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

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



Case Details

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VAERS ID: 1579228 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Irritability, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   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: LOSARTAN; SIMVASTATIN; HYDREX [HYDROCHLOROTHIAZIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Living in residential institution.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202100996870

Write-up: Sudden death; Irritability; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20213739. A 64-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 08Jul2021 (Batch/Lot Number: FE3065) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included living in enhanced service housing. Concomitant medications included losartan; simvastatin; and hydrochlorothiazide (HYDREX [HYDROCHLOROTHIAZIDE]). On 10Jul2021, the patient experienced sudden death and irritability, both resulted to fatal outcome. It was further reported that a man living in enhanced service housing received a booster vaccine on Thursday 08Jul. Did not verbally tell about the changes in his well-being, but the staff found that the resident was more aggressive than normal. Resident was met on Saturday 10Jul at 11:00 and was found dead in the apartment at 16:00. There was no information on the contribution of the vaccination to death. The deceased was delivered for medical autopsy. The patient died on 10Jul2021. An autopsy was performed and results were not provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death; Irritability


VAERS ID: 1579233 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003187 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVERSYL [PERINDOPRIL ARGININE]; KARDEGIC; CARDENSIEL; LASILIX [FUROSEMIDE]; PROCORALAN
Current Illness: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; Death of brother cardiac arrest; Left ventricular ejection fraction (40%); Overweight; smoking
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: AM20212231) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of CARDIAC ARREST in a 52-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003187) for COVID-19 vaccination. The patient''s past medical history included Smoking, Overweight, Left ventricular ejection fraction (40%) and Chronic respiratory failure. Family history included Death of brother; cardiac arrest. Concurrent medical conditions included Hypertension arterial. Concomitant products included PERINDOPRIL ARGININE (COVERSYL [PERINDOPRIL ARGININE]), ACETYLSALICYLATE LYSINE (KARDEGIC), BISOPROLOL FUMARATE (CARDENSIEL), FUROSEMIDE (LASILIX [FUROSEMIDE]) and IVABRADINE HYDROCHLORIDE (PROCORALAN) for an unknown indication. On 14-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant). The patient died on 14-Jul-2021. The reported cause of death was cardiac arrest. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment to the event was not reported. Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per list.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Event term, onset date and outcome captured per Authority reporting. Event seriousness per assessment by Authority and per list; Reported Cause(s) of Death: cardiac arrest.


VAERS ID: 1579269 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Infarction, Nausea, Neurosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Myocardial infarction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   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: Alcohol use; Pollen allergy; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101026443

Write-up: Dyspnea/difficulty in breathing; Arrest cardiac; nausea; neurosis; infarction; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number [FR-AFSSAPS-PB20215002]. A 54-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 13May2021 (Lot Number: FA5829) as dose 1, single for COVID-19 immunization. Medical history included smoker, alcohol user and pollen allergy. The patient''s concomitant medications were not reported. On 19May2021, the patient presented several effects: nausea, difficulty in breathing and cardiac arrest potentially due to either a neurosis or an infarction leading to the death of the patient despite the intervention of the firefighters. Therapeutic measures were taken as a result of the events. The patient died on 19May2021. Cause of death were cardiac arrest, dyspnea, nausea, neurosis and infarction. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Dyspnea; nausea; neurosis; infarction


VAERS ID: 1579276 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-05-20
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Computerised tomogram thorax, Fraction of inspired oxygen, Haemodynamic test, Multiple organ dysfunction syndrome, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNISONE; ESOMEPRAZOLE; GAVISCON [ALGELDRATE;ALGINIC ACID;MAGNESIUM TRISILICATE;SODIUM BICARBONATE]; LERCANIDIPINE; PERINDOPRIL; NEOMERCAZOLE; IVABRADINE; SIMVASTATIN; SYMBICORT; LEDERFOLINE; DAFALGAN; UVEDOSE
Current Illness: Arthritis rheumatoid; Dialysis (awaiting transplantation); Dyslipidaemia; End stage renal failure; Goiter; Hypertension arterial; Hyperthyroidism; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Herpes zoster; Interstitial pneumonitis (interstitial lung disease with a favourable evolution in 2001 with probable sequelae); Phlebitis; Pneumocystosis; Thrombophlebitis
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: thoracic CT scan; Result Unstructured Data: Test Result:severe damage greater than 50%; Test Date: 20210622; Test Name: FiO2; Test Result: 100 %; Comments: During the night of 22Jun2021 to 23Jun2021; Test Date: 20210623; Test Name: FiO2; Test Result: 100 %; Comments: During the night of 22Jun2021 to 23Jun2021; Test Date: 20210607; Test Name: oxygen saturation; Test Result: 83 %; Test Date: 20210622; Test Name: oxygen saturation; Test Result: 80 %; Comments: During the night of 22Jun2021 to 23Jun2021; Test Date: 20210623; Test Name: oxygen saturation; Test Result: 80 %; Comments: During the night of 22Jun2021 to 23Jun2021; Test Date: 20210604; Test Name: sars-cov-2 PCR test; Test Result: Positive ; Test Date: 202106; Test Name: Hemodynamics; Result Unstructured Data: Test Result:deteriorated; Test Date: 20210520; Test Name: body temperature; Result Unstructured Data: Test Result:hyperthermia
CDC Split Type: FRPFIZER INC202101016176

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20212356. A 61-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 08Apr2021 (Batch/Lot Number: Unknown) as dose 2, single, dose 1 intramuscular on 20Mar2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunization. Medical history included thrombophlebitis from 2012, ongoing end-stage chronic renal failure, ongoing dialysis awaiting transplantation, ongoing arterial hypertension, ongoing type 2 diabetes mellitus, ongoing dyslipidaemia, ongoing Arthritis rheumatoid, pneumocystis in 2010, femoropopliteal phlebitis in 2012, goitre with ongoing hyperthyroidism, herpes zoster and Interstitial pneumonitis (interstitial lung disease with a favourable evolution in 2001 with probable sequelae). No known history of allergy. Covid-19 history was No. Concomitant medications included prednisone; esomeprazole; algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON); lercanidipine; perindopril; carbimazole (NEOMERCAZOLE); ivabradine; simvastatin; budesonide, formoterol fumarate (SYMBICORT); calcium folinate (LEDERFOLINE); paracetamol (DAFALGAN); colecalciferol (UVEDOSE). On 20May2021 she presented with hyperthermia, myalgia and general deterioration. Positive PCR on 04Jun2021. Put on Augmentin for 7 days. On 07Jun2021, she was hospitalized in a specialized department due to increased dyspnea and desaturation at 83% after her usual dialysis session. The thoracic CT scan showed severe damage greater than 50%. No pleural effusion. During the night of 22Jun2021 to 23Jun2021, the patient''s respiratory status deteriorated with hypercapnic acidosis with major oxygen deprivation leading to desaturation of 80% despite a FiO2 of 100%. Hemodynamics deteriorated secondarily with increased doses of Noradrenaline up to 2 ug/kg/minute. Tazocillin and Amiklin were started on suspicion of septic shock with a pulmonary origin. The evolution towards a refractory multivisceral failure syndrome led to the death of the patient on 23Jun2021. In total, 61-year-old patient hospitalized for Covid-19 infection with severe respiratory failure leading to death, after vaccination with 2 doses of COMIRNATY. The patient died on 23Jun2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Covid-19 infection with severe respiratory failure; multivisceral failure syndrome; Covid-19 infection with severe respiratory failure.


VAERS ID: 1579296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-06
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; CANDESARTAN; DIAZEPAM; FOLIC ACID; METOJECT; OMEPRAZOLE; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthralgia (arising from rotator cuff injury); Colitis ulcerative; Hypertension; Rotator cuff syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992332

Write-up: This is a spontaneous report from a contactable physician received from Regulatory Authority. The regulatory authority report number is GB-MHRA-TPP30313820C968716YC1626777544107. A 5-years-old male patient received second dose of bnt162b2 (bnt162b2, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 15Jun2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included colitis ulcerative, hypertension, arthralgia, ongoing arising from rotator cuff injury and rotator cuff syndrome from an unknown date and unknown if ongoing. Concomitant medications included bisoprolol taken for an unspecified indication from 15Nov2018 to 07Jul2021; candesartan taken for hypertension from 21Oct2019 to 07Jul2021; diazepam taken for an unspecified indication from 12Nov2015 to 07Jul2021; folic acid taken for an unspecified indication from 03Jan2014 to 07Jul2021; methotrexate sodium (Metoject) taken for an unspecified indication from 23Sep2019 to 07Jul2021; omeprazole taken for an unspecified indication from 02Oct2018 to 07Jul2021; tramadol taken for an unspecified indication from 11Dec2018 to 07Jul2021. On 06Jul2021, patient experienced pulmonary embolus (pulmonary embolism) (death, medically significant) and on an unspecified date patient experienced deep vein thrombosis. On 06Jul2021, patient died due to pulmonary embolus. Cause of death from post-mortem determined as pulmonary embolus secondary to right calf deep vein thrombosis. The outcome of deep vein thrombosis was unknown. No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.; Reported Cause(s) of Death: Pulmonary embolism.


VAERS ID: 1579326 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-06-23
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound foetal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-28
   Days after onset: 35
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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy; Comments: Patient has not had symptoms associated with COVID- 19 and Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Date: 20210705; Test Name: ultrasound fetal; Result Unstructured Data: 1st scan due to a small bleed, should have been 7+2 weeks pregnant, embryo was measuring approx. . 5 wks; Test Date: 20210719; Test Name: ultrasound fetal; Result Unstructured Data: 2nd scan confirmed no growth and no heartbeat.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 25742447) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Early miscarriage), ABORTION SPONTANEOUS (surgical miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. Patient has not had symptoms associated with COVID- 19 and Patient is not currently breastfeeding. The patient''s past medical history included Miscarriage and Pregnancy. Concurrent medical conditions included Lactation decreased. Concomitant products included FOLIC ACID for Folic acid supplementation. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Jun-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (surgical miscarriage) (seriousness criteria hospitalization, medically significant and congenital anomaly) and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) (seriousness criteria hospitalization and congenital anomaly). The delivery occurred on 28-Jul-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. The patient died on 28-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ABORTION SPONTANEOUS (surgical miscarriage) had resolved and MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, Ultrasound foetal: 5 wks 1st scan due to a small bleed, should have been 7+2 weeks pregnant, embryo was measuring approx. . 5 wks. On 19-Jul-2021, Ultrasound foetal: abnormal (abnormal) 2nd scan confirmed no growth and no heartbeat.. On 26-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was stated that patient was exposed to the medicine before pregnancy. Details of scans or investigations: Scan at 7 weeks gestation showed 5 week measurements. Further scan at 9 weeks confirmed no growth and no heartbeat. Treatment medication was not provided by the reporter. Company Comment: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Case is confounded by patients age and history of previous miscarriage. RA reported the event with the seriousness criteria of death which is retained as reported but probably is referring to the child and not the patient (mother).; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Case is confounded by patients age and history of previous miscarriage. RA reported the event with the seriousness criteria of death which is retained as reported but probably is referring to the child and not the patient (mother).; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1579553 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998300

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108040856409310-DSWWG. Safety Report Unique Identifier is GB-MHRA-ADR 25750434. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not known, expiry date not reported), via an unspecified route of administration on 03Feb2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient had not had a COVID-19 test. The patient experienced death on 04Feb2021. The patient died on 04Feb2021. It was not reported if an autopsy was performed. Case narrative: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. Information about Lot/ Batch number cannot be obtained.; Reported Cause(s) of Death: Death.


VAERS ID: 1579624 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No adverse Event, no medical history per source document.
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: Pneumonia; This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No adverse Event, no medical history per source document. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria death and medically significant). The reported cause of death was Pneumonia. It is unknown if an autopsy was performed. No concomitant medications were provided. No treatment information was provided. This is a case of sudden death in a male patient of unknown age with no known past medical history, who died due to pneumonia after receiving a dose of the vaccine. Very limited information has been provided at this time. No further information is expected at this time.; Sender''s Comments: This is a case of sudden death in a male patient of unknown age with no known past medical history, who died due to pneumonia after receiving a dose of the vaccine. Very limited information has been provided at this time. No further information is expected at this time.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1579676 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, SARS-CoV-2 test
SMQs:, Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None.
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101028687

Write-up: Brain swelling; This is a spontaneous report from a contactable healthcare professional received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108091935046780-ZA83N, Safety Report Unique Identifier GB-MHRA-ADR 25776597 A 34-year-old male patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 08Aug2021 as single dose for COVID-19 immunisation. No relevant medical history. He has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced brain swelling (fatal per HA assessment) on 09Aug2021. He has not tested positive for COVID-19 since having the vaccine. He underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 09Aug2021. This report is not related to possible blood clots or low platelet counts. The patient died on 09Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Brain swelling


VAERS ID: 1579689 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / OT

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

Life Threatening? No
Birth Defect? 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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Scan; Result Unstructured Data: Test Result:showed the baby died just days after receiving the; Comments: vaccine just after 8 weeks.
CDC Split Type: GBPFIZER INC202101019814

Write-up: Baby died; Patient was exposed to the medicine first-trimester (1-12 weeks).; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus. This is a fetus report. The mother report is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108051925090980-SOJDR. Safety Report Unique Identifier GB-MHRA-ADR 25761509. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 transplacental on 17Jul2021 (Lot Number: FE1510) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included folic acid taken for vitamin supplementation. Baby died days after 2nd vaccine dose just over 8 weeks gestation (baby had not been conceived before first dose). Patient was exposed to the medicine first-trimester (1-12 weeks). Scan just before 12 weeks showed the baby died just days after receiving the vaccine just after 8 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) : GB-PFIZER INC-202101012902 case for mother; Reported Cause(s) of Death: Patient was exposed to the medicine first-trimester (1-12 weeks); baby died


VAERS ID: 1579698 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   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: ATACAND
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COVID-19 (The patient presented covid-19 disease months before and recovered at home under medication); Hyperplasia of prostate (Benign hyperplasia of prostate).
Allergies:
Diagnostic Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:40 Centigrade; Comments: fever up to 40 degree Celsius; Test Date: 20210723; Test Name: Fever; Result Unstructured Data: Test Result:$g39 Centigrade; Comments: over 39 degree Celsius.
CDC Split Type: GRPFIZER INC202101026136

Write-up: FEVER OVER 39 DEGREE CELSIUS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is GR-GREOF-20216444. This physician reported different events for both doses of COMIRNATY for the same patient. This is the first of two reports for events under the second dose. A 90-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Jul2021 (at the age of 90-year-old) (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included arterial hypertension, Hyperplasia of prostate (Benign hyperplasia of prostate). The patient also presented covid-19 months before and recovered at home under medication on unknown date. Concomitant medication included candesartan cilexetil (ATACAND) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation on unknown date (Batch/Lot Number: Unknown) and the patient after the first dose of COMIRNATY presented fever up to 40 degree celsius and received medication with antifebrile for 3 days. The patient experienced fever over 39 degree Celsius on 23Jul2021 and reported as serious due to death and medically significant. It was reported that on 23Jul2021 he received the second dose of COMIRNATY. At night he presented fever over 39 degree celsius. On 24Jul2021 he was found on floor at home unconscious. He was dead. Despite his age he was totally functional and self service. His wife died from covid-19 months before. The patient died on 24Jul2021 due to fever. 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.; Sender''s Comments: Linked Report(s) : GR-PFIZER INC-202101037434 the same patient, different doses and outcome; Reported Cause(s) of Death: Fever


VAERS ID: 1579782 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (treatment with antihypertensive drugs).
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101016246

Write-up: hypertension; Sudden cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-765753. A 62-years-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Jul2021 14:29 (Batch/Lot Number: FE2625; Expiration Date: 31Oct2021) at single dose, for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing (treatment with antihypertensive drugs). Concomitant medication included antihypertensive drugs. The patient experienced sudden cardiac arrest (death) on 15Jul2021 18:00. It was reported the actions taken (Cardiopulmonary resuscitation and unsuccessful adrenaline administration, family refuses diagnostic finding). It was reported from the resuscitation protocol to which the patient was subjected without success it is indicated that: the husband reported that after hearing a noise he saw patient unconscious on the ground. After a few minutes, help arrived and cadiopulmonary resuscitation with adrenaline sum was performed, but unfortunately the asystole was permanent, and the lady died. The general practitioner reported that the patient was hypertensive on treatment with antihypertensive drugs, but had strong doubts about the patient''s adherence to the therapy. Therapeutic measures were taken as a result of sudden cardiac arrest. The patient died on 15Jul2021. The cause of death was hypertension and sudden cardiac arrest. It was unknown if an autopsy was performed. The outcome of event was fatal. Reporters comment: Difficult to identify an etiology in the absence of diagnostic evidence, presumably the underlying hypertension represents the primary cause of sudden asystole - Reaction time: 18:00 - Posted by RA. Senders comment: 03Aug2021 Regulatory Authority: requests for follow-up information from the reporter regarding the clinical report of the case and any concomitant drugs. 05Aug2021 Regulatory Authority: the form is updated with the additional information provided by the reporter; Reporter''s Comments: Difficult to identify an etiology in the absence of diagnostic evidence, presumably the underlying hypertension represents the primary cause of sudden asystole - Reaction time: 18:00 - Posted by RA; Reported Cause(s) of Death: sudden cardiac arrest; hypertension


VAERS ID: 1579791 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 LA / OT

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

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-06-20
   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: FERPLEX FOL; CARDIOASPIRIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Pulse; Result Unstructured Data: Test Result: There was no longer a pulse.
CDC Split Type: ITPFIZER INC202101025916

Write-up: Maternal exposure during pregnancy, second trimester (14 weeks); There was no longer a pulse; Dimensions of the fetus were stopped at 14 weeks; This is a spontaneous report from a contactable consumer (patient''s mother). This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB (Regulatory Authority Report Number: IT-MINISAL02-762143). This consumer reported events for both mother and fetus. This is the fetus report. A 37-year-old mother received BNT162B2 (COMIRNATY; Lot Number: FC5089, Expiration Date: 31Oct2021), via an unspecified route of administration in left arm, on 20Jun2021 at 16:33 (at the age of 37 years), as dose 1, single, for COVID-19 immunization. The mother''s medical history included pregnancy. The mother''s concomitant medications included calcium folinate/ iron succinyl-protein complex (FERPLEX FOL) for pregnancy and acetylsalicylic acid (CARDIOASPIRIN). On 20Jun2021, the fetal patient of an unspecified gender experienced maternal exposure during pregnancy, second trimester via transplacental route of administration. The patient experienced congenital anomaly. On 14Jul2021, the mother made the visit (physician office visit) because she was in the eighteenth week of pregnancy, but she discovered that there was no longer a pulse, the dimensions (dimens) of the fetus were stopped at 14 weeks, that of the first dose vaccine (20Jun2021). The events were considered serious as medically significant. The outcome of the events was fatal. The patient died on 20Jun2021. 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) : IT-PFIZER INC-202100988280 Maternal case; Reported Cause(s) of Death: Maternal exposure during pregnancy, second trimester; There was no longer a pulse; Dimensions of the fetus were stopped at 14 weeks


