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

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

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Case Details

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VAERS ID: 1716425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101208870

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. Regulatory authority report number is 621253. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident on an unspecified date. The patient died on an unspecified date due to cerebrovascular accident. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1716474 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
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: SPIRIVA; PRESTARIUM NEO; EUTHYROX; ERDOMED; HELICID [OMEPRAZOLE]
Current Illness: Arterial hypertension; Atrial fibrillation; Chronic obstructive lung disease; Hyperlipidaemia; Hypothyreosis (eufunction goiter); Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101223356

Write-up: Collapses; Vertigo; Inappetence; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB. The regulatory authority report number for the first report is CZ-CZSUKL-21010340. A 85-year-old female patient received bnt162b2 (COMIRNATY) dose 1 intramuscular in 2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation; apixaban (trade name unknown) via an unspecified route of administration from an unspecified date to Mar2021 at unspecified dose for atrial fibrillation, drug intolerance. Medical history included ongoing arterial hypertension, ongoing non-smoker, ongoing hyperlipidaemia, ongoing chronic obstructive lung disease, ongoing hypothyreosis eufunction goiter, ongoing atrial fibrillation, she did not drink alcohol. Concomitant medications included tiotropium bromide monohydrate (SPIRIVA); perindopril arginine (PRESTARIUM NEO); levothyroxine sodium (EUTHYROX); erdosteine (ERDOMED); omeprazole (HELICID). The patient experienced collapses (hospitalization, medically significant, life threatening), vertigo (hospitalization, medically significant), inappetence (hospitalization) in 2021. The action taken in response to the events for apixaban was permanently withdrawn. The outcome of events was unknown. The patient died of arrhythmia and severe epileptic seizure with loss of consciousness on 23Aug2021. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-202101195126 same patient, different events after 1st/2nd dose of Comirnaty; Reported Cause(s) of Death: Arrhythmia; Severe epileptic seizure with loss of consciousness; Severe epileptic seizure with loss of consciousness


VAERS ID: 1716505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
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 INC202101194198

Write-up: The lethal outcome/ unknown cause of death; This is a spontaneous report downloaded from the Regulatory Authority-WEB number DE-PEI-CADR2021175847, Safety Report Unique Identifier DE-PEI-202100184325. An 84-year-old female patient received BNT162B2 (COMIRNATY) (Lot Number: FE8405) via unspecified route single dose for COVID-19 immunisation on 23Aug2021. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced the lethal outcome/ unknown cause of death. The patient died on 25Aug2021. It was unknown if an autopsy was performed. Relatedness of BNT162B2 to event was reported as unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1716509 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-20
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 INC202101187373

Write-up: vaccinated about 2 weeks ago and has now passed away; This is a spontaneous report from a non-contactable consumer based on information received by Pfizer from Biontech [manufacturer control number: 85663, license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration in Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was vaccinated about 2 weeks ago and has now passed away in 2021. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: vaccinated about 2 weeks ago and has now passed away


VAERS ID: 1716660 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-08-17
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, COVID-19 pneumonia, Drug ineffective, Dyspnoea, Haemoglobin, Oedema, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness: Atrial fibrillation (chronic, Pace-maker); Cancer of prostate (with transurethral resection and decapeptyl); Ischemic heart disease; Lung cancer stage IV (adenocarcinoma upper left lobe bronchial with hepatic metastases)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: hemoglobin; Result Unstructured Data: Test Result:5.7dg/ml; Test Date: 2021; Test Name: sars-cov-2 test; Test Result: Positive ; Comments: variant delta
CDC Split Type: FRPFIZER INC202101194893

Write-up: dyspnea; edema; fever; Anemia; COVID-19 pneumonitis; Drug ineffective; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20217345. A 90 year old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW2246) via an intramuscular route of administration on 14Apr2021 as dose 2, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ET3620) via an intramuscular route of administration on 18Mar2021 as dose 1, single for COVID-19 immunization. The patient''s medical history included Lung cancer stage IV (adenocarcinoma upper left lobe bronchial with hepatic metastases), ischemic heart diseases, Atrial fibrillation chronic, Pace-maker and Cancer of prostate with transurethral resection and decapeptyl. The patient''s concomitant medications were Cefotaxime sodium (CLAFORAN GALAXY ),Corticosteroids and Rivaroxaban(XARELTO) reported. On 17 Aug2021 the patient had experienced anemia, COVID-19 pneumonitis and drug ineffective and on an unspecified date the patient had experienced fever, oedema and dyspnea. The patient underwent lab tests and procedures which included sars-cov-2 test: positive and hemoglobin 5.7dg/ml. The patient was hospitalized for transfusion hemoglobin 5.7 -WHO at 4, dyspnea, edema of inferior members ,fever. The patient died on25Aug2021. An autopsy was not performed and the reported cause of death was Multiorgan failure. Outcome of all events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Multiorgan failure


VAERS ID: 1716685 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-08-21
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood culture, Blood pressure measurement, Body temperature, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Computerised tomogram, Fibrin D dimer, Glomerular filtration rate, Oxygen saturation, Platelet count, Respiratory rate, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 11
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: FUROSEMIDE; CYANOCOBALAMINE; LEXOMIL; CHOLECALCIFEROL; SILODOSINE; XARELTO; LYRICA; ALLOPURINOL; XAGRID; DELICAL BOISSON FRUITEE; HYDREA; ARANESP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asbestosis; Bladder injury; Chronic renal failure; Epilepsy; Essential thrombocythaemia; Leg ulcer; Phlebitis superficial; Post essential thrombocythemia myelofibrosis; Tabaquism
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Creatinine; Result Unstructured Data: Test Result:153 umol/l; Test Date: 20210823; Test Name: Hemoculture; Result Unstructured Data: Test Result:sterile; Test Date: 20210823; Test Name: blood pressure; Result Unstructured Data: Test Result:100/60 mmHg; Test Date: 20210823; Test Name: fever; Result Unstructured Data: Test Result:38.9 Centigrade; Test Date: 20210831; Test Name: chest X-ray; Result Unstructured Data: Test Result:flaky alveolar condensations; Test Date: 20210823; Test Name: CT scan not injected; Result Unstructured Data: Test Result:absence of parenchymal anomaly subject to an expir; Comments: SARS-CoV2 infectious pneumonia not excluded. Marked bronchopathy with mixed emphysematous dystrophy.; Test Date: 20210823; Test Name: CRP; Result Unstructured Data: Test Result:42 mg/l; Test Date: 20210823; Test Name: DDimers; Result Unstructured Data: Test Result:1875 ug/L; Test Name: GFR; Result Unstructured Data: Test Result:50-55; Comments: ml/min, basal; Test Date: 20210823; Test Name: GFR; Result Unstructured Data: Test Result:37; Comments: mL/min/m2; Test Date: 20210823; Test Name: SpO2; Test Result: 89 %; Test Date: 20210824; Test Name: SpO2; Test Result: 93 %; Comments: under 2L of O2; Test Date: 20210826; Test Name: SpO2; Test Result: 93 %; Test Date: 20210830; Test Name: SpO2; Test Result: 89 %; Test Date: 20210825; Test Name: platelets; Result Unstructured Data: Test Result:367 x10 9/l; Test Date: 20210831; Test Name: platelets; Result Unstructured Data: Test Result:54 x10 9/l; Test Date: 20210823; Test Name: respiratory rate; Result Unstructured Data: Test Result:20; Comments: cycles/min; Test Date: 20210823; Test Name: COVID rapid detection antigen test; Test Result: Positive ; Test Date: 20210824; Test Name: PCR COVID; Test Result: Positive ; Comments: presence of a 452R mutation and absence of 484K and 484Q mutations.
CDC Split Type: FRPFIZER INC202101194800

Write-up: Vaccination failure; COVID-19 pneumonitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, number FR-AFSSAPS-NY20214131 and investigation results received from a Product Quality Complaint Group. A 93-year old male patient received bnt162b2 (COMIRNATY), via intramuscular on 02Apr2021 (Batch/Lot Number: ET7205; Expiration Date: 31Jul2021) at age of 92 years old as DOSE 2, SINGLE, and via intramuscular on 07Mar2021 (Batch/Lot Number: ER2659; Expiration Date: 30Jun2021) as DOSE 1, SINGLE for vaccination against covid-19. Medical history included tabaquism, post essential thrombocythemia myelofibrosis, leg ulcer, bladder injury, the patient with medical history of non-mutated JAK 2 essential thrombocythemia, at the stage of myelofibrosis, asbestosis with pleural plaques, superficial phlebitis, epilepsy (seizures with contact rupture, complete amnesia without motor deficit in 2018), bilateral internal malleolar varicose ulcers in process of healing, chronic renal failure with basal GFR between 50-55 mL / min and cancerous lesion of the resected bladder. Cessation of smoking, daily consumption of wine. Concomitant medications included furosemide taken for chronic kidney disease from an unspecified start date to 31Aug2021; cyanocobalamine taken for vitamin supplementation from an unspecified start date to 31Aug2021; bromazepam (LEXOMIL) taken for insomnia from an unspecified start date to 31Aug2021; cholecalciferol taken for vitamin supplementation from an unspecified start date to 31Aug2021; silodosine taken for benign prostatic hyperplasia from an unspecified start date to 31Aug2021; rivaroxaban (XARELTO) taken for essential thrombocythaemia from an unspecified start date to 24Aug2021; pregabalin (LYRICA) taken for epilepsy from an unspecified start date to 31Aug2021; allopurinol taken for epilepsy, start and stop date were not reported; anagrelide hydrochloride (XAGRID) taken for epilepsy from May2021 to an unspecified stop date; nutrients nos (DELICAL BOISSON FRUITEE) taken for epilepsy, start and stop date were not reported; hydroxycarbamide (HYDREA) taken for epilepsy from an unspecified start date to May2021; darbepoetin alfa (ARANESP) taken for epilepsy, start and stop date were not reported. The patient experienced vaccination failure and covid-19 pneumonitis both on 21Aug2021. On 21Aug2021, 168 day after beginning Comirnaty, mRNA covid-19 (modified nucleoside) vaccine (mRNA encoding the peak viral protein (s) of sars-cov-2). The event was assessed as serious (Death). The patient was hospitalized for events on 23Aug2021. On 21Aug2021: occurrence of influenza-like illness associated with vomiting. On 23Aug2021: referred to the emergency room for fall due to flu and hyperthermia, with deterioration of general condition, weakness and vomiting. Concept of contage 15 days before. Covid rapid antigen test positive, delta variant. On admission, conscious and oriented patient, respiratory rate at 20 cycles / min, SpO2 at 89% in ambient air, blood pressure at 100/60 mmHg, fever at 38.9 Centigrade. Blood test: CRP at 42 mg/L, GFR at 37 mL/min/1,73 m2, creatinine 153 umol/L, D-dimers at 1875 ug/L. On non-injected CT scan, absence of parenchymal anomaly subject to an expiration X-ray, infectious pneumonitis with SARS-CoV2 not excluded. Marked bronchopathy with mixed emphysematous dystrophy. Sterile blood cultures. The patient was hospitalized. On entry, no sign of struggle, fatty cough without expectoration, bilateral vesicular murmur, expiratory sibilants. Discreet edemas limited to the ankles, with dermatitis and malleolar ulcers. No other abnormality on physical examination. Changing the anticoagulation to LOVENOX 8000 UI/j. On 23Aug2021, COVID rapid detection antigen test: positive; on 23Aug2021, Hemoculture: sterile. On 24Aug2021: PCR COVID positive with virus sequencing showing the presence of a 452R mutation and the absence of 484K and 484Q mutations. On 24Aug2021, PCR COVID: positive (comment: presence of mutation 452R and absence of 484K et 484Q.mutations); 93% SpO2 at 2 L / min oxygen (comment: under 2L of O2). On 25Aug2021: inclusion in the protocol COVITREM-1. On 25Aug2021, platelets: 367billion per litre. On 26Aug2021: introduction of dexamethasone. Eupneic under 1.5 L / min of oxygen (SpO2 at 93 %). On 30Aug2021: oxygen increased to 6 L / min with SpO2 at 89 %. Bi-basal crackles going back to mid-field with presence of diffuse sibilants, possible acute lung edema. Put under an 80% desaturation, increase of LASILIX to 60 mg/day. On 31Aug2021: respiratory degradation, change to a high concentration mask at 100 %. On chest x-ray, diffuse flaky alveolar condensations. Thrombocytopenia 54 G/L (367 G/L on 25Aug2021). Suspicion of heparin-induced thrombocytopenia. Decision to limit care. On 31Aug2021, platelets: 54billion per litre. On 01Sep2021: further respiratory degradation, leading to the death of the patient. The patient died on 01Sep2021. The patient died 11 days after the onset of symptoms due to respiratory failure. The patient died on 01Sep2021 from the following reported cause: Respiratory degradation on COVID-19. No autopsy was performed. The events outcome was fatal. The causality assessment was provided as follows: Comirnaty, concentrate for injection. mRNA covid-19 vaccine (modified nucleoside) and Pneumopathy covid-19 and Vaccination failure was not provided. 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 ET7205. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The 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. 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 ER2659. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Respiratory degradation on COVID-19; Respiratory degradation on COVID-19


VAERS ID: 1716686 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-08-08
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood gases, Blood potassium, Brain natriuretic peptide, C-reactive protein, COVID-19 pneumonia, Coma scale, Computerised tomogram thorax, Fall, Fibrin D dimer, Glomerular filtration rate, Haemoglobin, Oxygen saturation, SARS-CoV-2 test, Vaccination failure, White blood cell count, X-ray
SMQs:, Lack of efficacy/effect (narrow), Accidents and injuries (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NASONEX; SERETIDE DISKUS [FLUTICASONE PROPIONATE;SALMETEROL XINAFOATE]; SPIRIVA; XARELTO; AERIUS [DESLORATADINE]; EUTHYROX; TENORMINE; LASILIX [FUROSEMIDE]; TRIATEC [RAMIPRIL]
Current Illness: Atrial fibrillation; Cardiac failure; Cognitive disorder; COPD; Ex-tobacco user; Hypercholesteremia; Hypertension; Hypothyroidism; Knee osteoarthritis; Mixed aortic valve disease; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: Angiogram; Result Unstructured Data: Test Result:rules out pulmonary embolism.; Comments: Evidence of bilateral pleural effusion with subpleural condensations and lamellar atelectasis. Regular thickening of the interlobular septas and peribronchovascular thickening, predominantly peri-hilar. Signs of cardiac overload.; Test Date: 20210808; Test Name: blood gas; Result Unstructured Data: Test Result:pH 7.47 and lactates at 2.85 mmol/L.; Test Date: 20210808; Test Name: hyperkalemia; Result Unstructured Data: Test Result:5 mmol/L; Test Date: 20210808; Test Name: BNP; Result Unstructured Data: Test Result:286; Test Date: 20210815; Test Name: Glasgow; Result Unstructured Data: Test Result:6; Test Date: 20210809; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:Predominantly acute subedema of the lung.; Comments: Not clearly visible viral involvement occupying less than 10% of the pulmonary parenchyma (a few focal nodular frosted glass areas, an unequivocal crazy paving area). No CT angiography performed. Start of dexamethasone 6 mg / day.; Test Date: 20210808; Test Name: C-reactive protein; Result Unstructured Data: Test Result:15 mg/l; Test Date: 20210808; Test Name: D-Dimer; Result Unstructured Data: Test Result:20000 ng/ml; Test Date: 20210808; Test Name: GFR; Result Unstructured Data: Test Result:39.8 ml/min; Test Date: 20210808; Test Name: hemoglobin; Result Unstructured Data: Test Result:15.8 g/dl; Test Date: 20210815; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 20210808; Test Name: Sars-cov-2 test; Test Result: Positive ; Comments: English variant; Test Date: 20210808; Test Name: leukocytose count; Result Unstructured Data: Test Result:12 x10 9/l; Test Date: 20210808; Test Name: x-ray; Result Unstructured Data: Test Result:fractures of the right shoulder and right hip
CDC Split Type: FRPFIZER INC202101194626

Write-up: Vaccination failure; COVID pneumpathy <10%; Fall; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NY20214228. A 97-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EJ6789) via an intramuscular route of administration on 15Feb2021 as dose 2, single and received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EJ6788) via an intramuscular route of administration on 24Jan2021 as dose 1, single for COVID-19 immunization. Patient medical history included ongoing hypertension, atrial fibrillation, osteoarthritis, ex-tobacco user, chronic obstructive pulmonary disease, cognitive disorder, osteoporosis, aortic valve disease mixed (reported as mitro aortic valve disease), cardiac failure, hypothyroidism, and hypercholesterolaemia. The concomitant medications included mometasone furoate (NASONEX) taken as a dose of 2 DF, 1x/day nasal route of administration (strength 50 ug) for an unspecified indication, fluticasone propionate, salmeterol xinafoate (SERETIDE DISKUS (FLUTICASONE PROPIONATE;SALMETEROL XINA-FOATE)) taken as a dose of 2 DF, 1x/day via inhalation for chronic obstructive pulmonary disease, desloratadine (AERIUS [DESLORATADINE) taken as a dose of 1 DF, 1x/day (strength 5mg) for chronic obstructive pulmonary disease, levothyroxine sodium (EUTHYROX) taken as a dose of long course. Alternately 125 microgram 2 days / 3 then 100 microgram on the 3rd day (strength 125 microgram) via oral for hypothyroidism, tiotropium bromide monohydrate (SPIRIVA) taken as a dose of 1 DF, 1x/day (strength of 18 microgram) via inhalation for chronic obstructive pulmonary disease, furosemide (LASILIX [FUROSEMIDE) taken for hypertension, ramipril (TRIATEC (RAMIPRIL)) taken for hypertension start and stop date were not reported for all the drugs, rivaroxaban (XARELTO) taken as a dose of 1 DF, 1x/day (strength 15 mg) via oral atrial fibrillation from an unspecified stop date to 09Aug2021; atenolol (TENORMINE) taken for hypertension from an unspecified start date to Aug2021. The patient experienced covid pneumpathy less than 10 percent (death, hospitalization) and fall on 08Aug2021. The patient was hospitalized for covid pneumpathy less than 10 percent (covid-19 pneumonia) and fall from 08Aug2021 to an unknown date. Admission to the emergency room on the night of 08Aug2021 following desaturation, vomiting and muscle pain following a fall on 08Aug2021. On admission, altered general condition, patient conscious and oriented, right shoulder, hip and ankle pain on mobilization, edema of the right lower limb, going up into a sock. Pulmonary auscultation: crackling rales in both lung fields, without draught or cyanosis. Swelling of the white line (hernia, lipoma). On 10Aug2021, clinical status stationary, biological improvement with decrease of the inflammatory syndrome. Pain managed by Actiskenan. On 13Aug2021, respiratory congestion with bilateral bronchial rales, still on oxygen therapy. Beginning of physiotherapy and aerosol therapy. Start of Scopoderm. Change of antibiotic therapy to cefotaxime-spiramycin. Deterioration of the patient''s condition on 14Aug2021. The patient is unconscious and febrile, tachypneic and congested. Switch to tachycardia, with atenolol suspended due to state of consciousness. The patient became unconscious with a to state of consciousness. The patient be-came unconscious with a Glasgow 6, saturation 96% on 15Aug2021. The patient underwent lab tests and procedures which included angiogram: ruled out pulmonary embolism. Bilateral pleural effusion with subpleural condensations and lamellar atelectasis. Regular thickening of the inter-lobular septas and peribronchovascular thickening, predominantly perihilar predominance. Signs of cardiac overload on 09Aug2021, blood gases: ph 7.47 and lactates at 2.85 mmol/l, blood potassium: 5 mmol/l, brain natriuretic peptide: 286 on 08Aug2021, coma scale (Glasgow): 6 on 15Aug2021, computerised tomogram thorax: predominantly acute subedema of the lung. Not clearly visible viral involvement occupying less than 10% of the pulmonary parenchyma (a few focal nodular frosted glass areas, an unequivocal crazy paving area). No CT angiography performed. Start of dexamethasone 6 mg / day on 09Aug2021, c-reactive protein: 15 mg/l, fibrin d dimer: 20000 ng/ml, glomerular filtration rate: 39.8 ml/min, haemoglobin: 15.8 g/dl, hyperleukocytosis 12 G/L, x-ray: fractures of the right shoulder and right hip, Switch XARELTO for LOVENOX 6000UI 2/day, sars-cov-2 test: positive: English variant on 08Aug2021, oxygen saturation: 96 percent on 15Aug2021. Therapeutic measures were taken as a result of covid pneumpathy less than 10 per-cent (covid-19 pneumonia), fall. The patient died in cardiorespiratory arrest, in bilateral are active mydriasis on 16Aug2021 00:30 and autopsy was not performed. Conclusion: A 98 year old woman, vaccinated for 5 months and 3 weeks, was hospitalized for moderate COVID pneumoapthy in a context of fall with fractures the day before and COVID cluster in the an accommodation facility for dependent elderly people. Unfavourable evolution of her general condition with death one week later of polyfactorial nature (moderate COVID pneumopathy, heart failure). Case corresponding to a failure of vaccination in a very elderly subject. Reporter comment: A 98 year old woman, vaccinated for 5 months and 3 weeks, was hospitalized for moderate COVID pneumoapthy in a context of fall with fractures the day before and COVID cluster in the an accommodation facility for dependent elderly people. Unfavourable evolution of her general condition with death one week later of polyfactorial nature (moderate COVID pneumopathy, heart failure). Case corresponding to a failure of vaccination in a very elderly subject. No follow-up attempts were needed. No further information was expected.; Reporter''s Comments: A 98 year old woman, vaccinated for 5 months and 3 weeks, was hospitalized for moderate COVID pneumoapthy in a context of fall with fractures the day before and COVID cluster in the an accommodation facility for dependent elderly people. Unfavourable evolution of her general condition with death one week later of polyfactorial nature (moderate COVID pneumopathy, heart failure). Case corresponding to a failure of vaccination in a very elderly subject.; Reported Cause(s) of Death: moderate COVID lung disease in the context of a fall with fracture and heart failure; moderate COVID lung disease in the context of a fall with fracture and heart failure


VAERS ID: 1716740 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-05-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SA8016 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Bronchospasm, COVID-19, Computerised tomogram, Drug ineffective, Inappropriate schedule of product administration, Inflammation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 79
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: Metastases to lung; Osteosarcoma
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Thoracic CT scan; Result Unstructured Data: Test Result:multiple bilateral axillary; Comments: intra-mammary masses predominantly right subcutaneously and bilateral para-rachidian. Frosted glass opacity of the right pulmonary field reaching 10 to 25% of the surface of the pulmonary parenchyma, i.e. moderate impairment compatible with Covid-19.; Test Date: 20210818; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101194579

Write-up: Positive PCR test/covid-19; bronchospasm in a context of bronchitis; bronchospasm in a context of bronchitis; Drug ineffective; Persistence of biological inflammatory syndrome; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable pharmacist downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-RS20212807 . A 66-year-old female patient received second dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: SA8016), via intramuscular route of administration as dose 2, single on 31May2021 and dose 1 via intramuscular (COMIRNATY; Solution for injection; Lot Number: ER9470) as dose 1, single on 01Apr2021 for covid-19 immunisation. Medical history included Right shoulder osteosarcoma with pulmonary metastases to lung from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 03Aug2021, the patient was hospitalized for dyspnoea and bronchospasm in a context of bronchitis not improved on antibiotic (Pyostacin) for 4 days at home. Also had Positive PCR test/covid-19 on 03Aug2021. And patient put on oxygen. On 14Aug2021, she experienced persistence of biological inflammatory syndrome despite initiation of Tavanic. On 16Aug2021, the patient had resorption of bronchial congestion. About 2 and a half months after the dose 2 of the vaccine, on 18Aug2021, she tested positive with PCR test. Search for the variant: L452R mutation. On 19Aug2021 she was clinically degraded with dyspnoea, desaturation, oxygen-retaining, febrile and asthenia. No bronchial congestion. Patient was Introduced with dexamethasone, cefotaxime and Lovenox. On 23Aug2021, she had persistent dyspnoea with oxygen referral and bronchospasm, apyretic and installed aerosols. On 23Aug2021, Thoracic CT scan: multiple bilateral axillary intra-mammary masses predominantly right subcutaneously and bilateral para-rachidian. Frosted glass opacity of the right pulmonary field reaching 10 to 25% of the surface of the pulmonary parenchyma, i.e. moderate impairment compatible with Covid-19. On 24Aug2021, patient had respiratory degradation. Vaccine failure confirmed 2 months after dose 2 of the Comirnaty vaccine who resulted in her death. Therapeutic measures were taken as a result of adverse events except covid-19 with Pyostacin, Tavanic, dexamethasone, cefotaxime, aerosols and Lovenox. The patient died on 18Aug2021. An autopsy was not performed. The outcome of event Positive PCR test/covid-19 was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Drug ineffective; Covid19; Persistence of biological inflammatory syndrome; bronchospasm in a context of bronchitis; bronchospasm in a context of bronchitis


VAERS ID: 1716745 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-07-26
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   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: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101194606

Write-up: Death unexplained; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-ST20213327. A 53-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in the left arm on 02Jun2021 (Batch/Lot Number: FD0785) as 0.3 ml, single for COVID-19 immunisation. Medical history included COVID-19 from Nov2020. There were no concomitant medications. It was reported that the patient was a patient with no particular history, without concomitant treatment, independent (as reported). Declaration of a user for the unexplained death of a member of his family (his brother-in-law). The patient experienced death unexplained (report of unexplained death) on 26Jul2021. Contact with the attending physician on 03Sep2021: The death occurred suddenly in the street; the patient''s friend was 100 m away. The patient was resuscitated but did not respond. The patient died on 26Jul2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-ST20211336 AFSSAPS; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1716756 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-05-26
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal heart rate abnormal, Maternal exposure during pregnancy, Ultrasound uterus
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: Comments: ras
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: ultrasound; Result Unstructured Data: Test Result:could not see formed embryo well but could hear he; Test Date: 20210731; Test Name: ultrasound; Result Unstructured Data: Test Result:heart stopped beating
CDC Split Type: FRPFIZER INC202101205844

Write-up: heart stopped beating; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the regulatory authority [FR-AFSSAPS-LL20215923]. This physician reported information for both mother and fetus. This is a fetus report. A fetus patient received bnt162b2 (COMIRNATY) via transplacental route which was administered to patient''s mother via intramuscular on 28Jul2021 (Batch/Lot Number: FF0680) as Dose 2, single; via an unspecified route of administration on 26May2021 as Dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy, first trimester on 26May2021, heart stopped beating on 31Jul2021. The patient''s mother was 28 years old, vaccinated with bnt162b2 intramuscularly in the left arm, suffered a miscarriage on 31Jul2021. On 20May2021: date of start of pregnancy according to gynaecologist. On 25May2021: patient''s mother described peculiar periods. On 20Jul2021: dating ultrasound; could not see formed embryo well but could hear heartbeat. On 28Jul: Dose 2 vaccination. On 30Jul2021: patient''s mother had blood loss. On 31Jul2021: ultrasound consultation: heart stopped beating. Loss of baby estimated at 12 weeks + 4 days of gestation by gynaecologist. Outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101155243 Mother/child case;FR-PFIZER INC-202101205758 fetus case; Reported Cause(s) of Death: heart stopped beating; Maternal Exposure During Pregnancy, first trimester


VAERS ID: 1717082 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 2021-09-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211534

Write-up: Vaccination; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109150029464680-32XZH. Safety Report Unique Identifier is GB-MHRA-ADR 25942231. A female patient of an unspecified age patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (unknown age at time of vaccination) as single dose for COVID-19 immunization. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced "vaccination" (Seriousness criteria-Results in death) on an unspecified date. The patient underwent COVID-19 virus test with result negative on an unspecified date (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient died on 10Sep2021. The cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible. Information about Batch/Lot Number cannot be obtained.; Reported Cause(s) of Death: Vaccination


VAERS ID: 1717105 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7934 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Bone cancer, Inappropriate schedule of product administration, Magnetic resonance imaging, Mobility decreased
SMQs:, Parkinson-like events (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 67
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL; LERCANIDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (AGE 50); Hypertensive
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Comments: All blood result were normal; Test Date: 20210526; Test Name: MRI; Result Unstructured Data: Test Result:Spinal cancer; Comments: showed an aggressive form of cancer which was terminal
CDC Split Type: GBPFIZER INC202101185370

