cause of death. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inability to walk, covid-pneumonia, dizziness, mild dehydration and glucose positive was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210940121-Covid-19 vaccine ad26.cov2.s-Death, Covid-pneumonia, inability to walk, Dizziness, Mild dehydration , Glucose positive. 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: 1736306 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003603 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: DE-PEI-202100184693) on 17-Sep-2021 and was forwarded to MODERNA on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003603) for COVID-19 vaccination. No Medical History information was reported. On 19-Jun-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced PULMONARY EMBOLISM (seriousness criteria death, hospitalization, medically significant and life threatening). The patient was hospitalized on sometime in July 2021 due to PULMONARY EMBOLISM. The reported cause of death was Lung embolism. It is unknown if an autopsy was performed. Concomitant medications were not reported . Treatment information was not provided. As per senders comment, patient had an underlying disease of psychosis and cause of death was hypoxic brain damage. Company comment: This case concerns a 57 year-old female patient with a history of psychosis, who experienced the unexpected events of Pulmonary embolism and fatal event of hypoxic brain damage. The event of pulmonary embolism occurred 12 days after the vaccination with Spikevax. Time to onset from vaccination was not reported for the event hypoxic brain damage. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation Document Received on 21 SEP 2021 contains significant information. Medical history and cause of death updated.; Reporter''s Comments: Psychose: hypoxischer; Sender''s Comments: This case concerns a 57 year-old female patient with a history of psychosis, who experienced the unexpected events of Pulmonary embolism and fatal event of Hypoxia brain damage. The event of pulmonary embolism occurred 12 days after the vaccination with Spikevax. Time to onset from vaccination was not reported for the event hypoxic brain damage. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1736307 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Epilepsy, Myocarditis, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Pneumococcal pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Myocarditis; Asystole; Pulmonary embolus; Epileptic fit; This case was received via Regulatory Authority (Reference number: DE-PEI-202100184836) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis), CARDIAC ARREST (Asystole), PULMONARY EMBOLISM (Pulmonary embolus) and EPILEPSY (Epileptic fit) in a 46-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. The patient''s past medical history included Pneumococcal pneumonia and Depression. On 11-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EPILEPSY (Epileptic fit) (seriousness criteria death, hospitalization, medically significant and life threatening). On 19-Jul-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death, hospitalization, medically significant and life threatening), CARDIAC ARREST (Asystole) (seriousness criteria death, hospitalization, medically significant and life threatening) and PULMONARY EMBOLISM (Pulmonary embolus) (seriousness criteria death, hospitalization, medically significant and life threatening). The patient died on 19-Jul-2021. An autopsy was performed. The autopsy-determined cause of death was Pulmonary embolism. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Autopsy findings include the patient with a completely fresh pulmonary embolism of the pulmonary arteries was confirmed. In addition, there was diffuse lymphocytic borderline myocarditis with congestion in the lungs, liver, and spleen, lungs with interstitial pneumonitis and bronchiolitis and signs of shock. Also [mild] moderate chronic portal and lobular hepatitis in the liver. The cause of death was cardiorespiratory failure in the context of fresh pulmonary embolism, lymphocytic borderline myocarditis and interstitial pneumonitis and bronchiolitis. No relevant concomitant and treatment medications were reported Company Comment: This case concerns a 46 year old male with no relevant medical history who experienced unexpected events of Epilepsy, Pulmonary embolism, and Cardiac arrest and the listed event of Myocarditis with fatal outcome. The event of Epilepsy occurred 4 days after and the other events 8 days after the dose of Spikevax. Re-challenge is not known due lack of information about the doses. The event of Myocarditis is consistent with the current understanding of the mechanism of the vaccine. The Benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 21 Sept 2021:autopsy information were updated; Sender''s Comments: This case concerns a 46 year old male with no relevant medical history who experienced unexpected events of Epilepsy, Pulmonary embolism, and Cardiac arrest and the listed event of Myocarditis with fatal outcome. The event of Epilepsy occurred 4 days after and the other events 8 days after the dose of Spikevax. Re-challenge is not known due lack of information about the doses. The event of Myocarditis is consistent with the current understanding of the mechanism of the vaccine. The Benefit-risk relationship of Spikevax is not affected by this report.; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1736320 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-31
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214021 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Found dead (cause undetermined); This case was received via regulatory authority (Reference number: FR-AFSSAPS-LY202110552) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Found dead (cause undetermined)) in a 64-year-old female patient who received mRNA-1273 (batch no. 214021) for COVID-19 vaccination. The patient''s past medical history included Obesity and Depression. On 16-Aug-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. Death occurred on 31-Aug-2021 The patient died on 31-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company Comment: The case concerns a 64-year-old female patient with previous relevant medical history of obesity and depression, presented with unexpected event of death. Patient was found dead 15-days after receiving the a dose of mRNA 1273 vaccine. Dose number was not specified. Autopsy performance is unknown. The medical history of obesity and depression remains a cofounder. The benefit-risk relationship of vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation was received on 22 -Sep -2021 and contains no new information.; Sender''s Comments: The case concerns a 64-year-old female patient with previous relevant medical history of obesity and depression, presented with unexpected event of death. Patient was found dead 15-days after receiving the a dose of mRNA 1273 vaccine. Dose number was not specified. Autopsy performance is unknown. The medical history of obesity and depression remains a cofounder. The benefit-risk relationship of vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown


VAERS ID: 1736384 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   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: REXTAT
Current Illness: Hypercholesteremia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-781601) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH, HEADACHE, and ASTHENIA in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 vaccination. Concurrent medical conditions included Hypercholesteremia. Concomitant products included LOVASTATIN (REXTAT) from 01-Jan-2021 to 31-Aug-2021 for Primary hypercholesterolaemia. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced SUDDEN DEATH (seriousness criteria death and medically significant), HEADACHE (seriousness criterion death) and ASTHENIA (seriousness criterion death). The patient died on 01-Sep-2021. The reported cause of death was. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were not reported. The treatment information was not provided. Patient was found lifeless by his wife in the evening. Company Comment : This case concerns a 36-year-old, male patient with medical historyof Primary hypercholesterolaemia., who experienced the unexpected events of Sudden death, Headache and Asthenia . The events occurred approximately 2 days after the first dose of Spikevax and had a fatal outcome, with death occurring in the following day. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.Event seriousness assessed as per Regulatory Authority reporting,However,underlying co-morbidity may remain as confounding factor. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 22 Sep 2021 and narrative was updated with event description.; Sender''s Comments: This case concerns a 36-year-old, male patient with medical historyof Primary hypercholesterolaemia., who experienced the unexpected events of Sudden death, Headache and Asthenia . The events occurred approximately 2 days after the first dose of Spikevax and had a fatal outcome, with death occurring in the following day. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.Event seriousness assessed as per Regulatory Authority reporting,However,underlying co-morbidity may remain as confounding factor.; Reported Cause(s) of Death.


VAERS ID: 1736404 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-06-09
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   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: Diabetes mellitus; Disease risk factor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20213

Write-up: This case was received via Medicines Agency (Reference number: NL-LRB-00682473) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 300042721) for COVID-19 vaccination. Concurrent medical conditions included Disease risk factor and Diabetes mellitus. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (seriousness criteria death, medically significant and life threatening). The patient died on 22-Jun-2021. The reported cause of death was heart attack complications. It is unknown if an autopsy was performed. Concomitant medication were not provided. The patient had heart attack without prior indications: fatal outcome. Treatment information was not provided. Company comment: This case concerns 47-year-old female patient with a medical history of diabetes mellitus, who experienced the unexpected event of Myocardial infarction with fatal outcome after unspecified lapse of time after receiving the first dose of mRNA-1273 (Spikevax). Dose dates retained per RA report despite this being unlikely. Autopsy results or cause of death not reported. The rechallenge was not applicable. No reporter causality was provided. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 21-Sep-2021. Updated narrative with reported cause of death and event verbatim.; Sender''s Comments: This case concerns 47-year-old female patient with a medical history of diabetes mellitus, who experienced the unexpected event of Myocardial infarction with fatal outcome after unspecified lapse of time after receiving the first dose of mRNA-1273 (Spikevax). Dose dates retained per RA report despite this being unlikely. Autopsy results or cause of death not reported. The rechallenge was not applicable. No reporter causality was provided. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.; Reported Cause(s) of Death: heart attack complications


VAERS ID: 1736633 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-08-11
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiac tamponade, Myocardial rupture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (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: ELTROXIN; LAMOTRIGINE; SIMCORA; TARDYFERON; DAFALGAN
Current Illness: Coronaropathy; Hyperlipidemia; Hypothyroidism; Sleep apnea syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Anoxia cerebral (mental retardation secondary to cerebral anoxia at birth); Epilepsy; Mental retardation (mental retardation secondary to cerebral anoxia at birth)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: ; Myocardial rupture; Cardiac tamponade; This regulatory authority case was reported by a physician and describes the occurrence of ACUTE MYOCARDIAL INFARCTION , MYOCARDIAL RUPTURE (Myocardial rupture) and CARDIAC TAMPONADE (Cardiac tamponade) in a 75-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004219) for COVID-19 vaccination. The patient''s past medical history included Epilepsy, Mental retardation (mental retardation secondary to cerebral anoxia at birth) and Anoxia cerebral (mental retardation secondary to cerebral anoxia at birth). Concurrent medical conditions included Coronaropathy, Sleep apnea syndrome, Hypothyroidism and Hyperlipidemia. Concomitant products included LEVOTHYROXINE SODIUM (ELTROXIN), LAMOTRIGINE, SIMVASTATIN (SIMCORA), FERROUS SULFATE (TARDYFERON) and PARACETAMOL (DAFALGAN) for an unknown indication. On 07-Jul-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 10-Aug-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced MYOCARDIAL RUPTURE (Myocardial rupture) (seriousness criteria death and medically significant) and CARDIAC TAMPONADE (Cardiac tamponade) (seriousness criteria death and medically significant). On 11-Aug-2021 at 9:00 AM, the patient experienced ACUTE MYOCARDIAL INFARCTION (seriousness criteria death and medically significant). The reported cause of death was Autopsy, Myocardial rupture (post infarct) and Tamponade cardiac. An autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered ACUTE MYOCARDIAL INFARCTION, MYOCARDIAL RUPTURE (Myocardial rupture) and CARDIAC TAMPONADE (Cardiac tamponade) to be possibly related. Treatment information was not provided by reporter. It was reported On 11/08/2021, patient reported feeling ill starting in the morning, and then chest pain starting at 12:00 p.m and was found unconscious around 9:00 pm. CPR was performed without success. The patient was declared dead shortly after 9:00 p.m. On 24/08/2021 pathologist reported the patient died from a tamponade due to the rupture of the posterior ventricle in the context of an acute myocardial infarction due to a thrombosis in the medial part of the right coronary artery. It should be noted that the patient suffered from severe triple vessel coronary artery disease: 95% stenosis in the right coronary artery, 80% in the left common trunk, 95% in the proximal left anterior descending artery, and 95% in the circumflex artery. Severe atheromatous lesions were also found in the right external carotid artery as well as obliterating arteriopathy of the inferior limbs (e.g. 95% stenosis of the medial femoral artery). Company comment: The case concerns a 75-year-old female patient with relevant medical history of corononary artery disease and hyperlipidemia, presented with unexpected events of myocardial infarction, myocardial rupture and cardiac tamponade. Patient was feeling unwell one day after receiving the second dose of mRNA 1273 vaccine, he had chest pain and found unconscious at night, CPR performed but declared dead on the same day. According to the pathologist, the patient died from a tamponade due to the rupture of the posterior ventricle in the context of an acute myocardial infarction due to a thrombosis in the medial part of the right coronary artery. It was also noted that the patient suffered from severe triple vessel coronary artery disease. The patient''s history of coronary artery disease and hyperlipidemia remains a confounder to the events. The benefit risk relationship of vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 23-SEP-2021,contains dose 1 and 2 information update, medical history and Inarrative updated.; Sender''s Comments: The case concerns a 75-year-old female patient with relevant medical history of corononary artery disease and hyperlipidemia, presented with unexpected events of myocardial infarction, myocardial rupture and cardiac tamponade. Patient was feeling unwell one day after receiving the second dose of mRNA 1273 vaccine, he had chest pain and found unconscious at night, CPR performed but declared dead on the same day. According to the pathologist, the patient died from a tamponade due to the rupture of the posterior ventricle in the context of an acute myocardial infarction due to a thrombosis in the medial part of the right coronary artery. It was also noted that the patient suffered from severe triple vessel coronary artery disease. The patient''s history of coronary artery disease and hyperlipidemia remains a confounder to the events. The benefit risk relationship of vaccine is not affected by this report.; Reported Cause(s) of Death: Autopsy; Myocardial rupture (post infarct); Tamponade cardiac


VAERS ID: 1737727 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210948441

Write-up: DEATH; HEART SUDDENLY FAILED; This spontaneous report received from a consumer concerned a 56 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, route of administration, and batch number were not reported) dose was not reported, 1 total administered on AUG-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On 16-SEP-2021, while taking a walk, patient''s heart suddenly failed and died from an unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart suddenly failed was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0:20210948441-covid-19 vaccine ad26.cov2.-Death, Heart suddenly failed. 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: 1737857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Immune thrombocytopenia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210947953

Write-up: THROMBOSIS OF VENOUS SINUSES; IMMUNE THROMBOCYTOPENIA; This spontaneous report received from a physician by a Regulatory Authority (DE-PEI-202100194941) on 24-SEP-2021 and concerned a 50-year-old female of unspecified 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 admin not reported, batch number: 21C18-01 expiry: unknown) dose was not reported, 1 total, administered on 15-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced thrombosis of venous sinuses and immune thrombocytopenia. The patient was hospitalized (date unspecified). Number of days hospitalized and discharge information was not reported. On 26-AUG-2021, the patient died and cause of death was thrombosis of venous sinuses. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of immune thrombocytopenia on 26-AUG-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).; Reported Cause(s) of Death: THROMBOSIS OF VENOUS SINUSES


VAERS ID: 1737907 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-09-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Computerised tomogram, Drug ineffective, Hypotension, Pneumonia, Pulmonary sepsis, Respiratory failure, SARS-CoV-2 test, Septic shock, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), 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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-18
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness: Down''s syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: chest tomography; Result Unstructured Data: Test Result:major pulmonary impairment; Test Date: 20210911; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: BRPFIZER INC202101233825

Write-up: vomit with secretion; started to present severe symptoms of the disease / COVID-19/ fever / weakness / the reporter believes that the patient''s fever and weakness were related to COVID-19; started to present severe symptoms of the disease / COVID-19/ fever / weakness / the reporter believes that the patient''s fever and weakness were related to COVID-19; blood pressure low; weakness; septic shock; pulmonary sepsis; unspecified pneumonia; respiratory failure; This is a spontaneous report from two contactable consumers (patient''s father and patient''s aunt) received through portal. A 17-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via Intramuscular, administered in right arm on 23Aug2021 12:00 AM (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing Down''s syndrome (He was born with it). He did not have any medical history, only Down''s Syndrome. Concomitant medication included alprazolam taken for sedative therapy, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergic to any medications, food or other products. The patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. 13 days after taking the vaccine, the patient started to present severe symptoms of the disease and died in 7 days. The patient after taking the vaccine got sick and as result of the disease he died. The causes were written on the death certificate as follows bellow: Septic shock, Pulmonary sepsis, Unspecified pneumonia and Covid-19. The patient did not leave the house, did not receive visitors and his health was very good. The house members did the tests and as per the results, they were not infected. Reporter said that the patient was a very healthy boy and refused to take any vaccine, but he received the Pfizer vaccine against covid-19 on 23Aug2021. He started to show symptoms of fever on 06Sep2021 at 01:00 AM and as the fever did not go away and because he presented weakness (in Sep2021) and vomiting with secretions on 10Sep2021, he was taken to the emergency care unit on 11Sep2021. His condition was considered serious and, on that same day, he was taken to the ICU of the hospital. The patient underwent a PCR test on 11Sep2021 and on 14Sep2021 he received a positive result (the reporter believes that the patient''s fever and weakness were related to COVID-19). On 11Sep2021, he also performed a chest tomography and the result showed major pulmonary impairment, therefore, the patient was intubated from 11Sep2021 on with oxygen supplementation. Oxygen flow was decided according to the patient''s health status and the patient received supplemental oxygen during the 7 days of hospitalization. On the day of intubation, the patient had low blood pressure (in Sep2021) and received norepinephrine. The reporter does not know how the patient''s blood pressure was during hospitalization. During intubation, the reporter had no contact with the patient and did not talk to the medical team, so she was unable to say if there was a worsening of the Down Syndrome and was unable to say any exams and/or treatments performed. The physician only commented that all the patient''s organs were normal, with only the respiratory system being compromised. On 18Sep2021 (date of death), the patient suffered a respiratory arrest, respiratory failure, but the reporter was unable to give further details. The reporter commented that she did not know that the patient had pneumonia during hospitalization, she only found out when she saw the investigation. She reported that the patient used alprazolam as a concomitant medication and was unable to say whether the patient used it in the hospital until the date of death. The patient was hospitalized from 11Sep2021 to 18Sep2021. The patient died on 18Sep2021. In case of death, an autopsy was performed. Autopsy results: the medical report indicated the cause of death as pulmonary sepsis, nonspecific pneumonia and covid-19. The reporter said that the result of covid-19 in the final medical report had a question mark, indicating it as inconclusive, but she believed that the patient had COVID-19 due to the exam done on 11Sep2021, which was positive. An autopsy was performed that revealed pulmonary sepsis, unspecified pneumonia, covid-19, septic shock. The outcome of events COVID-19, drug ineffective, septic shock, pulmonary sepsis, unspecified pneumonia and respiratory failure was fatal, vomit with secretion was recovered on 10Sep2021, blood pressure low and weakness was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: COVID-19; respiratory failure; Autopsy-determined Cause(s) of Death: COVID-19; pulmonary sepsis; unspecified pneumonia; septic shock


VAERS ID: 1737980 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Psychotic disorder (approx. 8 years ago with 2 stays in psychiatry. Since then taking a neuroleptic, very low dose)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101228429

Write-up: Unknown cause of death; Unwell; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021180047. Safety Report Unique Identifier: DE-PEI-202100190846. A 61-year-old male patient received bnt162b2 (COMIRNATY) via unspecified route single dose for covid-19 immunisation on 27May2021. Medical history included ongoing psychotic disorder (approx. 8 years ago with 2 stays in psychiatry, since then taking a neuroleptic, very low dose). No allergies. The patient''s concomitant medications included low dose neuroleptic (unspecified). The patient experienced unknown cause of death on 06Jun2021, unwell/ feeling bad on 02Jun2021 with outcome of not recovered. The patient died on 06Jun2021. It was unknown if an autopsy was performed. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? no Psychosis approx. 8 years ago with 2 stays in psychiatry. Since then taking a neuroleptic, very low dose / On 02Jun2021 telephone message that he was feeling bad. Relatedness of bnt162b2 with the events unknown cause of death and unwell was reported as unclassifiable. 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: 1738091 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-07-29
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depressive disorder; Dyslipidaemia; Hypoacusis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ESPFIZER INC202101250557