VAERS ID: 1579806 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-16
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100987289

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122909. The patient was an 87-year-old male. Body temperature before vaccination was not provided. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunisation. On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 16Jul2021 (17 days after the vaccination), the patient experienced unknown cause of death. The outcome of the event was fatal. The outcome date was reported as 27Jul2021 (as reported).The course of the event was as follows: On 25Jul2021 (26 days after vaccination), in the evening, when the patient''s oldest son visited the patient''s home, he noticed that the package which was delivered on 18Jul2021 (19 days after vaccination) when he visited the previous time was left undisturbed. When the son searched around the neighborhood, the patient was dead on the bank under the patient''s field. The dead body was almost skeletonized. The last time when the patient was found alive was on 16Jul2021, at around 07:30 (17 days after vaccination) when the neighbor found the patient doing farm work. The last time when the oldest son, who was visiting the patient''s home every week, met the patient was on 11Jul2021, at around 18:00 (12 days after vaccination). The last hospital visit to the orthopedic surgery clinic, where the patient was periodically visiting for lumbago, was 13Jul2021 (14 days after vaccination). On both days, the patient seemed not to complain of physical deconditioning. Although the patient was an elderly, he was not periodically visiting the hospital for a medical disease. The involvement of severe injury associated with fracture was ruled out on the autopsy. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The possibility of heat illness or the onset of an acute disease was considerable. However, when the patient was found, the dead body was almost skeletonized. Thus, although the involvement of severe injury associated with fracture was ruled out, the cause of death was not identified. The reporting physician commented as follows: Although it was reported that the patient received the second dose of BNT162b2 vaccination on 29Jun2021 (the day of vaccination), the symptoms from the vaccination to the death were unknown. At least, the patient did not complain of physical deconditioning on 11Jul2021 (12 days after vaccination) when the son met the patient and on 13Jul2021 (14 days after vaccination) when the patient visited the hospital where he was periodically visiting. The dead body which was found on 25Jul2021 (26 days after vaccination) was almost skeletonized, and the cause of death could not be identified. Of note, it was judged that the patient died on around 16Jul2021 (17 days after vaccination, until 18Jul2021 [19 days after vaccination] at the latest) according to the last eyewitness information. However, it was the end of the rainy season in the district where the patient lived at that time, and the highest temperature was above 30 degrees Celsius. Thus, the possibility of heat illness other than the onset of an acute disease was fully considerable. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1579808 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-31
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAKEPRON; PREDNISOLONE; ALFAROL; FOLIAMIN [FOLIC ACID]; LIPITOR; ASPARA-CA; ALINAMIN [FURSULTIAMINE HYDROCHLORIDE]; DAIPHEN; IMURAN [AZATHIOPRINE]; SENNOSIDE [SENNOSIDE A+B]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Folate deficiency; Interstitial pneumonia; Microscopic polyangiitis; Vitamin B1 deficiency.
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result: 36.3 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100987359

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122145. A 87-year and 4-month-old female patient received second dose of bnt162b2 (COMIRNATY; Lot Number: EY0572; Expiration Date: 31Oct2021), via an unspecified route of administration on 16Jul2021 (at the age of 87-years-old) as dose 2, single for COVID-19 immunisation. On 25Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). Body temperature before vaccination was 36.3 degrees centigrade. The family history was not provided. The patient had medical histories of microscopic polyangiitis, interstitial pneumonia, dementia, folate deficiency, and vitamin B1 deficiency. The concomitant medications included lansoprazole (TAKEPRON OD tablet 15 mg) at 15 mg x 1 tablet, prednisolone (PREDNISOLONE oral powder 1% ) at 0.3 g, alfacalcidol(ALFAROL oral powder 1 ug/g) at 1 g, folic acid (FOLIAMIN 5mg) at 5 mg x 1 tablet, atorvastatin calcium hydrate (LIPITOR 5 mg) at 5 mg x 1 tablet, aspartate calcium (ASPARA-CA 200) at 200 x 2 tablets, fursulfianine hydrochloride (ALINAMIN 25 mg) at 25 mg x 2 tablets, sulfamethoxazole, trimethoprim (DAIPHEN granules) at 1 g, azathioprine (IMURAN 50 mg) at 50 mg x 1 tablet, and sennoside A,B calcium (SENNOSIDE) at 0.3 g. The patient experienced cardio-respiratory on 31Jul2021. The clinical course was reported as follows: On 31Jul2021 at 07:00 (15 days after the vaccination), the patient experienced cardio-respiratory arrest. The patient was receiving periodical doctor''s visit from the reporting hospital for the above described underlying diseases. The patient was orally taking above described drugs for interstitial pneumonia and others. In addition, the patient was undergoing home oxygen therapy. The patient received the first dose of BNT162b2 vaccination on 25Jun2021, and the second dose on 16Jul2021 (the day of vaccination). Until then, the course was observed with stable condition. No particular findings were observed at doctor''s visit on 26Jul2021 (10 days after vaccination). However, on 31Jul2021, at around 07:00 (15 days after vaccination), the patient had been already in a state of cardio-respiratory arrest. On the same day, at 04:00 (15 days after vaccination), no abnormal changes were observed. On 31Jul2021 (15 days after the vaccination), the outcome of the event was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were respiratory failure due to interstitial pneumonia and others. The reporting physician commented as follows: In this case, the patient who had a stable course until then suddenly died on Day 15 after the second dose of the vaccination. Thus, the causality between the event and BNT162b2 vaccination could not be ruled out, and thus, this case was reported. However, since the patient had an underlying disease of interstitial pneumonia which required home oxygen therapy and she was an elderly, these factors themselves were considered as the risks of a sudden change.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1579810 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-20
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100987495

Write-up: aortic rupture; cardiac arrest; This is a spontaneous report from a contactable physician received via a Pfizer employee. A 93-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), intramuscularly on 04Jun2021 as dose number unknown, 0.3 mL single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced aortic rupture and cardiac arrest on 20Jun2021. The clinical course was as follows: On 04Jun2021, the patient received Comirnaty. It had passed without any problems. On 20Jun2021, the patient died from cardiac arrest due to aortic rupture at the facility that the patient went for a short stay. The cause of death was aortic rupture. The patient died on 20Jun2021. It was not reported if an autopsy was performed and the reported causes of death were aortic rupture and cardiac arrest. The reporting physician commented as follows: It had passed more than two weeks after the vaccination, and the causality was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: aortic rupture; cardiac arrest


VAERS ID: 1579822 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine (Pre-existing disease)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100993482

Write-up: Death due to aortic dissection; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was a 73-year-old female. Medical history included migraine. The patient''s concomitant medications were not reported. On 05Jun2021 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose (at the age of 73-years-old) for COVID-19 immunization. On an unknown date (one week or more after the vaccination), the patient experienced aortic dissection. On an unknown date (one week or more after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had migraine as a pre-existing disease. On 05Jun2021, the patient received the first dose of Comirnaty. On unknown date (one week or more after the vaccination), the patient experienced aortic dissection and died (when Information was received from the patient''s family member about cancellation of the second vaccination, the occurrence of the event was revealed). Outcome of the events was fatal. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and considered that the event was unlikely related to BNT162b2 because the patient died one week or more after the vaccination. The reporting physician commented: Due to the characteristics of the event, it was impossible to collect detailed information from the patient''s family member about the hospital to which the patient was urgently transferred. There was thus no further information. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Due to the characteristics of the event, it was impossible to collect detailed information from the patient''s family member about the hospital to which the patient was urgently transferred. There was thus no further information.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event aortic dissection and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: Aortic dissection


VAERS ID: 1579823 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Body temperature, Disseminated intravascular coagulation, Hepatorenal syndrome, Hyperglycaemic hyperosmolar nonketotic syndrome, Respiratory failure, Somnolence, Vomiting
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood glucose; Test Result: 794 mg/dl; Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result: decreased; Comments: Blood pressure decreased; Test Date: 20210726; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210727; Test Name: Body temperature; Result Unstructured Data: Test Result:37s to 38s Centigrade.
CDC Split Type: JPPFIZER INC202100993491

Write-up: Respiratory failure; groggy after vomiting; groggy after vomiting; Hyperosmolar hyperglycaemic syndrome; disseminated intravascular coagulation; hepatorenal disorders; This is a spontaneous report from a contactable physician received from the Regulatory Authority; the Regulatory Authority report number is v21122205. An 85-year-old male patient (reported as 85-year and 5-month-old) received the second dose of BNT162B2 (COMIRNATY) Solution for injection (batch/lot number: EY0573 and expiration date: 30Sep2021) via an unspecified route of administration, on 26Jul2021 at 13:54 (the day of vaccination) at the age of 85 years old, as DOSE 2, SINGLE for COVID-19 immunization. Patient''s body temperature before vaccination was 36.7 degrees centigrade. Medical history included diabetes mellitus and dementia Alzheimer''s type, both from an unknown date. The patient''s family history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY) via an unspecified route of administration, on an unspecified date (batch/lot number and expiration date were unknown) as DOSE 1, SINGLE for COVID-19 immunization. On 02Aug2021 at 12:00 (7 days after the vaccination, as reported), the patient experienced hyperosmolar hyperglycaemic syndrome. On 02Aug2021 (7 days after the vaccination, as reported), the patient was admitted to the hospital. On 02Aug2021 at 17:23 (7 days after the vaccination, as reported), the outcome of the event was fatal. The course of the events was as follows: On 26Jul2021, the patient received the second dose of Comirnaty. From 27Jul2021, the patient had pyrexia of 37s to 38s degrees C (Centigrade). On 02Aug2021 at around 12:00, the patient became groggy after vomiting, and at around 12:45, he was urgently transferred to the reporting hospital. On arrival at hospital, the patient presented with consciousness disturbed, blood pressure decreased, and respiratory failure. Blood test showed blood glucose of 794 mg/dL, disseminated intravascular coagulation, and hepatorenal disorders. The patient was considered to have hyperosmolar hyperglycaemic syndrome, for which treatment was started but showed poor response. At 17:23, he was confirmed dead. Outcome of the event hyperosmolar hyperglycaemic syndrome was fatal. Outcome of the other events was unknown. The reporting physician classified the event hyperosmolar hyperglycaemic syndrome as serious (death and hospitalization) and assessed that the causality between the event and BNT162B2 was unassessable. Date of hospitalization was 02Aug2021, Date of discharge(death) was 02Aug2021. Other possible cause of the events such as any other diseases was diabetes mellitus. Outcome of the event hyperosmolar hyperglycaemic syndrome was fatal. It was not reported if an autopsy was performed. The reporting physician commented as follows: The event was considered likely to be related to the underlying disease of diabetes mellitus, however, the causality was unknown. Since the event occurred after the vaccination, this case was accordingly reported.; Reported Cause(s) of Death: Hyperosmolar hyperglycaemic syndrome


VAERS ID: 1579825 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CONIEL; URINORM [BENZBROMARONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Lung cancer; Varicose veins of lower extremities.
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100993556

Write-up: aortic dissection; This is a spontaneous report from a contactable physician received via the Regulatory Authority. A 68-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 13Jul2021 15:15 (Batch/Lot Number: EY0572; Expiration Date: 31Oct2021) as dose 1, single for covid-19 immunisation. Medical history included lung cancer, hypertension and varicose veins of lower extremities. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included benidipine hydrochloride (CONIEL) and benzbromarone (URINORM) both taken for an unspecified indication, start and stop date were not reported. On 26Jul2021 (13 days after the vaccination), the patient experienced death due to aortic dissection. The event resulted in emergency room/department or urgent care. The outcome of the event was fatal, and it was unknown if treatment was performed. The reporting physician assessed the event as serious (fatal). Since the vaccination, the patient has not been tested for COVID-19. The patient died on 26Jul2021 due to aortic dissociation. It was unknown if an autopsy was performed.; 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 the event aortic dissection 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: Aortic dissection


VAERS ID: 1579836 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lung neoplasm malignant, Neoplasm progression
SMQs:, Malignancy related conditions (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BEPOTASTINE BESILATE; TRANEXAMIC ACID; CARBAZOCHROME SODIUM SULFONATE; CODEINE PHOSPHATE; RINDERON [BETAMETHASONE DIPROPIONATE]
Current Illness: Lung cancer (for the treatment, the patient received on palliative therapy at home).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101023257

Write-up: died due to the underlying disease (lung cancer); died due to the underlying disease (lung cancer); This is a spontaneous report from a contactable consumer via a sales representative. A 74-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) as dose number unknown, single (at age of 74-years-old) for covid-19 immunisation. Medical history included ongoing lung cancer, for the treatment, the patient received on palliative therapy at home. Concomitant medications included bepotastine besilate; tranexamic acid tablet; carbazochrome sodium sulfonate tablet; codeine phosphate; betamethasone dipropionate (RINDERON). On 09Aug2021 (3 days after the vaccination), the patient died due to the underlying disease (lung cancer). The patient died on 09Aug2021. It was not reported if an autopsy was performed. 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.; Reported Cause(s) of Death: died due to the underlying disease (lung cancer); died due to the underlying disease (lung cancer)


VAERS ID: 1579838 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-08-09
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardio-respiratory arrest, Septic shock, Urinary tract infection
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), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: blood pressure; Result Unstructured Data: Test Result:60s
CDC Split Type: JPPFIZER INC202101023997

Write-up: septic shock due to urinary tract infection was suspected; Cardio-respiratory arrest; septic shock due to urinary tract infection was suspected; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21122832. A 73-year and 5-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot # unknown) at the age of 73 years, via an unspecified route of administration on 17Jul2021 (the day of vaccination) as dose 2, single for COVID-19 immunization. The family history was not provided. The medical history and concomitant medications were unknown. On 26Jun2021, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot# unknown) as a single dose for COVID-19 immunization. Body temperature before vaccination was unknown. On 09Aug2021 at 08:00 (23 days after the vaccination), the patient experienced the events. The course of the events was as follows: On 09Aug2021, at 08:00 (23 days after the vaccination), after the patient took a meal, the blood pressure was measured, which showed 60s. The patient did not respond to a call, and an ambulance was called. When the patient was transferred, she had shock vital. The results of the detailed examination showed that septic shock due to urinary tract infection was suspected. However, it was difficult to assess the definite cause. The patient had pulseless electrical activity (PEA), and then she had cardiopulmonary arrest (CPA), and she died. The outcome of the events was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardio-respiratory arrest; septic shock due to urinary tract infection was suspected; septic shock due to urinary tract infection was suspected


VAERS ID: 1579851 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004220 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acidosis, Cardiac death, Circulatory collapse, Computerised tomogram, Discoloured vomit, Hypersensitivity, SARS-CoV-2 test, Scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fruit allergy (kiwi); Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: whole-body CT scan after death; Result Unstructured Data: Whole-body CT scan after death was performed to investigate the cause of the death, which revealed a ground-glass opacity/consolidation in both lungs.; Test Date: 20210802; Test Name: SARS CoV-2 antigen test; Test Result: Negative; Result Unstructured Data: negative; Test Date: 20210802; Test Name: scan; Result Unstructured Data: image findings showed a tendency of cardiac enlargement. The right heart strain was particularly suspected by the right-sided enlargement.
CDC Split Type: JPTAKEDA2021TJP069671

Write-up: cardiac death; Acute circulatory failure; Allergy; Acidosis; Discoloured vomit; This case was received via Regulatory Authority (Reference number: 2021TJP069671) on 05-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This case, reported by a physician via a medical representative, and reported to the Regulatory Authority by a physician, was received via the RA (Ref, v21122425). A patient had allergy to kiwi fruits and obesity. On an unknown date, body temperature before the vaccination: unknown. On 02-Aug-2021, around 18:00, the patient received the 1st dose of the vaccine. Around 19:30, the patient did not complain of any symptom. Around 20:00, a gurgling sound was heard from the bed, and a small amount of yellow colored vomit was noted. The patient did not respond to calls and had ill complexion. An emergency call was made, and cardiopulmonary resuscitation was started as instructed by the operations center. At 20:17, on arrival of the ambulance team, the patient was asystole and was transported with intubation and adrenaline administration by a physician. At 20:42, the patient arrived at the hospital. On arrival, JCS was 300, and the patient was asystole, had no spontaneous breathing, both dilated pupils of 6 mm in diameter, and coldness with poor skin tone of the whole body including the face. The patient was obese. Marked acidosis was found on the blood gas measurement. Resuscitation was continued thereafter , but there was no response. At 22:06, the patient was confirmed dead. The result of the SARS CoV-2 antigen test was negative. A whole-body CT scan after death was performed to investigate the cause of the death, which revealed a ground-glass opacity/consolidation in both lungs. However, there was a possibility that changes associated with cardiac massage, pulmonary congestion, or aspiration occurred. In addition, image findings showed a tendency of cardiac enlargement. The right heart strain was particularly suspected by the right sided enlargement. On 03-Aug-2021, the body was moved through the police to the university, and a legal autopsy was performed. The following were the details: 1) there were findings of acute circulatory failure such as congestion of the face, petechiae of the palpebral conjunctiva, cerebral edema, and pulmonary congestion. 2) reportedly, there were findings of suspected allergy such as edema of the epiglottis and submucosal petechiae of the larynx. The exact cause of death was unclear, but acute circulatory failure/acute cardiac death was suspected from the findings in the legal autopsy. The outcome of acute circulatory failure, acute cardiac death, allergy, acidosis, and yellow-colored vomit was reported as fatal. Follow-up investigation will be made.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient''s underlying obesity is a confounder.; Reported Cause(s) of Death: Cardiac death; Acute circulatory failure; Allergy; Acidosis; Vomiting


VAERS ID: 1579910 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E40585 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Condition aggravated, Cough, Dysphagia, Dyspnoea, Headache, Nausea, Respiratory distress, Seizure, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101023160

Write-up: headache; Chills; Nausea; Vomit; Abdominal pain epigastric; Tachycardia; Cough; Dyspnea/ Respiratory distress; Dyspnea/ Respiratory distress; afebrile seizures; intolerance oral/Dysphagia; hospitalized due to deterioration; This is a spontaneous report from a non-contactable other hcp. This is a report received. The Regulatory authority report number 16987-8. A 40-year-old female non-pregnant patient received bnt162b2 (Pfizer vaccine), dose 1 intramuscular, administered in arm left on 07Jul2021 at her 40-year-old (Lot Number: E40585) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, chills, nausea, vomit, abdominal pain epigastric, tachycardia, cough, dyspnea, respiratory distress, afebrile seizures, dysphagia, hospitalized due to deterioration, all on an unspecified date with fatal outcome. Therapeutic measures were taken as a result of all events. The patient died on an unspecified date. It was not reported if an autopsy was performed. All events were assessed as serious with death, hospitalization. The clinical course was reported as follows: Female patient who presents hours past receiving Pfizer vaccine epigastric abdominal pain, nausea, and vomit, as well as oral intolerance, treatment, 48 hours past was hospitalized due to deterioration. Treatment administered: Yes; norepinephrine 98 mg in 100 mL at 0.5 MCG KG minute dose. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: hospitalized due to deterioration; Headache; Chills; Nausea; Vomit; abdominal pain epigastric; tachycardia; cough; dyspnea; respiratory distress; dyspnea; respiratory distress; Afebrile seizure; intolerance oral; dysphagia.