Write-up: Spinal cancer; First dose on 22Jan2021/ Second dose on 14Apr2021; Mobility deteriorated; This is a spontaneous report from a contactable consumer. This consumer reported two reports for this patient. This is the second of two reports for second dose. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER7934), via an unspecified route of administration, administered in arm left on 14Apr2021 (at the age of 81-year-old) as dose 2, single for COVID-19 immunisation at doctor''s office/urgent care. Medical history included breast cancer (Age 50) and hypertensive. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ramipril and lercanidipine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL0141) on 22Jan2021 at 10:00 am (at the age of 80-year-old) as dose 1, single for COVID-19 immunisation and within a week and a half developed pain in lower back and left leg. Also Headache. Back pain developed with more severe pains ongoing, sacral area swollen, lump on head appeared, headache. Unable to walk, Pain in upper quadrant of back & lower sacral swollen. Mobility deteriorated. The patient previously took paracetamol. It was reported mobility deteriorated even more after second dose administered in 2021. GP referred for an MRI Scan took weeks, all blood results were normal and 26May2021 diagnosed with spinal cancer from MRI scan. GP was confused with blood returning as normal but the scan showed an aggressive form of cancer which was terminal 3 weeks and 4 days after this diagnosis passed away. Since discussing with 2 other people they explained that similar circumstances with their spouse. This is why the reporter felt it was imperative to report this finding. The family felt that the death of the patient was contributed through receiving the vaccine. No treatment was received as a result of the events. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient died on 20Jun2021. The outcome of the event spinal cancer was fatal, of the event Mobility deteriorated was not recovered. It was unknown if an autopsy was performed.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101180791 same reporter/patient/product, different dose, similar events; Reported Cause(s) of Death: Spinal cancer


VAERS ID: 1717123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Biopsy muscle, Decubitus ulcer, Dermatomyositis, Investigation, Muscular weakness, Myositis, Oedema peripheral, Pneumonia aspiration, Respiratory failure, Sepsis, Septic shock, Skin infection, Uterine mass
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (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), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 82
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: NORVASC PROTECT; ZOLOFT; INDERAL GRADUALE; LEXOTANIL 6
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hypertension; Tachyarrhythmia
Allergies:
Diagnostic Lab Data: Test Name: muscle biopsy; Result Unstructured Data: Test Result:Result Unknown; Test Name: abdominal imaging; Result Unstructured Data: Test Result:uterine mass; Test Name: electromyography; Result Unstructured Data: Test Result:Result Unknown; Test Name: immunological testing; Result Unstructured Data: Test Result:Result Unknown
CDC Split Type: GRPFIZER INC202101193539

Write-up: Respiratory failure; Septic shock; Muscle weakness of upper and lower limbs (central); Myositis; Edema of upper limbs; Bloodstream infections; Skin infection from an decubitus ulcer; Skin infection from an decubitus ulcer; dermatomyositis; uterine mass; Pneumonia aspiration; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-20217412 . A 83-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 19May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hypertension, depression, tachyarrhythmia. Concomitant medications included amlodipine besilate, atorvastatin calcium (NORVASC PROTECT) taken for hypertension; sertraline hydrochloride (ZOLOFT) taken for Depression; propranolol hydrochloride (INDERAL GRADUALE) taken for tachyarrhythmia; bromazepam (LEXOTANIL 6) taken for hypertension. The patient previously took first dose of bnt162b2 (COMIRNATY) on 27Apr2021 for covid-19 immunisation. Three days after the second dose of the vaccine (on 22May2021), the patient developed edema of upper limbs with muscle weakness of upper and lower limbs (central and no peripheral) with progressive deterioration. Initially the patient was hospitalized in a general hospital, where the investigation revealed findings related to dermatomyositis (muscle biopsy, electromyography, immunological testing) and then the patient was transferred to another hospital for further treatment. The patient received intravenous Methylprednisolone, immunoglobulin gamma and Rituximab without response to the medication with the above. An abdominal imaging performed as part of the investigation revealed a uterine mass, the nature of which was not identified histologically, given the patient''s severe condition. Her hospitalisation was complicated by multiple bloodstream infections, skin infection from an decubitus ulcer and pneumonia aspiration. The patient experienced Muscle weakness of upper and lower limbs (central and no peripheral) with progressive deterioration on 22May2021 with outcome of fatal (hospitalization),Respiratory failure on 12Aug2021 with outcome of fatal (hospitalization), Myositis on 22May2021 with outcome of fatal ( hospitalization), Edema of upper limbs on 22May2021 with outcome of fatal (hospitalization, Disabling/Incapacitating), Bloodstream infections on an unspecified date with outcome of fatal, skin infection from an decubitus ulcer on an unspecified date with outcome of fatal, Septic shock on 12Aug2021 with outcome of fatal (hospitalization), Pneumonia aspiration on an unspecified date with outcome of fatal; all serious (Other medically important condition). Patient also had uterine mass and dermatomyositis on an unspecified date with outcome of unknown. The patient died on 12Aug2021. Autopsy done. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Pneumonia aspiration; Muscle weakness of upper and lower limbs (central); Myositis; Edema of upper limbs; Bloodstream infections; Skin infection from an decubitus ulcer; Skin infection from an decubitus ulcer; Septic shock; Respiratory failure


VAERS ID: 1717335 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Fluid retention, Oedema peripheral, Petechiae, Rash macular, Sudden death, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   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: ZYPREXA; CYMBALTA; TRITTICO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101194065

Write-up: suddenly collapses and dies/Sudden Death; Suspicion of thrombosis; Edema of the feet (feet begin to swell); red patches on the arms like bruises; red legs/legs remain very red; red spots; problem with water retention; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB IT-MINISAL02-781575. An 84-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 19Apr2021 (Batch/Lot Number: EX0893) as dose 2, single for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing. Concomitant medications included olanzapine (ZYPREXA), duloxetine hydrochloride (CYMBALTA) and trazodone hydrochloride (TRITTICO) all taken for unspecified indications, start and stop date were not reported. It was reported that from 21Apr2021, the patient experienced edema of the feet, after a few days on Apr2021, red legs and red patches on the arms like bruises. Suspicion of thrombosis. On 24May2021 sudden death. The patient''s daughter further reported that after a couple of days from the vaccine the patient''s feet begin to swell. After about a week, since the swelling did not go away, she called the doctor as she feared for a thrombosis. The doctor says that there is no danger of thrombosis and orders diuretics. In a week the swelling goes away but the legs remain very red. She is also seen by the general practitioner who believes there is a problem with water retention (unspecified date in 2021). Then some red spots on her arms like bruises but the reporter think they are bruises that she got herself accidentally. The patient also had red spots on an unspecified date. On 24May2021, the patient suddenly collapses and dies; 118''s attempt to revive her was in vain. No autopsy was performed. Therapeutic measures were taken as a result of suspicion of thrombosis, edema of the feet (feet begin to swell), red patches on the arms like bruises. The outcome of suddenly collapses and dies/Sudden Death was fatal, while the outcome of the other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: suddenly collapses and dies/sudden death


VAERS ID: 1717351 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-12
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure fluctuation, Echocardiogram, Electrocardiogram, Impaired quality of life, Interstitial lung disease, Investigation, Neuralgia, Paresis, Skin burning sensation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (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: Medical History/Concurrent Conditions: Vascular parkinsonism
Allergies:
Diagnostic Lab Data: Test Name: echo; Result Unstructured Data: Test Result:no neoplasms or other; Test Name: electrocardiogram; Result Unstructured Data: Test Result:no neoplasms or other; Test Name: General analysis checks; Result Unstructured Data: Test Result:infection
CDC Split Type: ITPFIZER INC202101209541

Write-up: bilateral interstitial pneumonia; Impact on quality of life (10/10); sudden pressure changes; paresis-like neuralgia of injection site; paresis-like neuralgia of injection site; burning sensation of skin; wheals in other areas; This is a spontaneous report from a contactable consumer downloaded from the Regulatory authority-WEB, regulatory authority number IT-MINISAL02-784189. The consumer reported different events for same patient. This is the first of two reports, for the second dose. An 84-year-old male patient received second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscular, administered in arm left on an unspecified date at 0.3ml single dose for covid-19 immunisation. Medical history included vascular parkinsonism. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2(COMIRNATY) for COVID-19 immunisation and experienced wheals under inoculation site. After second dose sudden pressure changes, paresis-like neuralgia of injection site, followed by wheals in other areas, burning sensation on skin on 12Mar2021. General analysis checks indicated only infection, from electrocardiogram, echo, etc. No neoplasms or other. One week before death bilateral interstitial pneumonia in a patient who was not bedridden and never suffered from bronchitis, asthma or allergies - Impact on quality of life (10/10). The outcome of events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter''s comments: Vascular Parkinsonism The lot number for [BNT162B2], was not provided and will be requested during follow up; Reporter''s Comments: Vascular Parkinsonism; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101223749 different events and doses; Reported Cause(s) of Death: sudden pressure changes; paresis-like neuralgia of injection site; paresis-like neuralgia of injection site; burning sensation of skin; wheals in other areas; bilateral interstitial pneumonia; Impact on quality of life (10/10)


VAERS ID: 1717352 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-05-04
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 99.108 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Investigation, Oxygen saturation, Oxygen saturation abnormal, Pneumonia bacterial, Pustule, Tachycardia, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chemotherapy; Non-Hodgkin''s lymphoma recurrent
Allergies:
Diagnostic Lab Data: Test Name: impact on quality of life; Result Unstructured Data: Test Result:10/10; Test Date: 202108; Test Name: saturation; Result Unstructured Data: Test Result:collapse
CDC Split Type: ITPFIZER INC202101209419

Write-up: tachycardic state; pustules on feet and arms; Pneumonia bacterial; saturation collapse; thrombosis; herpes zoster; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-784194. An 82-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right, on 09Apr2021 (Batch/Lot number: 99.108, expiration date not reported) as single dose, for covid-19 immunisation. Medical history included recurrence of Non-Hodgkin lymphoma from Mar2021 to Mar2021, and chemotherapy. The patient''s concomitant medications were not reported. The patient experienced herpes zoster (death) on 04May2021, thrombosis (death, hospitalization) in Jun2021, tachycardic state (death, hospitalization) in Aug2021, pustules on feet and arms (death, hospitalization) in Aug2021, pneumonia bacterial (death, hospitalization) in Aug2021, and saturation collapse (death, hospitalization) in Aug2021. It was reported the patient first developed herpes zoster in May2021, followed by jugular thrombosis the following month, requiring hospitalisation. The patient was discharged, but in Aug2021 he developed serous pustules on his feet and arms and contracted bacterial pneumonia, followed by hospitalisation and death. In anamnesis the patient had a recurrence of Non-Hodgkin lymphoma since Mar2021. Patient had 2 hospitalizations and 1 week intensive care. The impact on quality of life was 10/10. Additional information on drug was reported as "abuse/ misuse". The outcome of events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter''s comments: 82-year-old patient in relapsing NH lymphoma since March 21. The oncological staff indicated to carry out the two Pfizer doses in the interval of 20 days between the first and the second chemio. After the second dose: herpes zoster with stop at the second chemo / hospitalization jugular thrombosis / discharge / formation of serous pustules on feet and arms / second hospitalization for saturation collapse / diagnosis: bacterial pneumonia + tachycardic state + lymphoma''s upper hand since the stop at chemo by reaction. Sender''s comments: 05Sep21 Center of Pharmacovigilance: additional information requested from the reporter such as batch and time of vaccination, reports of diagnostic tests performed, detailed clinical report, medical history, concomitant medications taken, known allergies.; Reporter''s Comments: 82-year-old pt in relapsing NH lymphoma since Mar2021. The oncological staff indicated to carry out the two Pfizer doses in the interval of 20 days between 1st & 2nd chemio. After 2nd dose: herpes zoster with stop at the second chemo /hospitalization jugular thrombosis /discharge /formation of serous pustules on feet & arms /2nd hospitalization for saturation collapse /diagnosis: bacterial pneumonia +tachycardic state +lymphoma''s upper hand since stop at chemo by reaction.; Reported Cause(s) of Death: herpes zoster; thrombosis; tachycardic state; pustules on feet and arms; Pneumonia bacterial; saturation collapse


VAERS ID: 1717457 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Feeling abnormal
SMQs:, Dementia (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 INC202101177824

Write-up: This is a spontaneous report from a non-contactable consumer (patient''s niece). The patient was an elderly (reported as 75 or 76-year-old) female. On 03Jun2021 (the day of vaccination) at unknown time, the patient received the first dose of BNT162b2 (COMIRNATY, solution for injection, lot number not reported, expiration date not reported) via an unspecified route of administration as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unknown date in 2021 at unknown time, the patient died after the vaccination. The outcome, seriousness, and causality of this event was not reported. The course of this event was as follows: The reporter, who was a relative of the patient (niece), said that the patient died after the vaccination. The reporter stated that the causal relationship was unknown, and this case was not even counted by the country. Furthermore, the reporter heard that the patient said "I feel dull" on an unknown date in 2021, after the vaccination, although the reporter did not hear this directly. The outcome of the event died after the vaccination was fatal. The outcome of the event "I feel dull" was unknown. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. The lot number for BNT162b2 was not provided and will be requested during follow-up.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101183887 Same reporter, different patient, same drug, different AE; Reported Cause(s) of Death: Died after the vaccination.


VAERS ID: 1717462 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, Body temperature, C-reactive protein increased, Cholangitis acute, Hepatic enzyme, Liver function test, Platelet count, Septic shock, White blood cell count
SMQs:, Toxic-septic shock conditions (narrow), Infectious biliary disorders (narrow), Biliary tract disorders (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
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: Multiple sclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:60s to 70s; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: Before vaccination; Test Date: 20210827; Test Name: CRP; Result Unstructured Data: Test Result:19.29; Test Date: 20210827; Test Name: liver enzyme; Result Unstructured Data: Test Result:increase; Test Date: 20210827; Test Name: biliary enzyme; Result Unstructured Data: Test Result:increase; Test Date: 20210827; Test Name: platelet count; Result Unstructured Data: Test Result:52,000; Test Date: 20210827; Test Name: WBC; Result Unstructured Data: Test Result:46,200
CDC Split Type: JPPFIZER INC202101198836

Write-up: septic shock; cholangitis acute; This is a spontaneous report from a contactable other healthcare professional received from the Agency Regulatory Authority. Regulatory authority report number is v21127813. The patient was a 72-year and 1-month-old male. Body temperature before vaccination was 35.9 degrees centigrade. The family history was not provided. The patient had medical history of multiple sclerosis. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 25Aug2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF4204, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization at the age of 72 year and 1 month-old. On 29Aug2021 at 00:07 (3 days/9 hours/7 minutes after the vaccination), the patient died caused by septic shock due to cholangitis acute. On 29Aug2021 (4 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26Aug2021, the urine volume decreased, and the systolic blood pressure was fluctuating between 60s and 70s. On 27Aug2021, the test results showed increase in the liver enzyme and the biliary enzyme, and they showed the WBC of 46,200, the CRP of 19.29, and the platelet count of 52,000. Although the patient was treated with antibiotics (tazobactam/piperacillin [TAZ/PIPC]), the improvement in the vital signs was poor. The blood pressure gradually decreased, and the patient died on 29Aug2021 (3 days and 9 hours after vaccination). The surviving family did not wish a pathological autopsy. The reporting other healthcare professional classified the events as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was the death caused by septic shock due to cholangitis acute. Reporter''s comment: Although the date of death was close to the vaccination, it was considered reasonable that the death was caused by new infection which accidentally occurred in another incident. Thus, it was difficult to consider that the vaccination played some causal role.; Reporter''s Comments: Although the date of death was close to the vaccination, it was considered reasonable that the death was caused by new infection which accidentally occurred in another incident. Thus, it was difficult to consider that the vaccination played some causal role.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the fatality of the case.; Reported Cause(s) of Death: septic shock; cholangitis acute


VAERS ID: 1717465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-11
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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: 2021-09-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101200854

Write-up: Cardiac arrest; consciousness disturbed; This is a spontaneous report from a contactable physician received from the BNT162B2. Regulatory authority report number is v21126661. The patient was a 91-year-old female. Body temperature before vaccination was not provided. On unknown date (the day of vaccination), the patient received the second dose of BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. The family history was not provided. Medical history included; cardiac failure. Concomitant medications were not reported. On unknown date, the patient previously received the first dose of BNT162B2(COVID-19 Vaccine (Manufacturer Unknown), Lot# unknown, Expiration date unknown). On 11Sep2021 at 21:30 (unknown days after the vaccination), the patient experienced cardiac arrest. The course of the event was as follows: On 11Sep2021 (unknown days after vaccination), at 21:30, since the patient had consciousness disturbed, an ambulance was called. At 22:00, the emergency squad arrived on the site. At 22:12, the patient was confirmed to have cardiac arrest, and chest compression was performed. At 22:41, the patient arrived at the reporting hospital. At 22:10, the patient died. On 11Sep2021 (unknown days after the vaccination), the outcome of the events was fatal. The reporting physician classified the events as serious (death) and assessed that the event cardiac arrest was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was cardiac failure. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the limited information available it is not possible to completely rule out the role of the vaccine BNT162B2 in triggering/contributing to the reported event cardiac arrest. But also the strong contributory factors of the patient''s pre-existing condition (cardiac failure) and the age of the patient needs to be considered. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: consciousness disturbed; Cardiac arrest


VAERS ID: 1717466 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia aspiration
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: JPPFIZER INC202101207326

Write-up: Pneumonia aspiration; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (Solution for injection, Batch/Lot number was not reported) via intramuscular on an unspecified date as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date (after the vaccination), the patient experienced pneumonia aspiration. The patient died on an unspecified date due to Pneumonia aspiration. It was unknown if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 and reported events Pneumonia Aspiration which cannot be fully assessed/excluded. 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: Pneumonia aspiration


VAERS ID: 1717469 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-09
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Antibody test, Computerised tomogram, Electrocardiogram, Interstitial lung disease, Oxygen saturation, Stress cardiomyopathy
SMQs:, Interstitial lung disease (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VALSARTAN; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; AMLODIPINE; PREDNISOLONE; CELECOXIB; PREGABALIN; MAGNESIUM OXIDE
Current Illness: Cryptogenic organising pneumonia (prednisolone at 30 mg/day. Prednisolone was reduced to 5 mg/day, and then the dose was maintained.)
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract; Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: coronary angiography; Result Unstructured Data: Test Result:no stenosis in the coronary artery; Test Name: Anti-ARS antibody; Test Result: Positive ; Comments: obtained on admission; Test Name: anti-Jo-1 antibody; Test Result: Positive ; Comments: obtained on admission; Test Name: CT; Result Unstructured Data: Test Result:glass opacity in the lungs; Comments: glass opacity in the lungs, tractional bronchiectasis, and consolidation with predominance in the subpleural region; Test Date: 20210615; Test Name: electrocardiogram; Result Unstructured Data: Test Result:change in the waveform; Test Name: SpO2; Test Result: 80 %
CDC Split Type: JPPFIZER INC202101209562

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21127839. The patient was an 88-year and 3-month-old female. On 25May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date unknown) via an unspecified route of administration as a single dose, at age of 88 years of vaccination, for COVID-19 immunization. Body temperature before vaccination was not reported. The patient family history was not reported. Medical history included ongoing cryptogenic organising pneumonia diagnosed in Dec2020 (the patient started treatment with prednisolone at 30 mg/day. Prednisolone was reduced to 5 mg/day, and then the dose was maintained), hypertension, osteoporosis and cataract. The patient had no allergic history. The patient took the following oral concomitant medications: valsartan, esomeprazole magnesium (NEXIUM), amlodipine, prednisolone (PREDNISOLONE, PSL), celecoxib, pregabalin, and magnesium oxide. On 09Jun2021 (15 days after the vaccination), the patient experienced interstitial pneumonia. On 19Jun2021 (25 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: In Dec2020, the patient was diagnosed with cryptogenic organising pneumonia, for which she started treatment with prednisolone at 30 mg/day. Prednisolone was reduced to 5 mg/day, and then the dose was maintained. The patient had visited a nearby hospital regularly. On 25May2021, the patient received the first dose of COVID-19 vaccine. Approximately 1 week later (in early Jun2021), the patient presented with pyrexia, and on 09Jun2021, dyspnoea developed. On 11Jun2021, when the patient was seen by a nearby hospital, hypoxaemia and increased lung shadows were noted. The patient was thus referred to the reporting physician''s hospital. On initial consultation, oxygen saturation (SpO2) was 80% on room air. Computerised tomogram (CT) revealed ground glass opacity in the lungs, tractional bronchiectasis, and consolidation with predominance in the subpleural region, which were suggestive of acute interstitial pneumonia that had a background of interstitial change to the pattern of fibrotic non-specific interstitial pneumonia (fNSIP) with OP overlap.Methylprednisolone (mPSL) at 500 mg/day was administered for 3 days, and aftertreatment was initiated with PSL at 50 mg/day, but respiratory condition tended to be aggravated. The test for anti-ARS and anti-Jo-1 antibodies that were obtained on admission showed positive results. Although symptoms of skin eruption and myositis were not noted, interstitial pneumonia having the background of dermatomyositis/polymyositis was suspected. In addition, the patient developed feeling strange in the chest on 15Jun2021. Since a possibility of acute myocardial infarction was considered with change in the waveform on electrocardiography, coronary angiography was immediately performed on the same day. However, there was no stenosis in the coronary artery. Therefore, the diagnosis of Tako-Tsubo cardiomyopathy was made, and conservative therapy was performed. Thereafter, respiratory condition and lung shadows were further aggravated. On 17Jun2021, intermittent pulse intravenous cyclophosphamide therapy (IVCY) at 500 mg/day was conducted with no effect. On 19Jun2021, the patient died. The reporting physician classified the event as serious (Death) and assessed that the causality between the event and BNT162b2 as unassessable. As for other possible cause of the event such as any other diseases, the reporting physician stated as follows: The patient was diagnosed with cryptogenic organising pneumonia in Dec2020 and started on treatment with prednisolone (PREDONINE) at 30 mg/day. After that, prednisolone was reduced to 5 mg/day because of improvement of the shadows and respiratory condition, and then the dose was maintained. As interstitial shadows were slightly left even after the dose of prednisolone was maintained, it could not be ruled out the possibility of onset of acute interstitial pneumonia with no involvement of the vaccination. The reporting physician commented that, the relationship with the vaccine was suspected in consideration of the short interval between the vaccination and the onsets of pyrexia and dyspnoea. Also, since this patient yielded positive results for autoantibodies (anti-ARS antibody and Anti-Jo-1 antibody), it was considered that interstitial pneumonia might be triggered by immune response from the vaccine as the background of autoimmune disease. The outcome of event Tako-Tsubo cardiomyopathy was unknown. The patient died of Interstitial pneumonia. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Interstitial pneumonia


VAERS ID: 1717470 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hepatic failure, SARS-CoV-2 test
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-15
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LIXIANA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Cardiac failure; Cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: Nasal Swab, PCR test
CDC Split Type: JPPFIZER INC202101210351

Write-up: Hepatic failure; This is a spontaneous report from a contactable physician received via regulatory authority. An 89-year-old female patient (pregnant: no) received bnt162b2 (COMIRNATY), the first dose via unspecified route of administration on 31Aug2021 as single dose for COVID-19 immunisation. The relevant medical history included cerebral infarction from unspecified date, angina pectoris from unspecified date, cardiac failure from unspecified date. Concomitant medications included edoxaban tosilate (LIXIANA). It was unknown whether the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received edoxaban tosilate hydrate (LIXIANA) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. On 31Aug2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration in the unknown site for COVID-19 immunization. On 03Sep2021 (3 days after the vaccination), the patient experienced hepatic failure. The event resulted in hospitalization and death. Duration of hospitalization was 13 days. The outcome of the event was fatal with unknown treatment. The reporting physician assessed the event as serious (hospitalization and death). Since the vaccination, the patient has been tested for COVID-19. The patient died on 15Sep2021. No autopsy was performed. The patient underwent lab test included SARS-CoV-2 test showed negative (Nasal Swab, PCR test) on 03Sep2021. Therapeutic measures were taken as a result of the event. The outcome of the event was fatal.; Sender''s Comments: Based on known temporal relationship the possibility of causal association between the event hepatic failure 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: hepatic failure


VAERS ID: 1717471 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Computerised tomogram, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: Head CT scan; Result Unstructured Data: Test Result: extensive cerebral haemorrhage
CDC Split Type: JPPFIZER INC202101212276

Write-up: lost consciousness; Cerebral haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126775. The patient was a 66-year-old male. On 28Jul2021 (the day of vaccination), the patient received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown), dose number unknown, at 66-year-old, via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was not provided. Medical history, concomitant medications and family history were not provided. On 29Jul2021 (1 day after the vaccination), the patient developed cerebral haemorrhage and died. It was not reported if an autopsy was performed. The course of the events was as follows: On 28Jul2021 at around noon, the patient received the vaccination. On 29Jul2021 at around 05:00, the family found that the patient lost consciousness on sitting position, and they called an ambulance. Head CT scan revealed extensive cerebral haemorrhage. On the same day, the patient''s death was confirmed. The reporting physician classified the event as serious and assessed the causality between the event and BNT162B2 as unassessable. It was not provided if there was other possible cause of the event. The reporting physician commented as follows: Although the causal relationship with the vaccination was unknown, this case was reported.; Reported cause(s) of death: lost consciousness; cerebral haemorrhage.