Write-up: Decompensated heart failure; Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-970586. A 92-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EK9788) via an unspecified route of administration on 02Feb2021 as dose 2, single and received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EM0477) via an unspecified route of administration on 12Jan2021 as dose 1, single for covid-19 immunization. Patient medical history included dyslipidemia, depression, hyperacusis, type 2 diabetes mellitus. Patient was not a pregnant at the time of administration of the vaccine. The concomitant medications were not reported. The patient experienced covid-19 pneumonia on 29Jul2021, decompensated heart failure on an unspecified date. The time interval between beginning of drug administration and start of reaction / event was 199 days and time interval between last dose of drug and start of reaction / event was 178 days. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 20Jul2021. Therapeutic measures were taken as a broad-spectrum antibiotic therapy, diuretics, dexamethasone, oxygen therapy, and support measures is started as a result of covid-19 pneumonia, decompensated heart failure, despite which the patient presents an unfavorable clinical course and finally dies. The clinical outcome of the COVID-19 pneumonia was reported as recovered in 04Aug2021 and decompensated heart failure was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1738437 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Decreased appetite, General physical health deterioration, Incorrect route of product administration, Nausea
SMQs:, Acute pancreatitis (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   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: Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death unexplained; General physical health deterioration; Anorexia; Asthenia; Nausea; Inappropriate route of vaccination; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-NC20214025) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death unexplained) in a 77-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Hypertension arterial. On 02-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intradermal) 1 dosage form. On 02-Jul-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration), DECREASED APPETITE (Anorexia), ASTHENIA (Asthenia), NAUSEA (Nausea) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 02-Jul-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. The patient died on 12-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, GENERAL PHYSICAL HEALTH DETERIORATION (General physical health deterioration), DECREASED APPETITE (Anorexia), ASTHENIA (Asthenia) and NAUSEA (Nausea) had not resolved. No concomitant medication details were reported. No treatment medication details was reported. Company Comment - This case concerns a 77-year-old, male patient with medical history of hypertension arterial, who experienced unexpected fatal event of death and decreased appetite, general physical health deterioration and asthenia. Additionally incorrect route of vaccine administered was reported in this case. The events (decreased appetite, general physical health deterioration, asthenia) occurred the same day after the first dose of Spikevax and the fatal event occurred 10 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. There is no autopsy reported. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 22-Sep-2021 included medical history added.; Sender''s Comments: This case concerns a 77-year-old, male patient with medical history of hypertension arterial, who experienced unexpected fatal event of death and decreased appetite, general physical health deterioration and asthenia. Additionally incorrect route of vaccine administered was reported in this case. The events (decreased appetite, general physical health deterioration, asthenia) occurred the same day after the first dose of Spikevax and the fatal event occurred 10 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. There is no autopsy reported. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1738683 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-14
Onset:2021-02-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4244 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ketoacidosis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101252617

Write-up: Ketoacidosis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number and Safety Report Unique Identifier is GB-MHRA-ADR 25958422. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK4244), intramuscular on 14Feb2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced ketoacidosis on 28Feb2021. The event was reported as serious per seriousness criteria, results in death. The patient died on 28Feb2021. An autopsy was performed that revealed ketoacidosis. Autopsy-determined cause of death was reported as ketoacidosis. The clinical course was reported as follows: Sudden death - PM reported as ''ketoacidosis''. Unlikely to be due to vaccine. Death 28Feb2021. May be no connection but the reporter thought they should report this. The outcome of the event was fatal. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes.; Reported Cause(s) of Death: Ketoacidosis; Autopsy-determined Cause(s) of Death: Ketoacidosis


VAERS ID: 1738684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-04-04
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101252554

Write-up: Death; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25958430. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 05Mar2021 (Lot number was not reported) as second dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took bnt162b2 on 04Feb2021 (Lot number was not reported) as first dose, single for COVID-19 immunisation. The patient experienced death on 04Apr2021.The patient died on 04Apr2021 due to unknown cause of death. It was unknown whether 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: 1739037 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-22
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Lung neoplasm malignant, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Non-haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 86
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101252680

Write-up: 1affect lung; Breathing difficult; Cough; This is a spontaneous report from a contactable Consumer. This is a report received from the Regulatory authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202109211535088230-I0CCX], Safety Report Unique Identifier [GB-MHRA-ADR 25975346]. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown), via an unspecified route of administration on 08Apr2021 at unknown dose number, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced cough on 22Apr2021, 1affect lung (reported as lung cancer) on an unspecified and had breathing difficult on 17May2021. The events cause hospitalization. The patient underwent laboratory test which included Sars-cov-2 test: negative on unknown date. The patient died on 17Jul2021. The outcome of events was fatal. It was unknown if autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: breathing difficulty; cough; lung cancer


VAERS ID: 1739038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-09
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101252659

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109211729536930-PLR0P and Safety Report Unique Identifier GB-MHRA-ADR 25976594. A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death on 09Sep2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The patient died on 09Sep2021. It was not reported if an autopsy was performed. Additional information: Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. 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: 1739658 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-06
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Headache
SMQs:, Guillain-Barre 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: PHJNJFOC20210945666

Write-up: POOR APPETITE; HEADACHE; BODY WEAKNESS; This spontaneous report received from a physician via a Regulatory Authority [PHFDA-300106511] concerned a 63-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. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 213C21A expiry: unknown) dose was not reported, 1 total, administered on 06-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 06-AUG-2021, the patient experienced headache and body weakness. On 03-SEP-2021, he experienced poor appetite. On an unspecified date, the patient died from headache, weakness and poor appetite. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache, weakness and poor appetite was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210945666-covid-19 vaccine ad26.cov2.s-headache, body weakness, poor appetite . 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: HEADACHE; BODY WEAKNESS; POOR APPETITE


VAERS ID: 1739761 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002614 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Cerebrovascular accident, Lung disorder, Pleural effusion
SMQs:, Cardiac failure (narrow), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: SEMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: SE-MPA-2021-078438) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE, ATRIAL FIBRILLATION, CEREBROVASCULAR ACCIDENT (STROKE), LUNG DISORDER and PLEURAL EFFUSION in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002614) for COVID-19 vaccination. No Medical History information was reported. In July 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2021, the patient experienced CARDIAC FAILURE (seriousness criteria death, disability, medically significant and life threatening), LUNG DISORDER (seriousness criteria death, disability and life threatening) and PLEURAL EFFUSION (seriousness criteria death, disability and life threatening). In August 2021, the patient experienced ATRIAL FIBRILLATION (seriousness criteria death, disability, medically significant and life threatening) and CEREBROVASCULAR ACCIDENT (seriousness criteria death, disability, medically significant and life threatening). The reported cause of death was Cardiac failure, Atrial fibrillation, Stroke, Lung disorder NOS and Pleural effusion. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. Company Comment: This case concerns a 72 year old female with no medical history reported who experienced the unexpected events of Cardiac failure, Cerebrovascular accident and Pleural effusion resulting in death on an unknown date. Cause of death is reported as for all events. Spikevax was given in July 2021 without a firm date but the reporter states the events occurred after the vaccine also starting in July 2021 but without a firm date. Re-challenge was not applicable as the case was fatal and this was the first dose. With no medical history the only confounder is the patient''s age. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 72 year old female with no medical history reported who experienced the unexpected events of Cardiac failure, Cerebrovascular accident and Pleural effusion resulting in death on an unknown date. Cause of death is reported as for all events. Spikevax was given in July 2021 without a firm date but the reporter states the events occurred after the vaccine also starting in July 2021 but without a firm date. Re-challenge was not applicable as the case was fatal and this was the first dose. With no medical history the only confounder is the patient''s age. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Cardiac failure; Atrial fibrillation; Stroke; Lung disorder NOS; Pleural effusion


VAERS ID: 1739865 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-08-14
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Foetal hypokinesia, Stillbirth
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amniocentesis (Fetus had a normal chromosome variant (Chromosome 15 satellite variation))
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Stillbirth; Fetal movements decreased; This regulatory authority case was reported by an other health care professional and describes the occurrence of STILLBIRTH (Stillbirth) and FOETAL HYPOKINESIA (Fetal movements decreased) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): The mother''s past medical history included Amniocentesis (Fetus had a normal chromosome variant (Chromosome 15 satellite variation)). MEDICAL HISTORY (Patient): The patient''s past medical history included Amniocentesis (Fetus had a normal chromosome variant (Chromosome 15 satellite variation)). On 12-Jul-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Aug-2021, the patient was diagnosed with FOETAL HYPOKINESIA (Fetal movements decreased) (seriousness criteria death and medically significant). On 25-Aug-2021, the patient was diagnosed with STILLBIRTH (Stillbirth) (seriousness criteria death and medically significant). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred on 25-Aug-2021, which was reported as Still birth. For foetus 1, The outcome was reported as Stillbirth NOS. Labor was induced. The patient died on 25-Aug-2021. The reported cause of death was Fetal hypokinesia. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Mother of the patient regularly went for prenatal check-ups, After experiencing decreased fetal movement and increase of uterine contractions, labor was induced and patient had a stillbirth. Company Comment: This case concerns an unknown age and gender patient with medical history of Chromosome 15 satellite variation, who experienced the unexpected serious event of FOETAL HYPOKINESIA, within 1 day after the mother received the second dose of mRNA-1273 vaccine and experienced the unexpected serious event of STILLBIRTH, within 12 days after the mother received the second dose of mRNA-1273 vaccine. The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. Limited information regarding the events have been provided at this time. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns an unknown age and gender patient with medical history of Chromosome 15 satellite variation, who experienced the unexpected serious event of FOETAL HYPOKINESIA, within 1 day after the mother received the second dose of mRNA-1273 vaccine and experienced the unexpected serious event of STILLBIRTH, within 12 days after the mother received the second dose of mRNA-1273 vaccine. The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. Limited information regarding the events have been provided at this time. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.; Reported Cause(s) of Death: Fetal Hypokinesia


VAERS ID: 1740470 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 210058 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Feeling hot, Illness, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker (former smoker (quit smoking more than 30 years ago))
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: C-reactive protein; Test Result: Negative ; Test Date: 2021; Test Name: SARS-COV-2 TEST; Test Result: Negative
CDC Split Type: BRSA2021SA316420

Write-up: illness sudden and died for an unknown reason; disease of feeling burning in the face/ hot face warm feeling; This initial information about this spontaneous serious death case was received on 20-Sep-2021 from a non-health professional (son of the patient) through the agency, which was sent to the regulatory authority on 22-Sep-2021. On 19-Aug-2021, the agency received a report of a serious adverse event after the use of the coronavirus disease (COVID-19) (Inactivated) Adsorbed Vaccine via e-mail. The patient''s reporter and son, uninformed profession, reports that his father (co-morbidity, continuous medication use and unknown demographics) received an unknown dose of the vaccine on an unknown date and 4 days after receiving the vaccine had an illness sudden and died for an unknown reason [adverse event]. No further details were provided such as when the events started, intensity, duration, possible treatments or any other information relevant to the case. On 17-Sep-2021, the agency received via e-mail the report of a serious adverse event after the use of the Adsorbed Vaccine COVID-19 (Inactivated). Reporter, profession unknown informs that his father and patient male, medical history of hypertension, use of continuous medication on 13-Mar-2021 he received the first dose of vaccine batch number: 210058 (administration route and expiration date unknown) at the health unit, however after 3 days of the immunizing agent (17-Mar-2021) at 5:40 am, the reporter was informed by the patient, he had the symptom of hot face [warm feeling] and interrupted the contact. On the same day (17-Mar-2021) the patient died. The reporter adds that the patient underwent a test for COVID-19 after death, which showed a negative result. On 20-Sep-2021, the agency received additional information via e-mail about the report of a serious adverse event after the use of the COVID-19 Adsorbed Vaccine (Inactivated) and the Trivalent Influenza Vaccine (Fragmented and Inactivated). Reporter, profession unknown, informs that his father and patient with an unknown name had a medical history of being a former smoker (he stopped smoking more than 30 years ago), has no allergies and has not undergone surgical procedures. He reports that in addition to receiving the first dose of the adsorbed vaccine COVID-19 (Inactivated), he received the dose of the Influenza Vaccine on an unreported date (according to the reporter, the patient has all vaccine doses up to date), he reports that on the day he died on 17-Mar-2021 he presented the "disease of feeling burning in the face" [feeling of heat]. The reporter informs that the C-reactive Protein (CRP) test was performed, which showed a negative result, in addition he informs that "when the patient was found lifeless, he had a purple/ black face, but the body had a normal appearance". Note: Although the reporter mentioned that "they said that the patient died of COVID-19", as the result of the C-reactive protein (CRP) was negative, agency will not consider Covid-19 as an adverse event. It is unknown if the patient experienced any additional symptoms/ events. Lab data/ results: Exam: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test Date: 2021 Result: negative.; Sender''s Comments: This case concerns a 75 years old male patient who had illness, felt hot and died after vaccination with INFLUENZA VACCINE (TRIVALENT) and COVID-19 VACCINE INACT. The time to onset of the events with the INFLUENZA VACCINE (TRIVALENT) is unknown and with the COVID-19 VACCINE INACT was compatible. The patient''s ongoing medical history included hypertension and was a former smoker (quit smoking more than 30 years ago), has no allergies and has not undergone surgical procedures. On 2021, laboratory test showed a negative result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), due to which the agency did not consider Covid-19 as a cause of death. It was unknown if an autopsy was done. Further information regarding previous vaccination tolerance and other laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: illness sudden and died for an unknown reason; disease of feeling burning in the face/ hot face warm feeling


VAERS ID: 1740504 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient was skinny person and had no comorbodities.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20210949919

Write-up: COVID-19 INFECTION; FAINTED; This spontaneous report received from a patient via a company representative concerned a 50 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient was skinny person and had no comorbodities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total 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, after two weeks of vaccination, patient fainted and was admitted to hospital at ICU where she died. On unspecified date, an autopsy was performed and Physicians mentioned that she died due to COVID-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210949919-covid-19 vaccine ad26.cov2.s -COVID-19 infection. 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). 20210949919-covid-19 vaccine ad26.cov2.s -Fainted. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: COVID-19 INFECTION


VAERS ID: 1740631 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Cerebral infarction; Depression; Diabetes mellitus; Hypertension; Myocardial infarct; Respiratory insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101256780

Write-up: fell twice without external injuries; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number/Safety Report Unique Identifier is AT-BASGAGES-2021-044122. An 87-year-old female patient received third dose of BNT162B2 (COMIRNATY), intramuscular on 08Sep2021 13:30 (lot number: FE7051) as single dose for COVID-19 immunisation. The patient''s medical history included breast cancer, diabetes mellitus, depression, myocardial infarct, cerebral infarction, hypertension, and respiratory insufficiency. Concomitant medications included pentoxifylline (TRENTAL), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET), metoprolol succinate (METOHEXAL), enalapril, escitalopram oxalate (CIPRALEX), amlodipine, and acetylsalicylic acid (ASS). In the night on 09Sep2021, the patient fell twice without external injuries at 5 a.m. on 09Sep2021 death in bed. Case narrative: This serious spontaneous report was received from a Physician and concerns a Female patient of 87 Year. The patient''s medical history and concurrent conditions included: Breast cancer, Diabetes mellitus, Depression, Myocardial infarct, Cerebral infarction, Hypertension, Respiratory insufficiency. The patient''s weight was 50 kg, and height was 166 cm. The patient received the following suspect/interacting medications: COMIRNATY, 1 dosage form, every 1 Total, from 08.09.2021 to 08.09.2021 for the indication(s) COVID-19 vaccination. For COMIRNATY the batch/lot number was reported: FE7051. On 09.09.2021 the patient experienced Fall death. Action taken with COMIRNATY: Not applicable. The patient''s outcome was: fatal for Fall. Concomitant medications were: Janumet, Cipralex, Trental, ASS, Metohexal, Amlodipine, Enalapril. Summary (full translation available upon request). The patient died on 09Sep2021 05:00. 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: fell twice without external injuries


VAERS ID: 1740767 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-02-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101238934

Write-up: Drug overdose; Passed away; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number BE-FAMHP-DHH-N2021-106792. An 85-years-old female patient received bnt162b2 (COMIRNATY), the second dose via intramuscular on 16Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, 1st dose, IM) on 14Jan2021 for covid-19 immunisation. The patient passed away on 16Feb2021, experienced drug overdose on an unspecified date. The patient died on 16Feb2021. It was unknown if an autopsy was performed. The outcome of the event passed away was fatal. Reporter''s comments: Tests: Unable to speak to the treating physician. Special situations: Drug overdose. The lot number for bnt162b2, was not provided and will be requested during follow up.; Reporter''s Comments: Tests: Unable to speak to the treating physician. Special situations: Drug overdose.; Reported Cause(s) of Death: Passed away


VAERS ID: 1742011 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Illness, Intensive care
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101258779

Write-up: got sick the day she got the vaccine and was hospitalized / stayed for 30 days in the ICU and died; got sick the day she got the vaccine and was hospitalized / stayed for 30 days in the ICU and died; This is a spontaneous report from a non-contactable consumer communicated via legal affairs. A 49-year-old female patient received a dose of BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 49-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got sick the day she got the vaccine and was hospitalized. She stayed for 30 days in the ICU (Intensive Care Unit) and died on an unspecified date. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: got sick; patient died


VAERS ID: 1742239 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-04-17
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Fall, Herpes zoster, Interstitial lung disease, X-ray
SMQs:, Interstitial lung disease (narrow), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Name: computerized tomogram; Result Unstructured Data: Test Result:pneumonia; Test Name: x-ray; Result Unstructured Data: Test Result:pneumonia
CDC Split Type: DEPFIZER INC202101263692

Write-up: interstitial pneumonia; fall at home; herpes zoster; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech (manufacturer control number: 88692), license party for Comirnaty. An 85-years-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included dementia. The patient''s concomitant medications were not reported. The patient developed severe herpes zoster on 17Apr2021 and interstitial pneumonia on 04May2021. The lung problems on 04May2021. At first, micro metastases were suspected and CT (computerized tomogram) and X-ray were performed which gave a diagnosis of pneumonia. He was transferred to hospital (due to pneumonia) on 29May2021 and on 05Aug2021 he died in a hospice. He also fell at home, but it was unclear at what time in the course of events. The second dose was not administered. The outcome of the event interstitial pneumonia was fatal. The outcome of the other events was unknown. The patient died on 05Aug2021. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on temporal relationship the possibility of causal association between the reported events Interstitial pneumonia, Herpes Zoster, Fall 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: interstitial pneumonia