VAERS ID: 1579913 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Haemoptysis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC202101018490

Write-up: Reason of death was written as "old age"; coughed bloody sputum thereafter (time between vaccination and 1st incident of bloody sputum is unknown); This is a spontaneous report from a contactable consumer via Pfizer colleague. An 80-year-old female patient received 2nd dose of bnt162b2 (COMIRNATY, lot number was not provided) at 80-year-old, via an unknown route of administration on 06Aug2021 as dose 2, single for COVID-19 immunization. It was reported that the batch number and expiry date with vaccine details will be provided after funeral arrangements are sorted out. Patient''s medical history and concomitant medications were not reported. The patient passed away this morning on 09Aug2021. Patient had her 2nd dose of Comirnaty on 06Aug2021 and was coughing bloody sputum a few days after (It was also reported that She coughed bloody sputum thereafter, time between vaccination and 1st incident of bloody sputum is unknown). She passed away at home and her body was found haemorrhaging. She had other health issues as well. Police did not require post-mortem and reported the death as "old Age". Attached is the death certificate. Based on the information from the death certificate, it was noted that the patient''s age was 80 years 5 months and 14 days old and date of death was on 09Aug2021 at 10:20am. Reason of death was written as "old age". Therapeutic measure taken in response to the event was not provided. patient died on 09Aug2021. The autopsy was not performed. The lot number for bnt162b2, was not provided and will be requested during follow up. Reported Cause(s) of Death: Reason of death was written as old age.


VAERS ID: 1579945 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Infarction, Myocarditis, Pericarditis, Pneumonia
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via the Regulatory Authority (Reference number: 00648744) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PNEUMONIA, MYOCARDITIS, PERICARDITIS and INFARCTION in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. 3001946) for an unknown indication. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-May-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PNEUMONIA (seriousness criteria death and medically significant), MYOCARDITIS (seriousness criteria death and medically significant), PERICARDITIS (seriousness criteria death and medically significant), INFARCTION (seriousness criteria death and medically significant) and ABDOMINAL PAIN. The patient died on 02-Jul-2021. The reported cause of death was infarcts organs. It is unknown if an autopsy was performed. At the time of death, ABDOMINAL PAIN outcome was unknown. No concomitant medication reported. No treatment information was provided. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: infarcts organs


VAERS ID: 1579983 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Hallucination
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (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), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202100990208

Write-up: hallucinations; cardiac arrest; died as a result of cardiac arrest; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 35-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. In a patient with a massive physique, a few days after receiving 2 doses of Comirnaty, hallucinations appeared. The patient was taken to the hospital, where he died as a result of cardiac arrest. The reporting person claims that the patient was healthy. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome cardiac arrest was fatal while for hallucinatons was unknown. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1580049 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Computerised tomogram, Dyspnoea, Fatigue, Insomnia, Multiple organ dysfunction syndrome, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Hypertension; Marfan''s syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Computed tomography; Result Unstructured Data: Test Result:confirms widespread pulmonary embolism in both rig; Comments: confirms widespread pulmonary embolism in both right and left pulmonary lobes
CDC Split Type: SEPFIZER INC202101026632

Write-up: Pulmonary embolism; Breathlessness; Insomnia; decreased energy; Fatigue; multi-organ failure (heart, liver, kidneys); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number SE-MPA-2021-069638. A 54-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Jun2021 (Lot Number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. Patient took the first dose of vaccine with unknown batch number on an unknown date in Apr2021 for COVID-19 immunization. Medical history included ongoing marfan''s syndrome, ongoing cardiac failure, ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolism (death, hospitalization, life threatening) in Jul2021, multi-organ failure (heart, liver, kidneys) (death, hospitalization, life threatening) in 2021, breathlessness (death, hospitalization, life threatening) in Jun2021, insomnia (death, hospitalization, life threatening) in Jun2021, decreased energy (death, hospitalization, life threatening) in Jun2021, fatigue (death, hospitalization, life threatening) in Jun2021. The patient presented to the emergency department after a 4-week history of new onset symptoms of decreased energy, dyspnea (shortness of breath), insomnia which started 1 week after the 2nd dose of vaccine. The patient has never had problems with thrombosis before, and has not had any symptoms during the spring. No suspicion of malignancy. Dyspnea has progressed during July. Computed tomography approximately 1 month after onset of symptoms in 2021 confirms widespread pulmonary embolism in both right and left pulmonary lobes, which is considered likely to be caused by the vaccination. Significantly deteriorates during the course of care and develops multi-organ failure (heart, liver, kidneys). Dies in the aftermath after about two weeks in hospital. Cause of death was given as pulmonary embolism causing multi-organ failure. The patient died in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: multi-organ failure (heart, liver, kidneys); Pulmonary embolism


VAERS ID: 1581971 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-07-07
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hypoaesthesia, Pulmonary embolism
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma bronchial (well-tolerated); Diabetes mellitus; Hypertension; Lupus erythematosus (well-tolerated).
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CYMODERNATX, INC.MOD20212

Write-up: Pulmonary embolism; Numbness in hand; Fatigue extreme; This case was received via the Regulatory Authority (Reference number: 220721KK6) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus, Hypertension, Asthma bronchial (well-tolerated) and Lupus erythematosus (well-tolerated). On 31-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 28-Apr-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jul-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria death and medically significant), HYPOAESTHESIA (Numbness in hand) and FATIGUE (Fatigue extreme). The patient died on 07-Jul-2021. The reported cause of death was Acute massive pulmonary embolism. An autopsy was performed. The autopsy-determined cause of death was Acute massive pulmonary embolism. At the time of death, HYPOAESTHESIA (Numbness in hand) and FATIGUE (Fatigue extreme) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported y the reporter. This is a case of sudden death in a 62-year-old female subject with HX of diabetes mellitus, hypertension, asthma bronchial and lupus erythematosus, who died 39 days after receiving second dose of vaccine. Very limited information has been provided at this time. Patient''s medical history of lupus erythematosus might have contributed to the events occurrence.; Sender''s Comments: This is a case of sudden death in a 62-year-old female subject with hx of diabetes mellitus, hypertension, asthma bronchial and lupus erythematosus, who died 39 days after receiving second dose of vaccine. Very limited information has been provided at this time. Patient''s medical history of lupus erythematosus might have contributed to the events occurrence.; Reported Cause(s) of Death: Acute massive pulmonary embolism; Autopsy-determined Cause(s) of Death: Acute massive pulmonary embolism


VAERS ID: 1581975 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TORECAN; DRETACEN
Current Illness: Epilepsy (seizure maximum one per year, last time in 03/2021).
Preexisting Conditions: Medical History/Concurrent Conditions: Backache (14 days before vaccination, he got injection).
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a 34-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Backache (14 days before vaccination, he got injection) on 07-Jun-2021. Concurrent medical conditions included Epilepsy (seizure maximum one per year, last time in 03/2021). Concomitant products included THIETHYLPERAZINE MALEATE (TORECAN) for Seizure, LEVETIRACETAM (DRETACEN) for an unknown indication. On 21-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced DEATH (seriousness criteria death and medically significant), BACK PAIN, VOMITING, NAUSEA and ARTHRALGIA. The patient died on 30-Jun-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. At the time of death, BACK PAIN, VOMITING, NAUSEA and ARTHRALGIA outcome was unknown. Treatment information was not provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Found dead (cause undetermined)


VAERS ID: 1581976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Fall, Head injury, Loss of consciousness, Neurological examination, Pulmonary embolism, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   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: Nephrectomy
Allergies:
Diagnostic Lab Data: Test Name: X-ray CT of the head; Result Unstructured Data: Test Result:normal; Test Name: neurological examination; Result Unstructured Data: Test Result:normal
CDC Split Type: CZPFIZER INC202101016129

Write-up: Convulsions; Collapse/ Lost consciousness; Lung embolism; Fall; head injury; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21009285. A 58-years-old male patient received first dose of BNT162B2 (COMIRNATY) intramuscular single dose for COVID-19 immunisation on 17Jul2021. Medical history included: nephrectomy from 2017. No concomitant medication. The patient experienced convulsions, collapse/ lost consciousness and lung embolism all on 25Jul2021 (death, life threatening), fall (medically significant) on 22Jul2021 with outcome of recovered. The patient fell and had head injury on the 5th day after vaccination (22Jul2021). Day 8 after vaccination (25Jul2021) collapse, convulsions, after transport to the hospital died. Extensive pulmonary embolism. Lab test included X-ray CT of the head, neurological examinations showed normal. The patient died on 25Jul2021. An autopsy was performed and results were not provided. Outcome of the other event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Lung embolism; Convulsions; Collapse/ Lost consciousness


VAERS ID: 1581995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Interchange of vaccine products, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
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 INC202100987544

Write-up: Pulmonary embolus; Deep vein thrombosis; VAXZEVRIA DOSE 1, SINGLE/COMIRNATY DOSE 2, SINGLE; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority number DE-PEI-202100139560. A 53-year-old female patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), dose 2 via an unspecified route of administration on Jun2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historically received first dose of COVID-19 vaccine NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) on Apr2021, as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced pulmonary embolus and deep vein thrombosis. Outcome was fatal. The patient died on 02Jul2021. An autopsy was performed and results were not provided. This report is serious - death. Comirnaty/ PEI / all events/ unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Deep vein thrombosis; Pulmonary embolism


VAERS ID: 1582198 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-12
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033742

Write-up: Adverse event following immunization; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598302. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced adverse event following immunization on 12Jul2021 which is fatal. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunization


VAERS ID: 1582199 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Malaise, Pyrexia, Tachypnoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033743

Write-up: Diarrhoea; Malaise; Pyrexia; Tachypnoea; Vomiting; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598769. A 60-years-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhoea; malaise; pyrexia; tachypnoea; and vomiting. The outcome of events was fatal. The patient died on an unspecified date. The cause of death was diarrhoea; malaise; pyrexia; tachypnoea; and vomiting. 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: Diarrhoea; Malaise; Pyrexia; Tachypnoea; Vomiting


VAERS ID: 1582268 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Chills, Death, Decreased appetite, Fatigue, Feeling cold, Gastrointestinal haemorrhage, Headache, Malaise, Nausea, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pyrexia, Skin discolouration, X-ray
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 97
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: Ex-tobacco user (quit 30 years ago).
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: CRP; Result Unstructured Data: Test Result: increased; Test Date: 20210412; Test Name: oxygen saturation; Test Result: 45 %; Comments: When he entered the hospital, he was 45% saturated.; Test Date: 20210412; Test Name: oxygen saturation; Test Result: 75 %; Comments: 75% desaturation despite 4 liters of oxygen / minute; Test Date: 20210412; Test Name: X-ray; Result Unstructured Data: Test Result: pneumonia.
CDC Split Type: BEPFIZER INC202101026645

Write-up: He had 45% saturation/oxygen saturation low; Nausea; Feeling cold; Malaise; Fatigue; CRP increased; Discolouration skin/black face; Decreased appetite; Headache; Fever; Shivering; pneumonia; digestive bleeding/hemorrhage of digestive tract; Death; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-103977. A 66-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 12Apr2021 (at the age of 66-year-old) as single dose for covid-19 immunisation. Medical history included former smoker (quit 30 years ago). The patient''s concomitant medications were not reported. On 12Apr2021, patient experienced fever, malaise, shivering, fatigue, nausea, headache, feeling cold, discolouration skin, decreased appetite, oxygen saturation low, hemorrhage of digestive tract, CRP (C-reactive protein) increased. On 18Jul2021, patient experienced death. The clinical course was as follows: the very day of the vaccine, patient had a fever, a feeling of cold, black face, decreased appetite, fatigue, nausea, headache (X-ray: pneumonia). Then he went to the hospital. When he entered the hospital, he was 45% saturated. It was incubated and had 75% desaturation despite 4 liters of oxygen/minute. He had digestive bleeding after a gastroscopy (probably medical related). The outcome of the events was fatal. The patient died on 18Jul2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Nausea; Feeling cold; Malaise; Fatigue; CRP increased; Discolouration skin/black face; Decreased appetite; Headache; Fever; digestive bleeding/hemorrhage of digestive tract; Shivering; pneumonia; He had 45% saturation/oxygen saturation low; Death


VAERS ID: 1582288 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
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: LOSARTAN; NORVASC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101033956

Write-up: Death; This is a Spontaneous report from a contactable Physician. This is a report received from the Regulatory Authority via an on-line database search. Regulatory authority report number 000947581. This information was initially reported to Regulatory Authority on 26Apr2021 from the community. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included losartan taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1582327 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202100997770

Write-up: Stroke; She past away on the 14th of April/died; This is a spontaneous report received from a contactable consumer (son) or other non HCP via the Regulatory Authority. Regulatory authority report number CH-SM-2021-17194. A 89-year-old female, patient received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: EP9605, Expiration date: was not reported) via intramuscular on 25Mar2021 (Age at vaccination: 89-year-old) as DOSE 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (COMIRANTY; Formulation: Solution for injection; Batch/Lot number: EM0477, Expiration date: was not reported) via intramuscular on 25Feb2021 (Age at vaccination: 89-year-old) as DOSE 1, single for COVID-19 immunization. On 26Mar2021, she was found in bed (one day after vaccination), at around 13.00 hr. with a stroke (she could no longer speak and was partially paralyzed) and was immediately transported in the ambulance to hospital. She died on 14Apr2021. Reporter also stated her condition did not improve. A causal relationship between Comirnaty and Death and Stroke was assessed by Regulatory Authority as unlikely. RA assessed this case as serious with seriousness criterion results in death. The outcome of events was Fatal. Health Authority Comment: Unfortunately, we do not know whether an autopsy was performed that could have given important indications. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Death and Cerebrovascular accident and suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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


VAERS ID: 1583252 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Pyrexia, Staphylococcal sepsis, Staphylococcus test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 12
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: Atrial fibrillation; Cardiac failure; Essential hypertension.
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: Staphylococcus aureus; Result Unstructured Data: Test Result: Positive.
CDC Split Type: DEPFIZER INC202100987737

Write-up: Fever; General physical condition decreased; Staphylococcus aureus septicemia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is DE-DCGMA-21190509. A 94-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single (at the age of 94 years old) for COVID-19 immunisation. Medical history included cardiac failure, essential hypertension, atrial fibrillation. The patient''s concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY, solution for injection), dose 1 on 13Jan2021 for COVID-19 immunisation. The patient experienced fever, general physical condition decreased and staphylococcus aureus septicemia (Staphylococcus aureus test positive) on 05Feb2021. The events led to hospitalization. The patient died on 17Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Fever; General physical condition decreased; Staphylococcus aureus septicemia


VAERS ID: 1583272 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100133881

Write-up: Flu-like illness; Myalgia; Pyrexia; This case was received via the Regulatory Authority (Reference number: 202100133881) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like illness), MYALGIA (Myalgia) and PYREXIA (Pyrexia) in a 51-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like illness) (seriousness criterion death), MYALGIA (Myalgia) (seriousness criterion death) and PYREXIA (Pyrexia) (seriousness criterion death). The patient died on 10-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. This case concerns 51 year-old male patient who experienced the fatal events of myalgia, pyrexia and influenza like illness and died 3 days after receiving the dose of the mRNA-1273 vaccine. Cause of death was not specified. Very limited information has been provided at this time.; Sender''s Comments: This case concerns 51 year-old male patient who experienced the fatal events of myalgia, pyrexia and influenza like illness and died 3 days after receiving the dose of the mRNA-1273 vaccine. Cause of death was not specified. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1583317 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pemphigoid
SMQs:, Severe cutaneous adverse reactions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987782

Write-up: Bullous pemphigoid; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-202100144669. An 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: unknown), via an unspecified route of administration on 03Feb2021 (at the age of 87-years-old) at dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY; strength: 0.3 ml) received on 08Jan2021 (at the age of 87-years-old) at dose 1, 0.3 ml single for COVID-19 immunisation. On Feb2021, the patient experienced bullous pemphigoid. The patient died on an unspecified date in 2021 due to the event. It was reported that autopsy was not done. Outcome of the event was fatal. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Bullous pemphigoid


VAERS ID: 1583473 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033737

Write-up: Adverse event following immunisation; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 596980. An 80-year-old male patient 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 was not reported. The patient''s concomitant medications were not reported. The patient experienced adverse event following immunisation on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Event outcome was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunisation


VAERS ID: 1583474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-23
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Cardiomegaly, Myocardial fibrosis
SMQs:, Cardiac failure (broad), Cardiomyopathy (narrow), Other ischaemic heart disease (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 INC202101033741

Write-up: Arteriosclerosis coronary artery; Cardiomegaly; Myocardial fibrosis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598170. An 89-year-old male patient 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 experienced Arteriosclerosis coronary artery; Cardiomegaly; Myocardial fibrosis, all on 23APR2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events was Fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Arteriosclerosis coronary artery; Cardiomegaly; Myocardial fibrosis


VAERS ID: 1583475 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-22
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cough, Dyspnoea, Groin pain, Malaise, Myocardial infarction, Myocarditis
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033744

Write-up: Chest pain; Cough; Dyspnoea; Groin pain; Malaise; Myocardial infarction; Myocarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598851. A 52-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Jul2021, the patient experienced chest pain, cough, dyspnoea, groin pain, malaise, myocardial infarction, myocarditis. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Chest pain; Cough; Dyspnoea; Groin pain; Malaise; Myocardial infarction; Myocarditis


VAERS ID: 1583476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, General physical health deterioration, Lethargy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033745

Write-up: Fall; General physical health deterioration; Lethargy; Syncope; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598893. A 98-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fall (death) on 04Apr2021, general physical health deterioration (death) on 04Apr2021 , lethargy (death) on 04Apr2021 , syncope (death) on 04Apr2021. The patient died in 2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Fall; General physical health deterioration; Lethargy; Syncope


VAERS ID: 1583477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-02
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event following immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101033746

Write-up: Adverse event following immunization; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598895. An 87-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced adverse event following immunization on 02May2021 which was fatal. It was unknown if autopsy was done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Adverse event following immunization


VAERS ID: 1583478 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Lower respiratory tract infection, Oxygen saturation, Oxygen saturation decreased, Sepsis, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: decreased.
CDC Split Type: AUPFIZER INC202101033747