VAERS ID: 1717510 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-06-30
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood alkaline phosphatase, Blood creatinine, C-reactive protein, COVID-19, COVID-19 pneumonia, Chest X-ray, Culture, Dyspnoea, Gamma-glutamyltransferase, Glomerular filtration rate, Haemoglobin, Hypoxia, International normalised ratio, Lymphocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, Platelet count, Prothrombin time, Respiratory failure, SARS-CoV-2 test, Tachypnoea, Vaccination failure, White blood cell count
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   Days after onset: 61
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 61 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DIGOXIN; PERINDOPRIL; BUMETANIDE; SIMVASTATIN; ENOXAPARIN SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Heart disorder; Heart failure with preserved ejection fraction (HFpEF, Tricuspid regurgitation and atrial fibrillation); Hypertension; Smoker (1 to 2 cigarettes per day); Tricuspid regurgitation
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: ALP; Result Unstructured Data: Test Result:237; Comments: high; Test Date: 20210828; Test Name: ALP; Result Unstructured Data: Test Result:202; Comments: high; Test Name: Creatinine; Result Unstructured Data: Test Result:107 fell to 73; Comments: Tests on 20, 21, 22, 24, 26 and 28/08. High on 20/08, normal all other days and decreasing; Test Date: 20210820; Test Name: CXR; Result Unstructured Data: Test Result:Cardiomegaly Lung congested; Test Name: C-reactive protein; Result Unstructured Data: Test Result:107.7 fell to 10.5; Comments: Tests on 20, 21, 22, 24, 26 and 28/08. HIGH but consistent fall; Test Date: 20210820; Test Name: Culture; Result Unstructured Data: Test Result:Proteus Mirabilis; Test Date: 20210824; Test Name: gamma GT; Result Unstructured Data: Test Result:136; Comments: high; Test Date: 20210828; Test Name: gamma GT; Result Unstructured Data: Test Result:145; Comments: high; Test Name: EGFR; Result Unstructured Data: Test Result:62 rose to 97; Comments: Tests on 20, 21, 22, 24, 26 and 28/08. normal; Test Name: HEMOGLOBIN; Result Unstructured Data: Test Result:8.9 to 9.0; Comments: Tests on 20, 21, 22, 24, 26/08. LOW; Test Date: 20210828; Test Name: INR; Result Unstructured Data: Test Result:1.12; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.95 to 0.45; Comments: Tests on 20, 21, 22, 24, 26/08. Low and decreasing; Test Name: neutrophils; Result Unstructured Data: Test Result:8.66 to 5.83; Comments: Tests on 20, 21, 22, 24, 26/08. High on 20 and 21/08, normal all other days; Test Date: 20210828; Test Name: NT-ProBNP; Result Unstructured Data: Test Result:1255; Comments: High; Test Date: 20210830; Test Name: SpO2; Test Result: 88 %; Comments: on 4L/minute nasal swabs; Test Name: PLATELET COUNT; Result Unstructured Data: Test Result:258 to 221; Comments: Tests on 20, 21, 22, 24, 26/08. Normal; Test Date: 20210828; Test Name: PT; Result Unstructured Data: Test Result:11.6; Comments: high; Test Date: 20210630; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Not detected; Test Date: 20210803; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Not detected; Test Date: 20210810; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Not detected; Test Date: 20210820; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Detected - CT 25; Comments: positive; Test Name: WBC; Result Unstructured Data: Test Result:12.36 to 6.59; Comments: Tests on 20, 21, 22, 24, 26/08. High on 20/08, normal all other days and decreasing
CDC Split Type: MTPFIZER INC202101198093

Write-up: COVID-19 pneumonitis; respiratory failure; tachypnea; dyspnea; hypoxemia; tested covid positive; the patient experienced covid-19 pneumonitis and admitted in hospital on 30Jun2021; This is a spontaneous report from a contactable physician. A 73-years-old male patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection) via intramuscularly, administered in left arm on 22Apr2021 (Batch/Lot Number: EW4815) as single dose covid-19 immunisation and received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection) via intramuscularly, administered in left arm on 13May2021 (Batch/Lot Number: EW4815) as single dose for covid-19 immunisation. The patient''s medical history included hypertension and heart disease included (HFpEF (Heart failure with preserved ejection fraction), Tricuspid regurgitation and atrial fibrillation), tobacco user (1 to 2 cigarettes per day) from an unknown date and unknown if ongoing. The patient''s concomitant medications included digoxin (DIGOXIN), perindopril (PERINDOPRIL), bumetanide (BUMETANIDE), simvastatin (SIMVASTATIN), enoxaparin sodium (ENOXAPARIN SODIUM) taken for an unspecified indication, start and stop date were not reported. On unspecified date, the patient experienced covid-19 pneumonitis and admitted in hospital on 30Jun2021. Patient tested covid positive (vaccination failure) on 20Aug2021. Patient developed sudden shortness of breath on 30Aug2021 with dyspnea and hypoxemia followed by death. On unspecified date patient experienced tachypnea and respiratory failure. The patient underwent lab tests and procedures which included sars-cov-2 test not detected on 30Jun2021, 03Aug2021, 10Aug2021 and detected ct 25 on 20Aug2021, blood alkaline phosphatase was 237 (high) on 24Aug2021 and 202 (high) on 28Aug2021, blood creatinine: 107 fell to 73 tested on 20, 21, 22, 24, 26 and 28/08 and high on 20/08, normal all other days and decreasing, chest x-ray: cardiomegaly lung congested on 20Aug2021, c-reactive protein: 107.7 fell to 10.5 tested on 20, 21, 22, 24, 26 and 28/08 results high but consistent fall, culture: proteus mirabilis on 20Aug2021, gamma-glutamyl transferase was 136 (high) on 24Aug2021 and 145 (high) on 28Aug2021, glomerular filtration rate: 62 rose to 97 tested on 20, 21, 22, 24, 26 and 28/08. normal, haemoglobin: 8.9 to 9.0 tested on 20, 21, 22, 24, 26/08 results low, international normalised ratio: 1.12 on 28Aug2021, lymphocyte count: 0.95 to 0.45 tested on 20, 21, 22, 24, 26/08. low and decreasing, neutrophil count: 8.66 to 5.83 Tests on 20, 21, 22, 24, 26/08. high on 20 and 21/08, normal all other days, n-terminal prohormone brain natriuretic peptide: 1255 (high) on 28Aug2021, oxygen saturation: 88 % on 30Aug2021 on 4L/minute nasal swabs, platelet count: 258 to 221 Tests on 20, 21, 22, 24, 26/08. Normal, prothrombin time: 11.6 on 28Aug2021 high, white blood cell count: 12.36 to 6.59 Tests on 20, 21, 22, 24, 26/08 results high on 20/08, normal all other days and decreasing. SARS-CoV2 Antibody testing was not performed. Symptoms of heart failure were improving. Therapeutic measures were taken as a result of all the events. Treatment included Remdesivir from 21Aug2021 to 26Aug2021 at 200mg iv stat, then 100mg iv daily, Dexamethasone from 21Aug2021 to 26Aug2021 at 6mg iv daily, Ceftriaxone from 20Aug2021to 27Aug2021 at 2g daily iv and Metronidazole from 20Aug2021to 27Aug2021 at 500mg 3 per day iv. The patient died in hospital on 30Aug2021 after 61 days hospitalization. It was not reported if an autopsy was performed. The outcome of the event covid-19 pneumonitis was fatal and for remaining all events outcome was unknown. No follow-up attempts required. No more information are expected.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Covid-19 pneumonia, Covid-19, Vaccination failure, Respiratory failure, hypoxia)and the administration of the vaccine 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: On unspecified date, the patient experienced covid-19 pneumonitis and admitted in hospital on 30Jun2021 and tested covid positive on 20Aug2021 and developed sudden shortness of breath on 30Aug2021 with dyspnea and hypoxemia followed by death.


VAERS ID: 1717600 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-02-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Alanine aminotransferase, Aspartate aminotransferase, Bilirubin conjugated increased, Blood alkaline phosphatase, Blood bilirubin, Blood glucose, Blood pressure measurement, Blood test, C-reactive protein, Chills, Coma, Depressed level of consciousness, Gamma-glutamyltransferase, Heart rate, Hepatic failure, Hepatitis B core antibody, Hepatitis B surface antibody, Hepatitis B surface antigen, Hepatitis C, Hepatitis C RNA, Hepatitis C antibody, Loss of consciousness, Oxygen saturation, Somnolence, Stool analysis, Thermometry, Urine analysis, Vital signs measurement, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver infections (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Biliary system related investigations, signs and symptoms (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to wasp sting; Alzheimer''s disease; Dementia (Alzheimer''s disease); Esophageal varices; Essential hypertension; Hepatic cirrhosis; Hepatitis B; Hepatitis C; Osteoarthritis; Pneumonia; Portal hypertension; Thrombocytopenia; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210225; Test Name: Alanine transaminase; Result Unstructured Data: Test Result:92 IU/l; Comments: Blood test on day 5; Test Name: ALT; Result Unstructured Data: Test Result:She had slightly increased liver enzymes; Test Date: 20210306; Test Name: ALT; Result Unstructured Data: Test Result:increase; Comments: A second blood test on day 14; Test Date: 20210225; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:113 IU/l; Comments: Unit U/l Blood test on day 5; Test Name: AST; Result Unstructured Data: Test Result:She had slightly increased liver enzymes; Test Date: 20210306; Test Name: AST; Result Unstructured Data: Test Result:increase; Comments: A second blood test on day 14; Test Date: 20210225; Test Name: Conjugated bilirubin; Result Unstructured Data: Test Result:102 umol/l; Comments: Blood test on day 5; Test Date: 20210225; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:120 IU/l; Comments: Unit U/l Blood test on day 5; Test Name: ALP; Result Unstructured Data: Test Result:She had slightly increased liver enzymes; Test Date: 20210306; Test Name: ALP; Result Unstructured Data: Test Result:increase; Comments: A second blood test on day 14; Test Date: 2011; Test Name: bilirubin; Result Unstructured Data: Test Result:normal; Test Date: 20210306; Test Name: bilirubin; Result Unstructured Data: Test Result:decrease; Comments: A second blood test on day 14; Test Date: 20210225; Test Name: Total bilirubin; Result Unstructured Data: Test Result:137 umol/l; Comments: Blood test on day 5; Test Date: 20210223; Test Name: Blood glucose levels; Result Unstructured Data: Test Result:normal; Test Date: 20210223; Test Name: blood pressure; Result Unstructured Data: Test Result:105/93 mmHg; Test Date: 20210306; Test Name: blood test; Result Unstructured Data: Test Result:showed a decrease of bilirubin and CRP levels, but; Comments: a further increase of liver enzymes AST, ALT and ALP; Test Date: 2021; Test Name: blood test; Result Unstructured Data: Test Result:Hepatitis C; Test Date: 20210225; Test Name: C-reactive protein; Result Unstructured Data: Test Result:76 mg/l; Comments: Blood test on day 5; Test Date: 20210306; Test Name: C-reactive protein; Result Unstructured Data: Test Result:decrease mg/l; Comments: A second blood test on day 14; Test Date: 20210306; Test Name: CRP; Result Unstructured Data: Test Result:decrease; Test Date: 20210225; Test Name: Gamma-GT; Result Unstructured Data: Test Result:87 IU/l; Comments: Blood test on day 5; Test Name: GGT; Result Unstructured Data: Test Result:She had slightly increased liver enzymes; Test Date: 20210223; Test Name: heart rate; Result Unstructured Data: Test Result:92; Comments: bpm; Test Date: 20210225; Test Name: Hepatitis B anti-HBc; Test Result: Positive ; Comments: Blood test on day 5; Test Date: 20210225; Test Name: Hepatitis B anti-HBs; Result Unstructured Data: Test Result:51.3 MiU/mL; Comments: Positive Blood test on day 5; Test Date: 20210225; Test Name: Hepatitis B sAg; Test Result: Negative ; Comments: no viral replication Blood test on day 5; Test Date: 20210225; Test Name: Hepatitis C PCR; Result Unstructured Data: Test Result:269.229 IU/ml; Comments: positive Blood test on day 5; Test Date: 20210225; Test Name: Hepatitis C antibodies; Test Result: Positive ; Comments: Blood test on day 5; Test Date: 2021; Test Name: HCV; Result Unstructured Data: Test Result:elevated; Comments: HCV load increase a few days after vaccination; Test Date: 20210223; Test Name: oxygen saturation; Test Result: 95 %; Comments: [no dyspnea]; Test Date: 20210223; Test Name: Color of feces; Result Unstructured Data: Test Result:normal; Test Date: 20210223; Test Name: Rectal temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Comments: Two hours later; Test Date: 20210223; Test Name: Rectal temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210223; Test Name: Color of urine; Result Unstructured Data: Test Result:normal; Test Date: 20210223; Test Name: vital signs; Result Unstructured Data: Test Result:remained abnormal; Test Date: 20210225; Test Name: Leucocytes; Result Unstructured Data: Test Result:81 x10 9/l; Comments: Blood test on day 5
CDC Split Type: NLPFIZER INC202101210607

Write-up: loss of consciousness; coma; severe pain in the upper right abdomen, irradiating to the upper left abdomen; consciousness was decreased; chills; somnolence; hepatitis C reactivation; Liver failure; This is a literature report following Covid-19 vaccination. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (Covid- 19) emerged as a pandemic at the beginning of 2020. Several vaccines against Covid-19 have been developed with unprecedented speed, some of them using novel technologies such as mRNA-based approaches. While large Phase 3 trials provided evidence for efficacy and safety, registration of post-licensing is crucial for future safe use of these novel technologies. Here, we report a case of a hepatitis C virus reactivation following COVID-19 vaccination using the mRNA-based anti- COVID19 vaccine produced by BioNTech/Pfizer. A 82 years old woman with dementia [Alzheimers disease] was admitted to a nursing home in 2020. Her medical history included hepatitis C infection [2007], hepatitis B infection [1980], diabetes mellitus type 2 [2005], essential hypertension [2001], osteoarthritis [2007], portal hypertension with esophageal varices [2015], hepatic cirrhosis with thrombocytopenia, and allergy to wasp sting [2014]. She had slightly increased liver enzymes [AST, ALT, GGT, ALP], but normal bilirubin [since 2011]. The patient never tested positive for COVID - 19. On 21 February 2021, the patient was vaccinated against COVID-19 using Pfizer-BioNTech COVID-19 vaccine [first dose]. During the first two days after the first vaccination, no symptoms or signs were observed. On day 3 (23Feb2021) after vaccination jaundice, somnolence and chills were noticed. On clinical examination there was an obvious jaundice of skin and sclerae; her consciousness was decreased. Rectal temperature 38.1C, heart rate 92 bpm, oxygen saturation 95% [no dyspnea], blood pressure 105/93 mmHg. Two hours later rectal temperature was 37.4C, consciousness was somewhat improved, whereas other vital signs remained abnormal. Color of urine and feces was normal. Blood glucose levels were normal. Between day 4 and 10 the patient consciousness improved and the jaundice cleared. After day 10 (02Mar2021) of follow-up manifest jaundice again increased, accompanied by severe pain in the upper right abdomen, irradiating to the upper left abdomen, followed by loss of consciousness, coma and death on day 23 (15MAR2021). Hepatitis C was confirmed by the blood test. Patient refused treatment with hepatitis C medication. A second blood test on day 14 (06Mar2021) showed a decrease of bilirubin and CRP levels, but a further increase of liver enzymes AST, ALT and ALP. An 82-year old woman with multiple morbidities had reactivation of hepatitis C infection after vaccination with the mRNA-based Pfizer-BioNTech COVID-19 vaccine. Injection of fragments of mRNA that encode viral antigens induces a long-term immune response against COVID-19. Most frequently occurring side effects are mild, with transient fatigue and headache being the most common, followed by (in order of frequency): pain and swelling at the injection site, muscle aches, chills, joint pain, fever [more common after the second dose] and allergic reactions.2,3 However, the short-term experience with this new type of vaccines needs to be complemented by careful observation of the population after large-scale introduction of the vaccine, in order to monitor the occurrence of rare side effects. In our patient a strong increase in HCV load occurred a few days after vaccination. While we cannot exclude a coincidental occurrence of the HCV load increase by chance after the vaccination, a causal relationship seems likely given the close temporal proximity of vaccine administration and the elevated HCV. An alternative explanation is that she used oxycodone, which may induce cholestasis and thereby possibly viral reactivation. However, low-dose (5 mg daily) oxycodone had been already started six weeks before vaccination, i.e. without a close temporal proximity to HCV reactivation. In addition, one might argue that there had been a sustained viral response after the onset of hepatitis C in 2007, which, however, did not cause jaundice. Rather, an inflammatory response to the vaccine (in combination with the presence of viral replication) could have been sufficient to cause decay of liver cells, leading to her symptoms and severity of the disease. However, after the episode of hepatitis C in 2007, no other episodes of jaundice or other symptoms of liver disease occurred, apart from a stable slight increase in liver enzymes. Moreover, an episode of pneumonia six months before the current episode was not followed by any of these liver symptoms. However, in the absence of HCV viral load measurements between 2007 and 2020, we cannot fully rule out this possibility.The most likely explanation therefore is an HCV reactivation, caused by the COVID-19 vaccination. It is known for other vaccines that they can cause virus reactivation, especially in immunosuppressed patients and patients undergoing cancer treatment, eg as described for the herpes zoster subunit vaccine, causing reactivation of herpes zoster stromal keratitis.4 SARS-CoV-2 encoded proteins [and some anti- COVID-19 drugs] are able to induce reactivation of Kaposis sarcoma-associated herpesvirus.5 Hepatitis C virus reactivation has been described in patients receiving cancer treatments, in whom HCV reactivation occurred in 23% of patients.6 Another study revealed that psoriasis patients with hepatitis C infection were at risk for HCV reactivation with the use of biologic therapies.So far, no virus reactivations have been described after COVID-19 vaccination. We can only speculate on the mechanisms through which vaccination could have reactivated HCV. One possibility, as in the case of Kaposi sarcoma-associated herpesvirus, is that SARS-CoV-2 encoded proteins may cause reactivation of the hepatitis C virus. Alternatively, an indirect mechanism through induction of inflammation and cytokines, that would subsequently influence viral replication, is also possible. Finally, from another perspective, a COVID vaccination followed by jaundice may reveal [by supplementary diagnostics] a previously unrecognized but now reactivated hepatitis C infection. Conclusion This study describes a case of hepatitis C reactivation following COVID-19 vaccination. The patient received no hepatitis C medication and died three weeks following COVID-19 vaccination of liver failure. No other cases with a history of HCV infection and cirrhosis with a similar fatal course following COVID-19 vaccination have been described. This suggests a need for critical consideration of individuals with prior HCV infection and considered for COVID-19 vaccination. Blood test on day 5 (25Feb2021) showed: Total bilirubin 137 [ref 3-20 umol/l], Conjugated bilirubin 102 [ref 0-4 umol/l], Alkaline phosphatase 120 [ref 0-98 U/l], Gamma-GT 87 [ref 0-38 IU/l], Aspartate transaminase 113 [ref 0-31 U/l], Alanine transaminase 92 [ref 0-34 U/l], C-reactive protein 76 [ref 0-5 mg/l], Leucocytes 81 [ref 40-100 10x^9/l], Hepatitis C PCR positive [269.229 IU/ml], Hepatitis C antibodies positive, Hepatitis B sAg negative; no viral replication, Hepatitis B anti-HBs positive [51.3 mIU/ml], Hepatitis B anti-HBc positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: unchecked the product not administered field.; Sender''s Comments: Based on close temporal relationship the causal association between the events hepatitis c relapse, hepatic failure, abdominal pain, loss of consciousness, coma and decreased level of consciousness with the vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: hepatitis C reactivation; liver failure


VAERS ID: 1717629 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101193461

Write-up: Sudden death; This is a spontaneous report from a contactable nurse via Regulatory Authority. Regulatory authority report number is AEFI-A-010309.A 50-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 10Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sudden death on 10Aug2021 01:45. Outcome of event was fatal.The patient died on 10Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sudden death


VAERS ID: 1717632 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Malaise, Seizure, Vaccination site pain
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210930559

Write-up: SEIZURE; JOINT PAIN; BODY MALAISE; BODY WEAKNESS; PAIN ON INJECTION SITE; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA, PH-PHFDA-300105513] concerned a 76 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 ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A (Batch 1), and expiry: unknown) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 07:00, the patient experienced pain on injection site. On 08-SEP-2021 at 07:00, the patient experienced joint pain, body malaise, body weakness, and on the same day at 09:00, the patient experienced seizure. On an unspecified date, the patient died from pain on injection site, joint pain, body malaise, body weakness, and seizure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain on injection site, joint pain, body malaise, body weakness, and seizure was fatal. This report was serious (Death).; Sender''s Comments: V0: 20210930559-covid-19 vaccine ad26.cov2.s-seizure, pain on injection site, joint pain, body malaise, body weakness. 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: PAIN ON INJECTION SITE; JOINT PAIN; BODY MALAISE; BODY WEAKNESS; SEIZURE


VAERS ID: 1717685 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELU2243 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocardial infarction, Nausea, SARS-CoV-2 test, Thrombosis
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Covid-19 test; Test Result: Negative ; Comments: During autopsy
CDC Split Type: PTPFIZER INC202101215878

Write-up: thrombosis that caused a fatal heart attack; thrombosis that caused a fatal heart attack; Chest pain; Nausea; This is a spontaneous report from a contactable other HCP, the patient''s daughter. A 76-years-old female patient received bnt162b2 (COMIRNATY) at the age of 76-years, dose 1 intramuscular, administered in Arm Left on 08Apr2021 at 09:45 (lot number: ELU2243) as dose 1 single for COVID-19 immunisation. The vaccine was administered on a military base. There was no relevant medical history. The patient didn''t receive any concomitant medications within 2 weeks of vaccination with the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient started feeling nausea on 10Apr2021 and chest pain on 11Apr2021. The patient died on 12Apr2021 at noon from thrombosis that caused a fatal heart attack, the events caused Emergency Room Visit. The patient underwent tests and procedures which included COVID-19 test: negative in Apr2021 (during autopsy). The reported cause of death was thrombosis that caused a fatal heart attack. An autopsy report is available. No treatment received for the events. Outcome of the events nausea and chest pain was not recovered/not resolved Follow-up attempts are completed. No further Information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Myocardial infarction and Thrombosis cannot be totally 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: thrombosis that caused a fatal heart attack; thrombosis that caused a fatal heart attack


VAERS ID: 1717695 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Cerebral haemorrhage; Intra-abdominal metastases (abdominal cavity and lungs); Pulmonary metastases (abdominal cavity and lungs); Sarcoma metastatic (right foot)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT; Result Unstructured Data: Test Result:gives strong suspicion that the bleeding originate; Comments: from a cerebral metastasis
CDC Split Type: SEPFIZER INC202101193999

Write-up: Cerebral bleeding; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is SE-MPA-2021-024547. Additional reference number includes SE-MPA-1617110501540. A 48-year-old male patient received BNT162B2 (Batch/Lot Number: EJ6134), via intramuscular, on Jan2021 (at the age of 48 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included cerebral haemorrhage, metastatic sarcoma right foot on unspecified date in 2021, pulmonary metastases to the abdominal cavity and lungs. On unspecified date in Jan2021, it was reported that the patient experienced cerebral bleeding (death) and he died 3 days after the vaccination (also reported 2 days after the vaccination). The reported adverse event occurred on the same day as the vaccination. The reporter stated that the bleeding appearance in the computerized tomography (CT) gave a strong suspicion that the bleeding originated from a cerebral metastasis. The patient has had an advanced cancer disease based on a sarcoma in the right foot in 2012, which has given extensive metastases to the abdomen and the lungs. The reporter did not consider that there was a direct causal link to vaccination, the report was sent with regard to temporal coincidence which has also been pointed out by a relative. The patient died on unspecified date in 2021. 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: Cerebral hemorrhage.


VAERS ID: 1718611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210936417

Write-up: DEATH; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, frequency one total, administered on upper left arm on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the patient died after receiving the Janssen COVID 19 vaccine from unknown cause. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210936417-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: 1718614 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-06-25
   Days after vaccination:164
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cytomegalovirus infection, Thrombotic microangiopathy
SMQs:, Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 60
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: RUXOLITINIB; ENTOCORT; ASAFLOW; BISOPROLOL FUMARATE; DIFLUCAN; EFEXOR-EXEL; HYDROCORTISONE; L-THYROXINE [LEVOTHYROXINE]; LORMETAZEPAM EG; MELATONINE; PANTOMED [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; GANCICLOVIR; PENTAMIDINE
Current Illness: Stem cell transplant
Preexisting Conditions: Medical History/Concurrent Conditions: Acute GVH disease; Acute myeloid leukaemia (aml (diagnosed on 28Aug2019)in second complete remission); Blood pressure high; CMV infection; Diabetes; Enterocolitis bacterial (enterocolitis due to E Coli infection treated by Quinolones)); Stroke; Transient ischemic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101206912

Write-up: signs of transplant associated thrombotic microangiopathy TA-TMA with increased LDH levels; CMV infection with a high viral load (26140 UI/L); IMPACT OF THE IMMUNE SYSTEM ON RESPONSE TO COVID-19 VACCINE IN ALLOGENEIC STEM CELL RECIPIENTS (COV-ALLO STUDY) This is a report from a non-Pfizer Sponsored Interventional Study source for Protocol TJB2101 from a contactable Physician and a Nurse. A 51-year-old female subject received bnt162b2 (Pfizer), dose 1 via intramuscular on 16Jun2021 at age of 51-year-old as single dose, dose 2 intramuscular on 07Jul2021 at age of 51-year-old as single dose for COVID-19 immunisation, tacrolimus from 12Jan2021 to 02Jul2021 at unspecified dose for an unspecified indication. Medical history included stroke from 2017, transient ischemic attack 2019, high blood pressure, secondary diabetes cortico induced, hematopoietic stem cell allograft on 15Jan2021, AML (diagnosed on 28Aug2019) in second complete remission, gut acute GVH grade III from 27Jan2021, CMV (Cytomegalovirus) infection from 17May2021, enterocolitis due to E Coli infection treated by Quinolones) from 31May2021. Concomitant medications included ruxolitinib taken for GVH (Graft versus host) disease from 03Feb2021; budesonide (ENTOCORT) from 25Jun2021; acetylsalicylic acid (ASAFLOW); bisoprolol fumarate; fluconazole (DIFLUCAN); venlafaxine hydrochloride (EFEXOR-EXEL); hydrocortisone; levothyroxine (L-THYROXINE); lormetazepam (LORMETAZEPAM EG); melatonine; pantoprazole sodium sesquihydrate (PANTOMED); ganciclovir taken for CMV from 19May2021 to 14Jun2021, then from 09Jul2021 to an unspecified stop date; pentamidine. The subject previously took quinolones for enteropathogen E. Coli infection from 31May2021. The subject experienced signs of transplant associated thrombotic microangiopathy TA-TMA with increased LDH levels on 25Jun2021, CMV infection with a high viral load (26140 UI/L) on 07Jul2021. Clinical course: The subject received a hematopoietic stem cell allograft from an HLA-identical sibling donor on 15Jan2021 for the management of AML (diagnosed on 28Aug2019) in second complete remission at transplantation. This allograft was complicated by gut acute GVH (grade III on 27Jan2021) that was steroid-refractory but responded to savlage treatment with ruxolitinib started on 03Feb2021. She presented a CMV infection on 17May2021 that responded slowly to ganciclovir and valganciclovir. On 31May2021, she was diagnosed with an enterocolitis due to an enteropathogen E. Coli infection (treated by quinolones). Subject was vaccinated with Comirnaty anti COVID-19 vaccine by 16Jun2021. On 25Jun2021 the subject presented with diarrhea (in a context of decreasing dose of ruxolutinib). At the same time she developed signs of transplant-associated thrombotic microangiopathy (TA-TMA) with increased LDH levels, worsening of her chronic renal failure and presence of schizocytes. The TA-TMA was attributed to GVDH, concurrent tacrolimus medication, recent E-coli enterocolitis and CMV infection (a demonstrated possible trigger of TA-TMA). The GVHD was treated by restarting full dose of ruxolitinib and adding photophoresis (PCE) and entocort while the tacrolimus was discontinued as an attempt to improve the TA-TMA. The GVHD improved rapidly with this new treatment. On 07Jul2021 she presented with a new CMV infection with a high viral load (26140 UI/L). The subject received the second dose of Comirnaty on 07Jul2021. On 19Jul2021 she had a severe worsening of her TA-TMA and she was hospitalized at the ICU. The most probable cause of this worsening is the recurrent CMV infection but a role for the Comirnaty vaccination cannot be ruled out. Unfortunately the TA-TMA worsened despite treatment with plasmapheresis, corticosteroids and Eculizumab and the subject died on 24Aug2021 from refractory TA-TMA. The action taken in response to the events for bnt162b2 was not applicable, for tacrolimus was temporarily withdrawn on 02Jul2021. Therapeutic measures were taken as a result of the events. The subject died on 24Aug2021. It was not reported if an autopsy was performed. The lot number for bnt162b2, was not provided and will be requested during follow up. This is a preliminary report for notification of a fatal event.; Sender''s Comments: The events " thrombotic microangiopathy and Cytomegalovirus infection" are unlisted in the Safety Document (SD) of the vaccine (BNT162B2). There is not a reasonable possibility that the events are related to vaccine administration based on the absence of a plausible pathophysiological mechanism by which the vaccine would be expected to cause these events. Additionally, the patient''s underlying condition, CMV infection, and concomitant treatment provide a more plausible explanation for the event. The case will be re-assessed upon receipt of additional information. Pfizer''s safety database was reviewed for cases reporting BNT162B2 or blinded therapy through 31-AUG-2021 for adverse events encoding to MedDRA (v.24.0J) Preferred Term(s) of Cytomegalovirus infection; Thrombotic microangiopathy. Review of the database for the PT Cytomegalovirus infection had the following results: 0 serious clinical trial cases (0 of which were attributed to therapy) and 18 non clinical trial cases. Review of the database for the PT Thrombotic microangiopathy had the following results: 0 serious clinical trial cases (0 with fatal outcome) (0 of which were attributed to therapy) and 16 non clinical trial cases (2 with fatal outcome). The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study 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 Committee and Investigators, as appropriate.; Reported Cause(s) of Death: refractory TA-TMA; chronic renal failure aggravated; CMV infection with a high viral load (26140 UI/L)


VAERS ID: 1718622 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20213

Write-up: 19 year old woman got the Moderna vaccine in and died the next day.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (19 year old woman got the Moderna vaccine in and died the next day.) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant and treatment medications were reported. This case concerns a 19 year-old female patient with no details on past medical history, with unexpected events reported of Death which was happed one day after the administration of Moderna Vaccine (date of vaccination not reported including the dose number). The reported cause is unknown including if an autopsy was done. The benefit risk relationship of Moderna vaccine is not affected by this report. This case was linked to MOD-2021-319899 (Patient Link).; Sender''s Comments: This case concerns a 19 year-old female patient with no details on past medical history, with unexpected events reported of Death which was happed one day after the administration of Moderna Vaccine (date of vaccination not reported including the dose number). The reported cause is unknown including if an autopsy was done. The benefit risk relationship of Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1720548 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-31
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? Yes
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PLENDIL ACTIVE INGREDIENT EXTENDED-RELEASE TABLET; METOPROLOL
Current Illness: Hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: EEJNJFOC20210934596