VAERS ID: 1742443 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? 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: FRPFIZER INC202101239544

Write-up: stop of growth of the embryo; Maternal Exposure During Pregnancy; This is as spontaneous report received from a contactable consumer. The same reporter reported events after both vaccine doses for the mother and the fetus. This is the report for the fetus. The original report was downloaded from the EudraVigilance-FR-AFSSAPS-PS20212091. A fetus patient received bnt162b2 (COMIRNATY) via transplacental since the patient''s mother received the 2nd dose of bnt162b2 (COMIRNATY) intramuscular in the left arm on 31Jul2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced stop of growth of the embryo and maternal exposure during pregnancy. This a report of a spontaneous miscarriage 13 days after the second injection of the Comirnaty vaccine. There was a strong coincidence between the date of the stop of growth of the embryo given by the doctor and the date of this second injection. The embryo stopped at 6 WA + 6 days. Outcome of the event was fatal. No follow-up attempts possible. No further information expected. ; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101263402 Maternal case; Reported Cause(s) of Death: stop of growth of the embryo; Maternal Exposure During Pregnancy


VAERS ID: 1742720 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Catheter site infection, Confusional state, Glomerular filtration rate, Hypotension, Malaise, Urosepsis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-11
   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: Chronic kidney disease; End stage renal failure; Frailty; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.)); Living in care (Care home resident.)
Preexisting Conditions: Medical History/Concurrent Conditions: Obstructive uropathy; Recurrent urinary tract infection
Allergies:
Diagnostic Lab Data: Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:7
CDC Split Type: GBPFIZER INC202101258925

Write-up: pus in urinary catheter; probable urosepsis; confused; Hypotension; became increasingly unwell; This is a spontaneous report from a contactable physician received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109201552036640-0TCMP, and Safety Report Unique Identifier is GB-MHRA-ADR 25969026. A 90-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Sep2021 (batch/lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included ongoing immunodeficiency, has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef.); obstructive uropathy with indwelling catheter, recurrent urinary tract infection, ongoing living in care (Care home resident), ongoing frailty, ongoing end stage renal failure, and ongoing advanced chronic kidney disease. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced hypotension on 10Sep2021, became increasingly unwell on 10Sep2021, pus in urinary catheter on an unspecified date, confused on 10Sep2021, and probable urosepsis on an unspecified date. The events were considered serious with seriousness criteria of death and other medically important condition. The clinical course of events was reported as follows: Hypotension. Frail elderly patient with advanced chronic kidney disease (CKD) (glomerular filtration rate (GFR): 7). Obstructive uropathy with indwelling catheter. Became increasingly unwell, hypotensive, confused later same day of vaccine, pus in urinary catheter. Probable urosepsis but died very soon after arrival in emergency department (ED) before any investigations could be done. Family concerned that death may have been precipitated by vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included glomerular filtration rate: 7 on an unspecified date. The outcome of all the events was fatal. The patient died on 11Sep2021. It was not reported if an autopsy was performed. The report does not relate to possible blood clots or low platelet counts. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Hypotension; became increasingly unwell; pus in urinary catheter; confused; probable urosepsis


VAERS ID: 1742722 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-23
Onset:2020-12-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 39
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: Hashimoto''s thyroiditis (He had hashimotos thyroiditus, was auto immune. Took levothyroxine.); Immunodeficiency (auto immune, 91 years old)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101252725

Write-up: Death; became very sick; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109211325489570-EP3E7, Safety Report Unique Identifier GB-MHRA-ADR 25974734. A 92-year-old male patient received Bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 23Dec2020, as first dose, single for COVID-19 immunisation. Medical history included immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)), hashimotos thyroiditus. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient previously took levothyroxine for hashimotos thyroiditus. The patient experienced very sick on 25Dec2020 with outcome of unknown. The patient experienced death on 02Feb2021. "My father became very sick within two days of taking the first Pfizer vaccine, and was bedridden with rapid degeneration for the following six weeks until his untimely death on 2nd February 2021. He had ordered a large Christmas hamper to enjoy that remained untouched. He was auto immune, 91 years old but otherwise had been relatively fit and not sick. He had no idea that this was an mRNA experimental genetic therapy. He was not informed by any doctors of its potential dangers. He was coerced by NHS into taking a deadly cocktail." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient died on 02Feb2021 due to unknown cause of death. It was unknown whether an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1742734 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101265060

Write-up: Death; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109231740055320-CYIUH. Safety Report Unique Identifier is GB-MHRA-ADR 25985124. A 29-year-old male patient (age at vaccination: 29-year-old) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot unknown), via an unspecified route of administration on 23Sep2021 as dose 2, single for Covid-19 immunisation. Medical history was not reported. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient died on 23Sep2021. The patient underwent laboratory test which included Sars-cov-2 test: no- negative covid-19 test on unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1742791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Anuria, Condition aggravated, Death, Dyspnoea, Fibrin D dimer increased, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
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: HYDROXYUREA
Current Illness: Angina pectoris (under medication and received erythropoietin in conservative dosage)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease (under medication and received erythropoietin in conservative dosage); Hypertension (under medication and received erythropoietin in conservative dosage)
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:increased; Comments: without pulmonary embolism
CDC Split Type: GRPFIZER INC202101256734

Write-up: angina pectoris pain; tachycardia; dyspnea; increased d-dimers; POSSIBLE THROMBOSIS OF CORONARY BLOOD VESSELS; anuria; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number GR-GREOF-20217725. An 87-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Lot Number: not reported) at a single dose for covid-19 immunisation. Medical history included hypertension, chronic renal disease, and ongoing angina pectoris (she was under medication and received erythropoietin in conservative dosage). Concomitant medication included hydroxyurea. On unspecified date, the patient experienced possible thrombosis of coronary blood vessels, anuria, angina pectoris pain, tachycardia, dyspnea and increased d-dimers. About two months after the COMIRNATY vaccination on unspecified date, the patient presented angina pectoris pain, tachycardia and dyspnea where MD recommendation she was admitted to hospital where diagnosed increased d-dimers without pulmonary embolism confirmation. After a few days, she died with anuria. Events angina pectoris pain, tachycardia, dyspnea and increased d-dimers required physician office visit. Outcome of the events angina pectoris pain, tachycardia, dyspnea and increased d-dimers was unknown. The patient died on an unspecified date due to possible thrombosis of coronary blood vessels, anuria. 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: anuria; POSSIBLE THROMBOSIS OF CORONARY BLOOD VESSELS


VAERS ID: 1742798 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101265822

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable healthcare professional via agency (Regulatory authority report number: not provided) based on information received by Pfizer from company (manufacturer control number: HK-Fosun-2021FOS003573), license party for bnt162b2 (COMIRNATY). In the preceding week till 11:59 pm on 12-Sep-2021, agency received two death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. This case was split for 1 of 2 death cases. A 65-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), unknown on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient died due to unknown cause of death. The event unknown cause of death met the seriousness criterion of death. It was not reported if an autopsy was performed. Death is not a common adverse event in the package insert of COMIRNATY, so its expectedness is: unexpected. Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between death and COMIRNATY were considered as possible. This is one of seven reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003569 (master case), 2021FOS003570, 2021FOS003571, 2021FOS003572, 2021FOS003573, 2021FOS003574 and 2021FOS003575. Company comment: The medical review comments of department on the report of death as follows: The seriousness of death was serious. Death is not a common adverse event in the package insert of COMIRNATY, so its expectedness is: unexpected. Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between death and COMIRNATY were considered as possible. Causality assessment Unknown cause of death Per Reporter=Possible Per Company=Possible No follow-up attempts are possible; no information is required.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101266039 Same reporter/suspect, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1742854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   Days after onset: 53
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: Non-smoker
Preexisting Conditions: Comments: No other pathologies reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210948196

Write-up: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via social media via a company representative concerned a 36 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: non smoker, and other pre-existing medical conditions included: No other pathologies reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, start therapy date was not reported 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 in AUG-2021, the patient experienced suspected covid-19 infection (suspected clinical vaccination failure) and was hospitalized for one month in intensive care unit (date unspecified). He had been intubated for a few days at the hospital and on 23-SEP-2021 at 14:00, patient passed away. It was unknown whether autopsy was performed. It was reported that he may have contracted the virus while he was on duty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 23-SEP-2021 and the outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening). The case is associated with Product quality complaint.; Sender''s Comments: V0. 20210948196-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS 20210948196-COVID-19 VACCINE AD26.COV2.S- Suspected covid-19 infection. This event is considered unassessable. The event has a unknown/unclear 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: SARS COVID 19 INFECTION


VAERS ID: 1742975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia aggravated; Diabetes mellitus; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101250401

Write-up: cardiac decompensation; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority report number is IT-MINISAL02-787472. A 87 year old female patient received bnt162b2 (Comirnaty, Formulation: Solution for injection, Batch/Lot number: EJ6790) dose 1,0.3 ML Via an Intramuscular route of administration on 19Feb2021 at 13:30 pm as a single dose for COVID-19 immunisation. The patient''s medical history includes diabetes mellitus, COVID-19 pneumonia aggravated and arterial Hypertension. Concomitant drugs were not reported. She received the first dose of Pfizer vaccine, Symptoms appeared after 4 days. Her condition worsened. Patient undergone cardiac decompensation on 23Feb2021 an experienced death on 26Feb2021. The outcome of the event was Fatal. Reporter''s comments: The patient suffered from diabetes mellitus. She had been found positive for Covid 19 one month before vaccination and isolated until remission of symptoms, which were not severe. She received the first dose of Pfizer vaccine immediately thereafter. Her condition worsened until she died. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1742976 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1131 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache
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: Drug allergy (penicillin)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101250427

Write-up: after the first Pfizer administration very strong headache and death after 18 days; This is a spontaneous report received from a contactable consumer or other non hcp downloaded from the Regulatory Authority report number is IT-MINISAL02-788542. A 55-year-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FC1131 and expiry date was not reported), intramuscularly, on 01Jun2021 at 4:59 PM, as dose 1, 0.3ml, single for COVID-19 immunisation (Age at vaccination: 55 years). The patient medical history included penicillin allergy. Concomitant medications were not reported. After the first Pfizer administration, on 02Jul2021 the patient had very strong headache and death after 18 days. The patient received treatment for the event headache with brufen. The patient died on an unspecified date. It was unknwon if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reporter''s Comments: penicillin allergy; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1743178 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myeloid leukaemia, Blood test, Body temperature, Disseminated intravascular coagulation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: blood test; Result Unstructured Data: Test Result:white blood cell count increased (22,900) and blas; Comments: white blood cell count increased (22,900) and blasts of 7.5% in the peripheral blood; Test Date: 20210529; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101242527

Write-up: Disseminated intravascular coagulation; acute myeloid leukaemia; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Regulatory Authority report number is V21127433. An 85-year and 6-month-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration on 29May2021 (the day of vaccination, at age of 85-year old) as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.0 degrees centigrade. The patient had no family history. The patient had medical history of hypertension, for which she was treated. Concomitant medication was not reported. On 01Jun2021 (3 days after vaccination), although the patient was admitted to the previous hospital for haemorrhage of the right occipital lobe, expansion of the haemorrhagic focus was observed on 02Jun2021 (4 days after vaccination), and she was transferred to and admitted to the reporting hospital. The blood test on admission showed white blood cell count increased (22,900) and blasts of 7.5% in the peripheral blood, and the patient was suspected to have acute myeloid leukaemia, and she was diagnosed with disseminated intravascular coagulation (DIC). The patient did not respond to conservative treatment, and she died on 07Jun2021 (9 days after vaccination). 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. Other possible cause of the event such as any other diseases was acute myeloid leukaemia. Patient hospitalized from 01Jun2021 to 07Jun2021. The outcome of the events DIC and acute myeloid leukaemia were fatal.; Reported Cause(s) of Death: Disseminated intravascular coagulation; acute myeloid leukaemia


VAERS ID: 1743181 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-09-15
   Days after vaccination:106
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101259302

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Regulatory Authority report number is V21127505. A 79-year and 7-month-old male patient received second dose of BNT162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection), via an unspecified route of administration in Jun2021 (Batch/Lot number was not reported) (at the age of 79-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination and family history were unknown. In Jun2021 at unknown time, the patient previously received the first dose of COVID-19 Vaccine (MANUFACTURER UNKNOWN, Solution for injection, Lot number unknown, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. In Jun2021 at unknown time (the day of vaccination), the patient received the second dose of COVID-19 Vaccine. On 15Sep2021 at 14:10 (about 3 months after the vaccination), the patient died by cardiac arrest. It was not reported whether autopsy was done. The course of the event was as follows: on 15Sep2021 at 14:10 (about 3 months after the vaccination), the patient developed cardiac arrest without being witnessed. The cause was unknown. The reporting physician classified the event serious (death) and assessed the causality between the event and COVID-19 Vaccine as unassessable. There was no other possible cause of the event such as any other diseases. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1743182 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-09-19
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-19
   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: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101259356

Write-up: Cardio-respiratory arrest; Loss of consciousness; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Regulatory Authority report number is V21127504. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 18Jul2021 (at the age of 76-year-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing Chronic obstructive pulmonary disease (COPD). The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 27Jun2021 for COVID-19 Immunization. On 27Jun2021, the patient previously received the first dose of bnt162b2 (COMIRNATY). On 18Jul2021 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY). On 19Sep2021 (63 days after the vaccination) at 18:50, the patient experienced loss of consciousness and ambulance was requested. At 19:04, emergency squad confirmed cardio-respiratory arrest. At 19:18, the patient was transported to the reporting hospital. At 19:45, death was confirmed. The patient died on 19Sep2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was chronic obstructive pulmonary disease (COPD). Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardio-respiratory arrest; Loss of consciousness


VAERS ID: 1743183 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-20
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-20
   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: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: CT scan; Result Unstructured Data: Test Result:Acute aortic dissection
CDC Split Type: JPPFIZER INC202101259363

Write-up: acute aortic dissection; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127503. A 53-year-old (reported as 53-year and 9-month-old) male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on Aug2021 (Batch/Lot number was not reported) (at the age of 53-year and 9-month-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. The patient''s concomitant medications were not reported. On 20Sep2021 at 07:05, the patient experienced acute aortic dissection and died. The course of the events was as follows: On 20Sep2021 at around 07:05, the patient suddenly complained of chest pain. He was transferred to a hospital in a state of cardio-respiratory arrest. Acute aortic dissection was recognized on the CT (Computerised tomogram) scan. The patient died on 20Sep2021. It was not reported if an autopsy was performed. The outcome of the event acute aortic dissection was fatal. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Hypertension was considered as a possible cause of the event. The lot number for BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: acute aortic dissection


VAERS ID: 1743240 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Infarction
SMQs:, Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (smoked occasionally)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTJNJFOC20210943014

Write-up: INFARCTION NOS; DEATH; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, LT-SMCA-4293) on 22-SEP-2021 concerned 30 year old male of unspecified race and ethnic origin. The patient''s weight was 112 kilograms, and height was 185 centimeters. The patient''s concurrent medical history included smoker (smoked occasionally). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-02 and expiry: unknown) 0.5 ml, 1 total administered on 08-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 11-AUG-2021, the patient died from infarction nos. An autopsy was performed on an unspecified date. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 11-AUG-2021. This report was serious (Death, Other Medically Important Condition, and Life Threatening).; Reported Cause(s) of Death: INFARCTION NOS


VAERS ID: 1743242 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRIX; THYROZOL; CORONAL [BISOPROLOL FUMARATE]; CO AMLESSA; ETACIZINS; MOXONIDIN HEXAL; ROSULIP PLUS [EZETIMIBE;ROSUVASTATIN CALCIUM]
Current Illness: Arrhythmia NOS; Cardiac failure; Coronary heart disease; Dyslipidaemia; Primary hypertension; Thyrotoxicosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC202101263031

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number LV-SAM-2021096611. A 74-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 14Sep2021 12:45 (Lot Number: FF0900) as second dose, 0.3ml single for covid-19 immunisation. Medical history included coronary heart disease, arrhythmia NOS, primary hypertension, cardiac failure, thyrotoxicosis, dyslipidaemia all ongoing. Concomitant medications included spironolactone (SPIRIX) for primary hypertension, cardiac failure from 14Feb2017; thiamazole (THYROZOL) for thyrotoxicosis from 20Jul2021 and ongoing; bisoprolol fumarate (CORONAL [BISOPROLOL FUMARATE]) for cardiac failure, coronary heart disease, primary hypertension from 26Nov2019 and ongoing; amlodipine besilate, indapamide, perindopril erbumine (CO AMLESSA) for primary hypertension from 03Sep2019 and ongoing; ethacizine (ETACIZINS) for arrhythmia NOS from 23Nov2011 and ongoing; moxonidine (MOXONIDIN HEXAL) for primary hypertension from 25Feb2020 and ongoing; ezetimibe, rosuvastatin calcium (ROSULIP PLUS [EZETIMIBE;ROSUVASTATIN CALCIUM]) for dyslipidaemia from 30Oct2020 and ongoing. The patient previously took bnt162b2 (COMIRNATY) on unspecified date (Lot Number: not reported) as first dose, single for covid-19 immunisation. The patient experienced death on unspecified date (also reported as 19Jun2021, pending clarification). It was reported that the patient was found dead in bed - precise time of death not known. The patient did not complain of any symptoms after receiving the first or second vaccination dose. The patient died of unknown cause. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: death


VAERS ID: 1743248 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-28
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery (The patient was transferred to a higher-level care that could handle her condition.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210952687