Write-up: Fall; Lower respiratory tract infection; Oxygen saturation decreased; Sepsis; Syncope; Vomiting; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 598896. A 90-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fall (death) on 12Apr2021, lower respiratory tract infection (death) on 12Apr2021, oxygen saturation decreased (death) on 12Apr2021 , sepsis (death) on 12Apr2021 , syncope (death) on 12Apr2021 , vomiting (death) on 12Apr2021. The patient underwent lab tests and procedures which included oxygen saturation: decreased on 12Apr2021. The patient died in 2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Fall; Lower respiratory tract infection; Oxygen saturation decreased; Sepsis; Syncope; Vomiting


VAERS ID: 1583555 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation (Since years, exact date of diagnosis unknown); Coronary artery disease (Date of diagnosis unknown).
Preexisting Conditions: Medical History/Concurrent Conditions: Anterior myocardial infarction (anterior wall infarction).
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101032788

Write-up: fatal heart attack; This is a spontaneous report received from a contactable physician via the Regulatory Authority. Regulatory authority report number CH-SM-2021-19975. A 89-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 05Jan2021 (Batch/Lot number was not reported) at the age of 89-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing atrial fibrillation Since years, exact date of diagnosis unknown, a history of anterior wall infarction in 2004 (not ongoing), ongoing coronary artery disease, date of diagnosis unknown, otherwise cardiacally well-compensated until fatal episode. No allergies reported by doctor. The patient''s concomitant medications were not reported. The patient experienced fatal heart attack on 12Jan2021. It is not known whether medical intervention was possible. The patient died on 12Jan2021. An autopsy was not performed. The outcome of the event heart attack was fatal. A causal relationship between Comirnaty and Myocardial infarction was assessed as unlikely. Regulatory authority assessed this case as serious with fatal outcome. Reporter Comment: Fatal heart attack in 89-year-old male patient with cardiac history with a history of heart disease, 7 days after administration of Comirnaty. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: The event of myocardial infarction is assessed as not related to BNT162B2 and more likely due to the underlying medical condition of coronary artery disease in this elderly patient with a medical history of anterior wall infarction and atrial fibrillation.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1583661 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE0174 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 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 INC202100987666

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-202100150596. A 66-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: FE0174), via an unspecified route of administration on 23Jul2021 (at the age of 66-years-old) at dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY) received on an unspecified date for COVID-19 immunisation. On an unspecified date on 2021, the patient experienced infarct myocardial. The reporter assessed the event as serious since life-threatening and fatal outcome. The patient died on an unspecified date in 2021 due to the event. Autopsy was done; however, autopsy results are not available. Outcome of the event was fatal. Sender''s comments: Inquest; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1583780 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-26
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Herpes zoster, Immune system disorder, Pneumonia, Pyrexia, Sleep disorder, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 128
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 INC202100996489

Write-up: fever; apathy; struggling in sleep; after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition; after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition/ severely weakened immune system; after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition; after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021034283. Safety Report Unique Identifier DE-PEI-202100022184. This consumer reporter events after both doses. This is report for dose 1. A 95-year-old male patient received BNT162b2 (COMIRNATY, mRNA Tozinameran, Solution for injection), dose 1 intramuscular on 08Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced throat tightness, immune system disorder (nos), shingles, pneumonia; all on 26Jan2021. As reported, this report was serious of hospitalization. The patient''s weight was 90 kg, and height was 174 cm. It was reported that on 08Jan2021 first dose of Corona vaccination with Biontech/Pfizer was vaccinated, on 26Jan2021 shingles occurred. On 27Jan2021 the patient visit to the doctor with fever, apathy, struggling in sleep, severely weakened immune system (after the 1st Biontech vaccination: shingles. After the 2nd vaccination: collapse of the immune system / pneumonia, hospitalization, life-threatening condition). On 12Feb2021, the patient was transferred back to the retirement home. Since then, he was bedridden with care level 5. Patient was died on 04Jun2021. The outcome of the event throat tightness, immune system disorder (nos), shingles, pneumonia was recovered with sequelae while of other events was unknown. Senders comment: the person concerned had no known of any allergies. Information on risk factors or previous illnesses: before: good general condition without serious pre-existing illnesses. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101028277 same patient, first/second dose; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1584580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Cardiac arrest, Coma, Dyspnoea, Encephalopathy, General physical health deterioration, Hypoxia, Inflammation, Myocardial infarction, Pain in extremity, Pyrexia, Respiratory arrest, Skin ulcer
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 12
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: Arteriosclerosis; Bypass surgery; Coronary artery disease; Hypercholesterolaemia; Hypertension; Insulin-dependent diabetes mellitus; Metabolic syndrome; Polyneuropathy; Retinopathy; Sleep apnea.
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Dust allergy; Penicillin allergy (amoxicillin well tolerated).
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987763

Write-up: Encephalopathy; arrest cardiac; respiratory arrest; hypoxia; deep coma; Heart attack/Infarct myocardial; shortness of breath/Dyspnoea; anuria; very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear; very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear; very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear; very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear; slight pain in the arm- easier than with the first vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021146961, Safety Report Unique Identifier DE-PEI-202100146895. This report described events for the second dose. A 65-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 07Jul2021 (Lot Number: FE6975) as dose 2, single for COVID-19 immunisation. Medical history included ongoing insulin-dependent diabetes mellitus, hypertension, hypercholesterolaemia, retinopathy, polyneuropathy, metabolic syndrome, coronary artery disease, arteriosclerosis, bypass surgery, sleep apnea; allergy to grain and grasses, dust mites, probably to penicillin (amoxicillin well tolerated). The patient''s concomitant medications were not reported. The patient''s weight was 215 kg, and height was 186 cm. On 08Jul2021 (day 1/2), patient experienced slight pain in the arm - easier than with the first vaccination. On 10Jul2021, the patient experienced infarct myocardial, dyspnoea, anuria, very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear. On 13Jul2021, the patient experienced arrest cardiac. As reported, patient had heart attack, shortness of breath, anuria on the 3rd day after the 2nd injection. Biontech, stent placement on the 5th after the injection, despite the good condition of the heart on the 6th after the injection, respiratory arrest followed by cardiac arrest on 13Jul2021. It was reported that on Day 6 (13Jul2021), at noon at the ICU, respiratory arrest followed by a hypoxia-related myocardial infarction, despite immediate resuscitation, high-grade hypoxia and renewed resuscitation, duration of hypoxia about 30 minutes, deep coma due to hypoxia. Encephalopathy followed by death on 20Jul2021. This report is serious due to hospitalization, life threatening. The patient''s outcome was not recovered/not resolved for dyspnoea, anuria, recovered on 13Jul2021 for hypoxia, fatal for arrest cardiac, infarct myocardial and encephalopathy while unknown for the other events. The patient died on 20Jul2021. An autopsy was not performed. Events heart attack, dyspnea, anuria, cardiac arrest per RA was unclassifiable. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? Grains and grasses, dust mites, probably on penicillin (amoxicillin well tolerated) Information on risk factors or previous illnesses hypertension, hypercholesterolemia, insulin-dependent diabetes mellitus type 2 with retinopathy and polyneuropathy, metabolic syndrome, coronary artery Heart disease, coronary artery sclerosis Bypass OP, sleep apnea / day 1/2 - slight pain in the arm - easier than with the first vaccination Day 3) 10Jul20/21 shortness of breath, anuria, very poor general condition, slight fever, flare-up of inflammation, new open areas of skin in the legs appear Day 4 no better, but you don''t want to go to the hospital on Sunday Day 05-12Jul2021.-Ambulance, Clinic, Heart attack diagnosis, two attempts at stenting unsuccessful due to excess weight, in the evening transfer to Hospital, successful stenting and planned monitoring for 1-2 days in the intensive care unit, in the evening the circumstances correspondingly good, stable condition Day 6-13Jul2021-at noon at the ICU Respiratory arrest followed by a hypoxia-related myocardial infarction, despite immediate resuscitation, high-grade hypoxia and renewed resuscitation, duration of hypoxia about 30 minutes, deep coma due to hypoxia Encephalopathy followed by death on 20Jul2021; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101004075 same patient, different dose; Reported Cause(s) of Death: Infarct myocardial; Encephalopathy; Arrest cardiac


VAERS ID: 1584638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-10
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   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: Medical History/Concurrent Conditions: Blood pressure increased; Overweight; Smoker.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101039216

Write-up: death; This is a spontaneous report from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 79525], license party for Comirnaty. A 54-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 for COVID-19 immunisation. Medical history included high blood pressure, overweight, strong smoker. The patient''s concomitant medications were not reported. It was reported case of death 5 days after administration of the second vaccination. The patient died on 10Aug2021. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, 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: death


VAERS ID: 1584690 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Brain injury, Cardiac arrest, Fatigue, Intracardiac thrombus, Physical examination, Scan
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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 21
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: ATORVASTATIN TEVA; ELTROXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Hypothyroidism.
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown; Test Date: 202106; Test Name: Physical examination; Result Unstructured Data: Test Result: Unknown; Test Date: 202106; Test Name: Scan; Result Unstructured Data: Test Result: Unknown scan: unknown.
CDC Split Type: DKPFIZER INC202101026754

Write-up: Intracardiac thrombus; cardiac arrest; severe brain damage; tiredness; This is a spontaneous report from a contactable consumer (relative to the patient) downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0076168. A 61-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EW6126; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 24May2021 as single dose for covid-19 immunisation. Medical history included hypothyroidism and hypercholesterolaemia. Concomitant medications included atorvastatin calcium (ATORVASTATIN TEVA) taken for hypercholesterolaemia from 2019 to 01Jun2021; levothyroxine sodium (ELTROXIN) taken for hypothyroidism from 2019 to 01Jun2021. There was no information regarding past medication. The patient experienced severe brain damage on an unspecified date of Jun2021, tiredness on 30May2021, intracardiac thrombus and cardiac arrest on 02Jun2021. Clinical course: On 30May2021, 6 days after the vaccination, the patient developed tiredness. On 02Jun2021, 9 days after the vaccination, the patient experienced Intracardiac thrombus and cardiac arrest. On an unknown date thereafter in Jun2021 the patient developed severe brain damage. The ADRs were by the reporter reported as resulting in hospitalisation in the beginning of Jun2021 and fatal. The patient was resuscitated after the cardiac arrest. The physicians fought for the patient''s life for 15 days, however in vain due to the severe brain damage. The patient underwent lab tests and procedures which included blood test, physical examination and unknown scan, all with unknown result on an unspecified date of Jun2021. The outcome of events intracardiac thrombus, brain damage and cardiac arrest was fatal, tiredness was recovered on 01Jun2021. The patient died on 20Jun2021. Cause of death was reported as intracardiac thrombus, brain damage and cardiac arrest. 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: Intracardiac thrombus; Brain damage; Cardiac arrest


VAERS ID: 1584691 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   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: Medical History/Concurrent Conditions: Alcohol abuse.
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: CT brain scan; Result Unstructured Data: Test Result: Shows large intracerebral haemorrhage; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:191; Comments: Unit not specified.
CDC Split Type: DKPFIZER INC202101026542

Write-up: Intracerebral haemorrhage; This is a spontaneous report from three contactable physicians downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0079650. A 57-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: FD0932), dose 2 intramuscular on 14Jul2021 as single dose for covid-19 immunisation. Medical history included alcohol abuse from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Lot Number: FC2336) intramuscular on 09Jun2021 for covid-19 immunisation. The day after the second vaccination, the patient experienced intracerebral haemorrhage on 15Jul2021. The patient underwent lab tests and procedures which included CT brain scan: shows large intracerebral haemorrhage on an unspecified date of Jul2021, thrombocyte count: 191 (Unit not specified) on unknown date. Tests for Pf4, D-dimer or fibrinogen were not performed. No treatment due to the ADR was reported and no medical procedure was performed. The patient died on 17Jul2021. Reported causes of death: Intracerebral haemorrhage. An autopsy was performed and results were not provided. Causality: Another physician does by no means thinks that the patients death / Intracerebral haemorrhage is related to the vaccination with COMIRNATY. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Due to implausible temporal association, the event of intracerebral haemorrhage with fatal outcome is assessed as unrelated to the product BNT162B2.Case will be re-assessed upon the additional information provided.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: Intracerebral haemorrhage


VAERS ID: 1584702 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-01-17
Onset:2021-06-26
   Days after vaccination:526
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood pressure measurement, Chest pain, Electrocardiogram, Low density lipoprotein, Sudden cardiac death, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOLATRAMYL; PREGABALIN SANDOZ; MALFIN; CIPRAMIL [CITALOPRAM HYDROBROMIDE]; FUCICORT; IMOVANE; SUMATRIPTAN MYLAN
Current Illness: Chronic back pain
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Infected eczema; Neuropathic pain; Pain; Sleeplessness.
Allergies:
Diagnostic Lab Data: Test Date: 202001; Test Name: Cholesterol total; Result Unstructured Data: Test Result:5.7; Comments: unit not specified; Test Date: 202001; Test Name: Blood pressure; Result Unstructured Data: Test Result: normal; Test Date: 20210802; Test Name: EKG; Result Unstructured Data: Test Result: continuingly measured, unknown; Test Date: 20210802; Test Name: EKG; Result Unstructured Data: Test Result: ventricle fibrillation found, then asystole; Test Date: 202001; Test Name: LDL; Result Unstructured Data: Test Result: 3.7; Comments: unit not specified; Test Date: 20210802; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: stagnant cordis.
CDC Split Type: DKPFIZER INC202101045522

Write-up: sudden cardiac death, found lifeless after doing hedge trimming; Retrosternal chest pain on/off since 2nd vaccination; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0082510. A 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ,Lot Number: FE2083; Expiration Date: 31Oct2021) via an unspecified route of administration on 25Jun2021 as a dose 2 ,single for covid-19 immunisation, sumatriptan succinate (SUMATRIPTAN MYLAN), oral from 17Jan2020 (Batch/Lot Number: Unknown), at 100 mg as needed for migraine. Medical history included ongoing back pain, depression, pain, eczema infected, insomnia, neuralgia from an unknown date and unknown if ongoing. Concomitant medication(s) included tramadol hydrochloride taken for pain from 25Nov2015 to an unspecified stop date; pregabalin (PREGABALIN SANDOZ) taken for neuralgia from 18Feb2021 to an unspecified stop date; morphine sulphate taken for pain from 04May2017 to an unspecified stop date; citalopram hydrobromide taken for depression from 02Sep2019 to an unspecified stop date; betamethasone valerate, fusidic acid taken for eczema infected from 07Mar2016 to an unspecified stop date; zopiclone taken for insomnia from 24Jan2020 to an unspecified stop date. On 02Aug2021 the patient experienced sudden cardiac death, found lifeless after doing hedge trimming, on 26Jun2021 retrosternal chest pain on/off since 2nd vaccination. The patient was attempted treated with cardiopulmonary resuscitation when found lifeless. Upon arrival on the address. A detectable heart rhythm was found. The patient was given 5 direct current conversions, adrenaline and amiodaron i.o., without effect. The rhythm is primarily from ventricle fibrillation. The patient is transported with acute helicopter to a hospital and ventricle fibrillation is found using ultrasound. The patient was treated twice with direct current conversion and magnesium without effect, and the patient goes into asystole. The patient underwent lab tests and procedures which included blood cholesterol: 5.7 on Jan2020 unit not specified, blood pressure measurement: normal on Jan2020, low density lipoprotein: 3.7 on Jan2020 unit not specified. On 26Jun2021, the day after 2nd dose vaccination with Comirnaty, the patient developed Retrosternal chest pain (Retrosternal chest pain on/off since 2nd vaccination). Patient apparent to be a physical well and healthy and was not known to have any cardiovascular diseases or previous history with chest pain. The patient was attempted treated with cardiopulmonary resuscitation when found lifeless. Upon arrival on the address. A detectable heart rhythm was found. The patient was given 5 direct current conversions, adrenaline and amiodaron i.o., without effect. The rhythm was primarily from ventricle fibrillation. The patient was transported with acute helicopter to a hospital and ventricle fibrillation is found using ultrasound on 02Aug2021 which showed stagnant cordis. The patient was treated twice with direct current conversion and magnesium without effect. EKG continuingly measured, Ventricle fibrillation found and then patient gone to asystole. On 02Aug2021 the patient developed sudden cardiac death sudden cardiac death, found lifeless after doing hedge trimming). Physician had reported the death to the police and did not know if an autopsy will be performed. Respond from the Safety Authority awaits. Causality: The reporter states, that he is a summer substitute and has not seen the patient. All information in the report is from the patient''s electronic medical records. The reporter received information about the death of the patient and upon reading the patient''s medical records, the reporter started suspecting a possible relation between Comirnaty and the ADRs. The reporter also suspects Sumatriptan to be a possible suspected drug after reading the product resume However, nothing in the patient''s medical records suspects that the patient has reacted negatively to Sumatriptan before. There is no information weather the patient has experienced ADRs after the first dose vaccination with Comirnaty. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1584829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-28
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram cerebral, Computerised tomogram, Electroencephalogram, Ischaemic stroke, Platelet count, Scan brain
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Peripheral vertigo, unspecified; Vocal cord cyst.
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: Angiogram cerebral; Result Unstructured Data: Test Result: Study carried out after a second injection; Comments: Study carried out after a second injection of intravenous contrast, in arterial phase, of the TSA and polygon of Willis. Occlusion of right M1 prior to bifurcation and of the right anterior cerebral artery segment A2. Vertebral and basilar arteries and the rest of the normal circle of Willis; Test Date: 20210728; Test Name: CT scan; Result Unstructured Data: Test Result: Study carried out after the; Comments: Study carried out after the administration of intravenous contrast, the findings suggest an established infarction, however it is necessary to take into account the short time elapsed and the tension of the patient that can alter the maps.; Test Date: 20210730; Test Name: EEG; Result Unstructured Data: Test Result: a flare-suppression tracing, compatible with very; Comments: 2021 Electroencephalogram: shows a flare-suppression tracing, compatible with very severe diffuse brain involvement; Test Date: 20210728; Test Name: Platelet count; Result Unstructured Data: Test Result:260; Comments: Units:10*3/uL; Test Date: 20210729; Test Name: Scan brain; Result Unstructured Data: Test Result: Radiographic findings compatible with established; Comments: Brain CT (without contrast). Radiographic findings compatible with established ischemic stroke, without signs of hemorrhagic transformation that can be assessed using this technique. It exerts a certain mass effect on the ipsilateral ventricular system and the midline, shifted to the left by about 5 mm, with no obvious signs of parenchymal herniation at the present time.
CDC Split Type: ESPFIZER INC202101031963