Write-up: PULMONARY EMBOLISM; This spontaneous report received from a physician via Regulatory Authority (EE-SAM-50002109052) 17-SEP-2021 concerned a 90 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE423 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 13-AUG-2021 for active immunization. Concomitant medications included felodipine, and metoprolol. On 31-AUG-2021, the patient experienced pulmonary embolism, and was hospitalized (date unspecified). On 31-AUG-2021, the patient died from unknown cause of death. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1720648 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7C1BSA / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac disorder, Foetal death
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (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: Aucun
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101218927

Write-up: The baby''s heart stopped beating; The baby''s heart stopped beating; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority FR-AFSSAPS-LL20216048. This consumer reported information for both mother and fetus/baby. This is the fetus/baby report. A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 12Aug2021 (Lot Number: FE7C1BSA) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The mother pregnant in her 1st trimester, vaccinated on 12Aug2021 at 6 weeks pregnant. On 19Aug2021 the parent had a miscarriage (metrorrhagia presenting symptom). The baby''s heart stopped beating. Though on her follow-up visit on 10Aug2021 the heart was beating. Ultrasound on 19Aug2021: interrupted pregnancy at 9 weeks. The baby died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101166496 Maternal/baby case; Reported Cause(s) of Death: The baby''s heart stopped beating; The baby''s heart stopped beating


VAERS ID: 1720908 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Maternal exposure timing unspecified, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101181744

Write-up: pregnant and was vaccinated and still died of Covid-19; pregnant and was vaccinated and still died of Covid-19; pregnant and was vaccinated and still died of Covid-19; This is a spontaneous report from a non-contactable consumer. This consumer reported the same events for three patients. This is one three reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient was pregnant and was vaccinated and still died of Covid-19 on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101181745 same reporter, drug, and events; different patient.;GB-PFIZER INC-202101181747 same reporter, drug, and events; different patient.; Reported Cause(s) of Death: pregnant and was vaccinated and still died of Covid-19; pregnant and was vaccinated and still died of Covid-19


VAERS ID: 1720909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Maternal exposure timing unspecified, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101181745

Write-up: pregnant and was vaccinated and still died of COVID-19; pregnant and was vaccinated and still died of COVID-19; Reports 3 women who were pregnant and were vaccinated and still died of Covid-19; This is a spontaneous report from a non-contactable consumer. This consumer reported the same events for three patients. This is one of the three reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number unknown, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that the patient was pregnant and was vaccinated and still died of COVID-19 on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101181744 Same reporter, drug, and events; different patient;GB-PFIZER INC-202101181747 Same reporter, drug, and events; different patient; Reported Cause(s) of Death: pregnant and was vaccinated and still died of Covid-19; pregnant and was vaccinated and still died of Covid-19


VAERS ID: 1720910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Maternal exposure timing unspecified, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101181747

Write-up: pregnant and was vaccinated and still died of Covid-19; pregnant and was vaccinated and still died of Covid-19; pregnant and was vaccinated and still died of Covid-19; This is a spontaneous report from a non-contactable consumer. This consumer reported the same events for three patients. This is one of the three reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that patient was pregnant and was vaccinated and still died of Covid-19 on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101181745 Same reporter, drug, and events; different patient;GB-PFIZER INC-202101181744 same reporter, drug, and events; different patient.; Reported Cause(s) of Death: pregnant and was vaccinated and still died of Covid-19; pregnant and was vaccinated and still died of Covid-19


VAERS ID: 1720964 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
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 INC202101226191

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional. (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003431), license party for bnt162b2 (COMIRNATY). This case was split for 1 of 4 death cases. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 05-Sep-2021, Regulatory Authority received four death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. This case was split for 1 of 4 death cases. A 57-year-old female patient started to receive COVID-19 vaccine on unspecified date via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. This case was not associated with vaccination by the Expert Committee. The event unknown cause of death met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done and the reported cause of death was unknown. Initial report was received on 09-Sep-2021. 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: 2021FOS003425 (master case), 2021FOS003427, 2021FOS003431, 2021FOS003432, 2021FOS003433, 2021FOS003434 and 2021FOS003435. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. Company Remarks: The medical review comments of Department on the reports of Death is as follows: The seriousness of Death is 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 is considered as possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101223237 same reporter/product, different patient/event; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1720965 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
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: HKPFIZER INC202101226192

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (Regulatory authority report number: not provided/ The regulatory authority report number is not applicable), based on information received by Pfizer from a company (manufacturer control number: HK-Fosun-2021FOS003432), license party for bnt162b2 (COMIRNATY). This is one of seven reports. In the preceding week till 11:59 pm on 05-Sep-2021, regulatory authority received four death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. This case was split for 1 of 4 death cases. A 74-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via unknown route on an unspecified date as Dose Number Unknown, Single for covid-19 immunisation. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The case was pending assessment by the Expert Committee. On an unspecified date patient experienced unknown cause of death. The patient died on an unspecified date. It was unknown if an autopsy was performed. The event unknown cause of death met the seriousness criterion of death the reported cause of death was unknown. Initial report was received on 09Sep2021. This is one of seven reports received from the same reporter and this case has been linked with others. Company is a marketing authorization holder of one of COVID-19 vaccine Tozinameran in this country. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Company comment: The medical review comments of the company on the reports of Death is as follows: The seriousness of Death is: 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 is considered as possible. Follow-up closed, no further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101223237 same reporter, suspect, different patients.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1720966 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
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 INC202101226197

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via the Regulatory Authority (Regulatory authority report number: not provided), based on information received by a company from company 2 (manufacturer control number: HK-Fosun-2021FOS003434), license party for BNT162B2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 05-Sep-2021, DH received four death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. This case was split for 1 of 4 death cases. A 66-years-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death (death) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. There was no clinical evidence that the incident arose from vaccination. The case was pending assessment by the Expert Committee. The event unknown cause of death met the seriousness criterion of death. Initial report was received on 09-Sep-2021. 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: 2021FOS003425 (master case), 2021FOS003427, 2021FOS003431, 2021FOS003432, 2021FOS003433, 2021FOS003434 and 2021FOS003435. Company is a marketing authorization holder of one of COVID-19 vaccine Tozinameran. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. Company Remarks: The medical review comments of Department on the reports of Death is as follows: The seriousness of Death is: 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 is considered as possible. Company comment: The medical review comments of Department on the reports of Death is as follows: The seriousness of Death is: 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 is considered as possible. Causality Assessment for event death as per reporter and company was possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101223237 same reporter/product, different patient/event; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1721117 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-20
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101209349

Write-up: cardiac arrest; great difficulty in breathing; severe pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Agency-WEB, regulatory authority number IT-MINISAL02-783262. An 81-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot number: unknown), via intramuscular in right arm on 30Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number: unknown) on 26Feb2021 at single dose for COVID-19 immunisation. Healthy heart. After second vaccination, patient experienced severe pain and great difficulty in breathing on 20Apr2021. Patient was admitted on 24Apr2021 and kept under observation. More than 2 litres of water were sucked from the lungs twice and the patient was sedated. Impact on quality of life (10/10). The patient was hospitalized for events from 24Apr2021. Patient died of cardiac arrest on the night of 04May2021. Therapeutic measures were taken as a result of events. The outcome of event cardiac arrest was fatal. The outcome of other events was unknown. The patient died on 04May2021. It was not reported if an autopsy was performed. Sender''s comments: Obviously, reporter had updated the sheet and sent a request for further information to the reporter. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1721184 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Atrial fibrillation, Blood pressure measurement, Body temperature, Cyanosis, Depressed level of consciousness, Electrocardiogram, Heart rate, Heart rate decreased, Oxygen saturation, Weight, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RENIVACE; TOUGHMAC E; GASCON [DIMETICONE]; THYRADIN S; GOOFICE; SODIUM FERRIC CITRATE
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Apnoea (Although the patient restored breathing soon, the patient was transferred to another hospital.); Cerebral palsy; Hospitalization NOS; Intellectual disability; Oedema extremities; Pneumonia aspiration; Respiratory arrest (Although the patient restored breathing soon, the patient was transferred to another hospital.)
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: blood pressure; Result Unstructured Data: Test Result:could not be measured; Comments: at 13:00; Test Date: 20210806; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: Before vaccination; Test Date: 20210806; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:atrial fibrillation and arrhythmia; Comments: at 13:13; Test Date: 20210806; Test Name: pulse rate; Result Unstructured Data: Test Result:around 50; Test Date: 20210807; Test Name: pulse rate; Result Unstructured Data: Test Result:decreased; Comments: at around 03:20; Test Date: 20210806; Test Name: SpO2; Result Unstructured Data: Test Result:92 to 94 %; Comments: at 13:00; Test Date: 20210806; Test Name: SpO2; Test Result: 65 %; Comments: at 16:15; Test Date: 20210806; Test Name: SpO2; Result Unstructured Data: Test Result:90 or higher %; Comments: with use of oxygen; Test Name: Weight; Result Unstructured Data: Test Result:36.2 to 36.1 kg; Comments: during 3 months before the hospitalization; Test Date: 20210703; Test Name: Weight; Test Result: 39.6 kg; Test Date: 20210801; Test Name: Weight; Test Result: 35.4 kg
CDC Split Type: JPPFIZER INC202101191946

Write-up: heart rate decreased; wheezing; atrial fibrillation; arrhythmia; Cyanosis; depressed level of consciousness; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21126537. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Aug2021 09:35 (at the age of 67 years old, Lot Number: FF0843; Expiration Date: 31Oct2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cerebral palsy, intellectual disability (being admitted to an institution for patients with severe psychosomatic disorder), respiratory arrest (apnoea) from 31May2021, pneumonia aspiration and hospitalization due to pneumonia aspiration from 31May2021 to 29Jun2021, Severe oedema of extremities and stopped, ongoing hypertension. Concomitant medications included enalapril maleate (RENIVACE) via oral for hypertension and levothyroxine sodium (THYRADIN S) for respiratory arrest ; enzymes nos (TOUGHMAC E), dimeticone (GASCON [DIMETICONE]), elobixibat (GOOFICE), sodium ferric citrate (SODIUM FERRIC CITRATE) all via oral taken for an unspecified indication, start and stop date were not reported. Clinical course was reported as below: Body temperature before vaccination was 37.1 degrees centigrade on 04Aug2021. The family history was not provided. The patient had cerebral palsy and intellectual disability and was being admitted to an institution for patients with severe psychosomatic disorder. The vaccination and new onset of the disease within recent one month were reported as none. There was nothing significant to be noted about adverse drug event in the past. On 04Aug2021 at 09:35 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization.On 31May2021, the patient had respiratory arrest (apnoea). Although the patient restored breathing soon, the patient was transferred to another hospital.From 31May2021 to 29Jun2021, the patient was admitted to a hospital for the treatment of pneumonia aspiration. On 29Jun2021, the patient was discharged from the hospital. A nasogastric (NG) tube was inserted. The patient was in the condition of fasting and no drinking fluid. Oedema of extremities was severe, and the body weight was 39.6 kg (on 03Jul2021); however, oral intake was resumed. The drink of green tea was almost stopped, and the patient could drink only a small amount. Meal intake was gradually initiated. The oedema of extremities disappeared. The body weight improved to 35.4 kg on 01Aug2021, which improved than that of on hospitalization (the patient had oedema lower limb before the hospitalization, and the body weight during 3 months before the hospitalization was 36.2 to 36.1 kg.) On 06Aug2021, at 13:00 (2 days after the vaccination), after lunch, the patient had pallor facial, cyanosis peripheral, and coldness. Although the SpO2 was 92 to 94%, the heart rate was around 50, and the blood pressure could not be measured, and the patient had depressed level of consciousness. At 13:13, electrocardiogram (ECG) showed atrial fibrillation and arrhythmia. Since no improvement was observed, a drip infusion of SOLDEM 3A, a maintenance fluid, was initiated. At 14:30, the consciousness level slightly improved. At 15:00, the patient held eye contact in response to speaking to the patient, and the consciousness level obviously improved. Although the patient had a poor complexion, the lip color slightly improved. At 16:00, the consciousness level became almost as usual, and his face got slightly red. At 16:15, the SpO2 suddenly decreased to 65%. The patient had wheezing. Although oxygen administration via mask was initiated, the patient had jaw breathing and cyanosis in the upper and lower extremities. Although blood pressure decreased was observed, illegible characters, and no obvious depressed level of consciousness was noted. SpO2 increased to 90% or higher with use of oxygen. Since the family members wished treatment and deathwatch, the treatment and follow-up were performed; however, the heart rate decreased on 07Aug2021 at 03:20. on 07Aug2021 at 03:51, the patient died. An autopsy was not performed. The outcome of Cyanosis was fatal, for event depressed level of consciousness was resolved on 06-AUG-2021 16:00 and for other events was unknown. The reporting physician classified the event Cyanosis as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Although the patient had severe psychosomatic disorder, he had no epilepsy, and hypertension was maintained favorably with oral administration of enalapril maleate (RENIVACE). The respiratory function was normal with oral administration of levothyroxine sodium hydrate (THYRADIN), and the recent condition was more favorable than that of before. The patient, who had no direct factor for death, suddenly developed and died 3 days after the vaccination. Thus, it was clinically judged that the death was related to the vaccination.; Reported Cause(s) of Death: Cyanosis


VAERS ID: 1721185 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-24
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Axillary vein thrombosis, Cardiovascular disorder, Computerised tomogram thorax, Erythema, Fibrin D dimer, Glomerular filtration rate, Lymphoedema, Oedema peripheral, Peripheral coldness, SARS-CoV-2 test, Subclavian vein thrombosis, Ultrasound scan
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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: ANAFRANIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obsessive-compulsive disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: APTT; Result Unstructured Data: Test Result:27.9; Test Date: 20210910; Test Name: Chest contrast-enhanced CT; Result Unstructured Data: Test Result:led to a diagnosis of left axillary-subclavian vei; Comments: led to a diagnosis of left axillary-subclavian vein thrombus (no pulmonary embolus); Test Date: 20210910; Test Name: D-dimer; Result Unstructured Data: Test Result:2.28; Test Date: 20210910; Test Name: eGFR; Result Unstructured Data: Test Result:46.4; Test Date: 20210910; Test Name: Antigen test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210910; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210910; Test Name: Ultrasound; Result Unstructured Data: Test Result:showed left axillary vein thrombus without DVT
CDC Split Type: JPPFIZER INC202101193327

Write-up: Left axillary-subclavian vein thrombus; Left axillary-subclavian vein thrombus; Left-upper-limb venous return disorder; lymphoedema; coldness in the whole part of the left upper limb; oedema of the left upper limb; oedema of the left upper limb and mild redness; This is a spontaneous follow-up report from a contactable pharmacist via regulatory authority. A 55-year-old female patient (not pregnant) received the second dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 03Aug2021 (Lot Number: Unknown) at the age of 55-year-old as single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at hospital. Medical history included obsessive-compulsive disorder. There was no relevant past drug history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included clomipramine hydrochloride (ANAFRANIL) taken for obsessive-compulsive disorder. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The clinical course was as follows: On 24Aug2021 at unknown time, 21 days after the vaccination, the patient experienced left axillary-subclavian vein thrombus. On 03Aug2021 (the day of vaccination), the patient received the second vaccination. On 24Aug2021 (21 days after the vaccination), oedema of the left upper limb and mild redness developed. On 07Sep2021 (35 days after the vaccination), the patient presented to the dermatology department at the reporting hospital with oedema and coldness in the whole part of the left upper limb. Left-upper-limb venous return disorder or lymphoedema was suspected, and a consultation with the vascular surgery department was made. On 10Sep2021 (38 days after the vaccination), the patient visited the hospital. Ultrasound showed left axillary vein thrombus without deep vein thrombosis (DVT). The estimated glomerular filtration rate (eGFR) was 46.4, the activated partial thromboplastin time (APTT) 27.9, and the D-dimer 2.28. Chest contrast-enhanced computerised tomography (CT) led to a diagnosis of left axillary-subclavian vein thrombus (no pulmonary embolus). On the same date, antigen test and polymerase chain reaction (PCR) test of a nasal swab sample were negative. The event resulted in death. The death cause was not reported. It was not reported whether autopsy was performed. Anticoagulant therapy (continuous heparin) and compression therapy were given for treatment of the adverse events. The reporting pharmacist assessed the events as serious (death, life threatening, hospitalization). The causality of the events was not reported. Autopsy was not reported. The outcome of axillary vein thrombosis and subclavian vein thrombosis was fatal. The outcome of other events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Axillary vein thrombosis and Subclavian vein thrombosis and 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: Left axillary-subclavian vein thrombus; Left axillary-subclavian vein thrombus


VAERS ID: 1722075 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-06
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Overgrowth fungal, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUTTERCUP BRONCHOSTOP [THYMUS VULGARIS;THYMUS ZYGIS]
Current Illness: Dysautonomia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210808; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Overgrowth fungal; This case was received via RA (Reference number: 102403) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OVERGROWTH FUNGAL (Overgrowth fungal) in a 44-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Dysautonomia. Concomitant products included THYMUS VULGARIS, THYMUS ZYGIS (BUTTERCUP BRONCHOSTOP [THYMUS VULGARIS;THYMUS ZYGIS]) for Dysautonomia. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced OVERGROWTH FUNGAL (Overgrowth fungal) (seriousness criteria death and medically significant). The patient died on 07-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided. Company Comment: This case refers to a 44-year-old male patient with a medical history of Dysautonomia who experienced the unexpected event of Overgrowth Fungal approximately 1 month after the first dose of Spikevax. She eventually died one day later from an unspecified cause. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case refers to a 44-year-old male patient with a medical history of Dysautonomia who experienced the unexpected event of Overgrowth Fungal approximately 1 month after the first dose of Spikevax. She eventually died one day later from an unspecified cause. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1723496 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-22
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: BRPFIZER INC202101240098

Write-up: death; This is a spontaneous report received from a contactable consumer (unspecified relationship with the patient) from Medical Information Team. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was reported the reporter knew about a person''s death. The outcome of event was fatal. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death


VAERS ID: 1723676 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Depression; Restless leg syndrome; Wheelchair user
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101215718

Write-up: Found dead (cause undetermined); This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-202100188937. A 89-year-old Female patient received bnt162b2 (COMIRNATY) on 07Sep2021 at the age of 89-year-old (Batch/lot number: UNKNOWN) as 0.3 single dose for COVID-19 immunisation. The patient''s medical history included Arterial hypertension, Depression, Restless leg syndrome, Wheelchair user. Concomitant medications were not reported. On 08Sep2021 the patient experienced Found dead (cause undetermined). This report is serious due to death. Result of Assessment: Comirnaty/ event:/ Agency: D. Unclassifiable. No Autopsy Done. The outcome of the event was fatal. No follow-up attempts possible. No further information expected. Information about LOT/Batch number can not be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1724165 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-07-11
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Asthenia, Gastric haemorrhage, Portal vein thrombosis
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101222500

Write-up: Gastric haemorrhage; weakness; Anemia; Death temporally related to the anti-Covid-19 vaccination; This is a spontaneous report from a non-contactable consumer or other non-health care professional downloaded from the regulatory authority number DE-PEI-CADR2021179021. Sender''s Safety Report Unique Identifier: DE-PEI-202100189239. A 76-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 21Apr2021 as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (comirnaty, solution for injection) via an unspecified route of administration, on an unspecified date. On 11Jul2021, patient had portal vein thrombosis, gastric haemorrhage, weakness, anemia. On 10Jul2021 the patient was hospitalized. Determination of diffuse gastric bleeding and diagnosis of a pronounced portal vein thrombosis; died on 11Jul2021; judicial autopsy has taken place; that revealed compatible with bleeding to death in the case of bleeding of the upper gastrointestinal tract. At present, a causal relationship between vaccination against Covid-19 and acute death cannot be ruled out.; Reported Cause(s) of Death: Portal vein thrombosis; Autopsy-determined Cause(s) of Death: Gastric haemorrhage


VAERS ID: 1724166 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 26
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 (Information on risk factors or previous illnesses: Obesity)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101222282

Write-up: Death related to vaccination; Pyrexia; Pain; often coughed conspicuously recently; This is a spontaneous report from a non-contactable consumer or other non-health care professional downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021179036. A 46-years-old male patient received first dose of bnt162b2 (mRNA tozinameran), (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 23Jul2021 as dose 1, 0.3 ml single for COVID-19 immunization. Medical history reported as information on risk factors or previous illnesses included obesity. No known allergies. Concurrent conditions and concomitant medications were not reported. On an unspecified date in Jul2021, after first vaccination, patient had the usual symptoms such as fever and pain, which had already subsided. On 27Jul2021, Patient found dead. It was reported that, according to the father, patient often coughed conspicuously recently. Judicial autopsy has taken place, Autopsy resulted as macroscopically unclear, suspicion of underlying haematological or lymphatic disease. If necessary, excerpts from the autopsy protocol can be requested. At present, a causal relationship between vaccination and acute death cannot be ruled out. The events as fever and pain was recovered on an unspecified date in Jul2021 and cough was not recovered. The patient was died on 27Jul2021. This report is serious with death. An autopsy was performed that revealed suspected underlying congenital haematological disorder and lymphatic insufficiency. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death; Autopsy-determined Cause(s) of Death: Congenital haematological disorder; Lymphatic insufficiency


VAERS ID: 1724167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-24
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Viagra
Current Illness: Deep vein thrombosis leg; Mitral valve prolapse; Pulmonary thromboembolism
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral edema; Venous thrombosis NOS limb
Allergies:
Diagnostic Lab Data: Test Name: cardiac catheter examination; Result Unstructured Data: Test Result:a cardiac catheter examination that has been carri; Comments: a cardiac catheter examination that has been carried out has no tangible cardiac cause of cardiovascular arrest
CDC Split Type: DEPFIZER INC202101222569

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable consumer downloaded from the (regulatory authority number: DE-PEI-CADR2021179050), Sender''s Safety Report Unique Identifier DE-PEI-202100189249, Case identifiers DE-CADRPEI-2021179050. A 53-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as 0.3ml single for COVID-19 immunisation; sildenafil citrate (VIAGRA, Film-coated tablet), via an unspecified route of administration from 24Aug2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included ongoing mitral valve prolapse, ongoing deep vein thrombosis leg, ongoing pulmonary artery thromboembolism, cerebral edema, calf vein thrombosis. The patient''s concomitant medications were not reported. The patient previously took first dose bnt162b2 (COMIRNATY) on 19Jun2021 for COVID-19 immunisation. The patient experienced infarct myocardial on 24Aug2021. This report is serious - death. The patient underwent lab tests and procedures which included catheterisation cardiac: a cardiac catheter examination that has been carried out has no tangible cardiac cause of cardiovascular arrest on unknown date. The action taken in response to the event for sildenafil citrate was not applicable. Therapeutic measures were taken as a result of event. Physician Office Visit for event. The patient died on 24Aug2021. An autopsy was performed and results were not provided. The outcome of event was fatal. Causality for Infarct myocardial and Comirnaty / Viagra was reported as: D. Unclassifiable (Source of assessment: regulatory authority). Sender Comment: "Are you or the person concerned known of any allergies? If yes, which? not known. Information on risk factors or previous illnesses: previously known: mitral valve prolapse; In the autopsy, among other things. Calf vein thrombosis as well as peripheral pulmonary artery thromboembolism and pronounced cerebral edema / second vaccination with Comirnaty on 31Jul2021; collapsed at home on 19Aug2021 (as reported); Resuscitation measures are only about 10 minutes when the rescue workers are alerted initiated after the event; a cardiac catheter examination that has been carried out has no tangible cardiac cause of cardiovascular arrest; consumed Viagra just before collapse; existing: mitral valve prolapse; currently there may be a causal relationship between vaccinations against Covid-19 and acute death cannot be completely ruled out; if necessary, excerpts from the section protocol can be requested" No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1724361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-08-26
   Days after vaccination:197
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatinine, Blood urea, COVID-19, Decreased appetite, Dehydration, Loss of consciousness, Neutrophil count, SARS-CoV-2 test, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-06
   Days after onset: 11
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: BISOPROLOL [BISOPROLOL FUMARATE]; CAPTOPRIL; PARACETAMOL A; NICARDIPINE; METFORMINE [METFORMIN]; ACETYLSALICYLATE LYSINE; MACROGOL P
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Diabetes; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: serum creatinine; Result Unstructured Data: Test Result:174 mmol/L; Test Date: 20210902; Test Name: urea; Result Unstructured Data: Test Result:32.86 mmol/L; Test Date: 20210902; Test Name: polynuclear neutrophils; Result Unstructured Data: Test Result:15.25 x10 9/l; Test Date: 20210826; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: mutation L452R
CDC Split Type: FRPFIZER INC202101216139

Write-up: resident unconscious; acute renal failure; dehydration; Loss of appetite; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other hcp downloaded from the a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-CN20212934. An 89-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot Number: EK9788), dose 2 via an intramuscular route, administered in Arm Right on 10Feb2021 as DOSE 2, SINGLE, and received BNT162B2 (COMIRNATY, solution for injection, Lot Number: EM0477), dose 1 intramuscular, administered in Arm Right on 20Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included stroke, diabetes and arterial hypertension. Concomitant medication included bisoprolol fumarate (BISOPROLOL [BISOPROLOL FUMARATE]), captopril, paracetamol (PARACETAMOL A), nicardipine, metformin, acetylsalicylate lysine (ACETYLSALICYLATE LYSINE), macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MACROGOL P). Patient did not have history of COVID-19 and PCR test. It was unknown if patient had a medical history of allergy. On 26Aug2021, patient was covid-19 confirmed by positive covid-19 test. This indicated the vaccination failure. PCR test was carried out as part of a general screening for Covid cluster. The test was found to be positive and there was presence of the mutation L452R. No sequencing information was reported. Patient was asymptomatic at the onset of the disease. On 01Sep2021, patient had loss of appetite. She did not eat any more, do not drink. Medical prescription for subcutaneous infusion, oral care and blood test. On 02Sep2021, patient experienced dehydration and acute renal failure. Her serum creatinine was 174 mmol/l, urea was 32.86 mmol/l polynuclear neutrophils was 15.25 x10 9/l. On 03Sep2021, decision was made to hospitalise the patient because there was no improvement, she was unconscious and had renal failure and was dehydrated. Going to the emergency room: No indication of care given in the context and history. Patient returned from hospital on the same day with a prescription for IV infusion, oxygen therapy and a blood test on 06Sep2021. The patient died on 06Sep2021. Autopsy was not performed. At the time of death, the outcome of event loss of appetite, dehydration, acute kidney injury and resident unconscious was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: covid-19 infection


VAERS ID: 1724388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-09-05
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood pH, COVID-19, Oxygen saturation, PCO2, PO2, 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: 2021-09-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cancer of prostate; Chronic renal failure (severe renal failure on vascular nephropathy with upcoming dialysis); Dyslipidemia; Hypercholesterolaemia; Hypertension arterial; Peripheral arterial occlusive disease; Recovered smoker; Sleep apnea
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: bicarbonates; Result Unstructured Data: Test Result:22 mmHg; Test Date: 20210905; Test Name: Blood pH; Result Unstructured Data: Test Result:7.39; Test Date: 20210905; Test Name: Oxygen saturation; Test Result: 90 %; Test Date: 20210905; Test Name: pCO2; Result Unstructured Data: Test Result:37 mmHg; Test Date: 20210905; Test Name: pO2; Result Unstructured Data: Test Result:61 mmHg; Test Date: 20210905; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: E484K, E484Q, L452R mutations uninterpretable
CDC Split Type: FRPFIZER INC202101222623