Write-up: SICK; DEATH; This spontaneous report received from a consumer via social media concerned a female of an unspecified age, race, and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: surgery and she was transferred to a higher-level care that could handle her condition. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose and therapy start date were not reported, frequency time was 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, the patient got sick. The patient was in intensive care unit (reported as the Covid unit). On 28-AUG-2021, the patient died from an unknown cause. It was unspecified if an autopsy was performed. It was reported that the patient did not want to take the vaccine because of her religious beliefs but she was forced to take the vaccine. The patient got her first dose of vaccine after surviving this entire pandemic. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was serious (Death). This case, from the same reporter is linked to 20210945121.; Sender''s Comments: V0: 20210952687 -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: 1743395 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Dizziness, Dyspnoea, Headache, Toothache
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Heart disease, unspecified (Heart disease); Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Breathless; Dizziness; Tooth pain; Abdominal pain; Headache; This regulatory authority case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Breathless) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Heart disease, unspecified (Heart disease) and Parkinson''s disease. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Jul-2021, the patient experienced DIZZINESS (Dizziness), TOOTHACHE (Tooth pain), ABDOMINAL PAIN (Abdominal pain) and HEADACHE (Headache). On 06-Aug-2021, the patient experienced DYSPNOEA (Breathless) (seriousness criterion death). The patient died on 06-Aug-2021. The reported cause of death was breathless. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), TOOTHACHE (Tooth pain), ABDOMINAL PAIN (Abdominal pain) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DYSPNOEA (Breathless), DIZZINESS (Dizziness), TOOTHACHE (Tooth pain), ABDOMINAL PAIN (Abdominal pain) and HEADACHE (Headache) to be possibly related. On 07Jul2021, the patient received the first dose of the Moderna COVID-19 vaccine. After getting vaccinated, the patient experienced headache, dizziness, abdominal pain and tooth pain. The patient usually would visit the Neurology Department and Cardiology Department of (unknown) Hospital, and was given long-term medication for control. The patient''s spirit and mind were clear. She was almost in a wheelchair usually. For most of the dietary, feeding by the patient''s family members was required. In the early hours of 06Aug2021, the family members found the patient breathless, and called 119. Death was determined by the staff upon arrival. Treatment information was not provided by reporter. Company Comment: This case concerns an 82-year-old, female subject with medical history of heart disease and hypertension, who experienced the serious unexpected events dyspnoea (fatal outcome), among other non-serious events. The event occurred on the same day of administration of the first dose of the Moderna COVID-19 Vaccine. The event of dyspnoea (fatal outcome) occurred 1 month after the administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the patient died after the first dose. The medical history of heart disease and hypertension, as well as the patient''s age, remains confounders, however, cause of death was not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns an 82-year-old, female subject with medical history of heart disease and hypertension, who experienced the serious unexpected events dyspnoea (fatal outcome), among other non-serious events. The event occurred on the same day of administration of the first dose of the Moderna COVID-19 Vaccine. The event of dyspnoea (fatal outcome) occurred 1 month after the administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as the patient died after the first dose. The medical history of heart disease and hypertension, as well as the patient''s age, remains confounders, however, cause of death was not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Breathless


VAERS ID: 1744788 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-07-10
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Death, Exercise tolerance decreased, Fatigue, Influenza like illness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 53
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 use; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: This case was received regulatory authority (Reference number: AT-BASGAGES-2021-044125) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002920) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker and Alcohol use. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced CONFUSIONAL STATE, EXERCISE TOLERANCE DECREASED, INFLUENZA LIKE ILLNESS and FATIGUE. On 01-Sep-2021, EXERCISE TOLERANCE DECREASED had not resolved. The patient died on 01-Sep-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, CONFUSIONAL STATE, INFLUENZA LIKE ILLNESS. and FATIGUE had not resolved. No relevant concomitant medications were reported. Treatment information was unknown. Company comment: This case concerns a 51-year-old male patient, with history of smoking and alcohol use, who experienced the unexpected event of DEATH. Patient died approximately 1 month and 24 days after receiving the second dose of Spikevax. Rechallenge is not applicable as it is a fatal event. Autopsy report was not provided. Death certificate states: cause of death unclear. Medical history of tobacco and alcohol use remains as a confounder. The benefit-risk relation of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation document received on 24-Sep-2021 and included no new information.; Sender''s Comments: This case concerns a 51-year-old male patient, with history of smoking and alcohol use, who experienced the unexpected event of DEATH. Patient died approximately 1 month and 24 days after receiving the second dose of Spikevax. Rechallenge is not applicable as it is a fatal event. Autopsy report was not provided. Death certificate states: cause of death unclear. Medical history of tobacco and alcohol use remains as a confounder. The benefit-risk relation of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1744870 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-14
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation, Pain in extremity
SMQs:, Tendinopathies and ligament 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101248219

Write-up: Adverse event following immunisation; Pain in extremity; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 626642. A 56-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Aug2021 patient experienced adverse event following immunization and pain in extremity. Outcome of both events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Adverse event following immunisation; Pain in extremity


VAERS ID: 1745871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-15
Submitted: 0000-00-00
Entered: 2021-09-29
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: 2021-09-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Sleep apnea syndrome; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210956619

Write-up: DEATH; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, DE-DCGMA-21193497) on 29-SEP-2021 and concerned a 69 year old female of unspecified race and ethnic origin. The patient''s weight was 124 kilograms, and height was 165 centimeters. The patient''s concurrent conditions included: sleep apnea syndrome, and cardiac failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 26-MAY-2021 for an unspecified indication. The batch number was not reported. Per, procedure no follow-up will be requested for this case. No concomitant medications were reported. On 15-SEP-2021, the patient experienced death and the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1745901 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Echocardiogram, Inappropriate schedule of product administration, Pericardial effusion, Pericarditis
SMQs:, Cardiac failure (narrow), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echocardiography; Result Unstructured Data: Test Result: unknown result
CDC Split Type: DEPFIZER INC202101222432

Write-up: Pericarditis; Effusion pericardial; Shock cardiogenic; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority EudraVigilance-WEB, regulatory authority number DE-PEI-202100189616. An 84-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 15Jun2021 (Lot Number: FD9234) as dose 2, single at the age of 84-years-old for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 28Apr2021 for Covid-19 immunisation. The patient experienced inappropriate schedule of vaccine administered on 15Jun2021 and pericarditis, effusion pericardial, shock cardiogenic on an unspecified date. The patient underwent lab tests and procedures which included echocardiogram: unknown result. Outcome of the events pericarditis, effusion pericardial, shock cardiogenic was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Result of Assessment: Comirnaty/ event(s): pericarditis, effusion pericardial, shock cardiogenic/ PEI: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiogenic shock; Effusion pericardial; shock cardiogenic


VAERS ID: 1745986 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Encephalitis autoimmune, Generalised tonic-clonic seizure, Loss of consciousness, Lumbar puncture, Postictal state
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had no significant medical history.
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Lumbar puncture; Result Unstructured Data: Normal
CDC Split Type: COJNJFOC20210952991

Write-up: POSSIBLE AUTOIMMUNE ENCEPHALITIS; POSTICTAL STATE; TONIC-CLONIC SEIZURE; LOSS OF CONSCIOUSNESS; CARDIOGENIC SHOCK; This spontaneous report received from a health care professional via INVIMA Colombian health authority concerned a 25 year old of unspecified sex, race and ethnic origin. The patient''s height, and weight were not reported. The patient had no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213A21A, expiry: 21-DEC-2021) 1 total dose administered on 13-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 16-JUL-2021, patient underwent a medical consult and was sent to the Emergency Room in postictal state due to tonic-clonic seizure. Later the patient was admitted to the Intensive Care Unit (ICU) as the patient did not fully recover consciousness. A lumbar puncture was performed which was normal. Multiple laboratory tests were requested in search of the origin, evaluation by the neurology service suggested possible autoimmune encephalitis. The patient was hospitalized for unspecified number of days. On 20-AUG-2021, the patient died from cardiogenic shock. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to cardiogenic shock on 20-AUG-2021, and the outcome of possible autoimmune encephalitis, postictal state, tonic-clonic seizure and loss of consciousness was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report received from a health care professional via Colombian health authority, INVIMA, concerned a 25-year-old of person of unknown gender, and unspecified ethnicity who experienced tonic-clonic seizures, loss of consciousness, and possible autoimmune encephalitis 3 days after vaccination with a fatal progression. The patient had no significant medical history and concomitant medications were not reported. Three days after vaccination the patient was sent to the emergency room in a postictal state following tonic-clonic seizures. The patient was admitted to the ICU due to lack of consciousness. A lumbar puncture was performed and the results were reported as normal. Multiple lab tests were performed but the lab results were not provided. Neurology evaluation suggested a possible autoimmune encephalitis. The patient died due to cardiogenic shock 7 days after vaccination but clinical details were not provided. It was unknown if an autopsy was performed. Information regarding other potential etiologies was insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the events are assessed to have an indeterminate relationship with vaccination.; Reported Cause(s) of Death: CARDIOGENIC SHOCK


VAERS ID: 1745988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRW2 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
   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: Arterial bypass operation; Chronic renal insufficiency (stage 4); Coronary heart disease; Diabetes mellitus insulin-dependent; Polyneuropathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101215694

Write-up: The patient died 2 days after the first vaccination with Biontec; This is a spontaneous report downloaded from a regulatory authority. Regulatory authority report number: DE-PEI-CADR2021177563 with Safety Report Unique Identifier: DE-PEI-202100187883. An 82-year-old female patient received bnt162b2 (COMIRNATY) dose 1 via an unspecified route of administration on 18Aug2021 (Lot Number: SCRW2) as single dose for COVID-19 immunisation. Medical history included ongoing coronary artery disease, ongoing arterial bypass operation, ongoing polyneuropathy, ongoing chronic renal insufficiency stage 4, ongoing diabetes mellitus insulin-dependent. No known allergy. The patient''s concomitant medications were not reported. The patient experienced the patient died on 20Aug2021, 2 days after the first vaccination with bnt162b2. An autopsy was not performed. Relatedness of Comirnaty to event Unknown cause of death: was D. Unclassifiable per RA.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1745989 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-08-29
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101222573

Write-up: Pulmonary haemorrhage under resuscitation; Acute dyspnoea; Asystolia; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority. DE-PEI-CADR2021178429 Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100188431. A 50-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Jul2021 (Batch/Lot Number: Unknown) as SINGLE for covid-19 immunisation. The patient medical history was reported as none (no previous illnesses). concomitant medications were not reported. The patient''s weight was 80 kg, and height was 180 cm. The patient experienced acute dyspnoea and asystolia on 29Aug2021. On 11Sep2021 the patient experienced Pulmonary haemorrhage under resuscitation. The patient died in Sep2021. It was not reported if an autopsy was performed. The outcome of event Lung hemorrhage was fatal and for other events was not resolved. This report is serious - hospitalization. Sender Comment: Information on risk factors or previous illnesses No previous illnesses No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pulmonary haemorrhage under resuscitation


VAERS ID: 1746011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-29
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: DEPFIZER INC202101244734

Write-up: Died; This is a spontaneous report from a non-contactable consumer. A 21-year-old female patient received BNT162B2(COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose (dose number unknown) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient (student driver) died after Corona vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died


VAERS ID: 1746226 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCUD8 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood glucose, Blood pressure measurement, Body mass index, Body temperature, Carbon dioxide, Coma scale, Confusional state, Ejection fraction, Heart rate, Hypercapnic coma, Hypertension, Nervous system disorder, Neurological examination, Oxygen saturation, Respiratory rate, SARS-CoV-2 test, Tachypnoea, pH body fluid
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-16
   Days after onset: 15
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: Acute kidney failure; AFib (Chronic atrial fibrillation (Afib) not anticoagulated due to the increased risk of bleeding); Chronic alcoholism; Congestive (dilated) cardiomyopathy; Corneal graft; COVID-19; Dementia; Dilated cardiomyopathy (Ethylic dilated cardiomyopathy (LVEF 40% in 2017)); Fall (- Fall at home complicated by rhabdomyolysis); Gout; Hemorrhage of gastrointestinal tract, unspecified; Hyperuricaemia; Obesity (Obesity (BMI 34)); Peripheral arterial occlusive disease; Prostate adenoma; Rhabdomyolysis (- Fall at home complicated by rhabdomyolysis); Shakiness; Starvation; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: HCO3; Result Unstructured Data: Test Result:31.7 mmol/L; Test Date: 202109; Test Name: blood glucose; Result Unstructured Data: Test Result:2.65 g/l; Test Date: 202109; Test Name: blood pressure; Result Unstructured Data: Test Result:133 per 84 mmHg; Test Name: body mas index; Result Unstructured Data: Test Result:34; Test Date: 202109; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 202109; Test Name: co2; Result Unstructured Data: Test Result:53.7 mmHg; Test Date: 202109; Test Name: glasgow score; Result Unstructured Data: Test Result:4 pts including eyes: 2, verbal: 1, motor: 1; Test Date: 2017; Test Name: FEVG; Test Result: 40 %; Test Date: 202109; Test Name: heart rate; Result Unstructured Data: Test Result:71; Comments: per minute; Test Date: 202109; Test Name: neurological examination; Result Unstructured Data: Test Result:Vigilance: abnormal,; Comments: Vigilance: abnormal, Glasgow score: 4pts including eyes: 2, verbal: 1, motor: 1; Test Date: 202109; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 202109; Test Name: ph; Result Unstructured Data: Test Result:7.21; Test Date: 202109; Test Name: respiratory rate; Result Unstructured Data: Test Result:36; Comments: per minute; Test Date: 20210915; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101256392

Write-up: superficial polypnea; Confusional state; Neurological disorder NOS; Hypercapnic coma; BP left arm: 133/84mmHg; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-AN20213725. A 76-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: SCUD8) via intramuscularly on 13Sep2021 as dose 1, single for covid-19 immunization. Medical history included Ethylic dilated cardiomyopathy (LVEF 40% in 2017), Covid 19 in February 2021, Dementia, Chronic atrial fibrillation (Afib) not anticoagulated due to the increased risk of bleeding, Obesity (BMI 34), Type 2 diabetes, Fall at home complicated by rhabdomyolysis, Bilateral blindness. Failed corneal transplant, multiple surgeries, Digestive hemorrhage, oeso-gastro-duodenal fibroscopy (FOGD) refusal (2021), Distal obliterative arteriopathy of the lower limbs (OAMI), Circumcision for a phimosis sequellar to a lichen sclerosus (2010), uninvestigated tremors. Concomitant medications were not reported. The Person at risk of developing severe COVID-19 disease. The Patient living in an EHPAD (Residential facility for dependent elderly people) vaccinated with a first dose of COMIRNATY vaccine on 13Sep2021. The next morning on 14Sep2021, the patient presented a sudden confusion with superficial polypnea, which motivated his admission to the emergency room. Confusion then coma in a patient with multiple comorbidities vaccinated the day before with a first dose of comirnaty vaccine. On 15Sep2021 appearance of a deficit of the left hemisphere, no BBK, deviation of the mouth possibly. Decision of limitation or discontinuation of active therapies (LATA), no complementary explorations. Death of the patient was on 16Sep2021. Confusion then coma in a patient with multiple comorbidities vaccinated the day before by a 1st dose of Comirnaty. The patient underwent lab tests and procedures which included blood bicarbonate: 31.7 mmol/l, blood glucose: 2.65 g/l, blood pressure measurement: 133 per 84 mmhg, body temperature: 36.4 centigrade, carbon dioxide: 53.7 mmhg, coma scale: 4 pts including eyes: 2, verbal: 1, motor: 1, heart rate: 71 per minute, neurological examination: vigilance: abnormal, Glasgow score: 4pts including eyes: 2, verbal: 1, motor: 1 , oxygen saturation: 98 %, ph body fluid: 7.21, respiratory rate: 36 on an unspecified date in Sep2021, body mass index: 34, ejection fraction: 40 % on an unspecified date in 2017, sars-cov-2 test: negative on 15Sep2021. Outcome of the events neurological disorder NOS, confusional state, superficial polypnea were not resolved and outcome was unknown for BP left arm: 133/84mmHg.; Reported Cause(s) of Death: Hypercapnic coma


VAERS ID: 1746241 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-26
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker; Tabaquism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-BX20218225) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. The patient''s past medical history included Tabaquism and Smoker. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on 26-Aug-2021 The patient died on 26-Aug-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter. Company Comment: This case of death concerns a 55-year-old, male patient with unknown medical history, who experienced the unexpected serious event of death. The event occurred approximately 15 days after receiving first dose of the Moderna mRNA vaccine (Spikevax). The rechallenge is not applicable as death occurred before getting the second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation Received on 24-SEP-2021 as live follow up included Smoking (medical history); Sender''s Comments: This case of death concerns a 55-year-old, male patient with unknown medical history, who experienced the unexpected serious event of death. The event occurred approximately 15 days after receiving first dose of the Moderna mRNA vaccine (Spikevax). The rechallenge is not applicable as death occurred before getting the second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1746305 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-08-19
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: sars-cov-2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101256385

Write-up: tested positive for covid on 19Aug2021; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority EudraVigilance-WEB. The regulatory authority report number is FR-AFSSAPS-MP20217282. A 96-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: EJ6788) via an intramuscular route of administration on 10Feb2021 into left arm as dose 2, single for COVID-19 immunization; patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number EJ6788) via an intramuscular route of administration into left arm on 20Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant were not reported. It was reported that time Interval between Beginning of Drug Administration and Start of Reaction / Event was 212 days and time Interval between Last Dose of Drug and Start of Reaction / Event 191 days. On 19Aug2021 the patient had experienced COVID-19 confirmed by positive COVID-19 test. Main clinical signs was not described. On 19 Aug2021 the patient underwent lab test and procedures which included sars-cov-2 PCR test and diagnose with SARS COV-19 positive result. Characterization of the virus, variant: unknown. It was unknown if an autopsy was performed, and the reported cause of death was COVID-19 confirmed by positive COVID-19 test. The outcome of the event was fatal on 02sep2021 (death on 02Sep2021 as a result of the infection). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1746306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-08-23
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

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

Life Threatening? Yes
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: Dementia Alzheimer''s type
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: SARS-CoV-2 test; Test Result: Positive; Comments: Positive PCR test delta variant
CDC Split Type: FRPFIZER INC202101256378

Write-up: Symptomatic COVID (delta variant) with signs of seriousness and commitment to the vital prognosis: Alteration of the general condition, dyspnea (desaturation, put on O2), cough; Symptomatic COVID (delta variant) / COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable other health care professional downloaded from the regulatory authority EudraVigilance-WEB. The regulatory authority report number is FR-AFSSAPS-MP20217364 An 85-years-old male patient received bnt162b2 (COMIRNATY, solution for injection; lot number: ET3620, expiry date: unknown) intramuscularly administered in left arm on 16Mar2021 as dose 2, single and bnt162b2 (COMIRNATY, solution for injection; lot number: EP2163, expiry date: unknown) intramuscularly administered in left arm on 23Feb2021 as dose 1, single for COVID-19 immunization. Patient''s medical history included ongoing dementia alzheimer''s type. The patient''s concomitant medications were not reported. On 23Aug2021, the patient experienced symptomatic covid (delta variant) with signs of seriousness and commitment to the vital prognosis: alteration of the general condition, dyspnea (desaturation, put on o2), cough; symptomatic covid (delta variant) / covid-19 confirmed by positive covid-19 test. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Positive / Positive PCR test, delta variant on 04Aug2021.The patient died on 23Aug2021. It was not reported if an autopsy was performed. The outcome of the events was fatal on 23Aug2021. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: COVID-19


VAERS ID: 1746322 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-08-13
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EU
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Arterial hypertension; Dementia (alcoholic); Depression; Gastrectomy; GDU; Mental deficiency; Psychosis (schizophrenic psychosis); Suicide attempt (schizophrenic psychosis with 1 suicide attempt in 1999 and 2 in 2012); Type 2 diabetes mellitus (requiring insulin)
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: oxygen saturation; Test Result: 85 %; Test Date: 20210813; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101256700