Write-up: Ischaemic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [ES-AEMPS-962054]. A 43 years old male patient received the first dose of BNT162B2 (COMIRNATY, Lot number: FC1435) intramuscular at 0.3 ml single dose for COVID-19 immuniation on 16Jul2021. Relevant history included peripheral vertigo, unspecified and submucous cyst of right vocal string. Relevant concomitant drug was not reported. Past drug included sulpiride 50mg. The patient experienced ischaemic stroke on 28Jul2021. The clinical course was reported as: on 28Jul2021, at 12pm the patient was well, at 12:15 pm, the patient was found in the room with a decrease in the level of consciousness and relaxation of the sphinters. it is transferred to the hospital as a stroke code. Arrived at 1:12 pm, went to the lightning room at 1:20 pm, and was informed of stop in the initial segment of the right cerebral artery (m1) at 1:29 pm. in the perfusion infarction data established, but favorable aspects and it was in the first hours why interventionist radiology was advised. in front of left frontal craneoenephalic injury, fibrinolysis was discarded. arrived in the angiography room at 1:40 pm. being in the room, angiography presented an episode of rigidity of the 4 extremities and eye deviation to the left. before the possibility of acute symptomatic crisis, treatment with levetiracetam 1000 / 12h is started. tests performed: biochemical (28Jul2021): normal plate count, 260 103 / ul. no data on dimer d. 1.tc simple basal: no signs of intracranial hemorrhage. aspects 9-10; 2.tc perfusion: study carried out after the administration of endovenous contrast, the findings suggested an established infarction, however it was necessary to take into account the lack of time elapsed and the patient''s tension (supporting map. tsa) and willis polygon: study carried out after a second injection of endovenous contrast, in arterial phase, of the tsa and willis polygon. occlusion of right m1 prior to bifurcation and of the right anterior cerebral artery segment a2. vertebral arteries, basilar and the rest of the normal willis polygon. diagnostic impression: territory stroke of the right mca (m1) of undetermined etiology. territory stroke of the right aca of undetermined territory others: possible acute symptomatic crisis. Evolution: mechanical brain thrombectomy was performed. on 29Jul2021 brain TAC (without contrast): radiological findings compatible with established ischemic lca, without signs of hemorrhagic transformation valuable by this technique. it exercised a certain mass effect on the homolateral ventricular system and the middle line, offseted toward the left by about 5 mm, with no evident signs of parenchymate herniation at the current moment. on 30Jul2021 electroencephalogram: showed an outbreak-suppression trace, compatible with very severe degree diffuse brain involvement. on 01Aug2021 it presented refractory intracranial hypertension with very poor short-term evolution. on 02Aug2021, the patient presented encephal death at 12:15 am and subsequently exitus at 9:30 am. Causation assessment: compatible time sequence, 13 days after vaccination. thrombotic events were not described on the Pfizer vaccine data sheet. The data available did not allow to confirm or dismiss the existence of an alternative causal explanation other than the vaccine.; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1584857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101032160

Write-up: Acute myocarditis; This is a spontaneous report from a contactable consumer (A family member) downloaded from the Regulatory Authority-WEB [ES-AEMPS-969891]. An adult male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular on 21Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took first dose bnt162b2 (COMIRNATY) for COVID-19 immunisation. The patient experienced acute myocarditis (death) on 22Jun2021. The patient died in 2021. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Acute myocarditis


VAERS ID: 1584882 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Back pain, Dysgeusia, Feeling cold, Interchange of vaccine products, Investigation, Off label use, Pyrexia, Thrombosis, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial operation NOS (on both sides of the neck); Arterial operation NOS; Arteriosclerosis obliterans; Bypass surgery; Coronary artery bypass (at the age of 26 in 1987); Coronary heart disease; Familial hypercholesterolemia.
Allergies:
Diagnostic Lab Data: Test Name: images; Result Unstructured Data: Test Result: there was not anything that could have caused pain; Comments: there was not anything that could have caused pain in the right side.
CDC Split Type: FIPFIZER INC202100996837

Write-up: Back pain/pain coming in pulses to the right side of his back; Feeling cold; fever; bad taste in the mouth; suspicion of a thrombosis on the vascular side; arrhythmia/the rhythm changed from sinus rhythm to ventricular fibrillation; Ventricular fibrillation; Interchange of vaccine products; Interchange of vaccine products; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB FI-FIMEA-20213714. A 60-year-old male patient received 2nd dose (initial Pfizer dose) of BNT162B2 (COMIRNATY, Batch/Lot Number unknown) via an unspecified route of administration on 25May2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Medical history included severe arteriosclerosis obliterans and coronary heart disease. Familial hypercholesterolemia and coronary heart disease. Coronary artery bypass grafting was first performed at the age of 26 in 1987, then bypass surgery again in 2005. In addition, the lower limb arteries have had to be operated, as well as the carotid arteries on both sides of the neck. Concomitant medications were not reported. The patient previously received 1st single dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) for COVID-19 immunisation. Patient had a terrible pain coming in pulses to the right side of his back within a few days (in May2021). they fetched a painkiller injection against the back pain from the health center on 01Jun2021, but it only helped for a while. patient had to the hospital in ambulance in the morning on 02Jun2021 where his heart stopped. He was resuscitated for 40 min. and finally the heart was set in motion. To intensive care unit - but on 05Jun2021 upon waking up he died. The doctor said the vaccination certainly had an effect on what happened, but it could not be proven. Patient was 60-year-old and belonged to the risk group due to his illnesses. On 27Jul2021 follow up from reporter, it was reported that the back pain was weird. It came to the so-called healthy side (right) and was alternating and was really intense. The pain was such that patient already said sometimes he could not stand it. A day or two after the vaccination, patient said he was just feeling like he had a fever. A bad taste in the mouth and was feeling cold all the time. Patient did not get fever easily so the thermometer did not show it. The health station doctor who wrote the referral to the ambulance said that at no point did patient have any signs of heart problems, nor were they experienced at home. Reporter did not know exactly what happened there when not everything was told and he had made a reminder about this, and reporter was still waiting for an answer. There, in the emergency room, patient''s heart stopped anyway and he was resuscitated according to the death certificate for 40 min. Reporter only got information from the doctor about what happened in the afternoon at about one 1 pm. On the phone reporter was told that the resuscitation lasted 30 mins. Patient was kept anesthetized connected to the machine and when they started to wake him up and took the equipment off he died. Although it was known that he might not survive, reporter was not informed of it. The doctor called when patient was already dead. When reporter visited there earlier and talked to the doctor and asked about the effect of the Covid vaccination in this case, the answer was that it certainly did contribute, but it could not be proven. The back apparently was not examined at all, although that was the reason why he was taken there. The back physician thought that in the images which were taken there was not anything that could have caused pain in the right side. He said that new images should be taken upon recovery and also raised a suspicion of a thrombosis on the vascular side. Death certificate: A 60-year-old man with severe arteriosclerosis obliterans and coronary heart disease. Familial hypercholesterolemia and coronary heart disease. Coronary artery bypass grafting was first performed at the age of 26 in 1987, then bypass surgery again in 2005. In addition, the lower limb arteries have had to be operated, as well as the carotid arteries on both sides of the neck. Now came to the hospital due to severe back pain, at the emergency department went unresponsive and immediately resuscitation was started. Resuscitated for a total of about 40 minutes, receiving ample adrenaline and amiodarone during resuscitation. Defibrillation for ventricular fibrillation many times. The Return of spontaneous circulation was achieved and the patient was then treated under temperature control in the intensive care unit. At the intensive care unit hemodynamics have been moderately stable as long as the patient was asleep. Discussed with cardiology, due to severe arteriosclerosis obliterans disease, patient was not suitable for arterial dilation treatments, although there was a possible narrowing in the coronary arteries. After further discussion with a thoracic surgeon, the patient was also not suitable for bypass surgery because all the veins had already been used. Decided not to resuscitate anymore. On 05Jun2021 waking up was started, upon waking began to have signs of arrhythmia. After extubation, the rhythm changed from sinus rhythm to ventricular fibrillation, through which the asystole. Not resuscitated. Official time of death was on 05Jun2021 15:51. The outcome of the event Atherosclerotic cardiovascular disease was fatal, of other events was unknown. The patient died on 05Jun2021 15:51. 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.; Sender''s Comments: Linked Report(s) : FI-NAM-19900040; Reported Cause(s) of Death: arrhythmia/the rhythm changed from sinus rhythm to ventricular fibrillation


VAERS ID: 1585033 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-19
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Auscultation, Bacterial test, Blood pressure measurement, Body temperature, C-reactive protein, COVID-19 pneumonia, Computerised tomogram thorax, Drug ineffective, Electrocardiogram, Legionella test, Oxygen saturation, PO2, Physical examination, Pneumococcal infection, Respiratory rate, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 10
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: GLUCOPHAGE; ALLOPURINOL; DIAMICRON; RAMIPRIL; SPIRIVA
Current Illness: Chronic obstructive airways disease; Hypertension arterial; Obstructive sleep apnea syndrome; Type 2 diabetes mellitus.
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Cholecystectomy; Ganglionic tuberculosis; Prostatectomy.
Allergies:
Diagnostic Lab Data: Test Name: auscultation; Result Unstructured Data: Test Result: clear; Test Name: Pneumococcal; Test Result: Positive ; Test Name: blood pressure; Result Unstructured Data: Test Result:161/73 (121) mmHg; Test Date: 20210725; Test Name: fever; Result Unstructured Data: Test Result:39.5 Centigrade; Test Name: Chest CT; Result Unstructured Data: Test Result:50% parenchymal involvement, left basal; Comments: condensation; Test Name: CRP; Result Unstructured Data: Test Result:230; Test Name: ECG; Result Unstructured Data: Test Result: transthoracic echocardiography: integral; Comments: time-velocity under Aortic 18, E / A 0.6, no dilation right cavities, no pericardial effusion, visual left ventricular ejection fraction 50%; Test Name: Legionella; Test Result: Negative ; Test Name: oxygen saturation; Test Result: 90 %; Test Name: oxygen saturation; Test Result: 92 %; Test Name: oxygen saturation; Test Result: 92 %; Test Name: oxygen saturation; Test Result: 95 %; Test Date: 20210725; Test Name: oxygen saturation; Test Result: 79 %; Test Name: physical examination; Result Unstructured Data: Test Result: Neurologically: conscious and oriented, no; Comments: neurological deficit. Abdominal: supple depressible abdomen and painless, hydroaeric noises + No functional urinary signs. Preserved diuresis.; Test Name: PO2; Result Unstructured Data: Test Result:55; Test Name: respiratory rate; Result Unstructured Data: Test Result:22; Comments: /min; Test Name: respiratory rate; Result Unstructured Data: Test Result:26; Comments: /min; Test Date: 20210719; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: FRPFIZER INC202101026513

Write-up: Acute respiratory failure; pneumococcal positive; COVID-19 pneumonitis; Vaccination failure; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MP20216013. An 83 years old male patient received 1st dose of BNT162B2 (COMIRNATY) on unknown date and 2nd dose of BNT162B2 (COMIRNATY) in end of Apr2021, intramuscular for COVID-19 immunisation. Medical history included ongoing Chronic obstructive airways disease, Ganglionic tuberculosis, Appendectomy, ongoing Obstructive sleep apnea syndrome, Cholecystectomy, ongoing Type 2 diabetes mellitus, Prostatectomy, ongoing Hypertension arterial. Concomitant drugs included metformin hydrochloride (GLUCOPHAGE) for Type 2 diabetes mellitus, allopurinol, gliclazide (DIAMICRON) for Type 2 diabetes mellitus, ramipril for Hypertension arterial, tiotropium bromide monohydrate (SPIRIVA). The patient had COVID-19 pneumonitis and Vaccination failure on 19Jul2021 and Acute respiratory failure on unknown date. The patient was tested positive for COVID-19 on 19Jul2021 (variant not specified). Since 19Jul2021, the patient has presented with dyspnea with familial Covid contagion which motivates the realization of a PCR which returns positive on 19Jul2021. On 25Jul2021, he was sent to the emergency room for a 79% desaturation in ambient air and a fever of 39.5 centigrade. At emergency medical aid department, he was put under 9L with a high concentration mask to maintain a 92% SaO2, polypneic at 22 / min, no signs of respiratory distress. Chest CT not injected: 50% parenchymal involvement, left basal condensation. Faced with good clinical tolerance and the patient''s refusal, he was transferred to internal medicine. Biologically: C-reactive protein 230 without leukocytosis, no renal failure, hypoxemia at PO2 55 under 12L with a high concentration mask. Reminder from the doctor for an increase in oxygen dependence at 12L / min with SaO2 92% without sign of acute respiratory failure. Resuscitation care decision. Admission examination and initial development in the intensive care unit: On the respiratory level: SaO2 90% under 12L with a mask at high concentration respiratory rate 26 / min, no sign of struggle, some crackling on the left base, clear auscultation moreover. On the hemodynamic level: hypertensive side with arterial pressure, 161/73 (121) mmHg, no sign of right or left heart failure. Soft and painless calves. Neurologically: conscious and oriented, no neurological deficit. Abdominal: supple depressible abdomen and painless, hydroaeric noises + No functional urinary signs. Preserved diuresis. Initial management: High flow oxygen therapy then continuous positive airway pressure positive expiratory pressure 7 to maintain a 95% SaO2. Probabilistic antibiotic therapy with Augmentin. Legionella negative, pneumococcal positive. Corticosteroid therapy with dexamethasone. Preventive anticoagulation reinforced by Lovenox 0.4 mL x 2 / d. Blood pressure control by intravenous Loxen electric syringe. ECG: transthoracic echocardiography: integral time-velocity under Aortic 18, E / A 0.6, no dilation right cavities, no pericardial effusion, visual left ventricular ejection fraction 50%. In total: Acute respiratory failure in Covid pneumonia superinfected with Pneumococcus under non-invasive ventilation. Outcome of the events was fatal. The patient died on 29Jul2021. It was unknown whether 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: pneumococcal positive; COVID-19 pneumonitis; Vaccination failure; Acute respiratory failure


VAERS ID: 1585064 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Cured lymphoma progressive pulmonary fibrosis type 2 diabetes cognitive impairment.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210829148

Write-up: CARDIO-RESPIRATORY ARREST; SUDDEN DEATH; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, FR-AFSSAPS-NC20213380] concerned a 90 year old female. The patient''s height, and weight were not reported. The patient was cured from lymphoma progressive pulmonary fibrosis type 2 diabetes cognitive impairment. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms (total dose: 0.5 ml), 1 total administered (duration of drug administration: 1 day) on 27-JUL-2021 for covid-19 vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 29-JUL-2021, the patient had cardio-respiratory arrest and sudden death due to unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died with cardio-respiratory arrest on 29-JUL-2021. This report was serious (Death).; Sender''s Comments: V0: 20210829148- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Cardio-respiratory arrest, Sudden 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: 1585097 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-22
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diabetic ketoacidosis, Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Hyperglycaemia/new onset diabetes mellitus (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: 2021-05-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101026453

Write-up: diabetic ketoacidosis; Acute pancreatitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-PB20214934. A 27-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly on 23Apr2021 (Batch/Lot Number: EW4815) at single dose for COVID-19 immunisation. Medical history included obesity. The patient''s concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on 30Mar2021 for COVID-19 immunisation. Patient presented on 22May2021 with abdominal pain, emergency room visit for abdominal pain. Returned home with simple analgesics then on 24May2021 brought to the emergency room in a diabetic ketoacidosis on pancreatitis Balthazar E alithiasic, leading to death. The patient died on 24May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: diabetic ketoacidosis; pancreatitis


VAERS ID: 1585154 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASMELOR; ADENURIC; DOLIPRANE; AMIODARONE; DIFFU K; CALCIDOSE VITAMINE D; XARELTO; NOVOPULMON; ZOPICLONE; PERINDOPRIL; ZYMAD; LASILIX SPECIAL [FUROSEMIDE]; ESOMEPRAZOLE
Current Illness: Atrial fibrillation; Cardiac failure; Chronic obstructive airways disease; Hypertension arterial
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210831971

Write-up: COVID-19 PNEUMONITIS; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, FR-AFSSAPS-RE20212239] concerned an 87 year old male. Initial information was processed along with the additional information received on 17-AUG-2021: The patient''s weight was 98.1 kilograms, and height was 175 centimeters. The patient''s concurrent conditions included: atrial fibrillation, cardiac failure, hypertension arterial, and chronic obstructive airways disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) 1 dosage forms, 1 total administered on JUN-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. Concomitant medications included amiodarone, budesonide (Novopulmon), calcium carbonate/colecalciferol (Calcidose Vitamine D), colecalciferol (Zymad), esomeprazole, febuxostat (Adenuric), formoterol fumarate (Asmelor), furosemide (Lasilix special), paracetamol (Doliprane), perindopril, potassium chloride (Diffu K), rivaroxaban (Xarelto), and zopiclone. On 03-AUG-2021, the patient experienced covid-19 pneumonitis, and vaccination failure. On 10-AUG-2021, the patient died from covid-19 pneumonitis, and vaccination failure. It was unknown if an autopsy was performed. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210831971- Covid-19 vaccine ad26.cov2.s- Covid-19 pneumonitis. 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). 20210831971- Covid-19 vaccine ad26.cov2.s- Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19 PNEUMONITIS; VACCINATION FAILURE


VAERS ID: 1585470 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Headache, Hypertension, Maternal exposure during pregnancy, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEXANE; FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Hypertension; Pregnancy with advanced maternal age; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Test Result:166/101
CDC Split Type: GBPFIZER INC202100998230

Write-up: nausea; Maternal exposure during pregnancy; headaches; Hypertension worsened/ Hypertension; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108031756120450-Z4ZCI, Safety Report Unique Identifier is GB-MHRA-ADR 25748905. A 35-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 02Aug2021 (at the age of 35 years old) as single dose for COVID-19 immunisation. Medical history included hypertension, stroke, ongoing pregnancy, pregnancy with advanced maternal age, folic acid supplementation all from an unknown date. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medications included enoxaparin sodium (CLEXANE) taken for pregnancy with advanced maternal age from 11Jun2021 to an unspecified stop date; folic acid (FOLIC ACID) taken for folic acid supplementation, start and stop date were not reported. Historical vaccine was taken for first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot Number was not reported) for COVID-19 immunisation. The patient experienced nausea, maternal exposure during pregnancy all on an unspecified date; hypertension/ hypertension worsened on 02Aug2021. The events were reported as serious (life threatening). Clinical course was reported as follows: increased blood pressure (166/101), headaches and nausea. Medication not bringing blood pressure down significantly as expected but to safer levels. My died of stroke/ hypertension despite having been on blood pressure tablets recently, she had both Pfizer vaccines shortly beforehand. Wondering if there is a connection? Blood pressure checked by midwife and followed up at local hospital. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient was exposed to the medicine Third trimester (29-40 weeks). The outcome of nausea and headache was unknown. The patient died on an unspecified date. It was not reported if autopsy was performed. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Hypertension/ Hypertension worsened; Stroke