Write-up: COVID-19 confirmed by positive COVID-19 test; Vaccination failure; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20214861. A 82-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: EP9605) via intramuscular route of administration on 08Mar2021 as dose 2, 0.3ml Single and received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EJ6789) via intramuscular route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. Medical history included recovered smoker, Chronic renal failure, severe renal failure on vascular nephropathy with upcoming dialysis, Sleep apnea, AFib, Cancer of prostate from 2007, Hypertension arterial, Hypercholesterolaemia, Peripheral arterial occlusive disease, dyslipidemia. The patient concomitant medications were not reported. The patient had vaccination failure and COVID-19 on 05Sep2021. Hospitalization on 05Sep2021 for repeated falls and acute respiratory distress. On admission, patient G15, bilateral symmetrical vesicular murmur, bilateral crackles and diffuse sibilants, 90% saturation on 15L/min O2, polypnoeic and orthopnoeic with thoraco-abdominal sway, no cyanosis, no oedema of the lower limbs. The patient underwent lab tests and procedures which included blood bicarbonate: 22 mmhg on 05Sep2021, blood ph: 7.39 on 05Sep2021, oxygen saturation: 90 % on 05Sep2021, pco2: 37 mmhg on 05Sep2021, po2: 61 mmhg on 05Sep2021, sars-cov-2 test: positive on 05Sep2021 E484K, E484Q, L452R mutations uninterpretable. Therapeutic measures were taken with Oxygen therapy at 15L/min, initiation of treatment with dexamethasone 6mg/d, antibiotic therapy with ceftriaxone. Rapidly unfavourable evolution with death of the patient on 05Sep2021. Cause of death was reported due to COVID-19 pneumonia. Autopsy was performed but results were unknown. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1724394 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-08-13
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SD0168 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram, Diabetes mellitus, Fall, General physical health deterioration, Hepatic failure, Hypotension, Respiratory distress, Rhabdomyolysis, SARS-CoV-2 test, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic cirrhosis; Carcinoma hepatocellular; Oesophageal varices NOS (stage 1)
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: CT scan; Result Unstructured Data: Test Result:no pancreatic abnormality explaining the diabetes.; Comments: no pancreatic abnormality explaining the diabetes. Increase in lesions of chronic liver disease of cirrhosis with portosystemic diversion, ascites and splenomegaly.; Test Date: 20210818; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: no information on variant
CDC Split Type: FRPFIZER INC202101216033

Write-up: fall; respiratory distress; low blood pressure; Covid-19 confirmed by positive Covid-19 test; Vaccination failure; rhabdomyolysis; Diabetes; hepatocellular insufficiency; a deterioration in his general condition; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RS20212806. A 67-year-old male patient received BNT162B2 (COMIRNATY; Solution for injection), dose 2 via intramuscular on 18Jun2021 (Batch/Lot Number: SD0168) as dose 2, single, dose 1 via intramuscular on 10May2021 (Batch/Lot Number: EX6537) as dose 1, single for COVID-19 immunisation. The patient medical history included alcoholic cirrhosis with grade 1 Oesophageal varices and hepatocellular carcinoma lesions from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The Covid history and usual treatment was not known. On 13Aug2021, the patient was hospitalized for multiple trauma following a fall in the garden. The patient presented with rhabdomyolysis in the context of prolonged lying down following this fall, a deterioration in his general condition. In the emergency department, the patient had discovered of diabetes with hepatocellular insufficiency in this chronic alcoholic patient. On 18Aug2021, the patient had Covid-19 confirmed by positive Covid-19 test and vaccine failure after 2 months of dose 2 Comirnaty vaccine. On 19Aug2021 to 25Aug2021, the patient was respiratory asymptomatic and does not present with Covid symptoms. On 26Aug2021, the onset of respiratory distress at night with need to introduce oxygen therapy and low blood pressure. Rapid deterioration of the patient''s clinical condition thereafter with increased oxygen demand. Seriousness for the events Covid-19, vaccine failure, low blood pressure and respiratory distress reported as death, fall was reported as hospitalization, diabetes, rhabdomyolysis and hepatocellular insufficiency was reported as medically significant. On 28Aug2021, the patient died ,cause of death was reported as Covid-19, vaccine failure, low blood pressure and respiratory distress and autopsy was not performed. The patient laboratory investigations included on 16Aug2021, the patient had abdomin-pelvic CT scan: no pancreatic abnormality explaining the diabetes. Increase in lesions of chronic liver disease of cirrhosis with portosystemic diversion, ascites and splenomegaly. After 2 months of Dose 2 vaccine, on 18Aug2021: Positive PCR test, there was no information regarding variant and appearance of a delirium with disorientation. The outcome of the events fall, diabetes, rhabdomyolysis, hepatocellular insufficiency and a deterioration in his general condition was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Covid-19 confirmed by positive Covid-19 test; Vaccination failure; respiratory distress; low blood pressure


VAERS ID: 1724404 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-08-14
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0541 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, COVID-19, Computerised tomogram, 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: 2021-09-05
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VALACICLOVIR; BACTRIM; ZOMETA; COUMADINE; AMLOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cancer of prostate; Carotid artery thrombosis; Central retinal vein occlusion; Embolism pulmonary; Multiple myeloma; Renal colic; Venous thrombosis deep (limbs)
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: body temperature; Result Unstructured Data: Test Result:hyperthermia; Comments: hyperthermia and desaturation the day before; Test Date: 20210815; Test Name: body temperature; Result Unstructured Data: Test Result:afebrile; Comments: This morning stable under 3l of O2, afebrile; Test Date: 20210815; Test Name: computed tomography; Result Unstructured Data: Test Result:Prescribed; Test Date: 20210815; Test Name: CRP; Result Unstructured Data: Test Result:138 mg/l; Test Date: 20210814; Test Name: oxygen saturation; Result Unstructured Data: Test Result:desaturation; Comments: desaturation the day before at the end of the day increase of O2 to 5 litres; Test Date: 20210815; Test Name: oxygen saturation; Result Unstructured Data: Test Result:stable then worsened; Comments: This morning stable under 3l of O2, afebrile. At 15h06 worsening of desaturation despite O2 in the glasses Switch to mask at 4l then at 6l No improvement in saturation Prescribed gas measurement.; Test Date: 20210814; Test Name: Covid-19 PCR; Test Result: Positive ; Comments: VARIANT DELTA
CDC Split Type: FRPFIZER INC202101222853

Write-up: COVID-19 confirmed by positive COVID-19 test; Vaccination failure; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority-WEB FR-AFSSAPS-TO20217873. A 79-years-old male patient received bnt162b2 (COMIRNATY; Formulation: solution for injection, Lot Number: ER0541), dose 2 via an intramuscular route of administration on 17Feb2021 as DOSE 2, SINGLE and dose 1 (Lot Number: EM0477) via an intramuscular route of administration on 20Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history included arterial hypertension, central retinal vein occlusion, cancer of prostate, carotid artery thrombosis, renal colic, multiple myeloma from an unknown date and unknown if ongoing, embolism pulmonary from 2018 to an unknown date and venous thrombosis deep (limbs) from 2018 to an unknown date. Concomitant medications included valaciclovir 500 mg, oral route, 2/day; sulfamethoxazole, trimethoprim (BACTRIM) oral route, 3/week; zoledronic acid monohydrate (ZOMETA) IV, 1/month; warfarin sodium (COUMADINE) 5 mg, oral route, 1tablet/day and amlodipine besilate (AMLOR) 5mg, oral route, 1/day for an unknown indication, start date and stop date were not reported. On 14Aug2021, the patient experienced COVID-19 confirmed by positive COVID-19 test and vaccination failure. Therapeutic measures were taken as a result of the event. On 14Aug2021, the patient underwent lab tests and procedures which included body temperature: hyperthermia and desaturation the day before and this morning stable under 3l of O2, afebrile on 15Aug2021. Computerised tomogram: prescribed on 15Aug2021, C-reactive protein: 138 mg/L on 15Aug2021, Oxygen saturation: desaturation the day before at the end of the day increase of O2 to 5 litres on 14Aug2021 and on 15Aug2021, stable then worsened at 15:06 hours, worsening of desaturation despite oxygen in the glasses, switch to mask at 4 litres and then at 6 litres. There was no improvement in saturation. Prescribed gas measurement. On 31Aug2021 patient was still in intensive care. SARS-CoV-2 test: positive on 14Aug2021 (VARIANT DELTA). The patient died on 05Sep2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: covid 19


VAERS ID: 1724807 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
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 INC202101226196

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable healthcare professional via Regulatory authority (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003433), license party for bnt162b2 (COMIRNATY). This case was split for one of 4 death cases. This is a spontaneous report received from a non-contactable HCP received via Regulatory authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 05-Sep-2021, Regulatory authority received four death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. This case was split for 1 of 4 death cases. A 46-year-old male patient started to receive COVID-19 vaccine on unspecified date via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The case was pending assessment by the Expert Committee. The event unknown cause of death met the seriousness criterion of death. Patient died on an unknown date. It was unknown if the autopsy was done and the reported cause of death was unknown. Initial report was received on 09-Sep-2021.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: 2021FOS003425 (master case), 2021FOS003427, 2021FOS003431, 2021FOS003432, 2021FOS003433, 2021FOS003434 and 2021FOS003435. Regulatory authority is a marketing authorization holder of one of COVID-19 vaccine Tozinameran. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. Company Remarks: The medical review comments of Regulatory authority Department on the reports of Death is as follows: The seriousness of Death is: 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 is considered as possible. Causality Assessment between drug bnt162b2 and event unknown cause of death as per reporter and company was possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101223237 same reporter, suspect, different patients.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1724822 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Interchange of vaccine products, Off label use, Oxygen saturation, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Medication errors (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Metastases NOS; Rheumatism; Small cell carcinoma of the lung
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:Low
CDC Split Type: ISPFIZER INC202101228455

Write-up: Death; Oxygen saturation low; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number IS-IMA-4737. A 80-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection), dose 2 via an unspecified route of administration on 17Aug2021 (in the morning) (at the age of 80-years-old) (Batch/Lot Number: Unknown) as DOSE 2 (INITIAL PFIZER DOSE), SINGLE for covid-19 immunization. Medical history included small cell carcinoma of the lung, rheumatism, asthma, metastases NOS: all were ongoing. The patient previously took first dose of COVID-19 MRNA VACCINE MODERNA (CX-024414) as DOSE 1, SINGLE for COVID-19 immunization on unknown date. The patient''s concomitant medications were not reported. It was reported that the patient was fully vaccinated. The patient experienced oxygen saturation low on 17Aug2021, off label use and interchange of vaccine products occurred on 17Aug2021. The patient was not undergoing cancer treatment and was able to walk and did not have difficulty breathing before receiving the Covid-19 booster vaccination. It was reported that on 17Aug2021 (in the afternoon) the patient''s oxygen saturation dropped. The patient got oxygen goggles but on 22Aug2021 the patient got an oxygen mask as the oxygen goggles were not sufficient to get the oxygen levels to normal. The patient underwent lab test and procedure which included: Oxygen saturation: Low on 17Aug2021. The patient died on 24Aug2021. It was unknown if an autopsy was performed. The reporter assessed the event as Serious due to death and considered the event possibly related to the drug. Reporter Comment: The patient was not undergoing cancer treatment and was able to walk and did not have difficulty breathing before receiving the Covid-19 booster vaccination. The lot number for [generic name], was not provided and will be requested during follow up; Reported Cause(s) of Death: Oxygen saturation low; Death


VAERS ID: 1724877 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210930534

Write-up: DEATH; This spontaneous report received from a consumer via social media, concerned 810 patients of an unspecified sex, 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, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported ,1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. "As of 14-AUG-2021, COVID 19 injection fatality report mentioned that, the 810 patients died of unknown cause of death". It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal. This report was serious (Death). This case, from the same reporter is linked to 20210918421.; Sender''s Comments: V0: 20210930534-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: 1724995 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-08
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101228658

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician via Medical Information Team. A 64-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Jul2021 (Batch/Lot number was not reported) at the age of 64-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included asthma. The patient''s concomitant medications were not reported. The patient''s husband took the patient to a different hospital. However, the patient died on 08Aug2021 (9 days after the vaccination). The cause of death was unknown. It was unknown if an autopsy was performed. The event was classified as serious (death). The reporter stated that the causal relationship with BNT162b2 was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Unknown cause of death and 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: Unknown cause of death


VAERS ID: 1724996 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101228681

Write-up: Sudden death; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 4 weeks after the vaccination, the patient experienced sudden death. It was not reported whether autopsy was done. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Sudden death and the administration of the vaccine is unlikely.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1725171 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Extra dose administered, Haemoptysis, Illness, Interchange of vaccine products, Loss of consciousness, Off label use, Panic attack
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   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: Medical History/Concurrent Conditions: Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202101207952

Write-up: lost consciousness; non-contagious illness; death; bleeding while coughing; panic attack; The reporter stated that the patient took Biontech vaccine (3rd dose) as a reminder dose (3rd dose) after 2 doses of Sinovac vaccine; The reporter stated that the patient took Biontech vaccine (3rd dose) as a reminder dose (3rd dose) after 2 doses of Sinovac vaccine; The reporter stated that the patient took Biontech vaccine (3rd dose) as a reminder dose (3rd dose) after 2 doses of Sinovac vaccine; This is a spontaneous report from a contactable consumer. This is a report based on information received by Pfizer from LLP-Biontech SE manufacturer control number: 86771, license party for BNT162B2. A male patient of an unspecified age received third dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Aug2021 (Batch/Lot number was not reported) as dose 3, single for covid-19 immunization. Patient received first and second dose (in Jun2021) of Sinovac vaccine coronavac. There is a 2-month interval between the 3rd vaccine and the 2nd vaccine. Medical history included lung cancer. The patient''s concomitant medications were not reported. On 21Aug2021 patient experienced bleeding while coughing, had a panic attack in the hospital environment after waiting for 4 hours. The doctor in the ER prescribed a blood coagulant to stop the bleeding. He used the drug that day. The next day (22Aug2021), bled again while coughing, used the same medicine that day. On 23Aug2021, while coughing, so much blood came out that the bleeding almost did not stop, he finally lost consciousness and meat-like pieces of blood came and died. The 112 emergency doctor came but did not say the cause of death, only wrote non-contagious illness. The outcome of events was unknown. Patient died on 23Aug2021. 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: death


VAERS ID: 1725178 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Heart disease, unspecified. On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion death). The patient died on 19-Aug-2021. The reported cause of death was Fatigue. An autopsy was performed. Concomitant product use was not provided. It is reported that the family member found the patient as dead. It is stated that the cause of death should be determined by judicial necropsy on August 30. Treatment information was not provided. Company Comment: This case concerns a 53 year-old female subject with a history of hypertension and cardiac disorder, unspecified who experienced the unexpected event of fatigue, which was reported as the cause of death. The event occurred approximately 4 days after vaccination with mRNA-1273 (dose number unknown). The medical history of hypertension and unspecified cardiac disorder remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 53 year-old female subject with a history of hypertension and cardiac disorder, unspecified who experienced the unexpected event of fatigue, which was reported as the cause of death. The event occurred approximately 4 days after vaccination with mRNA-1273 (dose number unknown). The medical history of hypertension and unspecified cardiac disorder remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Fatigue


VAERS ID: 1725253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Angiocardiogram, Aspartate aminotransferase increased, Asthenia, Blood creatine phosphokinase, Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, Brain natriuretic peptide, C-reactive protein, Cardiac arrest, Catheterisation cardiac, Chest X-ray, Echocardiogram, Eosinophil count, Fatigue, Fibrin D dimer, Haematocrit, Haemoglobin, Heart rate, Influenza, Influenza B virus test, International normalised ratio, Legionella test, Lymphocyte count, Myocarditis, Oxygen saturation, Pain, Platelet count, Polymerase chain reaction, Procalcitonin, Red blood cell sedimentation rate, Respiratory syncytial virus test, SARS-CoV-2 test, Troponin I, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ANAGRELIDE
Current Illness: Essential thrombocytosis; Melanoma
Preexisting Conditions: Medical History/Concurrent Conditions: Malignant melanoma excision; Pneumonitis; Comments: The patient denied any recent infectious symptoms including fever, chills, myalgia, diarrhea, cough, or rhinitis prior to vaccine administration. She had no history of tobacco or illicit drug use. The patient was exercising daily and was participating in competitive sports without any complaints.
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: 96/67 mmHg; Test Name: Potassium; Result Unstructured Data: 5.4 mmol/L; Test Name: Oxygen saturation; Result Unstructured Data: 96 %; Test Name: Body temperature; Result Unstructured Data: 35.7 C; Test Name: Echocardiography; Result Unstructured Data: sinus tachycardia with T wave inversions in septal leads; Test Name: Chest X-ray; Result Unstructured Data: did not reveal any acute abnormalities; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Negative; Test Name: White blood cell count; Result Unstructured Data: 28.88 10*3/uL; Test Name: White blood cell count; Result Unstructured Data: 37.65 10*3/uL; Test Name: Lymphocytes; Result Unstructured Data: 4.4 %; Test Name: Lymphocytes; Result Unstructured Data: 9.7 %; Test Name: Hemoglobin; Result Unstructured Data: 18.5 g/dL; Test Name: Hematocrit; Result Unstructured Data: 56.9 %; Test Name: Platelet count; Result Unstructured Data: 940 10*3/uL; Test Name: Platelet count; Result Unstructured Data: 633 10*3/uL; Test Name: Creatinine; Result Unstructured Data: 1.12 mg/dL; Test Name: Creatinine; Result Unstructured Data: 1.04 mg/dL; Test Name: Blood urea nitrogen; Result Unstructured Data: 32 mg/dL; Test Name: Blood urea nitrogen; Result Unstructured Data: 30 mg/dL; Test Name: Glucose; Result Unstructured Data: 195 mg/dL; Test Name: Glucose; Result Unstructured Data: 201 mg/dL; Test Name: Sodium; Result Unstructured Data: 142 mmol/L; Test Name: Alanine aminotransferase increase; Result Unstructured Data: 74 U/L; Test Name: Aspartate aminotransferase increased; Result Unstructured Data: 59 U/L; Test Name: Aspartate aminotransferase increased; Result Unstructured Data: 137 U/L; Test Name: C-reactive protein; Result Unstructured Data: 49 mg/dL; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: 6 mm/h; Test Name: LDH; Result Unstructured Data: 402 U/L; Test Name: Legionella NOS antibody; Result Unstructured Data: Negative; Test Name: Influenza A virus infection; Result Unstructured Data: Not Detected; Test Name: Influenza B virus test; Result Unstructured Data: Not Detected; Test Name: Respiratory syncytial virus test; Result Unstructured Data: Not Detected; Test Name: PCR; Result Unstructured Data: Not Detected; Test Name: Troponin I; Result Unstructured Data: 4.7 ng/mL; Test Name: Troponin I; Result Unstructured Data: 6.4 ng/mL; Test Name: BNP; Result Unstructured Data: 30064 pg/mL; Test Name: BNP; Result Unstructured Data: 31802.70 pg/mL; Test Name: Echocardiogram; Result Unstructured Data: severe biventricular cardiomyopathy; Test Name: Angiograph coronary; Result Unstructured Data: demonstrated a cardiac output 5.1 L/ min; Test Name: Eosinophils; Result Unstructured Data: 0.02 10*3/uL; Test Name: Eosinophils; Result Unstructured Data: 0.07 10*3/uL; Test Name: Hemoglobin; Result Unstructured Data: 13.5 g/dL; Test Name: Hematocrit; Result Unstructured Data: 42.5 %; Test Name: Sodium; Result Unstructured Data: 132 mmol/L; Test Name: Lactic acid; Result Unstructured Data: 7.8 mmol/L; Test Name: Lactic acid; Result Unstructured Data: 13.5 mmol/L; Test Name: CPK; Result Unstructured Data: 1109 U/L; Test Name: CPK; Result Unstructured Data: 1319 U/L; Test Name: Fibrin D dimer; Result Unstructured Data: 2.33; Test Name: Cardiac catheterization; Result Unstructured Data: pulmonary artery pressure of 36/30 mm Hg, with a mean of 33 mm Hg; Test Name: Procalcitonin; Result Unstructured Data: 0.13 ng/mL; Test Name: INR; Result Unstructured Data: 4.2; Test Name: Heart rate; Result Unstructured Data: 123 /min
CDC Split Type: USJNJFOC20210927294

Write-up: CARDIAC ARREST; LYMPHOHISTIOCYTIC MYOCARDITIS; PROGRESSIVE BODY ACHES; WEAKNESS; WORSENING FATIGUE; This spontaneous report was received from literature. This report concerned a 62 year old Caucasian (white) female of an unspecified ethnicity. The objective of this study was to describe association between the COVID-19 viral vector vaccine and lymphohistiocytic myocarditis. The patient''s height, and weight were not reported. The patient''s past medical history included: melanoma surgical resection. The patient was previously treated with pembrolizumab over one year prior for melanoma, however it was discontinued due to pneumonitis. Concurrent conditions included: essential thrombocytosis, and melanoma. The patient denied any recent infectious symptoms including fever, chills, myalgia, diarrhea, cough, or rhinitis prior to vaccine administration. She had no history of tobacco or illicit drug use. The patient was exercising daily and was participating in competitive sports without any complaints. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) frequency time 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included anagrelide for essential thrombocytosis. On an unspecified date, the patient arrived at emergency department with complaints of progressive body aches, weakness and worsening fatigue approximately 4 days after administration of the Ad26.COV2.S (Janssen Johnson & Johnson) viral vector COVID-19 vaccine. On arrival, her blood pressure was 96/67 mmHg, heart rate 123 beats per minute, oxygen saturation 96 percent on room air, and temperature was 35.7 C. Electrocardiogram (ECG) revealed sinus tachycardia with T wave inversions in the septal leads with right atrial enlargement. The chest-x-ray did not reveal any acute abnormalities. Laboratory tests revealed a troponin elevation of 4.7 ng/mL, lactic acid of 7.8 mmol/L, NT-Pro-BNP of 30,064 pg/mL, and leukocytosis of 28.88 10x3/uL with left shift without peripheral eosinophilia. SARS-19 rapid test (also reported as COVID-19 rapid POC test) was negative. Bedside echocardiogram revealed a severe Biventricular Cardiomyopathy with Left Ventricular Ejection Fraction of 29 percent, and a small pericardial effusion with no evidence of increased intrapericardial pressure. Urgent cardiac angiography was completed which demonstrated a cardiac output 5.1 L/ min, cardiac index 3.26 L/min/m2 , left ventricular end-diastolic pressure 37 mm Hg, and no obstructive disease on maximum dose of Norepinephrine. Right heart catheterization demonstrated pulmonary artery pressure of 36/30 mm Hg (BP Dropped), with a mean of 33 mm Hg. Other laboratory data (dates unspecified) included: Alanine aminotransferase increase (NR: 13 - 56) 74 U/L, Aspartate aminotransferase increased (NR: 15 - 39) 59 U/L, 137 U/L, BNP (NR: 10 - 300) 31802.70 pg/mL, Blood urea nitrogen (NR: 7 - 18) 30 mg/dL, 32 mg/dL, C-reactive protein (NR: 0.16 - 3.00) 49 mg/dL, CPK (Creatine phosphokinase) (NR: 26 - 192) 1319 U/L, 1109 U/L, Creatinine (NR: 0.55 - 1.02) 1.04 mg/dL, 1.12 mg/dL, Eosinophils (NR: 0 - 0) 0.07 10x3/uL, 0.02 10x3/uL, Erythrocyte sedimentation rate (NR: 0 - 20) 6 mm/h, Glucose (NR: 74 - 106) 195 mg/dL, 201 mg/dL, Hematocrit (NR: 37 - 47) 42.5 percent, 56.9 percent, Hemoglobin (NR: 12 - 16) 13.5 g/dL, 18.5 g/dL, Influenza A virus infection (NR: not provided) Not Detected, Influenza B virus test (NR: not provided) Not Detected, LDH (NR: 84 - 246) 402 U/L, Lactic acid (NR: 0.4 - 2.0) 13.5 mmol/L, Legionella NOS antibody (NR: not provided) Negative, Lymphocytes (NR: 16 - 45) 4.4 percent, 9.7 percent, respiratory pathogen PCR (NR: not provided) Not Detected, Platelet count (NR: 140 - 450) 940 10x3/uL, 633 10x3/uL, Respiratory syncytial virus test (NR: not provided) Not Detected, Sodium (NR: 136 - 145) 142 mmol/L, 132 mmol/L, Troponin I (NR: 0.0 - 0.06) 6.4 ng/mL, White blood cell count (NR: 4.08 - 10.8) 37.65 10x3/uL, Procalcitonin (NR: 0.05 - 0.09) 0.13 ng/mL (increased), INR (International normalised ratio) (NR: 0.1 - 1.1) 4.2, Potassium (NR: 3.5 - 5.1) 5.4 mmol/L, and D-Dimer (NR: not provided) 2.33. The patient was transferred to the intensive care unit (hospitalized) with increasing vasopressor support with maximal dosing of vasopressin, phenylephrine, and epinephrine. Intravenous (IV) methylprednisolone 60 mg bolus was administered every 8 hours, and intravenous immunoglobulin was ordered but not administered. A cardiac arrest code was called 18 hours after presentation, and the patient expired after several rounds of advanced cardiovascular life support. Consent was obtained for an autopsy. The autopsy was performed on an unspecified date 9 hours postmortem. No remarkable changes were observed on the body surface. Autopsy revealed about 15 cc of straw-colored fluid in the pericardial sac. The heart weighed 250 g with unremarkable gross changes. No apparent coronary artery disease was appreciated. No focal lesions suggestive of acute or chronic hypoxic injury were identified. Microscopic view of the myocardial biopsy showing scattered positive CD3 (Cluster of Differentiation 3) immunostaining supporting T cell infiltration. Multiple immunohistochemistry staining like CD163 CD3 (Cluster of Differentiation 163) supports the diagnosis of lymphohistiocytic myocarditis with sparse eosinophils. Both lungs were congested and heavy (right 630 g and left 650 g). There were 850 and 320 cc of serosanguineous fluid on right and left pleural cavities, respectively. Grossly, multiple nodules were identified in all lobes of the lungs, ranging from 0.5 to 1.5 cm in size. The cut surfaces showed a variety of consistencies and colors from a firm red pink to a semisolid white with grumous material. Sampling of tissue from all nodules showed multiple sites of metastasis of melanoma in both lungs. Examination of blood vessels revealed numerous sites of thrombotic microangiopathy. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from cardiac arrest, and lymphohistiocytic myocarditis. The outcome of the progressive body aches was not reported. The authors concluded that, this study suggests a potential relationship between the COVID-19 viral vector vaccine and lymphohistiocytic myocarditis. Although, limited reports are currently available, increased vaccination will provide physicians data to further explore a possible relationship between cardiac involvement and the COVID-19 viral vector vaccine. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: This spontaneous report received from literature concerned a 62-year-old caucasian female who experienced lymphohistiocytic myocarditis 4 days after vaccine and died 18 hours later. Past medical history included pneumonitis (after administration of pembrolizumab), melanoma surgical resection and concurrent conditions included essential thrombocytosis and melanoma. Concomitant medications included anagrelide. The patient developed progressive body aches, weakness and worsening fatigue approximately 4 days after administration of the vaccine. On arrival at the ED, her BP was 96/67 mmHg, HR 123 beats per minute, SPO2 96% on room air, and temperature was 35.7 C. ECG revealed sinus tachycardia with T wave inversions in the septal leads with right atrial enlargement. Laboratory tests revealed a troponin elevation of 4.7 ng/mL, lactic acid of 7.8 mmol/L, NT-Pro-BNP of 30,064 pg/mL, and leukocytosis of 28.88 10x3/uL with left shift. SARS-19 rapid test was negative. Bedside echocardiogram revealed a severe Biventricular Cardiomyopathy with Left Ventricular EF of 29%, and a small pericardial effusion. Other laboratory data included CBP and LFT which were elevated and the patient was transferred to the ICU (hospitalized) and treated with inotropes and steroids. Despite several rounds of advanced cardiovascular life support, the patient died from cardiac arrest and lymphohistiocytic myocarditis. An autopsy supported a diagnosis of lymphohistiocytic myocarditis with sparse eosinophils. Confounders in this case include metastatic melanoma found on autopsy (which may be associated with lymphohistiocytosis) and the use of Anegrelide and remote use of pembrolizumab, which are known to cause cardiac toxicity. However, considering the temporal relationship, a relationship with Janssen Covid-19 vaccine cannot be ruled out. The event is therefore assessed to have an indeterminate relationship with vaccination.; Reported Cause(s) of Death: CARDIAC ARREST; LYMPHOHISTIOCYTIC MYOCARDITIS


VAERS ID: 1725419 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Product contamination physical
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: USMODERNATX, INC.MOD20213

Write-up: Three people died after second dose of Moderna vaccine; Little pieces of steel found in the vials also flakes of rubber were found in one of the vials; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Three people died after second dose of Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Three people died after second dose of Moderna vaccine) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION PHYSICAL (Little pieces of steel found in the vials also flakes of rubber were found in one of the vials). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT CONTAMINATION PHYSICAL (Little pieces of steel found in the vials also flakes of rubber were found in one of the vials) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a patient with not known age, gender or medical history, that was reported to had experienced the unexpected event of death and also product contamination phsysical. The latency to the second dose of mRNA-1273 Moderna vaccine (Spikevax) was not reported. The rechallenge was not applicable. The events were considered related to the product contamination physical per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this single report. More information has been requested.; Sender''s Comments: This case concerns a patient with not known age, gender or medical history, that was reported to had experienced the unexpected event of death and also product contamination phsysical. The latency to the second dose of mRNA-1273 Moderna vaccine (Spikevax) was not reported. The rechallenge was not applicable. The events were considered related to the product contamination physical per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this single report. More information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1725857 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004221 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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: JPMODERNATX, INC.MOD20213