Write-up: Vaccination failure; Covid-19; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20213749. A 72-years-old male patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: EP9605), dose 2 intramuscular on 15Mar2021 as dose 2, single, dose 1 intramuscular on 24Feb2021 (Batch/Lot Number: EP2163) as dose 1, single for covid-19 immunisation. Paracetamol (DOLIPRANE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included depression, intellectual disability, type 2 diabetes mellitus requiring insulin, hypertension from an unknown date and unknown if ongoing , gastrectomy from 1988 to an unknown date , alcoholism from 1988 to an unknown date , gastroduodenal ulcer from 1987 to an unknown date , psychotic disorder, schizophrenic psychosis , dementia from an unknown date and unknown if ongoing, alcoholic , suicide attempt from 1999 to an unknown date schizophrenic psychosis with 1 suicide attempt in 1999 and 2 in 2012. Concomitant medications included haloperidol (HALDOL, zopiclone (IMOVANE), tropatepine hydrochloride (LEPTICUR), metformin (METFORMIN), mianserin (MIANSERIN) macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), cyamemazine (TERCIAN [CYAMEMAZINE]), trimebutine maleate (TRIMEBUTIN), nacl (NACL), insulin glargine (ABASAGLAR), dexamethasone (DEXAMETHASONE) and enoxaparin sodium (LOVENOX [ENOXAPARIN SODIUM]) taken for an unspecified indication, start and stop date were not reported. On 13Aug2021, the patient experienced vaccination failure and covid-19 The patient underwent lab tests and procedures which included oxygen saturation: 85 % on 13Aug2021, sars-cov-2 test: positive on 13Aug2021. Therapeutic measures were taken as a result of covid-19. The patient died on 19Aug2021. It was not reported if an autopsy was performed. The outcome of the event vaccination failure was fatal. The event covid-19 outcome was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1746360 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-09-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Angiogram, Coronary artery thrombosis, Echocardiogram, Electrocardiogram, Fibrin D dimer, Physical examination, Troponin
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KARDEGIC; BRILIQUE; PANTOPRAZOLE; BISOPROLOL; RAMIPRIL; INSPRA; AMLOR; LASILIX [FUROSEMIDE]; ATORVASTATINE [ATORVASTATIN]; ABASAGLAR; APIDRA; PREGABALINE; SERESTA; ZOPICLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pulmonary oedema (Hospitalized in May2021 for ischemic acute lung edema); Angioplasty; Coronary artery occlusion; Coronary artery stenosis; Coronary stent placement; Ejection fraction low; Hypertension arterial; Insulin-dependent diabetes mellitus; Ischaemic heart disease; Leg amputation (2 legs)
Allergies:
Diagnostic Lab Data: Test Name: Coronary angiography; Result Unstructured Data: Test Result:stenosis of the proximal anterior interventricular; Comments: Significant stenosis of the proximal anterior interventricular artery. Chronic obstruction of the middle circumflex artery (small intestine downstream bed). Insignificant lesion of the first marginal. Significant stenosis of the proximal right coronary artery (dominated).; Test Date: 20210905; Test Name: Coronary angiography; Result Unstructured Data: Test Result:Tritronascular lesions.; Comments: Equivalent to acute coronary syndrome with ST segment elevation at H+15 Significant thrombotic restenosis of the focal proximal anterior interventricular artery at the site of implantation of the active stent. Chronic occlusion of the middle circumflex artery. Insignificant lesion of the first marginal. Significant stenosis of the proximal right coronary artery.; Test Name: transthoracic echocardiography; Result Unstructured Data: Test Result:ejection fraction altered to 35-40%; Comments: ejection fraction altered to 35-40%, flow preserved, severe anterolateral hypokinesia, apical and middle third of the infero-septal wall, lower basal third, the entire infero-lateral and apical wall, apical third of the antero-septal wall -septal. Minimal mitral insufficiency; Test Name: ECG; Result Unstructured Data: Test Result:Regular sinus rhythm at 94 bpm; Comments: Regular sinus rhythm at 94 bpm, PR at 120 ms, fine QRS, normal axis, no over or under offset, flattening of T waves in V4-V5-V6; Test Date: 20210905; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm 110 bpm; Comments: sinus rhythm 110 bpm, under ST shift in inferolateral; Test Date: 20210905; Test Name: D dimers; Result Unstructured Data: Test Result:1610 ng/L; Test Date: 20210905; Test Name: Clinical examination; Result Unstructured Data: Test Result:no chest pain. Stable hemodynamics.; Comments: no chest pain. Stable hemodynamics. Neck pain reproduced on palpation of C7T1; Test Date: 20210905; Test Name: troponin; Result Unstructured Data: Test Result:7636 ng/L
CDC Split Type: FRPFIZER INC202101222924

Write-up: Coronary thrombosis; Non ST segment elevation acute coronary syndrome/chest pain, atypical, neck pain type and in the left arm, suspected of false movement; This is a spontaneous report from a contactable physician downloaded from the regulatory authority; report number FR-AFSSAPS-PC20213770. A 67-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 26Aug2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included insulin-dependent diabetes, hypertension arterial, ischaemic heart disease stented in 2020, hospitalized in May2021 for ischemic acute lung edema. Transthoracic echocardiography: ejection fraction altered to 35-40%, flow preserved, severe anterolateral hypokinesia, apical and middle third of the infero-septal wall, lower basal third, the entire infero-lateral and apical wall, apical third of the antero-septal wall -septal. Minimal mitral insufficiency, ECG (electrocardiogram): Regular sinus rhythm at 94 bpm, PR at 120 ms, fine QRS, normal axis, no over or under offset, flattening of T waves in V4-V5-V6, Coronary angiography: Significant stenosis of the proximal anterior interventricular artery. Chronic obstruction of the middle circumflex artery (small intestine downstream bed). Insignificant lesion of the first marginal. Significant stenosis of the proximal right coronary artery (dominated). Successful angioplasty of the proximal anterior interventricular artery. Implantation of 2 active stents, patient with both legs amputated. Concomitant medications included acetylsalicylate lysine (KARDEGIC) 75 mg in the morning; ticagrelor (BRILIQUE) 90 mg morning and evening to continue 12 months minimum; pantoprazole 20 mg in the morning; bisoprolol 2.5 mg in the morning and evening; ramipril 2.5 mg in the morning and evening; eplerenone (INSPRA) 25 mg in the morning; amlodipine besilate (AMLOR) 5 mg in the morning; furosemide (LASILIX [FUROSEMIDE]) 40 mg in the morning; atorvastatine [atorvastatin] (ATORVASTATINE [ATORVASTATIN]) 10 mg in the evening; insulin glargine (ABASAGLAR) 22 IU in the evening; insulin glulisine (APIDRA) 6 IU morning, midday, evening; pregabaline 75 mg 1 in the morning; oxazepam (SERESTA) 10 mg in the evening; zopiclone 7.5mg in the evening; all taken for an unspecified indication, start and stop date were not reported. Patient presented an acute coronary syndrome on 04Sep2021 at 23:00. During coronary angiography, patient experienced extension of the thrombosis on 05Sep2021. Death of the patient. Clinical course was reported as 04Sep2021 at 23:00: Occurrence of chest pain, atypical, neck pain type and in the left arm, suspected of false movement. Call to urgent medical aid service at 02:00 (05Sep2021) who decided on a transfer to the emergency room. On emergency: Clinical examination (05Sep2021): no chest pain. Stable hemodynamics. Neck pain reproduced on palpation of C7T1. Pain relieved by simple and positional analgesics. ECG (05Sep2021) to emergencies: sinus rhythm 110 bpm, under ST shift in inferolateral. Blood test (05Sep2021): D dimers 1610 ng/L, troponine 7636 ng/L. Due to suspicion of an acute coronary syndrome without ST segment elevation: indication for coronary angiography. Coronary angiography (05Sep2021): Tritronascular lesions. Equivalent to acute coronary syndrome with ST segment elevation at H+15. Significant thrombotic restenosis of the focal proximal anterior interventricular artery at the site of implantation of the active stent. Chronic occlusion of the middle circumflex artery. Insignificant lesion of the first marginal. Significant stenosis of the proximal right coronary artery. Patient received predilation of the anterior interventricular artery. Implantation of an active stent. Immediately after implantation of the extensive thrombosis of the anterior interventricular artery and guiding stent with cardiocirculatory arrest. Extension of thrombosis to the circumflex. Transient recanalization of the anterior interventricular artery and circumflex with resumption of rhythm. New cardiac arrest with thrombosis of the common trunk. Anticoagulation received: 9000U of enoxaparin sodium (LOVENOX) IV 2h before the procedure. 9000U heparin at the time of thrombosis. Death of the patient after 30 minutes of massage with inability to recover a heartbeat and coronary flow. Clinicians were surprised by the numerous coronary thromboses during revascularization, pointing out the unusual nature of these multithromboses. Patient was hospitalized for the events. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the events was fatal. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Coronary thrombosis; acute coronary syndrome


VAERS ID: 1746440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-05-10
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-09-29
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, Fatigue, Hypoxia, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic hepatitis C; Dementia; Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101279979

Write-up: Vaccination failure; The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10May2021 (no variant testing).; fatigue; fever; hypoxia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-RE20211527. A 96-year-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EM0477, expiration: Apr2021), via intramuscular route of administration, administered in Arm Left on 18Jan2021 as dose 1, single and patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EK9788, expiration: May2021), via intramuscular route of administration, administered in left arm on 08Feb2021 as dose 2, single for covid-19 immunisation. Medical history included ischaemic stroke from an unknown date and unknown if ongoing, chronic hepatitis c from an unknown date and unknown if ongoing, dementia from an unknown date and unknown if ongoing. Concomitant medications included Kardegic (Acetylsalicylate Lysine) taken for an unspecified indication, start and stop date were not reported; Alprazolam taken for an unspecified indication, start and stop date were not reported; Transipeg (Macrogol 3350;Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous) taken for an unspecified indication, start and stop date were not reported; Zopiclone taken for an unspecified indication, start and stop date were not reported. Patient considered to be at risk of developing a severe form of COVID-19 disease. The patient experienced vaccination failure on 10May2021. Onset of fatigue, fever and hypoxia on 10May2021, requiring the use of anticoagulants, antibiotics and oxygen. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10May2021 (no variant testing). The patient died on 20May2021, following a very degraded general condition with slip form before infection with Covid-19. It was not reported if an autopsy was performed. Summary of Investigation: Lot number: EK9788, expiration: May2021 and Lot Number: EM0477, expiration: Apr2021. Conclusion: 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 RA ID resulted in the following conclusion: Reference RA ID 5648370 (see File attachment in this investigation record). The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot 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. regulatory authority 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. FDA 15-day report on QAEF must be checked as NO. Reporter confirmed that it was after the 1st dose that the patient developed the symptoms. No follow-up attempts possible. No further information expected. Information about batch number has been obtained. Follow-up (17Aug2021). New information via Product Quality Group included: investigation results. Follow-up (23Sep2021): This is a follow-up report to confirm previously submitted information for case 202101057364 was incorrectly submitted to the trading partners with the Authority number of FR-AFSSAPS-2021058512. Case 202101057364 is now considered invalid, Corresponding information is re-entered under new manufacturer reporter number 202101279979 under correct Authority number FR-AFSSAPS-RE20211527. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: COVID-19; fatigue; fever; hypoxia; Vaccination failure


VAERS ID: 1746462 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-27
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214009 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death unexplained; This case was received via regulatory authority (Reference number: FR-AFSSAPS-ST20213337) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unexplained) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214009) for COVID-19 vaccination. The patient''s past medical history included Obesity. On 02-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. Death occurred on 27-Aug-2021 The patient died on 27-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 were reported. No treatment information was provided by the reporter. Company Comment: This case concerns a 42 year-old, male subject, with clinical history of obesity who experienced the unexpected serious event of death. The event occurred approximately 25 days after a dose of [Spikevax] The rechallenge was not applicable since only information about this dose was disclosed The event was considered related to the study drug per the reporter''s assessment The event is consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of the vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation Document received Contains No New Information; Sender''s Comments: This case concerns a 42 year-old, male subject, with clinical history of obesity who experienced the unexpected serious event of death. The event occurred approximately 25 days after a dose of [Spikevax] The rechallenge was not applicable since only information about this dose was disclosed The event was considered related to the study drug per the reporter''s assessment The event is consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of the vaccine is not affected by this report; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1746480 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214004 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ischaemic heart disease; Weight above normal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death unattended; This case was received via regulatory authority (Reference number: FR-AFSSAPS-2021126539) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death unattended) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214004) for COVID-19 vaccination. Concurrent medical conditions included Ischaemic heart disease and Weight above normal. On 31-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medication were reported. Rechallenge was done and outcome was unknown Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation received on 27 Sep 2021 included no new information.; Sender''s Comments: This case concerns a 64-year-old, male patient with relevant medical history of ischemic heart disease and weight above normal, who experienced the unexpected event of Death (NOS). The event occurred approximately 8 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. However, this patient''s underlying medical conditions of Ischemic heart disease and weight above normal remains a contributory factor. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1746485 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-20
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C1302 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Infarction
SMQs:, Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-20
   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: Abstains from alcohol; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Infarction (No treatment received.); Comments: The patient had no known allergies, drug abuse or illicit drug use. The patient was not pregnant. The patient had no treatment when she was vaccinated.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210951914

Write-up: DEATH; INFARCTION; This spontaneous report received from a pharmacist concerned a 55 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included an antecedents of infarction in 2017 and no actual treatment given, and concurrent conditions included non-alcohol user, and nonsmoker. The patients other pre-existing medical conditions included the patient had no known allergies, drug abuse or illicit drug use. The patient was not pregnant. The patient had no treatment when she was vaccinated. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C1302, expiry: 19-SEP-2021) dose was not reported, 1 total administered to left deltoid on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. Reporter mentioned that after taking the approval of patient''s general physician they have administered the vaccine. The patient was about to visit cardiologist the week after vaccination but died before. After receiving the vaccine patient had absolutely no side effects. On 20-SEP-2021 the patient was totally fine in the morning but 1 hour after she recognized the signs of infarction, patient informed firefighters but when they came she was found dead (unknown cause of death). An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death and infarction on 20-SEP-2021. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210951914-COVID-19 VACCINE AD26.COV2.S-death, infarction. 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: 1746486 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal heart rate, Foetal heart rate abnormal, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-05
   Days after onset: 52
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: 20210905; Test Name: Foetal heart rate; Result Unstructured Data: Test Result:stopped
CDC Split Type: FRPFIZER INC202101210953

Write-up: my baby''s heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly; my baby''s heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly; 2 weeks pregnant at the time of injection; This is a spontaneous report from a contactable consumer (patient''s mother) received via COVID-19 adverse event self-reporting solution. This is a fetus report. A fetus patient of an unspecified gender exposed to BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number: unknown), via transplacental route which was administered to her mother in her left arm on 15Jul2021 as dose number unknown, single for COVID-19 immunisation for her mother. The patient''s medical history and concomitant medication was not reported. The patient was 2 weeks fetus. The patient''s mother was a 32-year-old female. The mother was 2 weeks pregnant at the time of injection on 15Jul2021. Pregnancy was normal. Then the mother reported that her baby''s heart suddenly stopped without reason one and a half month after the injection, whereas there was no anomaly. It was not reported if an autopsy was performed. No follow up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: 2 weeks pregnant at the time of injection; heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly


VAERS ID: 1746869 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-17
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Death; This case was received via Regulatory Authority (RA) (Reference number: GB-MHRA-ADR 25969869) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 17-Jun-2021 The patient died on 17-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medication was provided. Company comment: This case concerns a patient with unknown gender and age with no relevant medical history, who experienced the unexpected event of Death. The event occurred unknown days after the second dose of Spikevax . The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a patient with unknown gender and age with no relevant medical history, who experienced the unexpected event of Death. The event occurred unknown days after the second dose of Spikevax . The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1746928 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysstasia, Fatigue, Myocardial ischaemia
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Other ischaemic heart disease (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 68
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEPONEX
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101216010

Write-up: Myocardial ischaemia; Exhaustion/Fatigue; Dizziness; could not stand on his feet; This is a spontaneous report from a contactable consumer downloaded from the regualtory authority, regulatory authority number GR-GREOF-20217340. A 61-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28May2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included clozapine (LEPONEX). The patient was under treatment with antipsychotics for years. On 31May2021 he started feeling constant fatigue, dizziness, exhaustion. He could not stand on his feet. The patient experienced myocardial ischaemia on an unspecified date. The patient died on 07Aug2021. Myocardial ischaemia was the cause of death. He did not have a medical history of heart problem. It was unknown if an autopsy was performed. The outcome of the event myocardial ischaemia was fatal, the outcome of the other events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Myocardial ischaemia


VAERS ID: 1746929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-20
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   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: GRPFIZER INC202101216061

Write-up: Chest pain; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number GR-GREOF-20217664. An 81-year-old male patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Lot Number: Unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Aug2021 he had chest pain (fatal) and on 22Aug2021 he died. The cause of his death was thrombosis of the myocardium. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Chest pain; THROMBOSIS OF THE MYOCARDIUM


VAERS ID: 1746967 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory disorder, Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (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: 2021-08-17
   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: ITJNJFOC20210945519

Write-up: RESPIRATORY COMPLICATIONS DUE TO INFECTION; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a 70 year old male of unknown 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, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 04-AUG-2021, the patient became infected 3 months after administration of Covid-19 vaccine ad26.cov2.s (suspected covid-19 infection and suspected clinical vaccination failure). On 17-AUG-2021, the patient died from respiratory complications due to infection. 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 and suspected covid-19 infection was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210945519-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 20210945519-Covid-19 vaccine ad26.cov2.s-respiratory complications due to infection, suspected covid-19 infection. 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: RESPIRATORY COMPLICATIONS DUE TO INFECTION


VAERS ID: 1747041 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-30
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Fatigue, Haemorrhagic stroke, Pain in extremity, Paraesthesia, Vascular pain
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 88
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial (Controlled and on medication for years)
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple allergies (Unspecified past allergies resolved by clinical examinations between January and July 2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101228428