VAERS ID: 1585641 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-05-17
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Arteriosclerosis, Asthenia, Cardiac failure, Cough, Death, Dyspnoea, Fall, Lung disorder, Multiple organ dysfunction syndrome, Myocardial infarction, Paralysis, Peripheral swelling, Pneumonia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 61
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: Breast cancer
Allergies:
Diagnostic Lab Data: Test Name: Angiogram; Result Unstructured Data: Test Result:left artery was 95% blocked and right was 75%
CDC Split Type: GBPFIZER INC202101022281

Write-up: Passed away on 17Jul2021; Swelling in feet; He is having cardiac failure; Angiogram showed left artery was 95% blocked and right was 75%; Vaccine is like a poison for lungs and made him weak; Hospital acquired pneumonia; Multi organ failure; Fall; Silent heart attack; Couldn''t breathe in shower; Husband got a cough; weak; paralysis; This is a spontaneous report from a contactable other HCP (patient''s wife) via a medical information team.. A 76-year-old male patient (husband) received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 as single dose for COVID-19 immunisation. Medical history included breast cancer. The patient''s concomitant medications were not reported. The patient experienced passed away on 17Jul2021 (death, hospitalization) on 17Jul2021, hospital acquired pneumonia (death, hospitalization) on an unspecified date in 2021, multi organ failure (hospitalization, life threatening) on an unspecified date in 2021 with outcome of unknown, fall (hospitalization) on an unspecified date in 2021 with outcome of unknown, silent heart attack (hospitalization) on an unspecified date in 2021 with outcome of unknown, swelling in feet (hospitalization) on 17Jun2021 with outcome of unknown, cardiac failure (hospitalization) on an unspecified date in 2021 with outcome of unknown, open heart surgery. heart repair and double bypass completed (hospitalization) on an unspecified date in 2021 with outcome of unknown, angiogram showed left artery was 95% blocked and right was 75% (hospitalization) on an unspecified date in 2021 with outcome of unknown, vaccine is like a poison for lungs and made him weak (hospitalization) on an unspecified date in 2021 with outcome of unknown, paralysis (medically significant) on an unspecified date in 2021 with outcome of unknown, couldn''t breathe in shower on 17May2021 with outcome of unknown, got a cough on an unspecified date in 2021 with outcome of unknown, weak on an unspecified date in 2021 with outcome of unknown. Clinical course reported as follow: 2 weeks later, husband got a cough. Took antibiotics. On 17May2021, patient couldn''t breathe in shower. Ambulance came and took husband to hospital. Perfectly ok pre vaccine. The reporter had heart operation in June and have previously had breast cancer. Husband had silent heart attack and was kept as an inpatient. He was sure this was caused by the vaccine. Husband only took vaccine so he could go to Country. Husband was unable to be transferred to same hospital as the reporter. Since 17Jun2021, he has had breathing difficulties and swelling in feet. The reporter was a doctor and knew the patient was having cardiac failure. Took husband to hospital. 29Jun2021 he had an open heart surgery. Heart repair and double bypass completed. Angiogram showed left artery was 95% blocked and right was 75%. The reporter knew everything happened due to the vaccine. A doctor has confirmed this was due to the vaccination. He had multi organ failure, suffered a fall whilst in hospital and passed away on 17Jul2021. Vaccine was like a poison for lungs and made him weak. Patient in Country had paralysis from the vaccine. Husband contracted hospital-acquired pneumonia prior to passing. The reporter was not happy with the way her husband was treated in the hospital prior to passing as he would have been better off in the same hospital as her or at home. The patient underwent lab tests and procedures which included angiogram: left artery was 95% blocked and right was 75%. The patient died on 17Jul2021. 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.; Sender''s Comments: Based on the available information and noted underlying risk factors the reported events were more likely attributed to an underlying or an intercurrent medical condition and it is assessed as unrelated to the BNT162B2 in this 76 year old elderly subject. 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: passed away on 17Jul; Hospital acquired pneumonia


VAERS ID: 1585670 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: SARS-CoV2 antibody test; Result Unstructured Data: Test Result:85000; Test Date: 202108; Test Name: PCR test; Result Unstructured Data: Test Result:positive in SARS-CoV2 variant delta; Comments: positive for SARS-CoV2 variant delta
CDC Split Type: GRPFIZER INC202100962803

Write-up: severe pneumonia (COVID-19 pneumonia); severe pneumonia (COVID-19 pneumonia); The initial case was missing the following minimum criteria: identifiable reporter. Upon receipt of follow-up information on 17Aug2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 71-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unknown date in 2021 (Batch/Lot number was not reported) as dose 2, single, and received dose 1 via an unspecified route of administration on an unknown date in 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient completed the full vaccination scheme, administered both doses of the Pfizer-Biontech vaccine on time, and 14 days had passed since the second dose. The patient did not have any relevant medical history, he was healthy, athletic type, and was paying attention to his diet and healthy nutrition, he was not smoking. The patient was not taking any concomitant medications. The patient experienced vaccination failure and COVID-19 pneumonia on an unknown date in 2021, requiring hospitalization in 2021. The patient had a positive test for SARS-CoV2, he underwent a PCR in Aug2021 and was positive for SARS-CoV2 variant delta. The patient experienced severe pneumonia. The patient did not have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. It was still unknown how he and his family got infected. The patient was hospitalized in the ICU for 15 days before he died. It was unknown if the patient displayed any clinical signs at rest indicative of severe systemic illness. The patient required supplemental oxygen and received mechanical ventilation. It was unknown if the patient had multiorgan failure, any cardiovascular, gastrointestinal/hepatic, vascular, renal, neurological, hematological, dermatological, or any other symptoms. The patient did not receive any additional therapies for COVID-19. He did not receive any new medication or initiate other treatment or procedure. Two days before he died (Aug2021), the patient underwent an antibody test, the result was 85,000 (unknown units). The patient had not had any disease other than Corona virus to date. Both doses of the Pfizer-Biontech vaccine on time, caught the Corona virus and was subsequently hospitalized for severe pneumonia, but passed away despite all efforts. The reporter stated "This is the first case our hospital has seen since the start of vaccinations. The patient had severe pneumonia. We do not have the profile of the strain. The vigil was closed yesterday with an increase in admissions. He had the Pfizer vaccine, 14 days have passed. He has no underlying diseases. He is the exception that confirms the rule. The effectiveness of the vaccines protects 9 out of 10." The patient died on an unknown date in Aug2021 due to Covid-19 pneumonia, an autopsy was not performed.; Sender''s Comments: Based on the information currently available,The casual association between the reported event and suspected 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: COVID-19 pneumonia; COVID-19 pneumonia


VAERS ID: 1585931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
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: Medical History/Concurrent Conditions: Chronic disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101031665

Write-up: were vaccinated with the Corona vaccine and died a few days afterwards; This is a spontaneous report received from a physician via Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. A 9-decade-old (over 80 years old) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included few chronic disease from an unknown date. The patient''s concomitant medications were not reported. The patient died a few days afterwards on an unspecified date, event took place after use of product. The patient died on an unspecified date. It was not reported if an autopsy was performed. lot/batch number has been requested in follow-up.; Sender''s Comments: Based on the information in the case report, a possible causal relationship between the event 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.,Linked Report(s) : IL-PFIZER INC-202101032022 Same reporter, same product, same event, different patient; Reported Cause(s) of Death: were vaccinated with the Corona vaccine and died a few days afterwards


VAERS ID: 1585932 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
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: Medical History/Concurrent Conditions: Chronic disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101032022

Write-up: were vaccinated with the Corona vaccine and died a few days afterwards; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for two patients. This is the second of two reports. A 9-decade-old (reported as "over 80 years old") male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included chronic disease. The patient''s concomitant medications were not reported. The patient was vaccinated with the Corona vaccine and died a few days afterwards. Event took place after use of product. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event "death" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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.,Linked Report(s) : IL-PFIZER INC-202101031665 Same reporter, same product, same event, different patient; Reported Cause(s) of Death: were vaccinated with the Corona vaccine and died a few days afterwards


VAERS ID: 1585937 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Diarrhoea, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021125628

Write-up: death after 6 hours; asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine; asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine; asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine; asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number IT-MINISAL02-667618. A 42-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL1484), intramuscular on 07Jan2021 as DOSE NUMBER UNKNOWN, 0.3ML SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 07Jan2021 the patient experienced death after 6 hours and asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine. The outcome of event asthenia, diarrhea, headaches and myalgia occurred 6 hours after the 1st dose of the vaccine was recovered on an unspecified date. The patient died on 07Jan2021. It was not reported if an autopsy was performed. The signaler is contacted to get information about the concomitant diseases in which he suffers, and the date of the outcome (08.02.2021 still awaiting feedback) No Follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: death after 6 hours


VAERS ID: 1586050 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infantile cerebral palsy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This case was received via the Regulatory Authority (Reference number: IT-MINISAL02-764973) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA and PYREXIA in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003655) for COVID-19 vaccination. The patient''s past medical history included Infantile cerebral palsy on 31-May-1968. On 15-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced DYSPNOEA (seriousness criteria death and hospitalization) and PYREXIA (seriousness criteria death and hospitalization). The patient died on 30-Jul-2021. The reported cause of death was Dyspnea and Pyrexia. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. Treatment information was not provided. Company''s comment: Company''s comment: This case concerns an 53-year old female with medical history of Infantile cerebral palsy who had adverse events of dyspnoea and pyrexia and died 15 days after receiving mRNA-1273 vaccine. The reported cause of death was Dyspnea and Pyrexia. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information (translation) is expected. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Upon follow-up received: Updated seriousness criteria to death.; Sender''s Comments: This case concerns an 53-year old female with medical history of Infantile cerebral palsy who had adverse events of dyspnoea and pyrexia and died 15 days after receiving mRNA-1273 vaccine. The reported cause of death was Dyspnea and Pyrexia. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time. Further information (translation) is expected.; Reported Cause(s) of Death: Dyspnea; Pyrexia


VAERS ID: 1586117 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9599 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Alanine aminotransferase, Aspartate aminotransferase, Blood bilirubin, Blood calcium, Blood creatinine, Blood glucose, Blood sodium, Blood testosterone, Blood urea, Bone scan, Cardiac arrest, Dyspnoea, Haematology test, Haematoma, Haemoglobin, Neutrophil count, Platelet count, Prostatic specific antigen, Sopor, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNISONE TEVA; ZYTIGA; VALSARTAN; HYDROCHLOROTHIAZIDE; METFORMIN; TICLOPIDINE; QUETIAPINE; LANSOPRAZOLE; DECAPEPTYL [TRIPTORELIN]
Current Illness: Diabetes mellitus; Hypertension; Mixed anxiety and depressive disorder (in psychiatric therapy); Neoplasm prostate (diagnosed with biopsy in 2016, treated with Casodex and Decapeptyl quarterly.)
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker; Surgical intervention (Cervical spine surgery with titanium plate implant.)
Allergies:
Diagnostic Lab Data: Test Name: Alanine Aminotransferase; Result Unstructured Data: Test Result:9; Test Name: Aspartate Aminotransferase; Result Unstructured Data: Test Result:22; Test Name: bilirubin; Result Unstructured Data: Test Result:0.31; Comments: total: 0.31 direct: 0.16 indirect: 0.15; Test Name: calcium; Result Unstructured Data: Test Result:10.5; Test Name: creatinine; Result Unstructured Data: Test Result:1.27; Test Name: blood glucose; Result Unstructured Data: Test Result:120; Test Name: sodium; Result Unstructured Data: Test Result:136; Test Name: testosterone; Result Unstructured Data: Test Result:0.03; Test Name: Blood Urea Nitrogen; Result Unstructured Data: Test Result:34; Test Date: 20210216; Test Name: Bone scintigraphy; Result Unstructured Data: Test Result:Numerous images of focal pathological hyperfixatio; Comments: Numerous images of focal pathological hyperfixation to be referred to secondary level at the level of the whole spine, shoulder blades, sternum, costal arches, pelvis and femurs; Test Date: 20210308; Test Name: Hematology test; Result Unstructured Data: Test Result:unknown results; Test Name: haemoglobin; Result Unstructured Data: Test Result:13.5; Test Name: neutrophil; Result Unstructured Data: Test Result:7.67; Test Name: platelet count; Result Unstructured Data: Test Result:255; Test Date: 20210308; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:255 x10 3/mm3; Test Date: 20210308; Test Name: PSA; Result Unstructured Data: Test Result:4,567 iU; Test Name: white blood cell; Result Unstructured Data: Test Result:11.4
CDC Split Type: ITPFIZER INC202101032068

Write-up: Cardiac arrest; Hematomas in the posterior region of the thorax; Sleepy state; pasty abdomen; dyspnea; This is a spontaneous report received from a contactable consumer or other non hcp downloaded from the Regulatory Authority Report number is IT-MINISAL02-768322. An 81-year-old male patient received the first dose of BNT162B2 (COMIRNATY, EP9599) intramuscular at single dose for COVID-19 immunisation on 11Mar2021. Relevant history included ongoing mixed anxiety and depressive disorder, ongoing diabetes mellitus, ongoing neoplasm prostate since 2016, ongoing hypertension, surgical intervention (cervical spine surgery with titanium plate implant), non-smoker. Relevant concomitant drug included prednisone (PREDNISONE TEVA) orally, abiraterone acetate (ZYTIGA) orally at 1 DF for Carcinoma prostatic on 15Mar2021. Additional concomitant drugs included valsartan and hydrochlorothiazide, metformin, ticlopidine, quetiapine, lansoprazole, quarterly triptorelin (DECAPEPTYL), all received on 11Mar2021. Past drug included bicalutamide (CASODEX) for Neoplasm prostate, triptorelin (DECAPEPTYL) for Neoplasm prostate. The patient experienced sleepy state and dyspnea. Hematomas in the posterior region of the thorax and pasty abdomen since 15Mar2021 with fatal outcome. The clinical course was reported: From Apr2020 progressive Prostatic specific antigen rise, on the CT of the brain, thorax, abdomen of 15Dec2020 doubts at the skeletal level, at the scintigraphy of 16Feb2021 numerous images of pathological hyperfixation of a focal nature to refer to secondaryity in the whole spine, shoulder blades, sternum, rib arches, pelvis and femur. On 11Mar2021 access to Oncology, on a wheelchair due to walking difficulties arising from the previous month, administration of Pfizer vaccine and prescription of therapy with Deltacortene 5mg, 1 tablet x2 per day, and Zytiga 1000mg per day starting from 15Mar2021. Home therapy on 11Mar2021 included valsartan and hydrochlorothiazide, metformin, ticlopidine, quetiapine, lansoprazole, quarterly triptorelin (DECAPEPTYL). From the evening of 15Mar2021 onset of intense asthenia, urinary blockage and pain, with access to the Emergency Room on 17Mar2021, where a bladder catheter was placed, followed by home discharge. On 18Mar2021, hematemesis reported, next loss of consciousness, patient in a drowsy state, dyspnoic with hematomas in the posterior region of the thorax, urgently transported to a hospital, where he died, during hospitalization. Autopsy check requested and performed. White Blood cells: 11.4; Neutrophils: 7.67; platelets: 255; Haemoglobin: 13.5; Testosterone 0.03; Glucose level 120; Urea: 34; Creatinine: 1.27; Aspartate aminotransferase/Alanine aminotransferase 22/9; Calcium 10.5; Sodium 136; Bilirubin total: 0.31, direct: 0.16; indirect: 0.15; testosterone minor 0.03; PSA 4.567.0; Numerous images of focal pathological hyperfixation to be referred to secondary level at the level of the whole spine, shoulder blades, sternum, costal arches, pelvis and femurs. Reporter''s comment: Prostate cancer. Sender''s comment: Local Center of Pharmacovigilance 06Aug2021 Suspected Comirnaty vaccine. Adverse reaction after about 4 days. Booster dose number 1. 06Aug2021 updated clinical history and adverse reaction fields.; Reporter''s Comments: Prostate cancer.; Reported Cause(s) of Death: Haematoma; Haematoma; dyspnea; Abdominal distension; Sopor; Cardiac arrest; Autopsy-determined Cause(s) of Death: Cardiac arrest


VAERS ID: 1586121 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dyspnoea, Erythema, Pain in extremity, Peripheral swelling, Urinary tract obstruction
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Retroperitoneal fibrosis (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 88
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:severe renal blockage
CDC Split Type: ITPFIZER INC202101032064

Write-up: severe twinges in the legs; severe twinges in the legs, so much so that she could not sleep at night and they became profusely swollen and red; severe twinges in the legs, so much so that she could not sleep at night and they became profusely swollen and red; Shortness of breath; renal blockage; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority report number is IT-MINISAL02-768544. An 81-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly in arm left (left shoulder) on 13Mar2021 at single dose for COVID-19 immunisation. Medical history included cardiopathic. The patient''s concomitant medications were not reported. The patient experienced severe twinges in the legs, so much so that she could not sleep at night and then became profusely swollen and red, and shortness of breath on 20Mar2021. The patient was hospitalized from 10Jun2021 where she was treated with high dose of diuretic furosemide (LASIX) to try to reduce fluids and deflate her legs. Given the ineffectiveness of the therapy, a CT scan was performed, which found a severe renal blockage. The liquids had reached the lungs largely so that the patient had difficulty breathing and she was given oxygen. She was not even able to take breath to speak although she was unfortunately fully aware of what inevitable fate she would meet. The dosages of furosemide were further increased to try to unblock the situation but with no result. Finally, dialysis was attempted, but the same evening death occurred on 16Jun2021. Impact on quality of life (10/10). The patient died on 16Jun2021. 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: renal blockage; severe twinges in the legs; severe twinges in the legs, so much so that she could not sleep at night and they became profusely swollen and red; severe twinges in the legs, so much so that she could not sleep at night and they became p


VAERS ID: 1586129 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Neck pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210831959

Write-up: 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; 13/07/21 JANSSEN. 17/07/21 MORNING: FEVER 37,2. PAINS: ARM, SHOULDERS, BEHIND THE NECK. LITTLE APPETITE. 7 PM EMERGENCY ROOM AT BOBBIO CITY. TRANSFER TO PIACENZA AND PARMA. 20/07 AT 6 DEATH; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, IT-MINISAL02-769620] concerned an 87 year old female patient of unspecified race and ethnic origin. The patient''s weight was 45 kilograms and height was 148 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 13-JUL-2021 for covid-19. No concomitant medications were reported. In the morning on 17-JUL-2021, the patient experienced little appetite, fever 37.2, pain in arm, shoulders and behind the neck. On the same date at 19:00, she visited emergency room. On 20-JUL-2021 at 06:00, she died from an unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever 37.2, pains: arm, shoulders, behind the neck and little appetite was fatal. This report was serious (Death).; Reporter''s Comments: Ipertensione arteriosa controllata dalla terapia Nebivololo 28 unita 5 mg - uso orale 032210015 LOBIVON 28 CPR 5 MG -; Sender''s Comments: V0: 20210831959-covid-19 vaccine ad26.cov2.s -13/07/21 JANSSEN. 17/07/21 morning: fever 37,2. Pains: arm, shoulders, behind the neck. Little appetite. 7 pm Emergency room. Transferred. 20/07 at 6 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: 1586201 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-05-12
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30004272 / 1 - / OT