Write-up: Ischemic heart failure; Ischemic heart failure; Pyrexia; This case was received via regulatory authority on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21126784). On an unknown date, the patient received the 1st dose of this vaccine. On 24-Jul-2021, the patient received the 2nd dose of this vaccine. On 25-Jul-2021, pyrexia of nearly 39 degrees Celsius was noted. On 26-Jul-2021, pyrexia of nearly 39 degrees Celsius developed. On 27-Jul-2021, around 05:00, the patient was confirmed dead at home. On 29-Jul-2021, administrative autopsy was performed. The major lesions were (1) cardiac hypertrophy (428 g), (2) coronary atherosclerosis (maximum 75-90% stenosis in the left anterior descending), and (3) pulmonary congestive oedema. The cause of death was diagnosed as ischemic heart failure. The outcome of pyrexia and ischemic heart failure was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The patient experienced pyrexia after the vaccination, and the possibility of involvement in cardiac failure cannot necessarily be ruled out. Coronary arteriosclerosis is another possible contributing factor.; Sender''s Comments: This case concerns a 40 year old male who experienced the fatal unexpected events of Myocardial ischemia, Cardiac failure and Pyrexia within 3 days of the second dose of Moderna COVID-19 vaccine. No re-challenge was done and the causality was reported as possible by the RA. The medical findings at autopsy of Cardiac hypertrophy, Coronary atherosclerosis with 70-90% Stenosis of the LAD and Pulmonary congestive oedema remain as confounders as the presence of these diseases predated the vaccine by their natural history. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Pyrexia; Ischaemic heart disease; Cardiac failure


VAERS ID: 1725884 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiopulmonary failure, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 43
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: cardiopulmonary collapse; muscle pain; This regulatory authority case was reported by a pharmacist and describes the occurrence of CARDIOPULMONARY FAILURE (cardiopulmonary collapse) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jul-2021, the patient experienced MYALGIA (muscle pain). In August 2021, the patient experienced CARDIOPULMONARY FAILURE (cardiopulmonary collapse) (seriousness criteria death and medically significant). In August 2021, MYALGIA (muscle pain) had resolved. The patient died on 16-Aug-2021. The reported cause of death was cardiopulmonary collapse. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment information were providet. On 04-Jul-2021, the patient only had muscle pain and had no fever. The patient recovered from the symptoms 2-3 days later. On 16-Aug-2021, the patient passed away at home at midnight. The patient family member said that he might have cardiopulmonary collapse. Company comment: This case concerns a 72 year-old subject with no medical history provided, who experienced the unexpected event of Cardiopulmonary failure and death, with the expected event of myalgia. The event of Cardiopulmonary failure and Myalgia occurred approximately one month after the first dose of Moderna COVID-19 Vaccine.The rechallenge was not applicable since only information about the first dose was disclosed.The event was considered unrelated to the study drug per the reporter''s assessment.The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report; Sender''s Comments: This case concerns a 72 year-old subject with no medical history provided, who experienced the unexpected event of Cardiopulmonary failure and death, with the expected event of myalgia. The event of Cardiopulmonary failure and Myalgia occurred approximately one month after the first dose of Moderna COVID-19 Vaccine.The rechallenge was not applicable since only information about the first dose was disclosed.The event was considered unrelated to the study drug per the reporter''s assessment.The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report; Reported Cause(s) of Death: cardiopulmonary collapse


VAERS ID: 1725894 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223-CDC / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac hypertrophy, Cardiac valve disease, Myocardial fibrosis, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic dissection (thoracoabdominal aortic aneurysm dissection); Heart disease, unspecified; Heart valve replacement (Had replaced his cardiac valves)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Heart valve disease((mitral valve and aortic valve were replaced with artificial valves); Cardiac hypertrophy; Myocardial fibrosis; Somnolence/ drowsiness; This regulatory authority case was reported by an other and describes the occurrence of CARDIAC VALVE DISEASE (Heart valve disease((mitral valve and aortic valve were replaced with artificial valves)), CARDIAC HYPERTROPHY (Cardiac hypertrophy), MYOCARDIAL FIBROSIS (Myocardial fibrosis) and SOMNOLENCE (Somnolence/ drowsiness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004223-CDC) for COVID-19 vaccination. The patient''s past medical history included Heart disease, unspecified, Aortic dissection (thoracoabdominal aortic aneurysm dissection) and Heart valve replacement (Had replaced his cardiac valves). On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced CARDIAC VALVE DISEASE (Heart valve disease((mitral valve and aortic valve were replaced with artificial valves)) (seriousness criterion death), CARDIAC HYPERTROPHY (Cardiac hypertrophy) (seriousness criterion death), MYOCARDIAL FIBROSIS (Myocardial fibrosis) (seriousness criterion death) and SOMNOLENCE (Somnolence/ drowsiness) (seriousness criterion death). The patient died on 19-Aug-2021. The reported cause of death was heart valve disease((mitral valve and aortic valve were replaced with artificial valves), Cardiac hypertrophy, Myocardial fibrosis and somnolence . An autopsy was performed. Company Comment : This case concerns a 53year-old male patient with relevant medical history of Heart disease, unspecified, Aortic dissection (thoracoabdominal aortic aneurysm dissection) and Heart valve replacement, who experienced the unexpected events Cardiac valve disease, Cardiac hypertrophy, Myocardial fibrosis and Somnolence 7 days after unspecified dose number of Spikevax. The reporter did not provide causality assessment. The patient''s medical history of Heart valve replacement seems to be the confounding factor. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 53year-old male patient with relevant medical history of Heart disease, unspecified, Aortic dissection (thoracoabdominal aortic aneurysm dissection) and Heart valve replacement, who experienced the unexpected events Cardiac valve disease, Cardiac hypertrophy, Myocardial fibrosis and Somnolence 7 days after unspecified dose number of Spikevax. The reporter did not provide causality assessment. The patient''s medical history of Heart valve replacement seems to be the confounding factor. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.; Reported Cause(s) of Death: Heart valve disease((mitral valve and aortic valve were replaced with artificial valves); Cardiac hypertrophy; Myocardial fibrosis; Somnolence


VAERS ID: 1725897 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest discomfort, Coronary artery occlusion, Death, Heart rate, Myocardial infarction, Respiratory rate, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-21
   Days after onset: 0
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: Comments: No medical history was provided
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: Blood pressure; Result Unstructured Data: 112/74; Test Date: 20210821; Test Name: Body temperature; Result Unstructured Data: 36.3; Test Date: 20210821; Test Name: Heart rate; Result Unstructured Data: 96; Test Date: 20210821; Test Name: Respiratory rate; Result Unstructured Data: 18; Test Date: 20210821; Test Name: vital; Result Unstructured Data: B.T. 36.3�C; regular(+), tension(++)
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: coronary artery obstruction; chest tightness; acute Myocardial infarction; Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), CORONARY ARTERY OCCLUSION (coronary artery obstruction), CHEST DISCOMFORT (chest tightness) and MYOCARDIAL INFARCTION (acute Myocardial infarction) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CORONARY ARTERY OCCLUSION (coronary artery obstruction) (seriousness criteria hospitalization, medically significant and life threatening), CHEST DISCOMFORT (chest tightness) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (acute Myocardial infarction) (seriousness criteria hospitalization and medically significant). The patient died on 21-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CORONARY ARTERY OCCLUSION (coronary artery obstruction), CHEST DISCOMFORT (chest tightness) and MYOCARDIAL INFARCTION (acute Myocardial infarction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Blood pressure measurement: 112/74 mmHg (Low) 112/74. On 21-Aug-2021, Body temperature: 36.3 (Low) 36.3. On 21-Aug-2021, Heart rate: 96 (High) 96. On 21-Aug-2021, Respiratory rate: 18 (abnormal) 18. On 21-Aug-2021, Vital signs measurement: abnormal (abnormal) B.T. 36.3�C; regular(+), tension(++). For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported. Lab data included Conscious clear, Acute ill-looking,Conjunctiva not anemia, Sclera not icteric,Chest coarse BS, no wheezing, no rales,Heart RHB, no murmur Company comment: The case concerns a 65-year-old male patient with no details on past medical history, presented with unexpected events of chest discomfort, myocardial infarction, coronary artery occlusion and death. Patient was feeling chest discomfort 5 days after receiving Moderna vaccine and came to the emergency room where he was diagnosed to have myocardial infarction. In the ICU he was noted to have coronary artery obstruction and was supposed to undergo procedure, however patient lost consciousness and expired. The patient died 5 days after receiving Moderna vaccine. The benefit risk relationship of vaccine is not affected by this report.; Sender''s Comments: The case concerns a 65-year-old male patient with no details on past medical history, presented with unexpected events of chest discomfort, myocardial infarction, coronary artery occlusion and death. Patient was feeling chest discomfort 5 days after receiving Moderna vaccine and came to the emergency room where he was diagnosed to have myocardial infarction. In the ICU he was noted to have coronary artery obstruction and was supposed to undergo procedure, however patient lost consciousness and expired. The patient died 5 days after receiving Moderna vaccine. The benefit risk relationship of vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1725898 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-01
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Bone pain, Brain stem haemorrhage, Computerised tomogram, Death, Decreased appetite, Fatigue, Headache, Muscular weakness, Myalgia, Pain, Syncope, Weight
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: CT; Result Unstructured Data: CT showed diffuse hemorrhage in the brain stem; Test Name: Weight; Result Unstructured Data: weight dropped
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: syncope at work; Limb weakness; poor appetite; Bone pain; waist was very sore and painful; Muscle pain; poor in spirit,tired after work,did not want to bath,but just wanted to sleep; headache; Death; Altered state of consciousness/ fell down and lost consciousness; fainted; Diffuse hemorrhage in the brain stem; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness/ fell down and lost consciousness), BRAIN STEM HAEMORRHAGE (Diffuse hemorrhage in the brain stem), SYNCOPE (fainted), SYNCOPE (syncope at work) and MUSCULAR WEAKNESS (Limb weakness) in a 65-year-old male 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. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness/ fell down and lost consciousness) (seriousness criterion medically significant) and SYNCOPE (fainted) (seriousness criterion medically significant). In August 2021, the patient experienced BRAIN STEM HAEMORRHAGE (Diffuse hemorrhage in the brain stem) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (syncope at work) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Limb weakness) (seriousness criterion medically significant), DECREASED APPETITE (poor appetite), BONE PAIN (Bone pain), PAIN (waist was very sore and painful), MYALGIA (Muscle pain), FATIGUE (poor in spirit,tired after work,did not want to bath,but just wanted to sleep) and HEADACHE (headache). The patient died on 11-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness/ fell down and lost consciousness), BRAIN STEM HAEMORRHAGE (Diffuse hemorrhage in the brain stem), SYNCOPE (fainted), SYNCOPE (syncope at work), MUSCULAR WEAKNESS (Limb weakness), DECREASED APPETITE (poor appetite), BONE PAIN (Bone pain), PAIN (waist was very sore and painful), MYALGIA (Muscle pain), FATIGUE (poor in spirit,tired after work,did not want to bath,but just wanted to sleep) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Computerised tomogram: abnormal (abnormal) CT showed diffuse hemorrhage in the brain stem. On an unknown date, Weight: decreased (Low) weight dropped. No relevant concomitant medications were provided. Prior to vaccination, patient had stable physical condition, was able to work normally, used to exercise on a bicycle, and had no known physical discomfort symptoms or history of chronic diseases or drug allergy. The family members did not know whether he had sought medical treatment. 1-2 weeks before death, patient had complained to his wife that the waist was very sore and painful, which was very uncomfortable. It seemed that patient had gone to the clinic for injections on his own (the family was not sure about the contents of the drugs and the time of the visit). Company Comment: This case concerns a 65-year-old male patient without relevant medical history, who experienced the serious unexpected events altered state of consciousness, brain stem haemorrhage and Death . The event occurred approximately 28 days after the first dose of mRNA-1273 Moderna vaccine. The event was considered related to the study drug per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender''s Comments: This case concerns a 65-year-old male patient without relevant medical history, who experienced the serious unexpected events altered state of consciousness, brain stem haemorrhage and Death . The event occurred approximately 28 days after the first dose of mRNA-1273 Moderna vaccine. The event was considered related to the study drug per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1725899 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bacteraemia, Blood culture, Chills, Condition aggravated, Hepatic cancer, Jaundice cholestatic, Myalgia, Pyrexia, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Cholestasis and jaundice of hepatic origin (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Eosinophilic pneumonia (broad), Liver malignant tumours (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 25 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hepatic cancer (terminal liver cancer); obstructive jaundice
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Test Result: Positive ; Result Unstructured Data: GNB Positive - Bacteremia
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Rigors; Muscular pain; Fever; Sepsis; bacteremia; Obstructive jaundice; terminal liver cancer; condition aggravated; This regulatory authority case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis), PYREXIA (Fever), CHILLS (Rigors), MYALGIA (Muscular pain), BACTERAEMIA (bacteremia), JAUNDICE CHOLESTATIC (Obstructive jaundice), HEPATIC CANCER (terminal liver cancer) and CONDITION AGGRAVATED (condition aggravated) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) for COVID-19 vaccination. Concurrent medical conditions included Hepatic cancer (Terminal Liver cancer) and Obstructive jaundice. On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria death and medically significant), CHILLS (Rigors) (seriousness criteria death and hospitalization), MYALGIA (Muscular pain) (seriousness criteria death and hospitalization), BACTERAEMIA (bacteremia) (seriousness criteria death and medically significant), JAUNDICE CHOLESTATIC (Obstructive jaundice) (seriousness criteria death and medically significant), HEPATIC CANCER (terminal liver cancer) (seriousness criteria death and medically significant) and CONDITION AGGRAVATED (condition aggravated) (seriousness criterion death). The patient was hospitalized from 20-Jul-2021 to 13-Aug-2021 due to CHILLS, MYALGIA and PYREXIA. The patient died on 22-Aug-2021. The reported cause of death was Hepatic cancer, Obstructive jaundice and Bacteraemia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood culture: gnb positive (Positive) GNB Positive - Bacteremia. Action taken was not applicable. Company Comment This case concerns a 68-years-old male patient with medical history liver cancer and obstructive jaundice., who experienced the unexpected events Sepsis, Chills and Myalgia after unspecified days after and Pyrexia 4 after the unspecified dose number of Spikevax. The reporter did not provide causality assessment. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 68-years-old male patient with medical history liver cancer and obstructive jaundice., who experienced the unexpected events Sepsis, Chills and Myalgia after unspecified days after and Pyrexia 4 after the unspecified dose number of Spikevax. The reporter did not provide causality assessment. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.; Reported Cause(s) of Death: Hepatic cancer; Obstructive jaundice; Bacteraemia


VAERS ID: 1725904 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004729-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Death, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer metastatic; Hospitalization (For breast cancer)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; respiratory astma; fever; pneumonia; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), PYREXIA (fever), PNEUMONIA (pneumonia) and ASTHMA (respiratory astma) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004729-CDC) for COVID-19 vaccination. The patient''s past medical history included Breast cancer metastatic and Hospitalization (For breast cancer) on 28-Jul-2021. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Aug-2021, the patient experienced PYREXIA (fever) (seriousness criteria death and hospitalization prolonged). On 19-Aug-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria death, hospitalization prolonged and medically significant) and ASTHMA (respiratory astma) (seriousness criteria death and hospitalization prolonged). The patient died on 24-Aug-2021. The reported cause of death was death due to pneumonia. It is unknown if an autopsy was performed. Treatment details not provided. Concomitant drug details not provided. Action taken was not applicable. She was treated in Hospital for breast cancer on 28 Jul 2021 and was vaccinated after her condition was stable. After that, she developed a fever on 18 Aug 2021. The patient had a fever and visited Hospital on 18 Aug 2021, and returned home after being prescribed with oral medication. On 19 Aug 2021, the patient visited Clinic for respiratory asthma and was hospitalized on 19 Aug 2021 due to pneumonia and died on 24 Aug 2021. She was not sure whether it was caused by the vaccine. Company comment This case concerns a 63 year female with a medical history of metastatic breast cancer who experienced the the serious unexpected events of Pneumonia and Asthma leading to death 6 days after Moderna COVID-19 vaccine and Pyrexia 3 days after. No re-challenge was done. The cause of death is reported as pneumonia and causality for the pneumonia is reported as possible. The history of breast cancer with multiple metastases remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 63 year female with a medical history of metastatic breast cancer who experienced the the serious unexpected events of Pneumonia and Asthma leading to death 6 days after Moderna COVID-19 vaccine and Pyrexia 3 days after. No re-challenge was done. The cause of death is reported as pneumonia and causality for the pneumonia is reported as possible. The history of breast cancer with multiple metastases remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Death due to pneumonia


VAERS ID: 1725906 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure, Dyspnoea, Pneumonia, Sepsis, Shock
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 32
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: Chronic cough (Under medication); Hypertension (Under medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Shortness of breath; Pneumonia; Cardiac failure; Shock; Sepsis; This regulatory authority case was reported by an other and describes the occurrence of DYSPNOEA (Shortness of breath), PNEUMONIA (Pneumonia), CARDIAC FAILURE (Cardiac failure), SHOCK (Shock) and SEPSIS (Sepsis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Under medication) and Chronic cough (Under medication). On 08-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criteria death and hospitalization), PNEUMONIA (Pneumonia) (seriousness criteria death and medically significant), CARDIAC FAILURE (Cardiac failure) (seriousness criteria death and medically significant), SHOCK (Shock) (seriousness criteria death and medically significant) and SEPSIS (Sepsis) (seriousness criteria death and medically significant). The patient was hospitalized on 18-Jul-2021 due to DYSPNOEA. The patient died on 19-Aug-2021. The reported cause of death was Cardiac failure, Pneumonia, Shock and Sepsis. It is unknown if an autopsy was performed. No concomitant medications reported. The patient went to Hospital to seek medical attention and the physician administered inpatient treatment. Company Comment: This case concerns a 70-year-old male patient with a history of hypertension and chronic cough, who experienced the serious unexpected events dyspnoea, pneumonia, sepsis, cardiac failure and shock. The patient died on 08/19 and the reported death diagnosis was cardiac failure and the cause of death was shock, pneumonia and sepsis. The events started approximately 10 days after and death occurred 42 days after dose of mRNA-1273 Moderna vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report; Sender''s Comments: This case concerns a 70-year-old male patient with a history of hypertension and chronic cough, who experienced the serious unexpected events dyspnoea, pneumonia, sepsis, cardiac failure and shock. The patient died on 08/19 and the reported death diagnosis was cardiac failure and the cause of death was shock, pneumonia and sepsis. The events started approximately 10 days after and death occurred 42 days after dose of mRNA-1273 Moderna vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report; Reported Cause(s) of Death: Cardiac failure; Pneumonia; Shock; Sepsis


VAERS ID: 1725909 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute hepatitis B, Altered state of consciousness, Ammonia, Asthenia, Bandaemia, Biliary tract disorder, Biliary tract infection, Blood bilirubin, Blood pressure measurement, Body temperature, Cellulitis, Chills, Decubitus ulcer, Delirium, Heart rate, Hepatic failure, Hypokalaemia, Pyrexia, Respiratory rate, Sepsis
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver infections (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Infectious biliary disorders (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 50
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: Hepatic encephalopathy (hepatic encephalopathy (grade 3 � 4), suspected to be induced by liver failure); Hepatitis B (Hepatitis B with liver failure)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Ammonia; Test Result: Inconclusive ; Result Unstructured Data: 112; Test Date: 20210802; Test Name: Elevated bilirubin; Result Unstructured Data: 5.9 =$g 8.7; Test Date: 20210714; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 134/93 mmHg; Test Date: 20210802; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 146/103 mmHg; Test Date: 20210714; Test Name: Body Temperature; Test Result: Inconclusive ; Result Unstructured Data: 39.1?; Test Date: 20210802; Test Name: Body Temperature; Test Result: Inconclusive ; Result Unstructured Data: 37?; Test Date: 20210714; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: 107 beats per minute; Test Date: 20210802; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: 65 beats per minute; Test Date: 20210714; Test Name: Hypokalemia; Test Result: Inconclusive ; Result Unstructured Data: K 3.0 -$g 3.1; Test Date: 20210714; Test Name: Respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: 20 breaths per minute; Test Date: 20210802; Test Name: Respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: 18 breaths per minute
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: generalized asthenia/weakness; Delirium suspected biliary tract problem; Delirium suspected biliary tract problem; Hepatitis B with acute liver failure; Acute hepatitis B; Right forearm cellulitis; Sepsis; altered state of consciousness; chills; Fever; Hypokalemia; r/o pressure sore; biliary tract infection; bandemia; This regulatory authority case was reported by a pharmacist and describes the occurrence of ACUTE HEPATITIS B (Acute hepatitis B), HEPATIC FAILURE (Hepatitis B with acute liver failure), SEPSIS (Sepsis), CELLULITIS (Right forearm cellulitis), BILIARY TRACT DISORDER (Delirium suspected biliary tract problem), HYPOKALAEMIA (Hypokalemia), ASTHENIA (generalized asthenia/weakness), ALTERED STATE OF CONSCIOUSNESS (altered state of consciousness), CHILLS (chills), PYREXIA (Fever), DELIRIUM (Delirium suspected biliary tract problem), DECUBITUS ULCER (r/o pressure sore), BILIARY TRACT INFECTION (biliary tract infection) and BANDAEMIA (bandemia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hepatitis B (Hepatitis B with liver failure) and Hepatic encephalopathy (hepatic encephalopathy (grade 3 � 4), suspected to be induced by liver failure). On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced ACUTE HEPATITIS B (Acute hepatitis B) (seriousness criteria death, hospitalization and medically significant). On 14-Jul-2021, the patient experienced HEPATIC FAILURE (Hepatitis B with acute liver failure) (seriousness criteria death, hospitalization and medically significant), SEPSIS (Sepsis) (seriousness criteria death, hospitalization and medically significant), HYPOKALAEMIA (Hypokalemia) (seriousness criteria death, hospitalization and medically significant), ALTERED STATE OF CONSCIOUSNESS (altered state of consciousness) (seriousness criteria death, hospitalization and medically significant), CHILLS (chills) (seriousness criteria death and hospitalization), PYREXIA (Fever) (seriousness criteria death and hospitalization), DECUBITUS ULCER (r/o pressure sore) (seriousness criteria death and hospitalization), BILIARY TRACT INFECTION (biliary tract infection) (seriousness criteria death, hospitalization and medically significant) and BANDAEMIA (bandemia) (seriousness criteria death and medically significant). On 02-Aug-2021, the patient experienced CELLULITIS (Right forearm cellulitis) (seriousness criteria death, hospitalization and medically significant), BILIARY TRACT DISORDER (Delirium suspected biliary tract problem) (seriousness criteria death and hospitalization), ASTHENIA (generalized asthenia/weakness) (seriousness criteria death and hospitalization) and DELIRIUM (Delirium suspected biliary tract problem) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 14-Jul-2021 to 31-Jul-2021 due to ALTERED STATE OF CONSCIOUSNESS, BILIARY TRACT INFECTION, CELLULITIS, CHILLS, DECUBITUS ULCER, HYPOKALAEMIA, PYREXIA and SEPSIS. The patient died on 26-Aug-2021. The reported cause of death was hepatitis b with acute liver failure. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Ammonia: 112 (Inconclusive) 112. On 14-Jul-2021, Blood pressure measurement: 134/93 (Inconclusive) 134/93 mmHg. On 14-Jul-2021, Body temperature: 39.1? (Inconclusive) 39.1?. On 14-Jul-2021, Heart rate: 107 (Inconclusive) 107 beats per minute. On 14-Jul-2021, Hypokalaemia: k 3.0 -$g 3.1 (Inconclusive) K 3.0 -$g 3.1. On 14-Jul-2021, Respiratory rate: 20 (Inconclusive) 20 breaths per minute. On 02-Aug-2021, Blood bilirubin: 5.9 =$g 8.7 (High) 5.9 =$g 8.7. On 02-Aug-2021, Blood pressure measurement: 146/103 (Inconclusive) 146/103 mmHg. On 02-Aug-2021, Body temperature: 37? (Inconclusive) 37?. On 02-Aug-2021, Heart rate: 65 (Inconclusive) 65 beats per minute. On 02-Aug-2021, Respiratory rate: 18 (Inconclusive) 18 breaths per minute. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. Treatment information not provided. Company Comment: This case concerns a 71-year-old, female patient with relevant medical history of hepatitis B with liver failure and Hepatic encephalopathy, who experienced the unexpected events of acute hepatitis Hepatic failure, cellulitis, biliary tract disorder, hypokalemia, asthenia, altered state of consciousness, chills, pyrexia, delirium, decubitus ulcer, biliary tract infection and bandaemia. The events occurred approximately between 1 and 8 days after the first dose of mRNA-1273 and had a fatal outcome 12 days after. The rechallenge was not applicable, as the events happened after the first dose. The medical history of T hepatitis B with liver failure and Hepatic encephalopathy remains a cofounder. he benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 71-year-old, female patient with relevant medical history of hepatitis B with liver failure and Hepatic encephalopathy, who experienced the unexpected events of acute hepatitis Hepatic failure, cellulitis, biliary tract disorder, hypokalemia, asthenia, altered state of consciousness, chills, pyrexia, delirium, decubitus ulcer, biliary tract infection and bandaemia. The events occurred approximately between 1 and 8 days after the first dose of mRNA-1273 and had a fatal outcome 12 days after. The rechallenge was not applicable, as the events happened after the first dose. The medical history of T hepatitis B with liver failure and Hepatic encephalopathy remains a cofounder. he benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: hepatitis B with acute liver failure


VAERS ID: 1725917 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic aneurysm, Myocardial ischaemia, Myocardial necrosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Acute myocardial ischemic necrosis; Acute myocardial ischemic necrosis; Compression by aortic aneurysm (8 cm); This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDIAL ISCHAEMIA (Acute myocardial ischemic necrosis), MYOCARDIAL NECROSIS (Acute myocardial ischemic necrosis) and AORTIC ANEURYSM (Compression by aortic aneurysm (8 cm)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL ISCHAEMIA (Acute myocardial ischemic necrosis) (seriousness criteria death and medically significant), MYOCARDIAL NECROSIS (Acute myocardial ischemic necrosis) (seriousness criteria death and medically significant) and AORTIC ANEURYSM (Compression by aortic aneurysm (8 cm)) (seriousness criteria death and medically significant). The patient died on 15-Aug-2021. An autopsy was performed. The autopsy-determined cause of death was Aortic aneurysm, acute myocardial ischemic necrosis and acute myocardial ischemic necrosis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. Patients daughter found her lying rigid by the bed, face down, with no breathing or heartbeat. Autopsy was performed on 19AUG2021 and results mentioned, compression by aortic aneurysm (8 cm), left coronary artery opening, and acute myocardial ischemic necrosis. Apart from hypertension, no other conditions or issues mentioned. Family believed it was related to the vaccine. Company comment- This case concerns a 73 year-old, female patient with a relevant medical history of hypertension, who experienced the unexpected events of acute myocardial ischemia, acute myocardial necrosis and aortic aneurysm. The events occurred approximately one month (date unknown) after the first dose of Spikevax (Moderna COVID-19 vaccine) and had a fatal outcome, with death occurring 31 days after vaccination. The rechallenge was not applicable since the events occurred after the first dose. The medical history of hypertension and patient''s age remain as confounders. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 73 year-old, female patient with a relevant medical history of hypertension, who experienced the unexpected events of acute myocardial ischemia, acute myocardial necrosis and aortic aneurysm. The events occurred approximately one month (date unknown) after the first dose of Spikevax (Moderna COVID-19 vaccine) and had a fatal outcome, with death occurring 31 days after vaccination. The rechallenge was not applicable since the events occurred after the first dose. The medical history of hypertension and patient''s age remain as confounders. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Autopsy-determined Cause(s) of Death: Aortic aneurysm; Acute myocardial ischemic necrosis; Acute myocardial ischemic necrosis