Write-up: Pain legs; Memory loss transient; Hemorrhagic stroke; Pins and needles; Exhaustion; Vein pain; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-785945. An 82-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection), via intramuscular route on 16Apr2021 (Lot Number: EX0893) as single dose for COVID-19 immunisation. Medical history included ongoing hypertension arterial and on medication for years, multiple allergies (unspecified past allergies resolved by clinical examinations between Jan2021 and Jul2021). The patient concomitant medication was not reported. Patient previously received first dose of bnt162b2 (COMIRNATY; solution for injection), via intramuscular route on 26Mar2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. On 30Apr2021, the patient experienced pins and needles, exhaustion, vein pain. On 30Apr2021 he experienced haemorrhagic stroke (remained there until 27Jul2021). On unknown date in May2021, patient experienced memory loss transient. On 21Jul2021, patient experienced pain legs. The patient was hospitalized for pain legs from 21Jul2021 to 27Jul2021. The patient died on 27Jul2021. It was unknown whether autopsy was performed. Health Authority comments: 13Sep: Reporter only became aware of the various episodes of adverse events his/her father experienced following the second dose afterwards. The reporter was asked for concomitant drugs habitually taken by the patient, hospital admission records including medical history, therapies undertaken and evolution of the clinical picture from the onset to haemorrhagic stroke and death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pins and needles; Vein pain; Exhaustion; Memory loss transient; Pain legs; Hemorrhagic stroke


VAERS ID: 1747053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Pneumonitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:93
CDC Split Type: ITPFIZER INC202101250259

Write-up: A guest patient in a nursing home visited on the night of 13Apr2021 presents a likely allergic reaction and cough with an antihistamine prescription. Sat o2 goes down and in ER, pneumonia is found.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-788365. A 80-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: ET7205, Expiration date: unknown), intramuscular, administered at an unspecified anatomical location on 06Apr2021 (Batch/Lot Number: ET7205) as dose number unknown, 0.3 ml, single for COVID-19 immunization. The patient''s medical history and concomitant medications were unknown. On 13Apr2021 the patient experienced a guest patient in a nursing home visited on the night of 13apr2021 presents a likely allergic reaction and cough with an antihistamine prescription. sat o2 goes down and in er, pneumonia is found. The end date for event pulmonitis was 16Apr2021. Patient is subsequently taken to the ER and hospitalized for pneumonia in patients with negative antigen. And positivity for covid 19 in November. The patient underwent lab tests and procedures which included oxygen saturation which showed 93 result on 13Apr2021. Therapeutic measures were taken as a result of a guest patient in a nursing home visited on the night of 13apr2021 presents a likely allergic reaction and cough with an antihistamine prescription. sat o2 goes down and in er, pneumonia is found. The patient died on 16Apr2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: We are waiting to insert further documentation; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1747056 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-08-24
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Hyperpyrexia, Investigation, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatopathy; Kidney dysfunction
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC202101250526

Write-up: drug ineffective; Sick with Covid 19 with symptoms; cough; myalgia; Hyperpyrexia; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-788503. A 89-years-old patient of an unspecified gender received the second dose of BNT162B2 (COMIRNATY) intramuscular, administered in Arm Left/left shoulder on 17Mar2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single; the first dose intramuscular, administered in Arm Left on 24Feb2021 (Batch/Lot number was not reported) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included Hepatopathy, renal dysfunction. The patient''s concomitant medications were not reported. On 24Aug2021, the patient experienced drug ineffective, sick with COVID-19 with symptoms, Cough, myalgia, hyperpyrexia. Impact on quality of life (10/10). All events were assessed as serious with seriousness criteria of death, hospitalization. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter comments: Hepatopathy, onset of renal dysfunction. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reporter''s Comments: Liver disease, onset of renal dysfunction; Reported Cause(s) of Death: drug ineffective; sick with COVID-19 with symptoms; Cough; myalgia; hyperpyrexia


VAERS ID: 1747187 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Brain natriuretic peptide, C-reactive protein increased, Cardiac failure congestive, Catheterisation cardiac, Heart rate, Investigation, Myocardial infarction, Oxygen saturation, White blood cell count
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   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: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EU
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Dyslipidaemia; Late effects of cerebral infarction; Symptomatic epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: blood pressure; Result Unstructured Data: Test Result:96/60 mmHg; Test Date: 20210529; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210531; Test Name: body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Date: 20210531; Test Name: BNP; Result Unstructured Data: Test Result:2847.2; Test Date: 20210603; Test Name: cardiac catherter test; Result Unstructured Data: Test Result:Chronic obstruction in the right coronary artery a; Comments: Chronic obstruction in the right coronary artery and the left anterior descending branch and 90% stenosis in the left circumflex branch were observed; Test Date: 20210531; Test Name: CRP; Result Unstructured Data: Test Result:13.80; Test Date: 20210531; Test Name: pulse rate; Result Unstructured Data: Test Result:104; Test Date: 20210529; Test Name: investigation; Result Unstructured Data: Test Result:no abnormalities were observed in the vital signs,; Comments: no abnormalities were observed in the vital signs, and there was a possibility of a side reaction after the vaccination; Test Date: 20210531; Test Name: SpO2; Test Result: 92 %; Test Date: 20210531; Test Name: WBC; Result Unstructured Data: Test Result:10700
CDC Split Type: JPPFIZER INC202101259455

Write-up: Myocardial infarction suspected; suspected acute aggravation of cardiac failure congestive; This is a spontaneous report from a contactable pharmacist received from the Pharmaceuticals and Regulatory Authority report number is v21128376. The patient was an 86-year-old female. Body temperature before vaccination was 36.3 degrees centigrade on 29May2021. The family history was not provided. The patient had medical histories of Hypertension (ongoing), dyslipidaemia, late effects of cerebral infarction, symptomatic epilepsy, and dementia Alzheimer''s type. The concomitant medications included amlodipine besilate, olmesartan medoxomil, trichlormethiazide, bisoprolol fumarate, rosuvastatin calcium, clopidogrel sulfate, febuxostat (FEBURIC), memantine hydrochloride, ifenprodil tartrate, famotidine, cilostazol, and levetiracetam (E KEPPRA). The patient had no particular history of adverse drug reactions in the past. On 29May2021 at 10:24 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) at the age of 86 years old via an unspecified route of administration as a single dose for COVID-19 immunization. On 29May2021 at 20:00 (9 hours/36 minutes after the vaccination), the patient experienced myocardial infarction suspected. On 07Jun2021 (9 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 29May2021, at 20:00 (9 hours and 36 minutes after vaccination), the generalized malaise became severe, and thereafter, it did not improve, and thus, the patient was transferred to the reporting hospital by ambulance at 23:47. At the hospital visit, no abnormalities were observed in the vital signs, and there was a possibility of a side reaction after the vaccination. The patient was admitted to the hospital overnight, and she was discharged in the morning of the following day. However, since thereafter the patient had generalized malaise, headache, and muscle ache, she visited the reporting hospital again on 31May2021, at 18:00 (2 days, 7 hours, and 36 minutes after vaccination). The body temperature was 37.6 degrees Celsius, the pulse rate was 104, the blood pressure was 96/60 mmHg, the SpO2 was 92%, the WBC was 10700, the CRP was 13.80, and the BNP was 2847.2. The inpatient treatment was initiated for pneumonia suspected, acute aggravation of cardiac failure congestive, acute myocardial infarction suspected, and accumulation of pleural effusion. Although oxygen was administered, and an antihypertensive drug and a diuretic were used, no improvement was observed. On 01Jun2021 (2 days, 13 hours, and 36 minutes after vaccination), the patient was transferred to another medical center. On 03Jun2021 (4 days, 13 hours, and 36 minutes after vaccination), BiPAP was attached, and an emergency cardiac catheter test was performed on the same day. Chronic obstruction in the right coronary artery and the left anterior descending branch and 90% stenosis in the left circumflex branch were observed. Severe triple vessel disease was observed in the coronary artery, and percutaneous coronary intervention (PCI) was tried, but it was difficult. An intra-aortic balloon, pumping (IABP) was placed, and continuous hemodiafiltration (CHDF) was performed. On 07Jun2021 (8 days, 13 hours, and 36 minutes after vaccination), after the IABP was removed, the condition was aggravated, and the patient died at 15:05 on the same day. No autopsy was done. The reporting pharmacist classified the event as serious (hospitalization and death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute aggravation of old myocardial infarction and cardiac failure congestive.; Reported Cause(s) of Death: suspected acute aggravation of cardiac failure congestive; Myocardial infarction suspected


VAERS ID: 1747221 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3064 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Chest X-ray, Condition aggravated, Death, Dyspnoea, Hypoxia, Oxygen saturation, Pneumonia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CONCOR; ATORVASTATIN; VALTRICOM; DUOPLAVIN; SPIRIX
Current Illness: Adiposis; Heart failure (Patient has shortness of breath on a daily basis due to chronic heart failure and adiposis); Primary hypertension (Stage 2)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia; Headache (Patient had a headache episode prior to vaccination; used 1 ibuprofen tablet to resolve headache.); Pneumonia; Shortness of breath
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: chest x-ray; Result Unstructured Data: Test Result:severe, bilateral pneumonia; Test Date: 20210909; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:less than 50 %; Test Name: Oxygen saturation; Test Result: 92 %
CDC Split Type: LVPFIZER INC202101216267

Write-up: Hypoxemia; Severe, bilateral pneumonia; Unknown cause of death; Body temperature increased; Aggravation of shortness of breath due to adiposis and chronic heart failure; Aggravation of shortness of breath due to adiposis and chronic heart failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number LV-SAM-2021096593. A 71-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 08Sep2021 (Batch/Lot Number: FE3064) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included pneumonia from Aug2020 to Aug2020, ongoing cardiac failure chronic (Patient has shortness of breath on a daily basis due to chronic heart failure and adiposis), headache on 08Sep2021 (Patient had a headache episode prior to vaccination. Patient used 1 ibuprofen containing tablet to resolve headache), covid-19 pneumonia in Dec2020, ongoing Primary hypertension Stage 2, ongoing Adiposis. Concomitant medication included clopidogrel, acetylsalicylic acid (DUOPLAVIN) 75 mg/100 mg tablets, 1 tablet once per day, indication not specified; bisoprolol fumarate (CONCOR) tablets, 2.5 mg once per day, for the indication of Heart failure; amlodipine, valsartan, hydrochlorothiazide (VALTRICOM) 10 mg/160 mg/12,5 mg tablets, 1 tablet once per day, for the indication of primary hypertension; spironolactone (SPIRIX) 25 mg tablets, 1 tablet once per day, for the indication of primary hypertension; 40 mg atorvastatin containing tablets, 1 tablet once per day, indication not specified. On 09Sep2021 (24 hours after vaccination) the patient started to experience body temperature increased and aggravation of existing disorder (prior to vaccination the patient experienced shortness of breath due to them being overweight and having chronic heart failure; after vaccination the patient experienced worsening of shortness of breath). The emergency medical services (EMS) were called on two occasions. On 09Sep2021 at 19:00 the EMS measured hypoxemia (SpO2 <50% which was treated with oxygen inhalations after which the patient''s SpO2 was 92%), the patient was hospitalized. On 09Sep2021 the patient had a chest x-ray which showed bilateral pneumonia (severe, bilateral pneumonia). The patient died on 10Sep2021 at 06:55. Autopsy was in progress. Cause of death was not specified. The outcome of hypoxia, body temperature increased, condition aggravated and bilateral pneumonia is reported as unknown. The reporter has been contacted in order to gather follow-up information. No follow up attempts possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1747223 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Blood bilirubin, Blood chloride, Blood creatinine, Blood sodium, Blood urea, Body temperature, C-reactive protein, COVID-19 pneumonia, Cardiac failure, Chest X-ray, Dyspnoea, Fibrin D dimer, Glomerular filtration rate, Granulocyte count, Haematocrit, Haemoglobin, Hip fracture, Hypoxia, Investigation, Lymphocyte count, Mean platelet volume, Monocyte count, Neutrophil count, Nitrite urine, Platelet count, Procalcitonin, Red blood cell count, Red cell distribution width, Respiratory failure, SARS-CoV-2 antibody test, SARS-CoV-2 test, Tachypnoea, Thrombocytopenia, Vaccination failure, White blood cell count, X-ray
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (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), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteoporosis/osteopenia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 51 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Atrial fibrillation (under Dabigatran); Breast cancer; Congestive heart failure; Femur fracture; Gastrooesophageal reflux disease; Hyperthyroidism; Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: bilirubin; Result Unstructured Data: Test Result:26.6 micromol/l; Test Date: 20210827; Test Name: serum chloride; Result Unstructured Data: Test Result:90.4 mmol/L; Test Date: 20210828; Test Name: serum chloride; Result Unstructured Data: Test Result:87.2 mmol/L; Test Date: 20210829; Test Name: serum chloride; Result Unstructured Data: Test Result:87.9 mmol/L; Test Date: 20210907; Test Name: serum chloride; Result Unstructured Data: Test Result:84.6 mmol/L; Test Date: 20210910; Test Name: serum chloride; Result Unstructured Data: Test Result:82.5 mmol/L; Test Date: 20210912; Test Name: serum chloride; Result Unstructured Data: Test Result:94.3 mmol/L; Test Date: 20210827; Test Name: creatinine; Result Unstructured Data: Test Result:63 umol/l; Test Date: 20210828; Test Name: creatinine; Result Unstructured Data: Test Result:102 umol/l; Test Date: 20210829; Test Name: creatinine; Result Unstructured Data: Test Result:97 umol/l; Test Date: 20210907; Test Name: creatinine; Result Unstructured Data: Test Result:43 umol/l; Test Date: 20210910; Test Name: creatinine; Result Unstructured Data: Test Result:67 umol/l; Test Date: 20210912; Test Name: creatinine; Result Unstructured Data: Test Result:88 umol/l; Test Date: 20210910; Test Name: serum sodium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210827; Test Name: serum urea; Result Unstructured Data: Test Result:9.9 mmol/L; Test Date: 20210828; Test Name: serum urea; Result Unstructured Data: Test Result:15.4 mmol/L; Test Date: 20210829; Test Name: serum urea; Result Unstructured Data: Test Result:19.4 mmol/L; Test Date: 20210907; Test Name: serum urea; Result Unstructured Data: Test Result:12.7 mmol/L; Test Date: 20210910; Test Name: serum urea; Result Unstructured Data: Test Result:15.3 mmol/L; Test Date: 20210827; Test Name: body temperature; Result Unstructured Data: Test Result:39; Test Date: 20210706; Test Name: chest X-Ray; Result Unstructured Data: Test Result:possible airspace opacification in left lower zone; Test Date: 20210713; Test Name: chest X-Ray; Result Unstructured Data: Test Result:increased opacification at left lung base with par; Comments: with partial obscuration of left heart border. No pneumothorax or pleural effusions; Test Date: 20210804; Test Name: chest X-Ray; Result Unstructured Data: Test Result:lung congestion, heart enlarged, no pleural effusi; Test Date: 20210829; Test Name: chest X-Ray; Result Unstructured Data: Test Result:Airspace shadowing seen in the projection of the l; Comments: Airspace shadowing seen in the projection of the left lower lung zone and retrocardiac area with obscuration of the left hemidiaphragm in keeping with a consolidation; Test Date: 20210908; Test Name: chest X-Ray; Result Unstructured Data: Test Result:airspace shadowing in the left retrocardiac area w; Comments: airspace shadowing in the left retrocardiac area with an associated small left pleural effusion, round opacities noted in the right upper and middle lung zone as well as the left upper lung zone.; Test Date: 20210911; Test Name: chest X-Ray; Result Unstructured Data: Test Result:left retrocardiac opacification as well as increas; Comments: left retrocardiac opacification as well as increased patchy ill defined opacification in the right lower lung zone; Test Date: 20210827; Test Name: CRP; Result Unstructured Data: Test Result:11 mg/l; Test Date: 20210828; Test Name: CRP; Result Unstructured Data: Test Result:209 mg/l; Test Date: 20210829; Test Name: CRP; Result Unstructured Data: Test Result:251 mg/l; Test Date: 20210907; Test Name: CRP; Result Unstructured Data: Test Result:2 mg/l; Test Date: 20210910; Test Name: CRP; Result Unstructured Data: Test Result:242 mg/l; Test Date: 20210912; Test Name: CRP; Result Unstructured Data: Test Result:120 mg/l; Test Date: 20210828; Test Name: D-Dimer; Result Unstructured Data: Test Result:2924 ng/ml; Test Date: 20210907; Test Name: D-Dimer; Result Unstructured Data: Test Result:1355 ng/ml; Test Date: 20210910; Test Name: D-Dimer; Result Unstructured Data: Test Result:868 ng/ml; Test Date: 20210827; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210828; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210829; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210907; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210910; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210912; Test Name: GFR; Result Unstructured Data: Test Result:82, 47, 50, 128, 77, 56; Test Date: 20210827; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.18 x10 9/l; Test Date: 20210829; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.62 x10 9/l; Test Date: 20210907; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.54 x10 9/l; Test Date: 20210910; Test Name: immature granulocytes; Result Unstructured Data: Test Result:1.41 x10 9/l; Test Date: 20210912; Test Name: immature granulocytes; Result Unstructured Data: Test Result:1.30 x10 9/l; Test Date: 20210829; Test Name: haematocrit; Test Result: 33.8 %; Test Date: 20210907; Test Name: haematocrit; Test Result: 33.1 %; Test Date: 20210910; Test Name: haematocrit; Test Result: 31.2 %; Test Date: 20210912; Test Name: haematocrit; Test Result: 32.3 %; Test Date: 20210827; Test Name: haemoglobin; Result Unstructured Data: Test Result:12.5 g/dl; Test Date: 20210829; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.9 g/dl; Test Date: 20210907; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.9 g/dl; Test Date: 20210910; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.1 g/dl; Test Date: 20210912; Test Name: haemoglobin; Result Unstructured Data: Test Result:9.3 g/dl; Test Date: 20210827; Test Name: MSU for C/S; Result Unstructured Data: Test Result:Serratia ficaria cultivated; Test Date: 20210827; Test Name: lymphocytes; Result Unstructured Data: Test Result:1.0 x10 9/l; Test Date: 20210829; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.33 x10 9/l; Test Date: 20210907; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.52 x10 9/l; Test Date: 20210910; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.88 x10 9/l; Test Date: 20210912; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.32 x10 9/l; Test Date: 20210910; Test Name: mean platelet volume; Result Unstructured Data: Test Result:13.9 fl; Test Date: 20210912; Test Name: mean platelet volume; Result Unstructured Data: Test Result:13.8; Test Date: 20210907; Test Name: monocytes; Result Unstructured Data: Test Result:4.04 x10 9/l; Test Date: 20210910; Test Name: monocytes; Result Unstructured Data: Test Result:8.85 x10 9/l; Test Date: 20210912; Test Name: monocytes; Result Unstructured Data: Test Result:4.69 x10 9/l; Test Date: 20210827; Test Name: neutrophils; Result Unstructured Data: Test Result:10.77 x10 9/l; Test Date: 20210829; Test Name: neutrophils; Result Unstructured Data: Test Result:27.45 x10 9/l; Test Date: 20210907; Test Name: neutrophils; Result Unstructured Data: Test Result:23.98 x10 9/l; Test Date: 20210910; Test Name: neutrophils; Result Unstructured Data: Test Result:31.33 x10 9/l; Test Date: 20210912; Test Name: neutrophils; Result Unstructured Data: Test Result:13.13 x10 9/l; Test Date: 20210827; Test Name: Nitrites; Result Unstructured Data: Test Result:positive; Comments: pH 9.0; Test Date: 20210827; Test Name: platelets; Result Unstructured Data: Test Result:137 x10 9/l; Test Date: 20210829; Test Name: platelets; Result Unstructured Data: Test Result:84 x10 9/l; Test Date: 20210907; Test Name: platelets; Result Unstructured Data: Test Result:144 x10 9/l; Test Date: 20210910; Test Name: platelets; Result Unstructured Data: Test Result:84 x10 9/l; Test Date: 20210912; Test Name: platelets; Result Unstructured Data: Test Result:61 x10 9/l; Test Date: 20210907; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.068 ng/ml; Test Date: 20210829; Test Name: red cell count; Result Unstructured Data: Test Result:3.66 x10 12/l; Test Date: 20210907; Test Name: red cell count; Result Unstructured Data: Test Result:3.63 x10 12/l; Test Date: 20210910; Test Name: red cell count; Result Unstructured Data: Test Result:3.39 x10 12/l; Test Date: 20210912; Test Name: red cell count; Result Unstructured Data: Test Result:3.09 x10 12/l; Test Date: 20210827; Test Name: red cell distribution width; Test Result: 15.8 %; Test Date: 20210829; Test Name: red cell distribution width; Test Result: 15.7 %; Test Date: 20210907; Test Name: red cell distribution width; Test Result: 15.4 %; Test Date: 20210910; Test Name: red cell distribution width; Test Result: 15.8 %; Test Date: 20210912; Test Name: red cell distribution width; Test Result: 15.9 %; Test Date: 20210912; Test Name: Covid IgG; Result Unstructured Data: Test Result:more than 1000, positive; Test Date: 20210706; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210708; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210710; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210713; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210726; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210804; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210825; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:negative; Test Date: 20210827; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:positive; Comments: new infection, CT 32; Test Date: 20210907; Test Name: SARS Cov2 RT PCR; Result Unstructured Data: Test Result:positive; Comments: CT 18; Test Date: 20210827; Test Name: WBC; Result Unstructured Data: Test Result:12.84 x10 9/l; Test Date: 20210829; Test Name: WBC; Result Unstructured Data: Test Result:28.93 x10 9/l; Test Date: 20210907; Test Name: WBC; Result Unstructured Data: Test Result:29.15 x10 9/l; Test Date: 20210910; Test Name: WBC; Result Unstructured Data: Test Result:42.55 x10 9/l; Test Date: 20210912; Test Name: WBC; Result Unstructured Data: Test Result:19.49 x10 9/l; Test Date: 20210706; Test Name: hip right X-Ray; Result Unstructured Data: Test Result:displaced right subcapital fracture; Test Date: 20210706; Test Name: lumbar spine and SI joints X-Ray; Result Unstructured Data: Test Result:grade 1 anterolisthesis of L4 on L5. Multilevel de; Comments: Multilevel degenerative changes throughout lumbar spine. SI joints intact
CDC Split Type: MTPFIZER INC202101259173