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

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

Write-up: SARS-CoV-2 infection; Vaccination failure; This case was received via Regulatory Authority (Reference number: 39245) on 11-Aug-2021 and was forwarded to Moderna on 11-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. G26761A and 30004272) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was SARS-CoV-2 infection. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Very limited information regarding vaccination failure has been provided at this time. Further information is not expected. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.; Sender''s Comments: Very limited information regarding vaccination failure has been provided at this time. Further information is not expected. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1586225 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Basilar artery thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Gestorben 10 Stunden nach der Impfung basilaris Thrombose; This case was received via Regulatory Authority Agency (Reference number: 202100153191) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of BASILAR ARTERY THROMBOSIS (Gestorben 10 Stunden nach der Impfung basilaris Thrombose) in a 90-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced BASILAR ARTERY THROMBOSIS (Gestorben 10 Stunden nach der Impfung basilaris Thrombose) (seriousness criteria death and medically significant). The patient died on 01-Apr-2021. The reported cause of death was Basilar artery thrombosis. It is unknown if an autopsy was performed. Concomitant medications were not reported . Treatment information was not provided. Company comment This fatal case concerns a 90-year-old male with a serious unexpected event of basilar artery thrombosis. Event latency within 10 hours after first dose mRNA-1273. Cause of death reported as basilar artery thrombosis. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. Further information has been requested; Sender''s Comments: This fatal case concerns a 90-year-old male with a serious unexpected event of basilar artery thrombosis. Event latency within 10 hours after first dose mRNA-1273. Cause of death reported as basilar artery thrombosis. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. Further information has been requested; Reported Cause(s) of Death: Basilar artery thrombosis


VAERS ID: 1586233 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Insulin-requiring type 2 diabetes mellitus
Preexisting Conditions: Comments: Insulin-dependent diabetes HTA
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210832911

Write-up: DEATH; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, FR-AFSSAPS-LL20215345] concerned an 85 year old female. The patient''s weight was 56 kilograms, and height was 155 centimeters. The patient''s concurrent conditions included: insulin-requiring type 2 diabetes mellitus, and hypertension arterial, and other pre-existing medical conditions included: Insulin-dependent diabetes HTA. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-02 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 31-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced death and the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210832911- 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: 1586399 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bed rest, Cerebral haemorrhage, Dizziness, Haemorrhage, Hypoaesthesia, Nausea, Paralysis, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 31
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: ATMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE, CEREBRAL HAEMORRHAGE and PARALYSIS in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214001) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced DIZZINESS, BED REST, NAUSEA and PYREXIA. On 30-Jun-2021, the patient experienced HYPOAESTHESIA. On 01-Jul-2021 at 4:00 AM, the patient experienced CEREBRAL HAEMORRHAGE (seriousness criteria death, hospitalization and medically significant). On 02-Jul-2021, the patient experienced HAEMORRHAGE (seriousness criteria death, hospitalization and medically significant) and PARALYSIS (seriousness criteria hospitalization and medically significant). The patient died on 02-Jul-2021. It is unknown if an autopsy was performed. At the time of death, PARALYSIS, DIZZINESS, HYPOAESTHESIA, BED REST, NAUSEA and PYREXIA had not resolved. No concomitant medication was received by the patient. No treatment information was received by the patient. This case concerns an 49-year old female who had adverse events of DIZZINESS, BED REST, NAUSEA, PYREXIA, HYPOAESTHESIA, CEREBRAL HAEMORRHAGE, HAEMORRHAGE and PARALYSIS and died 10 days after receiving the 2nd dose of the vaccine. The reported cause of death was Cerebral haemorrhage and Haemorrhage. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time which impairs the overall understanding of the case and preclude proper medical assessment. This case was linked to AT-BASGAGES-2021-40229 (Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received on 16-AUG-2021: Start date of first dose and batch number for dose 2 was updated.; Sender''s Comments: This case concerns an 49-year old female who had adverse events of DIZZINESS, BED REST, NAUSEA, PYREXIA, HYPOAESTHESIA, CEREBRAL HAEMORRHAGE, HAEMORRHAGE and PARALYSIS and died 10 days after receiving the 2nd dose of the vaccine. The reported cause of death was Cerebral haemorrhage and Haemorrhage. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time which impairs the overall understanding of the case and preclude proper medical assessment. AT-BASGAGES-2021-40229:


VAERS ID: 1588664 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Hemiplegia, Pneumonia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 29
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immobile
Preexisting Conditions: Medical History/Concurrent Conditions: Urinary tract inflammation (antibiotics therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101046085

Write-up: Sudden death; Paralyzed of the left side of the body; Stroke; Pneumonia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority. An 89-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 01Jul2021 (30 sec) (Batch/lot number and expiration date unknown) as second dose, single for COVID-19 immunization. Medical history included urinary tract inflammation from Jun2021 (not ongoing), ongoing immobile. She was fine until the vaccination with the 2nd dose of Comirnaty, but she was immobile. She administered antibiotics for urinary tract infection. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE) on 28May2021 (Batch/lot number and expiration date unknown) as first dose, single for COVID-19 immunization with no event. The patient became paralysed on the left part of the body - she fell to the left while getting dressed after the vaccination with COMIRNATY. She was transported to neurology - a stroke and pneumonia were found. She was transferred to the following care on the 26Jul2021, where pneumonia was again detected (cured according to the hospital, not cured according to the following care). She died on the 30Jul2021. The outcome of paralysis one side of body was not resolved, of events stroke and pneumonia was unknown. On the 06Aug2021: Agency contacted the home for the elderly, so far without new information. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588696 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiovascular disorder, General physical health deterioration
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL
Current Illness: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038936

Write-up: Acute myocardial infarction with subtotal occlusion of the Left anterior descending artery; Deterioration in general condition in the last 1-2 weeks in terms of circulatory problems.; Deterioration in general condition in the last 1-2 weeks in terms of circulatory problems.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority DE-PEI-202100161650. A 61-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot number unknown) at single dose for COVID-19 immunisation on 25Jun2021 (61-year-old at vaccination). Relevant history included arterial hypertension. Relevant concomitant drug included metoprolol. The patient experienced general physical condition decreased in Jul2021. In the last 1-2 weeks the patient''s general condition was worsening in the sense of "circulatory problems". On 22Jul2021 the patient experienced acute myocardial infarction. The patient died due to Acute myocardial infarction on 22Jul2021. Autopsy was done. The outcome of event General physical condition decreased was unknown. Cause of death: acute myocardial infarction with subtotal occlusion of the Left anterior descending artery; no meaningful correlation between vaccination and onset of death. Reactions / Events Assessed by regulatory authority, Result of Assessment "D. Unclassifiable". No follow-up attempts possible. No further information expected.; Autopsy-determined Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1588697 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Light headedness
Allergies:
Diagnostic Lab Data: Test Name: Autopsy; Result Unstructured Data: Test Result:myocardial infarction
CDC Split Type: DEPFIZER INC202101038977

Write-up: Subacute myocardial infarction of the SW in severe 3-vessel coronary artery disease; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is [DE-PEI-202100161660]. A 61 years old female patient received 1st dose of bnt162b2 (COMIRNATY) on 23Jul2021 single dose for COVID-19 immunisation at age of 61 years old. The patient''s medical history and concurrent conditions included: Arterial hypertension, Light headedness from Jul2021. Concomitant drugs were not provided. On 24Jul2021 the patient experienced Infarct myocardial. The patient died on 24Jul2021. The patient had subacute myocardial infarction of the SW in severe 3-vessel coronary heart disease; no meaningful connection between vaccination and onset of death. Autopsy was done and revealed myocardial infarction. Event outcome was fatal. This report was serious - death. The causality assessment for suspect drug to event was reported as follows: unclassifiable by regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial; Autopsy-determined Cause(s) of Death: Myocardial infarction


VAERS ID: 1588698 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Myocardial infarction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-19
   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: Medical History/Concurrent Conditions: Lung inflammation (pneumonia); Swallowing impaired (swallowing disorder)
Allergies:
Diagnostic Lab Data: Test Date: 20210117; Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Comments: without pathological findings; Test Date: 20210117; Test Name: body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Comments: without pathological findings
CDC Split Type: DEPFIZER INC202101038574

Write-up: Myocardial infarction with occlusion of the circumflex branch, possibly stress-related; Pyrexia/38.7 - 39.2 centigrade; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, company number DE-PEI-202100161682. An 89-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 at age of 89 years old (Batch/Lot Number: Unknown) as dose number unknown, single for covid-19 immunisation. Medical history included lung inflammation (pneumonia) and swallowing impaired (swallowing disorder), both from unknown date and unknown if it was ongoing. The patient''s concomitant medications were not reported. On 19Jan2021 the patient experienced Infarct myocardial. On 17Jan2021 the patient experienced pyrexia. The patient underwent lab tests and procedures which included body temperature: 38.7 - 39.2 centigrade on 17Jan2021 without pathological findings. Patient was died on 19Jan2021.An autopsy was performed that revealed cause of death: Myocardial infarction with occlusion of the circumflex branch, possibly stress-related. The outcome of Infarct myocardial was fatal and the outcome of pyrexia was unknown.The causality assessment from regulatory authority was D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction; Autopsy-determined Cause(s) of Death: Myocardial infarction


VAERS ID: 1588699 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC202101045257

Write-up: Sudden cardiac death; This is a spontaneous report downloaded from the Regulatory Authority-WEB WWID reported as Regulatory Authority Number DE-PEI-202100161882 from the Healthcare Authority. A 56 years old male patient received bnt162b2 (COMIRNATY, lot FE6975) on 20Jul2021 single dose for COVID-19 immunisation at the age of 55 years old. Medical history and concomitant drugs were not provided. The patient experienced Sudden cardiac death on unknown date. Outcome of the event was fatal. It was unknown if autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1588700 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypercholesterolaemia; Hypertension; Type 1 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101046062

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100162527, from the Healthcare Authority. A 58-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 22Jul2021 (Batch/Lot Number: FE8405) as dose 2, single at the age of 58-years-old for covid-19 immunization. Medical history included ongoing type 1 diabetes mellitus, ongoing hypertension, ongoing hypercholesterolaemia. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 24Jun2021 for covid-19 immunisation. The patient experienced unknown cause of death on 2021. It was not reported if an autopsy was performed. Reaction(s) / Event(s) Assessed by Regulatory Authority, Result of Assessment: Unclassifiable. No follow-up attempts possible. No further information expected. Information about batch number has been obtained; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588701 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Interchange of vaccine products, Off label use
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiomyopathy (Grade 3); Liver fatty (Grade 3); Obesity (Grade 3); Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101045431

Write-up: Unknown cause of death; The 1. vaccination : Vaxzevria/ The patient was treated with Comirnaty; The 1. vaccination : Vaxzevria/ The patient was treated with Comirnaty; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB WWID reported as Regulatory Authority Number DE-PEI-202100162535 from the Healthcare Authority. A 60-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection), dose 2, initial Pfizer dose via an unspecified route of administration on 27Jul2021 (lot Number: FE8405) (at the vaccination age of 60-year-old) as single dose for COVID-19 immunisation. Medical history included Ongoing obesity (Grade 3), Type 2 diabetes mellitus, Cardiomyopathy (Grade 3), Liver fatty (Grade 3); Deep vein thrombosis (unknown the start date and unknown if ongoing). Historical vaccine included first dose of Vaxzevria on 04May2021 for Covid-19 immunisation (dose 1, single). The patient''s concomitant medications were not reported. As reported, the patient''s weight was 135 kg, and height was 189 cm. On 01Aug2021 the patient experienced unknown cause of death. Patient has been found dead in his home by the nursing service. The outcome of the event was fatal. It is unknown if autopsy was done. The causality of suspect product BNT162b2 and event unknown cause of death per Regulatory Authority, was reported as "D. Unclassifiable". No follow-up attempts are possible. No further information is expected. OR No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

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:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Type II diabetes mellitus; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210835510

Write-up: THROMBOSIS OF VENOUS SINUSES; This spontaneous report was received from a health care professional via the Regulatory Authority, case reference number DE-PEI-202100165005, and concerned a 52 year-old male patient. The patient''s height and weight were not reported. The patient''s concurrent conditions included arterial hypertension and type 2 diabetes mellitus. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration, batch number and expiry date not reported), dose and vaccination date not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 04-AUG-2021, the patient experienced thrombosis of venous sinuses and died the same day. The cause of death was reported as unknown. It was unknown if an autopsy was performed. The action taken with COVID-19 vaccine Ad26.CoV2.S was reported as not applicable. This report was serious (death).; Sender''s Comments: V0:This spontaneous report was received from a health care professional, case reference number DE-PEI-202100165005, and concerns a 52 year-old male patient with unknown past medical history and concomitant medications experienced thrombosis of venous sinuses and died the same day at unspecified time post vaccination. The patient''s concurrent conditions included arterial hypertension and type 2 diabetes mellitus. No other pertinent details reported. Information is limited in this case, and the occurrence of thrombosis of venous sinuses could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.; Reported Cause(s) of Death: DEATH CAUSE UNKNOWN


VAERS ID: 1588844 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-25
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Death, Pain, Psoriasis, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic pain; Diabetes; Lung cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038899

Write-up: Unknown cause of death; Psoriasis on both elbows outside. Excruciating pain all over the body. Painkillers with no effect/ Arthralgia; Psoriasis on both elbows outside. Excruciating pain all over the body. Painkillers with no effect/ Rash; Psoriasis on both elbows outside; Excruciating pain all over the body; This is a spontaneous report from a non-contactable consumer received from regulatory authority downloaded from the Regulatory Authority. Regulatory authority report number is DE-PEI-CADR2021153367; Safety Report Unique Identifier is DE-PEI-202100154861. A 60-year-old male patient (weight: 120kg, height: 186cm) received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN, strength: 0.3ml, Batch/Lot Number: Unknown), via an unspecified route of administration on 08Apr2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included ongoing chronic pain, ongoing lung cancer, ongoing diabetes. There were no known allergies. The patient''s concomitant medications were not reported. The patient experienced "psoriasis on both elbows outside. excruciating pain all over the body. painkillers with no effect/ rash" on 25Apr2021, "psoriasis on both elbows outside. excruciating pain all over the body. painkillers with no effect/ arthralgia" on 25Apr2021, "unknown cause of death" on 03May2021. Case narrative: This report is serious - death. On 25Apr2021 the patient experienced rash and arthralgia. On 03May2021 the patient experienced unknown cause of death. Therapeutic measures were taken as a result of the events other than "unknown cause of death" and included painkillers. The outcome of "unknown cause of death" was fatal; outcome of other events was unknown. The patient died on 03May2021. No autopsy was performed. The cause of death was unknown. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-15
Onset:2021-04-01
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038875

Write-up: Cerebral haemorrhage; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority DE-PEI-CADR2021155583, Safety Report Unique Identifier DE-PEI-202100157851. A 83-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jan2021 as dose number unknown, 0.3ml single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cerebral haemorrhage in Apr2021. The patient died in Apr2021. It was not reported if an autopsy was performed. The outcome of event was fatal. Source of assessment Regulatory Authority Result of Assessment D. Unclassifiable No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1588850 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038862

Write-up: Acute massive pulmonary embolism, pulmonary artery embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021156388. Safety Report Unique Identifier DE-PEI-202100158533. An 88-year-old female patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), via an unspecified route of administration on 20May2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Information on risk factors or previous illnesses: None. The patient was very mobile. No medication or previous illness. Concomitant medications were not reported. The patient experienced acute massive pulmonary embolism, pulmonary artery embolism. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Acute massive pulmonary embolism, pulmonary artery embolism


VAERS ID: 1588851 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cerebrovascular accident, Facial paralysis
SMQs:, Cardiac failure (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Photosensitivity reaction
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038889

Write-up: Accident cerebrovascular; failure symptoms and paralysis of the Half of the face; failure symptoms and paralysis of the Half of the face; This is a spontaneous report from non-contactable consumer downloaded from the regulatory authority DE-PEI-CADR2021156690, Safety Report Unique Identifier DE-PEI-202100158847. A 54-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ml), dose 2 via an unspecified route of administration on 12Jul2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included Sun allergy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 13Jul2021 the patient experienced Accident cerebrovascular. Also reported failure symptoms and paralysis of the Half of the face. Ambulance Hospital. The patient died for Accident cerebrovascular on 13Jul2021, outcome of other events was unknown. It was unknown if an autopsy was performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? Sun allergy / failure symptoms and paralysis of the Half of the face. Ambulance Hospital. Source of assessment regulatory authority. Result of. Assessment D. Unclassifiable. Dosage text: 2. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1588852 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Multiple organ dysfunction syndrome, Myocardial infarction, Pyrexia, Sepsis
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Ventricular fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: high fever; Result Unstructured Data: Test Result:39.5 Centigrade
CDC Split Type: DEPFIZER INC202101038992

Write-up: Multiple organ failure; Infarct myocardial/heart attack; sudden high fever (39.5); blood poisoning; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority DE-PEI-CADR2021157015, Safety Report Unique Identifier DE-PEI-202100159940. An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: ER9480, strength: 0.3 ml) (mRNA tozinameran) on 18May2021 at single dose for COVID-19 immunisation. Medical history included ongoing ventricular fibrillation. The patient had no known allergies. The patient''s concomitant medications were not reported. On 18Jun2021, the patient experienced sudden high fever (39.5), infarct myocardial/heart attack. The patient also experienced blood poisoning and placed in an artificial coma within 3 days and the patient died 6 days later. On 27Jun2021, the patient experienced multiple organ failure. This report was serious - hospitalization. The patient underwent lab tests and procedures which included high fever: 39.5 centigrade on 18Jun2021. The patient died on 27Jun2021. It was not reported if an autopsy was performed. Relatedness of drug to the events was assessed as D. Unclassifiable by Regulatory Authority. The outcome of event multiple organ failure was fatal. The outcome of events fever and infarct myocardial was not recovered. The outcome of event blood poisoning was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1588853 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Chronic left ventricular failure; Hypertensive heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038882