VAERS ID: 1725920 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-08-28
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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: Cholelithiasis; Coronary stent user
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified
Allergies:
Diagnostic Lab Data: Test Name: COVID 19; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: OHCA; not feeling well; This regulatory authority case was reported by a consumer and describes the occurrence of CARDIAC ARREST (OHCA) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Cardiovascular disease, unspecified. Concurrent medical conditions included Cholelithiasis and Coronary stent user. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced CARDIAC ARREST (OHCA) (seriousness criteria death and medically significant) and FEELING ABNORMAL (not feeling well). On 28-Aug-2021, FEELING ABNORMAL (not feeling well) outcome was unknown. The patient died on 28-Aug-2021. The reported cause of death was Coronary heart disease, severe lung malignancy, Chronic kidney disease and Aortic atherosclerosis. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Concomitant product was not provided by the reporter Treatment product was not provided by the reporter Company comment This case concerns a 73- year-old fe?male patient with a history of cardiovascular disorder, coronary stent user and cholelithiasis, who experienced the serious unexpected event Cardiac arrest and died. The event occurred approximately 57 days after the first dose of mRNA-1273 Moderna vaccine. An autopsy was performed and postmortem examination showed the cause of death: Coronary heart disease and severe lung malignancy, and others: Chronic kidney disease, aortic atherosclerosis. No causality assessment was provided by the reporter. The medical history of Cardiovascular disorder and undiagnosed severe lung malignancy and chronic kidney disease could be potentially confounder/cosuspects. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender''s Comments: This case concerns a 73- year-old fe?male patient with a history of cardiovascular disorder, coronary stent user and cholelithiasis, who experienced the serious unexpected event Cardiac arrest and died. The event occurred approximately 57 days after the first dose of mRNA-1273 Moderna vaccine. An autopsy was performed and postmortem examination showed the cause of death: Coronary heart disease and severe lung malignancy, and others: Chronic kidney disease, aortic atherosclerosis. No causality assessment was provided by the reporter. The medical history of Cardiovascular disorder and undiagnosed severe lung malignancy and chronic kidney disease could be potentially confounder/cosuspects. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: coronary heart disease; severe lung malignancy; Chronic kidney disease; Aortic atherosclerosis


VAERS ID: 1725921 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Asthenia, Chest discomfort, Chest pain, Headache, Hypopnoea, Limb discomfort, Multiple organ dysfunction syndrome, Musculoskeletal stiffness, Pain
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac catheter ablation; Hyperlipidemia; Resuscitation
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: multiple organ failure; acute myocardial infarction; Generalized pain; Limb weakness; rapid shallow breathing due to poor systole; muscular stiffness; weakness; chest distress; Headache; chest tightness, chest pain; This regulatory authority case was reported by a physician and describes the occurrence of MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiple organ failure), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction), PAIN (Generalized pain), LIMB DISCOMFORT (Limb weakness), HEADACHE (Headache), CHEST PAIN (chest tightness, chest pain), HYPOPNOEA (rapid shallow breathing due to poor systole), MUSCULOSKELETAL STIFFNESS (muscular stiffness), ASTHENIA (weakness) and CHEST DISCOMFORT (chest distress) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Hyperlipidemia, Cardiac catheter ablation and Resuscitation. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criteria death and hospitalization) and CHEST PAIN (chest tightness, chest pain) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiple organ failure) (seriousness criteria death, hospitalization and medically significant), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction) (seriousness criteria death, hospitalization and medically significant), PAIN (Generalized pain) (seriousness criteria death and hospitalization), LIMB DISCOMFORT (Limb weakness) (seriousness criteria death and hospitalization), HYPOPNOEA (rapid shallow breathing due to poor systole) (seriousness criteria death and hospitalization), MUSCULOSKELETAL STIFFNESS (muscular stiffness) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization) and CHEST DISCOMFORT (chest distress) (seriousness criterion hospitalization). The patient was hospitalized on 12-Jul-2021 due to ACUTE MYOCARDIAL INFARCTION, HEADACHE, LIMB DISCOMFORT, MULTIPLE ORGAN DYSFUNCTION SYNDROME and PAIN. The patient was treated with GLYCERYL TRINITRATE (NITROGLICERIN) for Adverse event, at a dose of UNK UNK, prn; INSULIN HUMAN (HUMULIN R) for Adverse event, at a dose of 1 dosage form every six hours; FUROSEMIDE (FURSEMIDE) for Adverse event, at a dose of 10 milligram twice a day; ATORVASTATIN CALCIUM (TULIP [ATORVASTATIN CALCIUM]) (oral) for Adverse event, at a dose of 40 milligram once a day; ACETYLSALICYLIC ACID (BOKEY) (oral) for Adverse event, at a dose of 100 milligram once a day; TICAGRELOR (BRILINTA) (oral) for Adverse event, at a dose of 90 milligram twice a day; CALCIUM POLYSTYRENE SULFONATE (KALIMATE) (oral) for Adverse event, at a dose of 5 gram four times per day; METHYLDOPA (DOPAMIN [METHYLDOPA]) for Adverse event, at an unspecified dose and frequency and HEPARIN SODIUM (AGGLUTEX) for Adverse event, at an unspecified dose and frequency. The patient died on 17-Aug-2021. The reported cause of death was Multiple organ failure, Acute myocardial infarction and Cardiopulmonary resuscitation. It is unknown if an autopsy was performed. At the time of death, MUSCULOSKELETAL STIFFNESS (muscular stiffness), ASTHENIA (weakness) and CHEST DISCOMFORT (chest distress) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN (Generalized pain), LIMB DISCOMFORT (Limb weakness), HEADACHE (Headache) and CHEST PAIN (chest tightness, chest pain) to be possibly related. No further causality assessments were provided for MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiple organ failure), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction), HYPOPNOEA (rapid shallow breathing due to poor systole), MUSCULOSKELETAL STIFFNESS (muscular stiffness), ASTHENIA (weakness) and CHEST DISCOMFORT (chest distress). No relevant concomitant medications were reported. On 13-JUL-2021 according to the patient''s physical signs, the dosages of dopamin and Agglutex in the doctor''s advice were adjusted. Patient was also given D50W Q6H PRN and Isosin 10mg once as treatment medications. No relevant concomitant medications were reported. Company comment This case concerns a 69-year-old, male patient with medical history of hyperlipidemia, who experienced the unexpected serious events (Death and Hospitalization) of MULTIPLE ORGAN DYSFUNCTION SYNDROME, ACUTE MYOCARDIAL INFARCTION, HEADACHE, CHEST PAIN, HYPOPNOEA, MUSCULAR STIFFNESS, ASTHENIA and CHEST DISCOMFORT. The event occurred approximately 1day after the first dose of Spikevax and had a fatal outcome, with death occurring on August, 24, 2021. 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; Sender''s Comments: This case concerns a 69-year-old, male patient with medical history of hyperlipidemia, who experienced the unexpected serious events (Death and Hospitalization) of MULTIPLE ORGAN DYSFUNCTION SYNDROME, ACUTE MYOCARDIAL INFARCTION, HEADACHE, CHEST PAIN, HYPOPNOEA, MUSCULAR STIFFNESS, ASTHENIA and CHEST DISCOMFORT. The event occurred approximately 1day after the first dose of Spikevax and had a fatal outcome, with death occurring on August, 24, 2021. 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: multiple organ failure; acute myocardial infarction; cardiopulmonary resuscitation


VAERS ID: 1725922 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939600-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Brain death, Dizziness, Pallor
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Dizziness; pale face; Brain death; This regulatory authority case was reported by a consumer and describes the occurrence of BRAIN DEATH (Brain death), DIZZINESS (Dizziness) and PALLOR (pale face) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939600-CDC) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRAIN DEATH (Brain death) (seriousness criteria death, hospitalization prolonged and medically significant), DIZZINESS (Dizziness) (seriousness criterion hospitalization prolonged) and PALLOR (pale face) (seriousness criterion hospitalization prolonged). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness) and PALLOR (pale face) outcome was unknown. No concomitant medical information were not reported. No treatment information was reported. Company comment This case concerns a 65-year-old, male subject who experienced the unexpected events of BRAIN DEATH, DIZZINESS and PALLOR. The event brain death with fatal outcome. The events occurred after the first dose of Moderna COVID-19 Vaccine, and death on an unknown date. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 65-year-old, male subject who experienced the unexpected events of BRAIN DEATH, DIZZINESS and PALLOR. The event brain death with fatal outcome. The events occurred after the first dose of Moderna COVID-19 Vaccine, and death on an unknown date. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1725930 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-08-04
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Myocardial infarction
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   Days after onset: 29
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 (more than 5 years); Hypertension (more than 5 years)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Myocardial infarction; Altered state of consciousness; This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) and ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. Concurrent medical conditions included Diabetes (more than 5 years) and Hypertension (more than 5 years). On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) (seriousness criterion medically significant). On 02-Sep-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria death and medically significant). On 02-Sep-2021, ALTERED STATE OF CONSCIOUSNESS (Altered state of consciousness) outcome was unknown. The patient died on 02-Sep-2021. The reported cause of death was Myocardial infarction. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient had a cyanotic face when he felt down. Action taken was not applicable. Company comment This case concerns a 70-year-old, male patient with medical history of diabetes mellitus and hypertension, who experienced the unexpected events of altered state of consciousness, and myocardial infarction. The event altered state of consciousness occurred approximately 27 days after vaccination with Spikevax. The event myocardial infarction occurred 1 month and 25 days after vaccination with Spikevax, with a fatal outcome, with death occurring on that same day. The rechallenge was unknown, as there is no information that states vaccination dose number and there is only one dose reported. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per RA from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 70-year-old, male patient with medical history of diabetes mellitus and hypertension, who experienced the unexpected events of altered state of consciousness, and myocardial infarction. The event altered state of consciousness occurred approximately 27 days after vaccination with Spikevax. The event myocardial infarction occurred 1 month and 25 days after vaccination with Spikevax, with a fatal outcome, with death occurring on that same day. The rechallenge was unknown, as there is no information that states vaccination dose number and there is only one dose reported. The benefit-risk relationship of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per RA from Regulatory Authority reporting.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1725937 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
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: PUD
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; Facial cyanosis; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) and CYANOSIS (Facial cyanosis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included PUD. Concurrent medical conditions included Hypertension. On 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and CYANOSIS (Facial cyanosis) (seriousness criterion life threatening). The patient died on 15-Aug-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, CYANOSIS (Facial cyanosis) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Medical history included Operation history S/P Abdominal surgery: Active duodenal ulcer s/p Argon plasma coagulate. lab test-Vital signs-ECG display: Asystole, comprehensive assessment: pulse (times/min) 0, respiratory rate (times/min) 0, blood pressure (mmHg) 0/0, coma scale E/V/M1/1/1 Administration-Bos min 1 mg IV push. During continuous CPCR concomitant information was not provided by reporter No treatment information was provided. Company Comment: This case concerns a 60 year old female with a history of Peptic ulcer disease and Duodenal ulcers with surgical treatment who experienced the events of Cyanosis with the outcome of the event Death 3 days after Moderna COVID-19 vaccine. No cause of the events is reported. The event Cyanosis is reported as possibly related for Moderna COVID-19 vaccine by the RA. The events of Peptic ulcer and Duodenal ulcer disease remain as confounders. Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 60 year old female with a history of Peptic ulcer disease and Duodenal ulcers with surgical treatment who experienced the events of Cyanosis with the outcome of the event Death 3 days after Moderna COVID-19 vaccine. No cause of the events is reported. The event Cyanosis is reported as possibly related for Moderna COVID-19 vaccine by the RA. The events of Peptic ulcer and Duodenal ulcer disease remain as confounders. Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1725939 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-09-02
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Death, Headache, Inappropriate schedule of product administration, Insomnia, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-10
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Spinal laminectomy (Spine surgery (bone spur) was performed about 3-4 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; Chest tightness; Insomnia; Nausea; Headache; Inappropriate schedule of vaccine administered; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death), CHEST DISCOMFORT (Chest tightness), INSOMNIA (Insomnia), NAUSEA (Nausea) and HEADACHE (Headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Spinal laminectomy (Spine surgery (bone spur) was performed about 3-4 years ago). On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST DISCOMFORT (Chest tightness) (seriousness criterion death), INSOMNIA (Insomnia) (seriousness criterion death), NAUSEA (Nausea) (seriousness criterion death) and HEADACHE (Headache) (seriousness criterion death). The patient was treated with PROPRANOLOL (oral) on 09-Sep-2021 at a dose of 10 milligram once a day and EPINEPHRINE (BOSMIN [EPINEPHRINE]) 10-Sep-2021 at an unspecified dose and frequency. On 02-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. The patient died on 10-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Lab Data included test EKG (24 hrs Holtor''s), EKG,CXR,CBC, Scr, K, GPT. Results not provided. It was reported that on the evening of 08-Sep-2021, the patient experienced nausea, insomnia, headache, and chest tightness. On 09-Sep-2021, in the morning, the patient went to the department of cardiology. On 10-Sep-2021, the patient did not respond and was sent to the emergency department of Hospital, in the early morning. By arrival, breathing stopped, vital signs E1V1M1, pupil size (R: -6.0 L: -6.0), limb strength [upper limb: Left(-1) Right(-1) / Lower extremities: Left (-1) Right (-1)]. Bosmin and CPCR were given, and the first aid was ineffective, and death was declared 10-Sep-2021. On 09-Sep-2021, the patient''s wife found his body cold, and she called emergency phone number to send the case to Hospital, but the first-aid was ineffective. Considering the last wishes and the body integrity, they did not accept judicial review; therefore, the hospital has issued a death certificate. The case would be transferred to the Health Bureau/Institute to assist in handling the application. Company comment: This is a case of inappropriate schedule of vaccine administration of a 72-year-old male patient with no relevant past medical history, presented with unexpected events of Death, chest tightness, nausea, insomnia, and headache. Events chest tightness, nausea, insomnia and headache occurred 6 days after second dose of vaccine. On the 8th day after second vaccine, patient was brought to the hospital where he was declared dead after CPR and first aid was ineffective. The benefit risk relationship of vaccine is not affected by this report.; Sender''s Comments: This is a case of inappropriate schedule of vaccine administration of a 72-year-old male patient with no relevant past medical history, presented with unexpected events of Death, chest tightness, nausea, insomnia, and headache. Events chest tightness, nausea, insomnia and headache occurred 6 days after second dose of vaccine. On the 8th day after second vaccine, patient was brought to the hospital where he was declared dead after CPR and first aid was ineffective. The benefit risk relationship of vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1725942 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Mood altered, Muscular weakness, Somnolence, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-02
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Diabetes; Hypertension; Stroke
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: The family found her lost breathing, so they called to assist CPR. arrived, the case had died; drowsiness; myasthenia; due to unsteady mood, the case had; Pain at the vaccination site; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (The family found her lost breathing, so they called to assist CPR. arrived, the case had died) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Diabetes, Stroke and Alzheimer''s disease. On 09-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced VACCINATION SITE PAIN (Pain at the vaccination site). In August 2021, the patient experienced MOOD ALTERED (due to unsteady mood, the case had). On 27-Aug-2021, the patient experienced SOMNOLENCE (drowsiness) and MUSCULAR WEAKNESS (myasthenia). On 13-Jul-2021, VACCINATION SITE PAIN (Pain at the vaccination site) outcome was unknown. The patient died on 02-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MOOD ALTERED (due to unsteady mood, the case had), SOMNOLENCE (drowsiness) and MUSCULAR WEAKNESS (myasthenia) outcome was unknown. No concomitant medication was reported. No treatment was reported. Company Comment: This case concerns a 84-year-old female, with medical history of hypertension, diabetes, stroke and Alzheimer''s disease who experienced the fatal event of death. The event occurred approximately 1 month and 25 days after the reported dose of Spikevax, which it is unknown if it is the first or the second dose. Medical history of hypertension, diabetes, stroke and alzheimer''s disease, as well as the patient�s advanced age, remain confounders. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 84-year-old female, with medical history of hypertension, diabetes, stroke and Alzheimer''s disease who experienced the fatal event of death. The event occurred approximately 1 month and 25 days after the reported dose of Spikevax, which it is unknown if it is the first or the second dose. Medical history of hypertension, diabetes, stroke and alzheimer''s disease, as well as the patient�s advanced age, remain confounders. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Death


VAERS ID: 1725949 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-16
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Death
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cirrhosis liver; Gastric ulcer
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Abdominal pain; Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of DEATH (Death) and ABDOMINAL PAIN (Abdominal pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Cirrhosis liver and Gastric ulcer. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and ABDOMINAL PAIN (Abdominal pain) (seriousness criteria hospitalization and medically significant). The patient died on 16-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ABDOMINAL PAIN (Abdominal pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. Company comment: This case concerns an unknown age male, with medical history of cirrhosis and gastric ulcer, who experienced the unexpected events of Abdominal pain and Death. Both events occurred on 16 August 2021. Dates of vaccination were not provided, hence rechallenge is unknown. Autopsy report was not provided. Medical history of cirrhosis and gastric ulcer, as well as missing information on patient�s demographics and vaccination dates remain confounders. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns an unknown age male, with medical history of cirrhosis and gastric ulcer, who experienced the unexpected events of Abdominal pain and Death. Both events occurred on 16 August 2021. Dates of vaccination were not provided, hence rechallenge is unknown. Autopsy report was not provided. Medical history of cirrhosis and gastric ulcer, as well as missing information on patient�s demographics and vaccination dates remain confounders. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1725950 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-08-04
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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: Anemia; Bone marrow aplastic; Diabetes; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Blood transfusion
Allergies:
Diagnostic Lab Data: Test Name: Hb; Result Unstructured Data: 3.0 gm/dl patient was unconscious and was set to emergency department.; Test Date: 20210803; Test Name: Hb; Test Result: Inconclusive ; Result Unstructured Data: 10.0 gm/dl
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. The patient''s past medical history included Blood transfusion on 03-Aug-2021. Concurrent medical conditions included Diabetes, Hypertension, Anemia since 2011 and Bone marrow aplastic. On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 04-Aug-2021 The patient died on 04-Aug-2021. The reported cause of death was Anemia, htn and Diabetes. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Haemoglobin: 10.0 gram per decilitre (Inconclusive) 10.0 gm/dl. On an unknown date, Haemoglobin: 3.0 gram per decilitre (Low) 3.0 gm/dl patient was unconscious and was set to emergency department.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported On 03-Aug-2021, the blood transfusion was completed at about 01:00 p.m. At about 01:00 a.m., 04-Aug, it was found that the hands and feet of the case began to turn black, the body was cold, and there was no breathing and heartbeat. After 119 arrival, the medical professional conducted CPR and AED first aid and then sent the case to [see source] Hospital at 02:55 a.m. It was reported that the patient was not mentally well and wanted to sleep. On 04-Aug, it was found that the hands and feet of the case began to turn black, the body was cold, and there was no breathing and heartbeat. After 119 arrival, the medical professional conducted CPR and AED first aid and then sent the case to Hospital at 02:55 a.m. The first aid with intubation was ineffective. The patient was declared dead at 03:27a.m. Administrative verification:Natural death due to (A) anemia, (B) diabetes, and hypertension. 4. Cremation was done on 17 Aug 2021 Treatment information not provided. Company comment: This case concerns a female patient of unknown age who died approximately one month after the first dose of the vaccine. Medical history of diabetes, HTN, and chronic anemia are confounders. Dechallenge is not applicable and rechallenge is not applicable. The benefit-risk relationship is not affected by this report. Death certificate noted natural death due to anemia, diabetes and HTN.; Sender''s Comments: This case concerns a female patient of unknown age who died approximately one month after the first dose of the vaccine. Medical history of diabetes, HTN, and chronic anemia are confounders. Dechallenge is not applicable and rechallenge is not applicable. The benefit-risk relationship is not affected by this report. Death certificate noted natural death due to anemia, diabetes and HTN.; Reported Cause(s) of Death: anemia; HTN; diabetes


VAERS ID: 1725951 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Malnutrition, Oropharyngeal pain, Pain in extremity, Pneumonia, Vision blurred, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 49
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: pneumonia; severe malnutrition; vomiting after eating; Loss of appetite; sore throat; pain in the left arm; blurred vision of eyes; This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia), MALNUTRITION (severe malnutrition), DECREASED APPETITE (Loss of appetite), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (pain in the left arm), VISION BLURRED (blurred vision of eyes) and VOMITING (vomiting after eating) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria death, hospitalization and medically significant), MALNUTRITION (severe malnutrition) (seriousness criteria death and hospitalization), DECREASED APPETITE (Loss of appetite) (seriousness criterion death), OROPHARYNGEAL PAIN (sore throat) (seriousness criterion death), PAIN IN EXTREMITY (pain in the left arm) (seriousness criterion death) and VISION BLURRED (blurred vision of eyes) (seriousness criterion death). On 10-Jul-2021, the patient experienced VOMITING (vomiting after eating) (seriousness criterion death). The patient died on 26-Aug-2021. The reported cause of death was Pneumonia, Malnutrition, Decreased appetite, Sore throat, Pain in extremity, blurred vision of eyes and Vomiting. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment- This case concerns a 83-year-old male patient with no medical history. The experienced fatal events of pneumonia, Malnutrition, Decreased appetite, sore throat, Pain in extremity, blurred vision of eyes and Vomiting 6 days after unspecified dose number of Spikevax. The reporter did not provide causality assessment. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 83-year-old male patient with no medical history. The experienced fatal events of pneumonia, Malnutrition, Decreased appetite, sore throat, Pain in extremity, blurred vision of eyes and Vomiting 6 days after unspecified dose number of Spikevax. The reporter did not provide causality assessment. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.; Reported Cause(s) of Death: pneumonia; Malnutrition; Decreased appetite; sore throat; Pain in extremity; blurred vision of eyes; Vomiting


VAERS ID: 1725965 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-09-08
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperglycemia; Hyperlipidemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Hyperglycemia and Hyperlipidemia. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 08-Sep-2021 The patient died on 08-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Treatment details not provided. Concomitant drug details not provided. On 08-Sep-2021 The charger at the parking area found that the case was lying on a van at about 03:00 p.m. on 08-Sep, with a mask on the face, and was not moving. The case did no response to other people''s calling. The window was broken by the fireman, and the man was confirmed to die many hours ago. Company Comment: This case concerns a 64-year-old male patient with previous relevant medical history of Hypertension, Hyperglycemia and Hyperlipidemia, who experienced an unexpected event of death. The event occurred 29 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). In the time between receiving the first dose of the vaccine and up to the time of death no other AEs were reported. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 64-year-old male patient with previous relevant medical history of Hypertension, Hyperglycemia and Hyperlipidemia, who experienced an unexpected event of death. The event occurred 29 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). In the time between receiving the first dose of the vaccine and up to the time of death no other AEs were reported. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1725969 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003184-CDC / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose, Gait disturbance, Ischaemia, Pruritus, Syncope, Tachycardia, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-04
   Days after onset: 46
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes (regular visits every three months); Hypertension (regular visits every three months)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood sugar; Result Unstructured Data: blood sugar between 50 and 60.
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: ischemia was suspected by a physician; Syncope; Itchy skin; Tachycardia; Wheezing; at the time the case developed unsteady gait; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope), PRURITUS (Itchy skin) and ISCHAEMIA (ischemia was suspected by a physician) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3003184-CDC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension (regular visits every three months) and Diabetes (regular visits every three months). On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criteria death, hospitalization and medically significant) and PRURITUS (Itchy skin) (seriousness criteria death and hospitalization). On 07-Aug-2021, the patient experienced GAIT DISTURBANCE (at the time the case developed unsteady gait). On an unknown date, the patient experienced ISCHAEMIA (ischemia was suspected by a physician) (seriousness criterion hospitalization), TACHYCARDIA (Tachycardia) and WHEEZING (Wheezing). The patient was hospitalized on 02-Sep-2021 due to PRURITUS and SYNCOPE. The patient died on 04-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ISCHAEMIA (ischemia was suspected by a physician), GAIT DISTURBANCE (at the time the case developed unsteady gait), TACHYCARDIA (Tachycardia) and WHEEZING (Wheezing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: normal (normal) blood sugar between 50 and 60.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product information were provided by the reporter. Patient had experienced events wheezing and tachycardia and results were fatal. Patient took blood transfusion as treatment medication. Company comment- The case concerns a 68-year-old male patient with past medical history of Hypertension and Diabetes, presented with unexpected events of Syncope. The event occurred 44 days after the first dose of the mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit risk relationship of vaccine is not affected by this report. There is noted discrepancy in the onset date of the event Syncope in the structured field vs that in the narrative.; Sender''s Comments: The case concerns a 68-year-old male patient with past medical history of Hypertension and Diabetes, presented with unexpected events of Syncope. The event occurred 44 days after the first dose of the mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit risk relationship of vaccine is not affected by this report. There is noted discrepancy in the onset date of the event Syncope in the structured field vs that in the narrative.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1725981 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-09-06
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939599-CDC / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Dyspnea; resuscitation failure; This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Dyspnea) and RESUSCITATION (resuscitation failure) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939599-CDC) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Sep-2021, the patient experienced DYSPNOEA (Dyspnea) (seriousness criterion death) and RESUSCITATION (resuscitation failure) (seriousness criterion death). The reported cause of death was Dyspnea and Resuscitation. It is unknown if an autopsy was performed. Patient was short of breath when the IV was ongoing, and the first aid was ineffective. He was declared dead. Age of the patient reported as 74.8 No concomitant medication reported. Company Comment: The case concerns a 74-year-old male patient with no details on past medical history, presented with unexpected events of dyspnea and resuscitation. Patient experienced dyspnea 64-days after receiving the first dose of mRNA 1273 vaccine, on the same day resuscitation was done and was unsuccessful. It is unknown if an autopsy was performed. The benefit risk relationship of vaccine is not affected by this report; Sender''s Comments: The case concerns a 74-year-old male patient with no details on past medical history, presented with unexpected events of dyspnea and resuscitation. Patient experienced dyspnea 64-days after receiving the first dose of mRNA 1273 vaccine, on the same day resuscitation was done and was unsuccessful. It is unknown if an autopsy was performed. The benefit risk relationship of vaccine is not affected by this report; Reported Cause(s) of Death: Dyspnea; Resuscitation


VAERS ID: 1725983 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-23
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: 2021-08-26
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Died one month after vaccination; This regulatory authority case was reported by an other and describes the occurrence of DEATH (Died one month after vaccination) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 26-Aug-2021 The patient died on 26-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. The case died on 26 Aug 2021. On 07 Sep 2021, the family member reported that the patient had chronic diseases. Although the patient died one month after vaccination, the family member was now not willing to apply for drug injury relief and will continue to wait for (the death certificate) to confirm the cause of death. No treatment information was provided. Company comment: The case concerns a female patient with chronic diseases, presented with unexpected event of Death. Patient died due to unknown cause. Patient''s comorbidities remain as confounding factors to the event death. The benefit risk relationship of vaccine is not affected by this report.; Sender''s Comments: The case concerns a female patient with chronic diseases, presented with unexpected event of Death. Patient died due to unknown cause. Patient''s comorbidities remain as confounding factors to the event death. The benefit risk relationship of vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1726153 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous thrombosis, Coma, Headache
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101222329

Write-up: cerebral vein thrombosis; coma; headache; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional downloaded from the WEB, regulatory authority number DE-PEI-CADR2021177674, Safety Report Unique Identifier: DE-PEI-202100188028. A 61-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Jun2021 as single dose (dose number unknown), at an unspecified age, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was healthy. The patient experienced headache in Jun2021, coma in Jun2021 and cerebral vein thrombosis (death) on 19Jun2021. Clinical course: First a headache, then coma. Emergency surgery. Later died after cerebral vein thrombosis. Events resulted in emergency room visit. Treatment received for the events. The outcome of the events (headache and coma) was unknown. The outcome of the event (cerebral vein thrombosis) was fatal. The patient died on 21Jun2021. An autopsy was not performed. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous illnesses: Healthy. Headache, coma. Emergency surgery, death Relatedness: Thrombosis cerebral vein; Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Sender Comment added.; Reported Cause(s) of Death: cerebral vein thrombosis


VAERS ID: 1726595 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Death, Malaise
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-22
   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: unknown
Current Illness: none known
Preexisting Conditions: none known
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received the vaccine 9/3/2021 when visiting. They left on 9/5 and felt fine at that time. It''s unknown when symptoms started but she became sick and passed away 9/22/21. We were notified by their host family and I have limited information on the patient. They were told she passed away from Covid but I have no medical information to evaluate.