Write-up: hip fracture; hypoxemia (SpO2 70% on RA); respiratory failure (Decreased SpO2); heart failure (Known case of CHF but no signs of decompensation); thrombocytopenia (84000 dropped to 61000); Tachypnea (RR more than 30); dyspnea/shortness of breath; Asthma worsened; covid-19 infection; Pneumonia due to Covid-19 Infection (Bilateral basal/ left mid-zone); This is a spontaneous report from a contactable physician. A 87-years-old female patient received BNT162B2 (COMIRNATY Formulation: solution for injection Lot Number: EJ6788) via intramuscular, administered in Arm Left on 05Feb2021 as dose 2, single for COVID-19 immunisation and received first dose BNT162B2 (COMIRNATY Formulation: solution for injection Lot Number: EJ6796) via intramuscular on 15Jan2021 as single for COVID-19 immunisation. Relevant Medical history included cardiac failure congestive, asthma, breast cancer from, atrial fibrillation under Dabigatran, hyperthyroidism from an unknown date and unknown if ongoing, femur fracture from Jul2021 to an unknown date, non-tobacco user, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medications included bumetanide (BUMETANIDE); diltiazem (DILTIAZEM); carbimazole (CARBIMAZOLE); dabigatran (DABIGATRAN); tamoxifen (TAMOXIFEN); bromhexine (BROMHEXINE); lactulose (LACTULOSE); beclometasone (BECLOMETHASONE); salbutamol (SALBUTAMOL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date the patient experienced covid-19 infection, pneumonia due to covid-19 infection, She had been admitted to the acute general hospital on the 06Jul2021 due to a hip fracture until the 26Aug2021 During the period of hospitalization she had a total of eight COVID swabs - all negative. On the 26Aug2021 she was transferred to a long term care facility. On Covid diagnosis she was transferred to a COVID ward in the facility. The patient was not admitted to an Intensive Care Unit, dyspnea/shortness of breath, tachypnea, hypoxemia, respiratory failure, heart failure, thrombocytopenia (84000 dropped to 61000), asthma worsened. The patient display clinical signs at rest indicative of severe systemic illness: Fever of 39 on 27Aug2021, Decreased SPO2 on RA, RR more than 30 per minute. The patient required supplemental oxygen: Oxygen 15L/min via NRM. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Patient died at the long term care facility due to COVID IgG more than 1000 on 12Sep2021. Primary cause of death was Pneumonia due to Covid-19 Infection. Other contributory causes was CHF, AF on NOACs, Ca Breast, Asthma, GORD, Pathological Fracture Right Neck of Femur July 2021. On 06Jul2021 the patient underwent lab test and procedures included SARS Cov2 RT PCR: negative, Hip right X-Ray: displaced right subcapital fracture, Lumbar spine and SI Joints X-Ray: Grade 1 anterolisthesis of L4 on L5. Multilevel degenerative changes throughout lumbar spine. SI joints intact. Chest X-Ray: possible airspace opacification in left lower zone. On 08Jul2021 she had SARS Cov2 RT PCR: negative. On 10Jul2021 she had SARS Cov2 RT PCR: negative. On 13Jul2021 she had SARS Cov2 RT PCR: negative, Chest X-Ray: increased opacification at left lung base with partial obscuration of left heart border. No pneumothorax or pleural effusions. On 26Jul2021 She had SARS Cov2 RT PCR: negative. On 04Aug2021 she had SARS Cov2 RT PCR: negative, Chest X-Ray: lung congestion, heart enlarged, no pleural effusion. On 25Aug2021 she had SARS Cov2 RT PCR: negative. On 27Aug2021 She had SARS Cov2 RT PCR: positive CT32, blood creatinine: 63 [45-84 umol/l], body temperature: 39 (no units provided), c-reactive protein: 11 [0-5 mg/L], WBC 12.84 [4.30 - 11.40 x10^9/L], neutrophils 10.77 [1.90 - 7.70 x 10^9/l], immature granulocytes 0.18 [0 -0.09x10^9/L], lymphocytes 1 [1.30 -3.60 x 10^9], red cell distribution width 15.8 [11.9-14.6 %], urea serum 9.9 [1.7-8.3 mmol/l], chloride 90.4 [98-107 mmol/l], MSU for C/S: Serratia ficaria cultivated. On 28Aug2021 She had her blood creatinine: 102 [45-84 umol/l], c-reactive protein: 209 [0-5 mg/l], D-Dimer 2924 [0-500 ng/ml], serum urea 15.4 [1.7-8.3 mmol/l], chloride 87.2 [98-107 mmol/l], bilirubin 26.6 [0-21 micromol/l]. On29Aug2021 she had her blood creatinine: 97 [45-84 umol/l], chest x-ray: abnormal, c-reactive protein: 251 [0-5 mg/l], Chest X-Ray: Airspace shadowing seen in the projection of the left lower lung zone and retrocardiac area with obscuration of the left hemidiaphragm in keeping with a consolidation, WBC 28.93 [4.30 - 11.40 x10^9/L], neutrophils 27.45 [1.90 - 7.70 x 10^9/l], immature granulocytes 0.62 [0 -0.09x10^9/L], lymphocytes 0.33 [1.30 -3.60 x 10^9], red cell distribution width 15.7 [11.9-14.6 %], red cell count: 3.66 [3.90-5.40x10^12/L], haemoglobin 10.9 [12-15.5 g/dl], haematocrit 33.8 [35.6-46%], platelets 84 [132-349x10^9/L], serum urea 19.4 [1.7-8.3 mmol/l], chloride 87.9 [98-107 mmol/l]. On 07Sep2021 she had SARS Cov2 RT PCR: positive CT18, blood creatinine: 43 [45-84 umol/l], c-reactive protein: 2 [0-5 mg/l], D-Dimer 1355 [0-500 ng/ml], WBC 29.15 [4.30 - 11.40 x10^9/L], neutrophils 23.98 [1.90 - 7.70 x 10^9/l], immature granulocytes 0.54 [0 -0.09x10^9/L], lymphocytes 0.52 [1.30 -3.60 x 10^9], monocytes 4.04 [0.40 - 1.10x10^9/L], red cell distribution width 15.4 [11.9-14.6 %], red cell count: 3.63 [3.90-5.40x10^12/L], haemoglobin 10.9 [12-15.5 g/dl], haematocrit 33.1 [35.6-46%], platelets 144 [132-349x10^9/L], serum urea 12.7 [1.7-8.3 mmol/l], chloride 84.6 [98-107 mmol/l], procalcitonin 0.068 [0.02-0.046 ng/ml]. On 08Sep2021 she had Chest X-Ray: airspace shadowing in the left retrocardiac area with an associated small left pleural effusion, round opacities noted in the right upper and middle lung zone as well as the left upper lung zone. On 10Sep2021 she had her blood creatinine: 67 [45-84 umol/l], c-reactive protein: 242 [0-5 mg/l], WBC 42.55 [4.30 - 11.40 x10^9/L], neutrophils 31.33 [1.90 - 7.70 x 10^9/l], immature granulocytes 1.41 [0 -0.09x10^9/L], lymphocytes 0.88 [1.30 -3.60 x 10^9], monocytes 8.85 [0.40 - 1.10x10^9/L], red cell distribution width 15.8 [11.9-14.6 %], red cell count: 3.39 [3.90-5.40x10^12/L], haemoglobin 10.1 [12-15.5 g/dl], haematocrit 31.2 [35.6-46%], platelets 84 [132-349x10^9/L], mean platelet volume: 13.9 [9.4-13.4 fl], D-Dimer 868 [0-500 ng/ml], serum urea 15.3 [1.7-8.3 mmol/l], chloride 82.5 [98-107 mmol/l], serum sodium 134 [136-145 mmol/l]. On 11Sep2021 she had chest x-ray: left retrocardiac opacification as well as increased patchy ill defined opacification in the right lower lung zone. On 12Sep2021 she had her blood creatinine: 88 [45-84 umol/l], c-reactive protein: 120 [0-5 mg/l], WBC 19.49 [4.30 - 11.40 x10^9/L], neutrophils 13.13 [1.90 - 7.70 x 10^9/l], immature granulocytes 1.30 [0 -0.09x10^9/L], lymphocytes 0.32 [1.30 -3.60 x 10^9], monocytes 4.69 [0.40 - 1.10x10^9/L], red cell distribution width 15.9 [11.9-14.6 %], red cell count: 3.09 [3.90-5.40x10^12/L], haemoglobin 9.3 [12-15.5 g/dl], haematocrit 32.3 [35.6-46%], platelets 61 [132-349x10^9/L], mean platelet volume: 13.8 [9.4-13.4 fl], serum urea 15.1 [1.7-8.3 mmol/l], chloride 94.3 [98-107 mmol/l].The outcome of event Pneumonia due to Covid-19 Infection (Bilateral basal/ left mid-zone) was fatal. The outcome of events was unknown. Therapeutic interventions included treatment with Dexamethasone 6mg iv dly from 28Aug2021 to 07Sep2021.; Sender''s Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 pneumonia, Hip facture, hypoxia, respiratory failure, cardiac failure, thrombocytopenia 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: Pneumonia due to Covid-19 Infection; Pneumonia due to Covid-19 Infection


VAERS ID: 1747361 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-30
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8871 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101213153

Write-up: Dyspnea; Cough; Sore throat; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300104572. A 30-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 20Aug2021 (Lot Number: FF8871) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dyspnea on 04Sep2021, cough and sore throat on 30Aug2021 08:00 with fatal outcome. The patient died on an unspecified date. The cause of death was reported as dyspnea, cough and sore throat. 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: Dyspnea; Cough; Sore throat


VAERS ID: 1747377 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-14
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID test; Test Result: Negative ; Test Date: 20210914; Test Name: COVID test; Test Result: Positive
CDC Split Type: PHPFIZER INC202101220095

Write-up: myocardial infarction; Covid test positive; Covid test positive; This is a spontaneous report from a contactable physician. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 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 epilepsy, asthma. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction (death) on an unspecified date, covid test positive (medically significant) on 14Sep2021 with outcome of unknown. It was reported that the patient received the full dose of Pfizer covid-19 vaccine. The patient''s covid-19 test result was negative last 07Sep2021. Unfortunately, on 14Sep2021, the patient died because of myocardial infarction as a final diagnosis. Covid test was also performed and it turned out the patient was Covid -19 positive. The patient died on 14Sep2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. 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 Myocardial infarction, COVID-19, Drug ineffective 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: myocardial infarction


VAERS ID: 1747462 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   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: ETURION; AMLODIPINE; METFORMIN; LOSART
Current Illness: Coronary artery disease; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SGPFIZER INC202101226341

Write-up: passed away in the hospital, believed arrhythmia was the cause of death; collapsed 8 hours after she received her first dose of vaccination on 25thJul 2021; This is a spontaneous report from a contactable consumer (patient''s daughter) and an other HCP. A 64-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at single dose, administered in Arm Left on 25Jul2021 10:15 (Batch/Lot Number: Not available/provided to reporter at the time of report completion) for covid-19 immunisation (64-years-old at the time of vaccination). Medical history included ongoing hypertension from an unknown date, coronary artery disease (CAD) from an unknown date. Concomitant medications included atorvastatin calcium (ETURION) 40mg; amlodipine (AMLODIPINE) 10mg; metformin (METFORMIN) 550mg; losartan potassium (LOSART). No other vaccine in four weeks. No COVID prior vaccination. No COVID post vaccination. Known allergies were none. The patient was not pregnant. The patient collapsed 8 hours after she received her first dose of vaccination on 25Jul2021. The patient later passed away in the hospital that very evening as the doctor failed to resuscitate her on 25Jul2021 at 18:30. No treatment for AE. The patient died on 25Jul2021. Autopsy was done and result was hypertension and CAD. The patient''s daughter commented that autopsy result was not shared but was told as hypertension and CAD. The patient''s daughter informed that most of the elderly, hypertension was common and she believed arrhythmia was the cause of death. The outcome of event collapsed was not resolved. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Reported Cause(s) of Death: arrhythmia; Autopsy-determined Cause(s) of Death: Hypertension and CAD; Hypertension and CAD


VAERS ID: 1749121 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-23
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-30
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: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VOLTAREN RETARD; BISOPROLOL; GLUCOPHAGE; ACTRAPID [INSULIN HUMAN]; LOORTAN PLUS; AMLOR; HUMALOG; INSULATARD [INSULIN HUMAN INJECTION, ISOPHANE]; LEDERTREXATE [METHOTREXATE]; LANTUS; FOLIC ACID; FUROSEMIDE EG; OMEPRAZOL [OMEPRAZOLE]; SIMVAST
Current Illness: Adenoma (small adenoma surrenal left(CT abdo 25/02/2020)); Arterial hypertension; Carcinoma basal cell (follow up in dermato (13/04/21)); Carotid artery stenosis (asymptomatic); COVID-19 (Infection SARS-cov2); Folic acid deficiency; Hallux valgus; Heart disease, unspecified; Hypercholesterolemia (treated with simvastatine); Ophthalmic zoster (zona ophthalmic right eye); Plantar fasciitis; Renal insufficiency; Rheumatoid arthritis; Tuberculosis (under investigation)
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus (Insulin dependent)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20213

Write-up: 23/04/2021; This case was received via Regulatory Authority (Reference number: BE-FAMHP-DHH-N2021-106719) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (23/04/2021) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Family history included Heart disease, unspecified since an unknown date, Hypercholesterolemia (treated with simvastatine) since an unknown date, Carotid artery stenosis (asymptomatic) since an unknown date, Adenoma (small adenoma surrenal left(CT abdo 25/02/2020)) since an unknown date, Folic acid deficiency since an unknown date, Rheumatoid arthritis since an unknown date and Tuberculosis (under investigation) since an unknown date. Concurrent medical conditions included Carcinoma basal cell (follow up in dermato (13/04/21)), COVID-19 (Infection SARS-cov2) since February 2021, Ophthalmic zoster (zona ophthalmic right eye) since February 2020, Hallux valgus, Plantar fasciitis, Renal insufficiency, Arterial hypertension and Type 2 diabetes mellitus (Insulin dependent). Concomitant products included DICLOFENAC (VOLTAREN RETARD), BISOPROLOL, METFORMIN HYDROCHLORIDE (GLUCOPHAGE), INSULIN HUMAN (ACTRAPID [INSULIN HUMAN]), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOORTAN PLUS), AMLODIPINE BESILATE (AMLOR), INSULIN LISPRO (HUMALOG), INSULIN HUMAN INJECTION, ISOPHANE (INSULATARD [INSULIN HUMAN INJECTION, ISOPHANE]), METHOTREXATE (LEDERTREXATE [METHOTREXATE]), INSULIN GLARGINE (LANTUS), FOLIC ACID, FUROSEMIDE (FUROSEMIDE EG), OMEPRAZOL [OMEPRAZOLE], SIMVASTATIN, CEFTRIAXONE SODIUM (ROCEPHINE) and METFORMIN HYDROCHLORIDE (GLUCOPHAGE) for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 23-Apr-2021 The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No treatment medications were reported. Patient had fasciitis plantaire and hallux valgus D (orthopedic shoes). It is reported that patient was using actrapid penfill 100 UI/ML and insulatard PENFILL 100 IU/ML. Event as reported by primary source was changed to unexplained death on 23-Apr-2021. "Follow-up received on 22-SEP-2021 included no new information This case concerns a 70-year-old, male patient with history of Basocellular carcinoma ulcerated, SARS-coV-2, Zona ophthalmic, plantar fasciitis, hallux valgus D, renal insufficiency, arterial hypertension and insulin dependent type 2 diabetes, who experienced unexplained death. The event occurred approximately 15 days after the first dose of Spikevax and had a fatal outcome. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 26 Sep 2021 contains no new information.; Sender''s Comments: This case concerns a 70-year-old, male patient with history of Basocellular carcinoma ulcerated, SARS-coV-2, Zona ophthalmic, plantar fasciitis, hallux valgus D, renal insufficiency, arterial hypertension and insulin dependent type 2 diabetes, who experienced unexplained death. The event occurred approximately 15 days after the first dose of Spikevax and had a fatal outcome. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1749176 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-08-13
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Asthenia, Body temperature, COVID-19, Chronic obstructive pulmonary disease, Cough, Diarrhoea, Dyspnoea, Pyrexia, SARS-CoV-2 test, Septic shock, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 11
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: Chronic obstructive pulmonary disease (GOLD 4D oxygen-dependent at home); Dependence on oxygen therapy; Ischemic heart disease (stented); Polymyalgia rheumatica
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210819; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 20210820; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: CHPFIZER INC202101257246