VAERS ID: 1728593 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Brain herniation, Cerebral haemorrhage, Cerebral vascular occlusion, Cerebral ventricular rupture, Coma scale, Computerised tomogram head, Ischaemic stroke, Platelet count, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   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: LANTUS; NOVORAPID; ASPIRIN CARDIO; BELOC ZOK; COVERSUM N; MARCOUMAR; DERMOVATE; FLAMMAZINE; OPTIDERM [POLIDOCANOL;UREA]; DEXERYL [GLYCEROL;PARAFFIN, LIQUID;WHITE SOFT PARAFFIN]; DER-MED
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement (Mechanical aortic valve replacement 1997); Arterial hypertension; Basal cell carcinoma (Status after multiple, ulcerative, nodular basal cell carcinomas); Carotid artery stenosis (Moderate stenosis in the region of the right carotid terminus); Chronic renal failure; Pruritus (Chronic pruritus with reactive perforating collagenosis); Reactive perforating collagenosis (Chronic pruritus with reactive perforating collagenosis); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: GCS; Result Unstructured Data: Test Result:unclear GCS reduction; Test Date: 20210321; Test Name: GCS; Result Unstructured Data: Test Result:maximal GCS 6; Test Date: 20210321; Test Name: In the course CT skull; Result Unstructured Data: Test Result:an extensive secondary hemorrhage was found; Comments: an extensive secondary hemorrhage was found on the left parenchymatous with ventricular rupture, midline displacement, and sub-herniation into the falx; Test Date: 20210321; Test Name: platelets; Result Unstructured Data: Test Result:420 10*9/mL
CDC Split Type: CHPFIZER INC202101217309

Write-up: ischemic stroke with multiple vascular occlusions in the left anterior circulation; ischemic stroke with multiple vascular occlusions in the left anterior circulation; subarachnoid hemorrhage; hemorrhage was found on the left parenchymatous with ventricular rupture; hemorrhage was found on the left parenchymatous with ventricular rupture; sub-herniation into the falx; Atrial fibrillation; This is a spontaneous report received from a contactable physician via, the regulatory authority. Regulatory authority report number CH-SM-2021-16855. An 83-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 18Mar2021 (Batch/Lot number was not reported) at the age of 83-years-old as 0.3 ML SINGLE for covid-19 immunisation. Medical history included mechanical aortic valve replacement in 1997, Arterial hypertension, Diabetes mellitus type 2, Chronic renal failure, Moderate stenosis in the region of the right carotid terminus, Chronic pruritus with reactive perforating collagenosis, and Status after multiple, ulcerative, nodular basal cell carcinomas. Concomitant medications included insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported; insulin aspart (NOVORAPID) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN CARDIO) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (BELOC ZOK) taken for an unspecified indication, start and stop date were not reported; perindopril arginine (COVERSUM N) taken for an unspecified indication, start and stop date were not reported; phenprocoumon (MARCOUMAR) taken for an unspecified indication, start and stop date were not reported; clobetasol propionate (DERMOVATE) taken for an unspecified indication, start and stop date were not reported; sulfadiazine silver (FLAMMAZINE) taken for an unspecified indication, start and stop date were not reported; polidocanol, urea (OPTIDERM) taken for an unspecified indication, start and stop date were not reported; glycerol, paraffin, liquid, white soft paraffin (DEXERYL) taken for an unspecified indication, start and stop date were not reported; disodium undecylenamide sulfosuccinate (DER-MED) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) for covid-19 immunisation, it was not known when the 1st dose was administered. Atrial fibrillation was Initial diagnosed on 21Mar2021. With a latency period of 3 days after the 2nd dose, the patient was emergency hospitalized by flight Rescue on 21Mar2021 for an unclear GCS reduction. The patient was found in the train with a hemisyndrome on the right side and conjugate eye deviation to the left. At the hospital, the cause was found to be multiple acute vascular occlusions in the left anterior circulation. With an open time window, interventional thrombectomy with incomplete recanalization was performed. Periinterventionally, there was complicating small subarachnoid hemorrhage of the left sylvian fissure without space-occupying effect. Postinterventionally, the patient was transferred to the intensive care unit. In the awakening test, the patient showed a maximal GCS 6. In the course CT skull, an extensive secondary hemorrhage was found on the left parenchymatous with ventricular rupture, midline displacement, and sub-herniation into the falx. According to the neurologists involved, there was no possibility of intervention and, with a poor prognosis, the patient was switched to comfort therapy. On 23Mar2021, the patient died. An autopsy was declined by the relatives. The patient underwent lab tests and procedures which included Platelets (150-450 G/L) on 21Mar2021: 420 G/L. The outcome of the events was fatal. This case was reported by Regulatory Authority as serious with seriousness criteria results in death, life threatening, caused/prolonged hospitalization and other medically important condition. Ischaemic stroke and cerebral bleeding were both reported as causes of death. A causality between Comirnaty and cerebral thrombosis was assessed as being possible by regulatory authority according to agency method. No follow-up attempts are possible. Information about Batch/Lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: sub-herniation into the falx; hemorrhage was found on the left parenchymatous with ventricular rupture; Atrial fibrillation; ischemic stroke with multiple vascular occlusions in the left anterior circulation; ischemic stroke with multiple vascular oc


VAERS ID: 1728606 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Coronary artery thrombosis, Loss of consciousness, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arteriosclerosis; Organic blood flow disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101222353

Write-up: Death related to vaccination; suddenly collapsed; ruptured myocardial infarction in coronary thrombosis; ruptured myocardial infarction in coronary thrombosis/ Intraluminal coronary thrombosis; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional downloaded from the Medicines Agency (MA) EudraVigilance-WEB DE-PEI-CADR2021178872, Safety Report Unique Identifier DE-PEI-202100189098. A 76-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Jun2021 as single dose, at an unspecified age, for COVID-19 immunisation. Medical history included ongoing arteriosclerosis/ atherosclerosis, ongoing organic blood flow disorder/ chronic congestion of the liver and spleen. The patient''s concomitant medications were not reported. The patient experienced death related to vaccination (cardiac death) on 25Jun2021, ruptured myocardial infarction in coronary thrombosis in Jun2021, ruptured myocardial infarction in coronary thrombosis/ intraluminal coronary thrombosis in Jun2021, suddenly collapsed on 25Jun2021. The outcome of the event (suddenly collapsed) was unknown, of other remain events was fatal. The patient died on 25Jun2021. Autopsy was performed. Autopsy result: ruptured myocardial infarction in coronary thrombosis. Cause of death reported as intraluminal coronary thrombosis. Sender''s comment: Do you or the person concerned known of any allergies? If yes, which? No information about allergies was given to the autos. Information about risk factors or previous illnesses. According to the autopsy results, inter alia. higher grade general. Atherosclerosis and chronic congestion of the liver and spleen. Second vaccination against Covid-19 with COMIRNATY; suddenly collapsed on 25Jun2021; Judicial autopsy takes place; Autopsy result: ruptured myocardial infarction in coronary thrombosis; causal link between vaccination and acute death may currently cannot be safely excluded; If necessary, excerpts from the autopsy protocol can be requested Assessment: COMIRNATY/ Cardiac death/ PEI: D. Unclassifiable The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Intraluminal coronary thrombosis; Death related to vaccination; Autopsy-determined Cause(s) of Death: ruptured myocardial infarction in coronary thrombosis; ruptured myocardial infarction in coronary thrombosis


VAERS ID: 1728607 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-16
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: post-mortem examination; Result Unstructured Data: Test Result: association with acute left heart failure; Comments: with severe aortic stenosis.
CDC Split Type: DEPFIZER INC202101222472

Write-up: Death in temporal connection with the vaccination; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number DE-PEI-CADR2021179047. A 50-years-old male patient received bnt162b2 (COMIRNATY, strength 0.3 ml), dose 2 via an unspecified route of administration on Jul2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death in temporal connection with the vaccination (cardiac death) on 16Aug2021. An autopsy was performed that revealed left ventricular failure. In the post-mortem examination, among other things, high-grade calcification of the aortic bicuspid aortic valve and exceeding the critical heart weight; No previous illnesses known / hereditary thrombosis in the family; Affected person had been tested for thrombosis disease before vaccination; no previous illnesses known; forensic autopsy has taken place; post-mortem examination result: association with acute left heart failure with severe aortic stenosis. At present, a causal connection between vaccination and acute death cannot be ruled out. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac death; Autopsy-determined Cause(s) of Death: Left ventricular failure


VAERS ID: 1728608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Clostridium difficile infection, Diarrhoea, General physical health deterioration, Investigation, Magnetic resonance imaging, Meningoencephalitis herpetic, Ophthalmic herpes zoster
SMQs:, Pseudomembranous colitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular infections (narrow), Noninfectious diarrhoea (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 68
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: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperaemia (venous congestion of the legs)
Allergies:
Diagnostic Lab Data: Test Name: further examinations; Result Unstructured Data: Test Result: herpes encephalitis; Test Name: MRI; Result Unstructured Data: Test Result: no evidence of apoplexy
CDC Split Type: DEPFIZER INC202101222488

Write-up: Hospital germ Clostridium difficile infection; Herpes zoster ophthalmicus with the following herpes encephalitis; Herpes zoster ophthalmicus with the following herpes encephalitis; Diarrhea; General physical condition decreased; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Medicines Agency (MA) EudraVigilance-WEB DE-PEI-CADR2021179195. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100189548. A elderly female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation. Medical history included ongoing hypertension, venous congestion of the legs. The patient''s concomitant medications were not reported. The patient experienced herpes zoster ophthalmicus with the following herpes encephalitis, diarrhea, general physical condition decreased on 16Apr2021. Events seriousness criteria was hospitalziation. It was reported onset of swollen eye on 16Apr2021, 2 days later suspected stroke: hospitalisation, magnetic resonance showed no evidence of apoplexy, further examinations revealed diagnosis of herpes encephalitis. Hospital germ Clostridium difficile infection. Serious loss of physical strength due to massive diarrhoea. The relatives decided to take the patient into home care. At the end of palliative care, the patient deceased on 23Jun2021. The outcome of Hospital germ Clostridium difficile infection was unknown; of Herpes zoster ophthalmicus, Diarrhea, General physical condition decreased was not recovered; of Encephalitis herpes was fatal. The patient died on 23Jun2021. An autopsy was not performed. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No Information on risk factors or previous illnesses Mild hypertension, venous congestion of the legs / Onset of swollen eye on 16Apr2021, 2 days later suspected stroke: hospitalisation, magnetic resonance showed no evidence of apoplexy, further examinations revealed diagnosis of herpes encephalitis. Hospital germ Clostridium difficile infection. Serious loss of physical strength due to massive diarrhoea. The relatives decided to take the patient into home care. At the end of palliative care, deceased on 23Jun2021. Causal relationship between all the events and the administration of CORMINATY was assessed as Unclassifiable by the PEI. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Encephalitis herpes


VAERS ID: 1728632 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-09-10
   Days after onset: 98
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: FIPFIZER INC202101222546

Write-up: Anencephaly; The pregnancy started on 10Jun2021, patient mother received second dose on 10Aug2021; Vaccine exposure before pregnancy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20214728. This consumer reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 04Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 transplacental on 20Aug2021 (Batch/Lot Number: UNKNOWN) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced anencephaly (death, congenital anomaly) on 10Sep2021, vaccine exposure before pregnancy on 04Jun2021. The patient''s mother was pregnant which had started on 10Jun2021. She received dose 1 via an unspecified route of administration on 04Jun2021 and dose 2 on 20Aug2021. The pregnancy had to be terminated on 10Sep2021 due to severe malformation of the fetus (anencephaly). The link to the vaccine was only theoretical. However, the report was made because the pregnancy started soon after the first dose of the vaccine and this was a serious injury. Failure of neural tube closure was known to occur in early pregnancy. The patient died on 10Sep2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : FI-PFIZER INC-202101230256 mother 2nd dose/fetus case;FI-PFIZER INC-202101230891 mother 1st dose/fetus case; Reported Cause(s) of Death: Anencephaly


VAERS ID: 1728636 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-08-03
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1248 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Altered state of consciousness, Angiogram, Areflexia, Arterial occlusive disease, Cerebral haematoma, Chest pain, Computerised tomogram, Death, Electrocardiogram, Electrocardiogram ST segment elevation, Haemorrhagic stroke, Hemiplegia, Intracranial pressure increased, Mydriasis, Myocardial infarction, Nervous system disorder, Subarachnoid haemorrhage
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Crohn''s disease ((suspected Crohn''s disease))
Preexisting Conditions: Medical History/Concurrent Conditions: Cannabis use; Drug addict; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: Coronary angiography; Result Unstructured Data: Test Result:bi-truncular lesions; Comments: (bi-truncular lesions with an acute occlusion of the proximal right coronary artery of thrombotic appearance with implantation of an active stent, a stenosis of the middle right coronary artery and a stenosis of the ostium of the middle circumflex artery); Test Date: 20210806; Test Name: angiocomputed tomography scan; Result Unstructured Data: Test Result:hyperacute left frontal lobar haematoma; Comments: (a hyperacute left frontal lobar haematoma associated with a diffuse subarachnoid haemorrhage responsible for a right left subfactorial and left medial temporal involvement was found. Evidence of intracranial hypertension with preservation of white matter gray matter differentiation. No obvious underlying vascular abnormality); Test Date: 20210806; Test Name: Electrocardiography; Result Unstructured Data: Test Result:ST segment elevation in inferior
CDC Split Type: FRPFIZER INC202101195041

Write-up: Myocardial infarction; chest pain; ST segment elevation in inferior; acute occlusion of the proximal right coronary artery; neurological disorders; altered consciousness; agitation; right hemiplegia; hyperacute left frontal lobar haematoma; diffuse subarachnoid haemorrhage; intracranial hypertension; bi-lateral mydriasis; abolition of reflexes; Haemorrhagic stroke; natural causes; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BS20211701. A 44-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular, administered in Arm Left on 17Jul2021 (batch/Lot Number: FE1248) as single dose for COVID-19 immunisation. Medical history included ongoing Crohn''s disease (suspected Crohn''s disease), smoking, cannabis use, drug addict. The patient had no medical history of COVID. The patient''s concomitant medications were not reported. The patient experienced haemorrhagic stroke (death, medically significant) on 06Aug2021, natural causes (death, medically significant) on 06Aug2021, myocardial infarction (hospitalization, medically significant) on 03Aug2021, chest pain (hospitalization) on 03Aug2021, ST segment elevation in inferior (medically significant) on 06Aug2021, acute occlusion of the proximal right coronary artery (medically significant) on 06Aug2021, neurological disorders (medically significant) on 06Aug2021, altered consciousness (medically significant) on 06Aug2021, agitation (medically significant) on 06Aug2021, right hemiplegia (medically significant) on 06Aug2021, hyperacute left frontal lobar haematoma (medically significant) on 06Aug2021, diffuse subarachnoid haemorrhage (medically significant) on 06Aug2021, intracranial hypertension (medically significant) on 06Aug2021, bi-lateral mydriasis (medically significant) on 06Aug2021, abolition of reflexes (medically significant) on 06Aug2021. The patient was hospitalized for myocardial infarction from 06Aug2021 to an unknown date. The patient was hospitalized for chest pain from 06Aug2021 to an unknown date. The clinical course was reported as follows: 17 days later, on 03Aug2021, onset of chest pain. 20 days later, on 06Aug2021, the patient is hospitalised due to persistent chest pain indicative of a threatening syndrome. 06Aug2021: Electrocardiography: ST segment elevation in inferior. 06Aug2021: Coronary angiography revealed bi-truncular lesions with an acute occlusion of the proximal right coronary artery of thrombotic appearance with implantation of an active stent, a stenosis of the middle right coronary artery and a stenosis of the ostium of the middle circumflex artery. The procedure was carried out without difficulty and the revascularisation was successful.Initiation of treatment with KARDEGIC, BRILIQUE and AGRASTAT. A few hours after the coronary angiography, the patient experienced neurological disorders with altered consciousness, agitation and right hemiplegia. 06Aug2021: An angiocomputed tomography scan was performed urgently: a hyperacute left frontal lobar haematoma associated with a diffuse subarachnoid haemorrhage responsible for a right left subfactorial and left medial temporal involvement was found. Evidence of intracranial hypertension with preservation of white matter gray matter differentiation. No obvious underlying vascular abnormality found given the incomplete investigation. The patient''s state evolves very quickly to a bi-lateral mydriasis with abolition of reflexes despite a reversion of anti-platelet drugs and platelet transfusion. Due to the seriousness of the clinical picture, the patient is out of neurosurgical therapeutic resources. The patient died the same day at the end of the day, of natural causes according to the doctors. In conclusion, myocardial infarction 17 days after a first vaccination with COMIRNATY, in a male patient who was a smoker and drug addict. Physician Office Visit for events. Therapeutic measures were taken as a result of events. The patient died on 06Aug2021. It was not reported if an autopsy was performed. The outcome of events haemorrhagic stroke and natural causes was fatal. The outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; natural causes


VAERS ID: 1728644 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-06-01
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acquired haemophilia, Activated partial thromboplastin time, Atrial fibrillation, Blood creatinine, Blood test, C-reactive protein, Creatinine renal clearance, Haemoglobin, Mean cell volume, Neutrophil count, Platelet count, SARS-CoV-2 test, White blood cell count
SMQs:, Haemorrhage laboratory terms (broad), Supraventricular tachyarrhythmias (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; COVID-19; Diabetes; Obstructive arteriosclerosis of lower extremities; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result: normal seconds; Test Date: 2021; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result: greater than 84 seconds; Comments: greater than 84 sec for a control at 34 sec; Test Date: 20210630; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result: spontaneously lengthened seconds; Test Date: 20210816; Test Name: activated partial thromboplastin time; Test Result: 70 s; Comments: 70sec for a control at 34sec; Test Date: 20210816; Test Name: Creatinine; Result Unstructured Data: Test Result:26.4 mg/l; Comments: stable; Test Date: 2021; Test Name: factor VIII; Result Unstructured Data: Test Result: deficiency at 3%; Test Date: 20210816; Test Name: ionogram; Result Unstructured Data: Test Result: normal; Test Date: 20210816; Test Name: CRP; Result Unstructured Data: Test Result:32 mg/l; Test Date: 20210816; Test Name: clearance; Result Unstructured Data: Test Result:21 ml/min; Test Date: 202107; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.1 g/dl; Comments: normocytic and a regenerative; Test Date: 20210816; Test Name: hemoglobin; Result Unstructured Data: Test Result:6.6 g/dl; Test Date: 20210816; Test Name: mean corpuscular volume; Result Unstructured Data: Test Result:100; Comments: �3; Test Date: 20210816; Test Name: polynuclear neutrophil; Result Unstructured Data: Test Result:22 000 /mm3; Test Date: 20210816; Test Name: Platelets; Result Unstructured Data: Test Result:298 000 /mm3; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 20210816; Test Name: leukocytes; Result Unstructured Data: Test Result:25 000 /mm3
CDC Split Type: FRPFIZER INC202101222708

Write-up: Acquired haemophilia; atrial fibrillation; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20216149. A 90-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 23Mar2021 (Batch/Lot Number: ET3620) as single dose for covid-19 immunisation. Medical history included diabetes, stroke, obstructive arteriosclerosis of lower extremities, chronic renal failure and COVID-19. SARS-CoV-2 test was positive. He was considered at risk. The patient''s concomitant medications were not reported. In Jun2021 appearance of acquired hemophilia in patient. Activated partial thromboplastin time was normal in May2021. Activated partial thromboplastin time spontaneously lengthened in 30Jun2021. The patient was hospitalization in Jul2021 for hemorrhagic syndrome, discontinuation of antiagregants and anti-vitamin K recently introduced for atrial fibrillation, multiple transfusions for digestive hemorrhage. Acquired hemophilia diagnosis made on 13Aug2021, corticosteroid therapy started prednisone 1mg/kg. He had been hospitalized from 17Aug2021 to 23Aug2021 for the management of acquired hemophilia. The patient was hospitalized in the gastroenterology department from 29Jul2021 for the management of an anemic syndrome with a hemoglobin at 6.1g/dl (in 2021) normocytic and a regenerative in the emergency room. It was discovered a prolonged activated partial thromboplastin time in an isolated manner greater than 84 sec for a control at 34 sec and the coagulation factor dosage found a factor VIII deficiency at 3% in 2021. Acquired hemophilia was therefore suspected and the patient was transferred to the internal medicine department. This patient presented with asthenia and dyspnea at rest in the context of anemia. He presented with mucocutaneous pallor. The patient presented with a sheet of bruising. Blood test from 16Aug2021 included there was a biological inflammatory syndrome with leukocytes at 25 000/mm3 with polynuclear neutrophil at 22 000/mm3, CRP at 32mg/l. Anemia with hemoglobin at 6.6g/dl and a mean corpuscular volume at 100�3. Platelets at 298,000 / mm3. activated partial thromboplastin time at 70sec for a control at 34sec, normal ionogram. Creatinine at 26.4mg/l (stable with a clearance at 21ml/min). Corticosteroid therapy alone was therefore started at a dosage of 80 mg per day since 13Aug2021. Approximate period of onset of the adverse reaction was 21Jun2021. The outcome of the event Acquired haemophilia was fatal. The outcome of the event atrial fibrillation was unknown. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Comments: case completed by the Pharmacovigilance Center, additional information obtained on 03Sep2021 No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acquired haemophilia


VAERS ID: 1728650 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-09-02
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic valve incompetence, Asthenia, Blood pressure measurement, COVID-19 pneumonia, Dermatologic examination, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Rectal examination, Respiratory rate, SARS-CoV-2 test, Tachypnoea, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-10
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Chronic renal failure; Congestive (dilated) cardiomyopathy; COPD; Dyslipidemia; Hypertension arterial; Insulin-requiring type 2 diabetes mellitus; Obstructive sleep apnoea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: BP; Result Unstructured Data: Test Result:128/68; Test Date: 20210905; Test Name: Skin examination; Result Unstructured Data: Test Result:unremarkable; Test Date: 20210905; Test Name: O2 saturation; Test Result: 92 %; Test Date: 20210910; Test Name: O2 saturation; Test Result: 91 %; Comments: under 9L of O2; Test Date: 20210905; Test Name: Rectal examination; Result Unstructured Data: Test Result:loose stools, no blood; Test Date: 20210905; Test Name: Respiratory rate; Result Unstructured Data: Test Result:22; Test Date: 20210910; Test Name: Respiratory rate; Result Unstructured Data: Test Result:28; Comments: /min; Test Date: 20210902; Test Name: RT-PCR; Result Unstructured Data: Test Result:postive
CDC Split Type: FRPFIZER INC202101222672

Write-up: Aortic insufficiency; polypnoea; Asthenia; Dyspnea; COVID-19 pneumonia; Vaccination failure; Oxygen saturation decreased; This is a spontaneous report from a contactable Pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PB20216245. A 97-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number:ER9470), via intramuscular route of administration on 30Mar2021 as dose 1, single and second dose of BNT162B2 (Batch/Lot Number: ET6956), via intramuscular route of administration on 27Apr2021 as dose 2, single for COVID-19 immunisation. Medical history included congestive (dilated) cardiomyopathy, benign prostatic hyperplasia, COPD, hypertension arterial, dyslipidemia, obstructive sleep apnoea syndrome, insulin-requiring type 2 diabetes mellitus, chronic renal failure; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 02Sep2021, the patient had a positive COVID-19 PCR test. The patient had COVID-19 Pneumonia. On 05Sep2021, he was taken to the emergency room for dyspnoea and asthenia. Desaturation at aortic insufficiency with polypnea without externalized bleeding during examination. On 05Sep2021, the clinical examination on admission showed conscious patient, slight slowing down, no focal neurological deficit, respiratory rate 22, 2L O2, oxygen saturation 92%, bronchial congestion, crackles in the 2 pulmonary hemifields, no sweat, no sign of respiratory distress, warm extremities, soft and painless calves, no sign of right heart failure, regular heart sounds without breath, blood pressure 128/68, symmetrical palpated pulses, painless soft abdomen, no palpated mass, rectal examination: loose stools, no blood and unremarkable skin examination. The clinical examination on 06Sep2021, revealed heart noise normal, irregular, no sign of right heart failure (no lower limbs edema), no sign of left heart failure except crackling of the bases. On 09Sep2021, increase in oxygen saturation to 9L at the end of the day and received 1 dose of TOCILIZUMAB (8 mg/kg). On 10Sep2021, at 01:00 AM, last taken oxygen saturation was 91% constant under 9L and respiratory rate 28/min. On 10Sep2021, at 03:45 AM, the nurse during her turn declared the patient death. The conclusion was a Probable vaccine failure in a 97-year-old patient with an oxygen referee on the complete vaccination schedule. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Positive on 02Sep2021; blood pressure measurement: 128/68, skin examination: unremarkable, oxygen saturation: 92 % on 05Sep2021, rectal examination: loose stools, no blood, respiratory rate: 22 on 05Sep2021; oxygen saturation: 91 % under 9L of O2, respiratory rate: 28/min on 10Sep2021. Therapeutic measures were taken as a result of the events. The patient died on 10Sep2021. The cause of death was reported as COVID-19. It was not reported if an autopsy was performed. The outcome of the events was fatal while asthenia and dyspnea was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Covid-19


VAERS ID: 1728651 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-07-05
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Body temperature, Mouth haemorrhage, Osteomyelitis, Pain in jaw, SARS-CoV-2 test, Stomatitis
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Osteonecrosis (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 42
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101222919

Write-up: Buccal inflammation/very fragile oral mucosa, inflammatory; Oral mucosa bleeding; Infection bacterial; purulent discharge in the lower left mandible; mandibular pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority report number FR-AFSSAPS-PC20213877. An 87-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY, lot number EX6537) at single dose on 07May2021 intramuscular for COVID-19 immunisation. Medical history included COVID-19. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY, lot number ET7205) on 01Apr2021 intramuscular in left arm for COVID-19 immunisation. SARS-CoV-2 test on an unknown date was positive. Serious adverse event was reported as oral mucosa bleeding with onset date of 22Jul2021 and infection bacterial with onset date of 05Jul2021, both with seriousness criterion of death. The clinical course was reported as follows: Patient experienced purulent discharge in the lower left mandible + localized pain. On 05Jul2021, patient presence of pus in the left mandibular area. Between 22Jul2021 and 28Jul2021, patient had 3 episodes of red blood in the mouth. On 12Aug2021, patient was very fragile oral mucosa, inflammatory, bleeding of oral origin, buccal inflammation. On 14Aug2021, body temperature was 38,6 degree C. Patient died on 16Aug2021. Outcome of oral mucosa bleeding and infection bacterial was fatal. Outcome of the other events was unknown. No autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Oral mucosa bleeding; Infection bacterial


VAERS ID: 1728862 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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: ATPFIZER INC202101222564

Write-up: DEATH!; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number AT-BASGAGES-2021-044136. An 80-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that 3 days after first vaccination with Comirnaty, first symptoms were noticed; subsequently hospitalization, death within one week. On 04Apr2021 the patient experienced Death. It was not reported if an autopsy was performed. Sender''s comments: The report is for a relative. No mail was sent to the reporter! 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: 1728939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-23
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   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:
CDC Split Type: DEPFIZER INC202101222404

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB [DE-AMK-253070], Safety Report Unique Identifier [DE-PEI-202100189576]. A 63-year-old female patient received bnt162b2 (COMIRNATY, 0.3 ml, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 23Jul2021. The patient died on 23Jul2021. Cause of death was not reported. It was not reported if an autopsy was performed. The PEI assessed the causal relationship between bnt162b2 (COMIRNATY) and event unknown cause of death as D. Unclassifiable. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Unknown cause of death cannot be totally excluded. The impact of this report the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1728943 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-11
   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: Apoplexy; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101215643

Write-up: Sudden death; Off label; Extra dose administered; This is as spontaneous report received from a physician downloaded from the Medicine Agency (MA) EudraVigilance-WEB. The regulatory authority report number is DE-PEI-202100188860. An 85-year-old male patient received bnt162b2 (COMIRNATY) dose 3 via an unspecified route of administration on 08Sep2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included apoplexy, dementia. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 09Jan2021, second dose of BNT162B2 on 30Jan2021 for COVID-19 immunisation. The patient experienced sudden death on 11Sep2021. The patient died on 11Sep2021. It was not reported if an autopsy was performed. Relatedness Assessment for event Sudden death: B. Indeterminate per PEI. No follow-up attempts possible, information about batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Sudden death


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