Write-up: SARS-CoV-2 infection; sars-cov-2 infection; COPD exacerbation /possible exacerbation of bacterial origin; Dyspnea in deterioration; Asthenia; Fever up to 40�; Cough without sputum; Diarrhea; Acute respiratory distress; incipient septic shock; This is a spontaneous report received from a contactable physician. Regulatory authority report number is CH-SM-2021-23154. A 73-year-old female patient received 2 injections of the COVID-19 mRNA vaccine (Comirnaty) on 15Mar2021 (batch: unknown) and 12Apr2021 (batch: unknown); both intramuscularly as single dose (1 DF in total) for COVID-19 immunization. The patient was 73-year-old at vaccination. Medical history included GOLD 4D chronic obstructive pulmonary disease (COPD), oxygen-dependent at home, stented ischemic heart disease, polymyalgia rheumatica; all were ongoing. Concomitant medications were not reported. The patient experienced acute respiratory distress (death, hospitalization, medically significant) on 24Aug2021 with outcome of fatal, incipient septic shock (death, hospitalization, medically significant) on 24Aug2021 with outcome of fatal, sars-cov-2 infection (death, hospitalization, medically significant) on 20Aug2021 with outcome of fatal, COPD exacerbation/possible exacerbation of bacterial origin (hospitalization, medically significant) on 20Aug2021 with outcome of not recovered, dyspnea in deterioration (hospitalization, medically significant) on 13Aug2021 with outcome of not recovered, asthenia (hospitalization, medically significant) on 13Aug2021 with outcome of not recovered, fever up to 40� (hospitalization, medically significant) on 13Aug2021 with outcome of not recovered, cough without sputum (hospitalization, medically significant) on 13Aug2021 with outcome of not recovered, diarrhea (hospitalization, medically significant) on 13Aug2021 with outcome of not recovered. On 20Aug2021, 130 days after the 2nd dose, she presented a positive test for SARS-CoV-2 in a context of worsening dyspnea, asthenia, fever up to 40�, cough without sputum and diarrhea evolving since 13Aug2021. A self-test at home would have returned positive on 19Aug2021. She was hospitalized since 20Aug2021 in the context of a COPD exacerbation and treated with dexamethasone 6mg 1x/d. Due to clinical deterioration with acute respiratory distress, she was transferred to intermediate care on 24Aug2021. Despite treatment with non-invasive ventilation (NIV), continuous ipratropium/salbutamol (Ipramol) and salbutamol (Ventolin) aerosols, intravenous magnesium sulphate, methylprednisolone (SoluMedrol), and levofloxacin (Tavanic) for a possible bacterial exacerbation with incipient septic shock, as well as therapeutic anticoagulation. The evolution was unfavorable and the patient died on 24Aug2021 at 12:47. It was unknown if an autopsy was performed. A causal relationship between Comirnaty and all events was assessed. They assessed this case as serious with serious criteria Results in death, Caused/prolonged hospitalization and Other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Acute respiratory distress syndrome; SARS-CoV-2 infection; Septic shock; SARS-CoV-2 infection


VAERS ID: 1749190 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Glycosylated haemoglobin
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bypass surgery; Coronary artery disease; Hypercholesterolaemia; Hyperlipidaemia; Hypertension; Myocardial infarction; Obesity; Peripheral arterial occlusive disease; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: HbA1C; Test Result: 7.2 %
CDC Split Type: DEPFIZER INC202101262333

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the WEB DE-DCGMA-21190578. This report was received and concerns a patient (Male), age: 71 Year (born: PRIVACY). A 71-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 18May2021 (Batch/Lot Number: Unknown) at the age of 71-years-old as Dose number unknown, 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concurrent conditions included: Hypertension, Hypercholesterolaemia, Atrial fibrillation, Type II diabetes mellitus, Myocardial infarction, Hyperlipidaemia, Coronary artery disease, Peripheral arterial occlusive disease, Obesity, Bypass surgery (not ongoing). Concomitant medications included atorvastatin taken for hypercholesterolaemia; torasemide taken for hypertension; hydrochlorothiazide, ramipril (RAMIPLUS AL) taken for hypertension; insulin human (HUMINSULIN NORMAL) taken for type 2 diabetes mellitus; lercanidipine taken for hypertension; bisoprolol fumarate (BISOLICH) taken for hypertension; apixaban (ELIQUIS) taken for atrial fibrillation; insulin detemir (LEVEMIR) taken for type 2 diabetes mellitus; metformin taken for type 2 diabetes mellitus. Historical vaccine included first dose of Comirnaty (lot/batch number: unknown) on 17Apr2021 for COVID-19 immunisation. On 24May2021 the patient experienced Death. The patient''s outcome was: fatal for Death. The cause of death was unknown. An autopsy was performed, and results were not provided. HbA1C was 7.2% on an unspecified date. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1749207 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-06
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-30
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: 2021-09-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Unknown cause of death; This case was received via Regulatory Authority (Reference number: DE-PEI-202100190443) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Unknown cause of death) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 06-Sep-2021 The patient died on 06-Sep-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. Treatment information not provided. Company Comment : This case concerns a 53 Male-year-old patient, with unknown medical history, who experienced the unexpected event of Death (fatal outcome). The event occurred approximately 11 days after the vaccination with Moderna (1st. dose) . The cause of death is unknown and the autopsy results were not provided. The rechallenge was not applicable (1st. dose). The benefit-risk relationship of Moderna is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation document received on 27-Sep-2021 with information as autopsy results pending.; Sender''s Comments: This case concerns a 53 Male-year-old patient, with unknown medical history, who experienced the unexpected event of Death (fatal outcome). The event occurred approximately 11 days after the vaccination with Moderna (1st. dose) . The cause of death is unknown and the autopsy results were not provided. The rechallenge was not applicable (1st. dose). The benefit-risk relationship of Moderna is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1749214 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCUE1 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-14
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Arteriosclerosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101256271

Write-up: Sudden cardiac death; Extra dose administered; off label use; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB [regulatory authority DE-PEI-202100194203]. A 78-years-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on 09Sep2021 at age of 78-years-old (Batch/Lot Number: SCUE1) as single dose for covid-19 immunisation. Medical history included arteriosclerosis and arterial hypertension. The concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY) first and second dose for covid-19 immunisation. The patient experienced sudden cardiac death on 14Sep2021. The patient died on 14Sep2021. The outcome of sudden cardiac death was fatal, of other events was unknown. It was not reported if an autopsy was performed. This report is serious - death. Event assessment: Comirnaty/ event /RA/Result of Assessment : D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1749217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-17
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101262327

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable consumer or other non HCP downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100194305. A 59-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05May2021 (Batch/Lot Number: EX3599) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced acute myocardial infarction (death, hospitalization, life threatening) on 17May2021. The patient died on an unspecified date. An autopsy was not performed. Sender comment: The patient was in the PRIVACY Clinic and the PRIVACY Clinic; Autopsy after death was rejected by the relatives. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1749218 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-08-03
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant; Polycystic kidney; Polycystic liver disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101256506

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB number DE-PEI-202100194311. A 65-year-old female patient received BNT162B2 (COMIRNATY), the second dose on 18May2021 (lot number: 1C006A) and the first dose on 08Apr2021 (lot number: EW8904), both via an unspecified route of administration at age of 65 years old as single dose for COVID-19 immunisation. Medical history included kidney transplant in 2012, polycystic kidney disease, polycystic liver. Concomitant medications were unknown. On 03Aug2021, the patient experienced vaccination failure, COVID-19. The patient died on 07Aug2021. It was unknown if autopsy was performed. Outcome of the events was fatal. This report is serious - death. Sender Comment: Initials: PRIVACY. Infection with COVID-19 Delta variant resulting in death despite double vaccination. Affected person died of cardiovascular failure on 07Aug2021. Affected person had kidney transplant in 2012, polycystic kidney disease and liver. Event assessment: Comirnaty/ all events /RA/Result of Assessment: B. Indeterminate; Vaccination failure, COVID-19: Date of end of reaction/event: 07Aug2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19; cardiovascular failure


VAERS ID: 1749253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Lung disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101274122

Write-up: Covid19 infection 3-4 month after two Comirnaty doses in April; Covid19 infection 3-4 month after two Comirnaty doses in April; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 89051], license party for Comirnaty. A 72-years-old female patient received first and second dose of bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration in Apr2021 as single dose for covid-19 immunisation. Medical history included lung disease from an unknown date. Concomitant medications were not reported. The patient had Covid-19 infection 3-4 month afterwards. Patient died on an unknown date. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1749285 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-07-30
   Days after vaccination:100
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Alanine aminotransferase, Aspartate aminotransferase, Auscultation, Basophil count, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, COVID-19 pneumonia, Chest X-ray, Eosinophil count, Fibrin D dimer, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, Interleukin level, International normalised ratio, Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Monocyte count, Neutrophil count, Oxygen saturation, Platelet count, Prothrombin level, Prothrombin time, Prothrombin time ratio, Pyrexia, Red blood cell count, Red cell distribution width, SARS-CoV-2 test, Serum ferritin, Vaccination failure, Vaccine associated enhanced disease, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Dyslipidaemia; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Activated Partial Thromboplastin Time; Result Unstructured Data: Test Result:31 sec; Test Date: 20210804; Test Name: APTT ratio; Result Unstructured Data: Test Result:1.00; Test Date: 20210804; Test Name: GPT; Result Unstructured Data: Test Result:21 IU/l; Test Date: 20210804; Test Name: GOT; Result Unstructured Data: Test Result:55 IU/l; Test Name: auscultation; Result Unstructured Data: Test Result:with basal crackles; Test Date: 20210804; Test Name: Absolute basophils; Result Unstructured Data: Test Result:0.02 x10 9/l; Test Date: 20210804; Test Name: Basophils; Test Result: 0.30 %; Test Date: 20210804; Test Name: Creatine kinase; Result Unstructured Data: Test Result:56 IU/l; Test Date: 20210804; Test Name: Creatinine; Test Result: 1.00 mg/dl; Test Date: 20210804; Test Name: Derived fibrinogen; Test Result: 919 mg/dl; Test Date: 20210804; Test Name: Glucose; Test Result: 155 mg/dl; Test Date: 20210804; Test Name: LDH; Result Unstructured Data: Test Result:463 IU/l; Test Date: 20210804; Test Name: Potassium; Result Unstructured Data: Test Result:4.70 mmol/L; Test Name: blood pressure; Result Unstructured Data: Test Result:135/85; Test Date: 20210804; Test Name: Sodium; Result Unstructured Data: Test Result:142 mmol/L; Test Date: 20210804; Test Name: Urea; Test Result: 64 mg/dl; Test Name: body temperature; Result Unstructured Data: Test Result:fever; Test Date: 20210731; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Free costophrenic sinuses, increased density with; Comments: Free costophrenic sinuses, increased density with air bronchogram in lingula.; Test Date: 20210804; Test Name: Absolute eosinophils; Result Unstructured Data: Test Result:0.10 x10 9/l; Test Date: 20210804; Test Name: Eosinophils; Test Result: 1.30 %; Test Date: 20210804; Test Name: D-dimer; Result Unstructured Data: Test Result:1413 ng/ml; Test Date: 20210804; Test Name: GGT; Result Unstructured Data: Test Result:76 IU/l; Test Date: 20210804; Test Name: ESTIMATED GFR; Result Unstructured Data: Test Result:53 mL/min/1.73 m2; Test Date: 20210804; Test Name: Hematocrit; Test Result: 40.40 %; Test Date: 20210804; Test Name: Hemoglobin; Result Unstructured Data: Test Result:12.50 g/dl; Test Date: 20210804; Test Name: Interleukin; Result Unstructured Data: Test Result:472.0 pg/mL; Test Date: 20210804; Test Name: INR; Result Unstructured Data: Test Result:1.12; Test Date: 20210804; Test Name: Absolute lymphocytes; Result Unstructured Data: Test Result:0.50 x10 9/l; Test Date: 20210804; Test Name: Lymphocytes; Test Result: 6.50 %; Test Date: 20210804; Test Name: Mean erythrocyte corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:30.90 g/dl; Test Date: 20210804; Test Name: Red cell mean corpuscular hemoglobin; Test Result: 27.90 pg; Test Date: 20210804; Test Name: Mean corpuscular volume; Result Unstructured Data: Test Result:90.20 fL; Test Date: 20210804; Test Name: Absolute monocytes; Result Unstructured Data: Test Result:0.22 x10 9/l; Test Date: 20210804; Test Name: Monocytes; Result Unstructured Data: Test Result:2.80; Test Date: 20210804; Test Name: Absolute Neutrophils; Result Unstructured Data: Test Result:6.89 x10 9/l; Test Date: 20210804; Test Name: Neutrophil; Test Result: 89.10 %; Test Name: saturation o2; Result Unstructured Data: Test Result:86-90 %; Comments: Mass Air Flow; Test Name: saturation o2; Test Result: 90 %; Comments: with reservoir mask; Test Date: 20210804; Test Name: Platelets; Result Unstructured Data: Test Result:334 x10 9/l; Test Date: 20210804; Test Name: Prothrombin activity; Test Result: 82.0 %; Test Date: 20210804; Test Name: Prothrombin Time; Result Unstructured Data: Test Result:13 sec; Test Date: 20210804; Test Name: COAGULATION Prothrombin time ratio; Result Unstructured Data: Test Result:1.1; Test Date: 20210804; Test Name: Hematies; Result Unstructured Data: Test Result:4.48 x10 12/l; Test Date: 20210804; Test Name: Red cell distribution width; Test Result: 15.30 %; Test Name: covid-19 test; Test Result: Positive ; Test Date: 20210804; Test Name: Ferritin; Result Unstructured Data: Test Result:496.0 ng/ml; Test Date: 20210804; Test Name: Leukocytes; Result Unstructured Data: Test Result:7.73 x10 9/l
CDC Split Type: ESPFIZER INC202101262658

Write-up: Vaccine associated enhanced disease; Vaccination failure; COVID-19 pneumonia; Fever; This is a spontaneous report from a contactable pharmacist downloaded from the WEB, regulatory authority number ES-AEMPS-976565. A 81-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW2239), via an unspecified route of administration, administered in arm on 31Mar2021 as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: EW6326), via an unspecified route of administration, administered in arm on 21Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypertension arterial, type 2 diabetes mellitus, dyslipidaemia, depression; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. Narrative stated that the patient with the aforementioned antecedents came for about a week with low-grade fever, marked asthenia and a dry cough, the COVID-19 antigen test was carried out on an unspecified date (reported as today), being positive. No dyspnea, no chest pain, no other symptoms accompanying admission. On follow-up, the patient complained of severe asthenia and dyspnea just talking. She denied pain. Fever persisted. Pulmonary auscalation (PA) with basal crackles. MMIIs without edema. Blood pressure (BP) 135/85. Oxygen saturation (SAT O2) with Mass Air Flow 86-90%. Very bad clinical situation. Sat O2 90 with reservoir mask. The patient underwent lab tests and procedures which included auscultation: with basal crackles, blood pressure measurement: 135/85, body temperature: fever, oxygen saturation: Mass Air Flow 86-90 % and 90 with reservoir mask, sars-cov-2 test: positive on an unspecified date. On 04Aug2021, blood test revealed Hematies: 4.48 x10^12/L (4.20 - 5.00), Hemoglobin: 12.50 g/dL (12.00 - 15.50), Hematocrit: 40.40 % (36.00 - 44.30), Mean corpuscular volume: 90.20 fL (81 - 99), Red cell mean corpuscular hemoglobin: 27.90 pg (26.00 - 33.00), Mean erythrocyte corpuscular hemoglobin concentration: 30.90 g/dL (31.00 - 36.00), Red cell distribution width: 15.30 % (11.00 - 15.50), Leukocytes: 7.73 x10^9/L (4.00 - 11.00), Neutrophils: 89.10 % (50 - 80), Absolute Neutrophils: 6.89 x10^9/L (1.50 - 7.50), Lymphocytes: 6.50 % (15 - 50), Absolute lymphocytes: 0.50 x10^9/L (1.00 - 4.00), Monocytes: 2.80 % (3 - 10), Absolute monocytes: 0.22 x10^9/L (0.15 - 0.90), Eosinophils: 1.30 % (0 - 4), Absolute eosinophils: 0.10 x10^9/L (0.05 - 0.50), Basophils: 0.30 % (0 - 1), Absolute basophils: 0.02 x10^9/L (0.01 - 0.20), Platelets: 334 x10^9/L (130 - 450), Coagulation Prothrombin time ratio: 1.1 (0.8 - 1.2), Prothrombin activity: 82.0 % (75 - 130), Prothrombin Time: 13 sec (9 - 15), INR: 1.12 (0.80 - 1.20), Activated Partial Thromboplastin Time (aPTT): 31 sec (24 - 40), APTT ratio: 1.00 (0.8 - 1.3), Derived fibrinogen: 919 mg/dL (150 - 600), D-dimer: 1413 ng/mL (0 - 500); Clinical chemistry included Glucose: 155 mg/dL (82 - 115), Urea: 64 mg/dL (16 - 48.5), Creatinine: 1.00 mg/dL (0.5 - 0.9), ESTIMATED GFR: (CKD-EPI) 53 mL/min/1.73 m2, Sodium: 142 mmol/L (136 - 146), Potassium: 4.70 mmol/L (3.5 - 5.3), LDH: 463 UI/L (135 - 250), Creatine kinase (CK): 56 IU/L, GOT: 55 UI/L (0 - 32), GPT: 21 UI/L (0 - 33), GGT: 76 UI/L (0 - 40), Ferritin: 496.0 ng/mL, Interleukin 6: 472.0 pg/mL (0 - 7). On 31Jul2021, chest x-ray: Free costophrenic sinuses, increased density with air bronchogram in lingula. The patient died on 05Aug2021. It was not reported if an autopsy was performed. The outcome of the events was fatal and fever was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia


Result pages: prev   91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=190&PERPAGE=100&VAX=COVID19&VAXTYPES=COVID-19&DIED=Yes


Copyright © 2022 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166