Write-up: My patient died of sudden cardiac death 5 days after receiving a Pfizer vaccine.; general condition worsening with dyspnoea the day after vaccination, then progressing; general condition worsening with dyspnoea the day after vaccination, then progressing; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021157145. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100160016. A 71-years-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 mL), via an unspecified route of administration on 29Jul2021 (Lot Number: FE8405) as SINGLE for covid-19 immunisation. Medical history included ongoing hypertensive heart disease, ongoing atrial fibrillation, ongoing chronic left ventricular failure, covid-19 from Oct2020 to Oct2020, cardiac failure on the basis of hypertensive heart disease. No known allergies. The patient''s concomitant medications were not reported. The patient died of sudden cardiac death 5 days after receiving a pfizer vaccinemon an 03Aug2021, general condition worsening with dyspnoea the day after vaccination, then progressing on 30Jul2021. The patient died on 03Aug2021. It was not reported if an autopsy was performed. General condition worsening with dyspnoea the day after vaccination, then progressing. no doctor consulted. The patient experienced also Sudden cardiac death. Relatedness of drug to reaction/event assessed by Regulatory Authority, Result of Assessment: D. Unclassifiable No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1588854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-31
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Mucormycosis, Septic shock, Swelling of eyelid, Visual impairment, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary heart disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101045499

Write-up: Vomiting; Eyelid swellings on both sides, visual disturbances when developing the full picture of a mucor; Eyelid swellings on both sides, visual disturbances when developing the full picture of a mucor; Eyelid swellings on both sides, visual disturbances when developing the full picture of a mucor; Septic shock; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021157327, Safety Report Unique Identifier DE-PEI-202100159987. A 66-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Jul2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing coronary artery disease. The patient''s concomitant medications were not reported. The patient experienced Septic shock on 31Jul2021 with outcome as fatal, vomiting (hospitalization), eyelid swellings on both sides, visual disturbances when developing the full picture of a mucor on an unspecified date with outcome of not recovered. The patient died on an unspecified date. It was not reported if an autopsy was performed. Clinical course as reported: On 31Jul2021 the patient experienced Septic shock. The patient experienced also Vomiting, Mucormycosis, Visual disturbance. Sender''s comment: expression of a full picture of a mucor with development of necrosis in the area of the nose, both eyes and forehead; antifungal therapy with isovuconazole and later liposomal amphotericin B; no surgical removal possible, patient dies in septic shock. Assessment: Comirnaty/ Visual disturbance / RA: D. Unclassifiable. Assessment: Comirnaty/ Vomiting / RA: D. Unclassifiable. Assessment: Comirnaty/ Mucormycosis / RA: D. Unclassifiable. Assessment: Comirnaty/ Septic shock / RA: D. Unclassifiable. Comirnaty''s Dosage text: "1". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Septic shock


VAERS ID: 1588855 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Dizziness, Dyspnoea, Nausea, Tachycardia, Vaccination site haemorrhage, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101038956

Write-up: Unknown cause of death; Tachycardia; nausea; could hardly breathe; pain in the chest area; Bleeding at the injection site; Bleeding at the injection site, pain; severe dizziness; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021158100, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100160608. A 52-year-old female patient received BNT162B2 (COMIRNATY) at 52-year-old, via an unspecified route of administration on 02Jul2021 at single dose for COVID-19 immunisation. Medical history included hay fever. The patient''s concomitant medications were not reported. On 02Jul2021, the patient experienced light headedness, tachycardia, thorax pain, nausea, dyspnea, vaccination site pain, vaccination site hemorrhage, and unknown cause of death. Heavy bleeding after vaccination, doctor was surprised himself, dizziness shortly afterwards. Bleeding at the puncture site, pain, racing heart; before the ambulance came she was dead in the hallway. Patient experienced severe dizziness; pain in the chest area, nausea, could hardly breathe, this came the evening after the 2 vaccinations. This report was serious - hospitalization. Outcome of events was not resolved. The patient died on 02Jul2021. It was not reported if an autopsy was performed. Reactions / Events Assessed by RA, Result of Assessment: "D. Unclassifiable". No follow-up attempts possible. No further information expected. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588895 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Bacterial test, Confusional state, Cough, Depressed level of consciousness, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic valve replacement; Artificial cardiac pacemaker user; Depressed mood (Has recently expressed a lack of desire to live); Diabetes mellitus; Reduced general condition (Over the last 2-3 years loss of function, not able to have visitors or cook dinner)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: Bacterial culture; Result Unstructured Data: Test Result:4 bacteria found
CDC Split Type: DKPFIZER INC202100996509

Write-up: Confused; Fever; Consciousness decreased; Bacterial infection; Cough; Difficulty breathing; This is a spontaneous report from a contactable consumer and from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0072640. An 87-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Jan2021 (Lot Number: EJ6134) as single dose for COVID-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing depressed mood (has recently expressed a lack of desire to live), ongoing aortic valve replacement, ongoing artificial cardiac pacemaker, and ongoing reduced general condition (over the last 2-3 years loss of function, not able to have visitors or cook dinner). The patient''s concomitant medications were not reported. There is no information regarding past medications. On 30Jan2021, 2 days after, the patient developed cough and difficulty breathing. On 06Feb2021, 9 days after, the patient was confused, developed fever, and consciousness decreased. On an unknown date in Feb2021, the patient developed bacterial infection. Bacterial culture on 06Feb2021 showed 4 bacteria found. The ADRs were by the relative reported as resulting in hospitalisation on 06Feb2021 and being fatal on 10Feb2021. No autopsy was performed. The patient was initial treated for a bacterial infection (not specified), but after cultivation of resistance, the treatment was changed to palliative treatment (not specified) by request from the patient. The patient was informed that it could be fatal to oppose the necessary treatment. Causality: The patient''s general practitioner stated that he believes this was an expected death, and it was not related to the vaccination with Comirnaty. The patient has recently expressed a lack of desire to live. The patient was informed that it could be fatal to oppose the necessary treatment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: difficulty breathing; cough; confused; fever; consciousness decreased; Bacterial infection


VAERS ID: 1588901 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Glycosylated haemoglobin, Investigation
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRIX; CARDACE [RAMIPRIL]; ATORVASTATIN; ZOPITIN; TAMSULOSIN; PRADAXA; BETALOC ZOK; METFORMIN
Current Illness: Duodenitis; Gastritis; Hyperlipidemia NOS; Insomnia (non-organic); Non-insulin-dependent diabetes mellitus; Prostatic hyperplasia; Unspecified hypertensive heart disease without congestive heart failure
Preexisting Conditions: Medical History/Concurrent Conditions: Old myocardial infarction (2 infarctions); Prostatic cancer
Allergies:
Diagnostic Lab Data: Test Date: 20201208; Test Name: HbA1c; Test Result: 8.1 %; Test Date: 20201208; Test Name: tests; Result Unstructured Data: Test Result:in order
CDC Split Type: EEPFIZER INC202101054614

Write-up: Asthenia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number EE-SAM-46552107297. A 67-years-old male patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FC8889) via an intramuscular route of administration on 10Jun2021 (at the age of 67 years) as dose 2, 0.3mL single for COVID-19 immunization. Medical history included ongoing type 2 diabetes mellitus, ongoing duodenitis, ongoing hypertensive heart disease, ongoing insomnia, prostate cancer from an unknown date and unknown if ongoing, ongoing benign prostatic hyperplasia, myocardial infarction from an unknown date and unknown if on-going with description: 2 infarctions, ongoing hyperlipidemia, ongoing gastritis. Concomitant medications taken for an unspecified indication included spironolactone (SPIRIX) taken 50 mg 2 times/week oral, start and stop date were not reported; ramipril (CARDACE (RAMIPRIL)) 5 mg, daily oral, start and stop date were not reported; atorvastatin (ATORVASTATIN) 20 mg, daily oral, start and stop date were not reported; zopiclone (ZOPITIN) 7.5 mg, as needed oral , start and stop date were not reported; tamsulosin (TAMSULOSIN) 0.4 mg, daily oral, start and stop date were not re-ported; dabigatran etexilate mesilate (PRADAXA) 150 mg, daily oral, start and stop date were not reported; metoprolol succinate (BETALOC ZOK) 100 mg, daily oral, start and stop date were not reported; metformin (METFORMIN) 500 mg, 2 times/day oral, start and stop date were not report-ed. Patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/lot number: EW6126) via an intramuscular route of administration on 30Apr2021 as dose 1, 0.3mL single for COVID-19 immunization with no adverse event. On 10Jun2021, the patient experienced asthenia (death and medically significant). The patient underwent lab tests and procedures which included glycosylated hemoglobin: 8.1 percent on 08Dec2020, not specified investigations: in order as a result performed on 08Dec2020. The patient died on 21Jul2021. It was not reported if an autopsy was performed. The clinical outcome of the event fatal on 21Jul2021. Health Authority Comment: Serious, fatal adverse reaction, but sufficient data are lacking for evaluation. The relationship could not be assessed.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1588986 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Incorrect route of product administration
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract; Epilepsy; Hysterectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101038587

Write-up: Death unexplained; Inappropriate route of vaccination; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-BR20213021. A 67-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intradermal on 10Feb2021 (Batch/Lot Number: EJ6789) as single dose for covid-19 immunisation. Medical history included hysterectomy, cataract, epilepsy. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 26Feb2021. On 26Feb2021, patient found deceased, sudden death. The patient died on 26Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1588987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-30
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6789 / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Heart valvular prosthesis wearer; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101038579

Write-up: CVA; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-BR20213052. A 97-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 10Feb2021 (Batch/Lot Number: EJ 6789) as Dose 2, single for covid-19 immunisation. Medical history included hypertension arterial, diabetes, heart valvular prosthesis wearer. The patient''s concomitant medications were not reported. The patient experienced CVA (cerebrovascular accident) on 30Apr2021. The event was serious per life threatening and death. The outcome of the event was fatal. The patient died on 30Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: CVA


VAERS ID: 1589007 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-27
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Blood creatine, Blood creatine phosphokinase, Blood potassium, Blood urea, Brain natriuretic peptide, C-reactive protein, CSF cell count, Cardiac index, Chlamydia test, Coma scale, Computerised tomogram, Cytomegalovirus test, Echocardiogram, Electroencephalogram, Electrophoresis, HIV test, Haemoglobin, Lumbar puncture, Magnetic resonance imaging, Oxygen saturation, Polymerase chain reaction, Prothrombin level, Varicella virus test
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   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: DOLIPRANE; ESOMEPRAZOLE; ALPRAZOLAM; GAVISCON [CALCIUM CARBONATE;SODIUM ALGINATE]; PAROXETINE [PAROXETINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Depression; Fibromyalgia; Fracture of vertebra; GERD; Hypertension arterial; Hysterectomy; Renal impairment; Spinal operation
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: creat; Result Unstructured Data: Test Result:531; Test Date: 20210627; Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:18000; Test Date: 20210627; Test Name: iono k; Result Unstructured Data: Test Result:5.1; Test Date: 20210627; Test Name: urea; Result Unstructured Data: Test Result:26; Test Date: 20210627; Test Name: Brain natriuretic peptide; Result Unstructured Data: Test Result:56000; Test Date: 20210627; Test Name: index cardiac; Result Unstructured Data: Test Result:49; Test Name: chlamydial serology; Test Result: Positive ; Comments: positive chlamydial serology in IgG and IgM, rickettsi serology positive at the threshold, serology of old measles and mumps neg, serology lyme neg, IgG mycoplasma neg; Test Date: 20210709; Test Name: glasgow scale; Result Unstructured Data: Test Result:5 at best; Test Date: 20210719; Test Name: glasgow scale; Result Unstructured Data: Test Result:E2M1V4 at best with eye wandering, reactive interm; Comments: E2M1V4 at best with eye wandering, reactive intermediate pupils.; Test Name: Computed tomography thorax-abdomen-pelvis scans; Result Unstructured Data: Test Result:Excavated pneumonia and polyviceral failure; Test Date: 20210627; Test Name: Computed tomography thorax-abdomen-pelvis scans; Result Unstructured Data: Test Result:possibly anoxic encephalopathy; Comments: found areas of possibly anoxic encephalopathy and areas of occipital ischemia with doubt about a neurological infectious process. Associated with pulmonary cavities: inhalation pneumonia.; Test Date: 20210627; Test Name: crp; Result Unstructured Data: Test Result:332; Test Date: 20210709; Test Name: cerebrospinal fluid; Result Unstructured Data: Test Result:25 cells, 92% lympho, prot 0.44g / l no hypoglycor; Comments: 25 cells, 92% lympho, prot 0.44g / l no hypoglycorachia, culture neg,; Test Name: PCR CMV; Result Unstructured Data: Test Result:positive blood; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:formamen ovale permeable but no vegetation.; Test Date: 20210719; Test Name: EEG; Result Unstructured Data: Test Result:reactive with absence of epileptogenic activity.; Test Name: electrophoresis of serum proteins; Result Unstructured Data: Test Result:Globulinemia at 5g / l; Test Date: 20210627; Test Name: Hb; Result Unstructured Data: Test Result:11.9; Test Name: HIV serology; Test Result: Negative ; Test Date: 20210627; Test Name: lumbar puncture; Result Unstructured Data: Test Result:without nucleated element; Comments: without nucleated element with a few red blood cells and a non-purulent appearance which precludes the diagnosis of infectious encephalitis. no elements, prot at 0.42g / l, no hypoglycorachia, PCR enterovirus neg, universal PCR neg,; Test Date: 20210709; Test Name: lumbar puncture; Result Unstructured Data: Test Result:brings back some elements in favor of an Inflammat; Comments: brings back some elements in favor of an Inflammation with in particular the presence of polymorphonuclear cells unlike the 1st lumbar puncture.; Test Date: 20210628; Test Name: Cerebral MRI; Result Unstructured Data: Test Result:large ischemic areas of the white matter on the up; Comments: large ischemic areas of the white matter on the upper and sub-tentorial stages as well as on the corpus callosum and the pallidums, not systematized, aspecific but in favor of a toxic cause of the carbon monoxide type; Test Date: 20210719; Test Name: Cerebral MRI; Result Unstructured Data: Test Result:decrease in edema and the pseudo-tumoral appearanc; Comments: decrease in edema and the pseudo-tumoral appearance of supra and intratentorial leukoencephalopathy lesions. Appearance of necrotizing-looking areas and in places where hemosiderin is deposited: acute hemorrhagic leukoencephalopathy? Another hyperacute demyelinating disorder? other?; Test Date: 20210627; Test Name: oxygen saturation; Test Result: 60 %; Test Name: multiplex PCR; Test Result: Negative ; Comments: (E COli / haemophilius / listeria / neisseria / strepto agalactiae, pneumoniae / CMV / Enterovirus / HHV6 / HSV & et 2 / VVZ / cryptococcus / parechovirus); Test Date: 20210627; Test Name: prothrombin; Test Result: 61 %; Test Name: VZV; Test Result: Negative
CDC Split Type: FRPFIZER INC202101038943

Write-up: necrotico-hemorrhagic acute disseminated encephalomyelitis; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-LY20218843. A 64-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 09Jun2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included fibromyalgia, HTA (hypertension arterial), moderate renal impairment (creatinine 95umol/L), depressive syndrome, GERD with treated H Pylori, dorsal vertebrae fracture operated on L5-S1 in 2010, cholecystectomy and hysterectomy. Concomitant medications included paracetamol (DOLIPRANE), esomeprazole, alprazolam, calcium carbonate, sodium alginate (GAVISCON [CALCIUM CARBONATE;SODIUM ALGINATE]), paroxetine hydrochloride (PAROXETINE [PAROXETINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported. The patient experienced necrotico-hemorrhagic acute disseminated encephalomyelitis (ADEM) on 27Jun2021. Clinical course was reported as On 27Jun2021: patient was found unconscious in her bed with 60% saturation, vomiting and stools; coma of indefinite duration and undetermined etiology. Computed tomography thorax-abdomen-pelvis scans found areas of possibly anoxic encephalopathy and areas of occipital ischemia with doubt about a neurological infectious process. Associated with pulmonary cavities: inhalation pneumonia. A lumbar puncture returns without nucleated element with a few red blood cells and a non-purulent appearance which precludes the diagnosis of infectious encephalitis. Biology: Gds PH7 with PCO2 60mmHg, Hb: 11.9, prothrombin: 61%; iono k: 5.1, creatine: 531 and urea: 26. Major hepatic cytolysis, creatine phosphokinase 18000; Brain natriuretic peptide: 56,000, high index cardiaque: 49, CRP: 332. The patient also presented with multi-visceral failure after prolonged stationary ground secondary to impaired consciousness. (Following hospitalization, organ failures (hemodynamic, renal, respiratory and hepatic) have completely regressed and can be part of a table of significant dehydration + rhabdomyolysis linked to the ground station). Additional tests: Cerebral MRI (28Jun2021): large ischemic areas of the white matter on the upper and sub-tentorial stages as well as on the corpus callosum and the pallidums, not systematized, aspecific but in favor of a toxic cause of the carbon monoxide type. Brain MRI (19Jul2021): decrease in edema and the pseudo-tumoral appearance of supra and intratentorial leukoencephalopathy lesions. Appearance of necrotizing-looking areas and in places where hemosiderin is deposited: acute hemorrhagic leukoencephalopathy? Another hyperacute demyelinating disorder? other? Differential diagnosis: no detection of carbon oxide (CO) at the sensor, no gas heating, little argument for CO poisoning during treatment. In addition, on GDS entry on 27Jun2021 at 11 a.m., HbCO is dosed at 0.8. Negative toxic balance. Patient with intense relational life, no dark thoughts. Trans-thoracic echocardiography: formamen ovale permeable but no vegetation. Computed tomography thorax-abdomen-pelvis: Excavated pneumonia and polyviceral failure. Initial lumbar punction 27Jun2021: no elements, prot at 0.42g/l, no hypoglycorachia, PCR enterovirus neg, universal PCR neg, PCR HSV VZV neg LBA and hemoc pos in strepto anginosus. HIV negative serology, electrophoresis of serum proteins hypogammaGlobulinemia at 5g/l, positive chlamydial serology in IgG and IgM, rickettsi serology positive at the threshold, serology of old measles and mumps neg, serology lyme neg, IgG mycoplasma negative, cerebrospinal fluid on 09Jul2021: 25 cells, 92% lympho, prot 0.44g / l no hypoglycorachia, culture negative, PCR Whipple negative, negative multiplex PCR (E COli / haemophilius / listeria / neisseria / strepto agalactiae, pneumoniae / CMV / Enterovirus / HHV6 / HSV & et 2 / VVZ / cryptococcus / parechovirus), PCR CMV positive blood. EVOLUTION: 09Jul2021: No neurological improvement, patient glasgow 5 at best. She remained non-stimulable despite stopping the sedations on 06/30. The 2nd lumbar puncture today brings back some elements in favor of an Inflammation with in particular the presence of polymorphonuclear cells unlike the 1st lumbar puncture. 16Jul2021: Neuro opinion: The clinical picture is very suggestive of a necrotico-hemorrhagic type ADEM (form of HURST) whose prognosis is poor. It is an acute inflammatory disease with microvascular vasculitis. The etiology may be postinfectious or post vaccination. Corticosteroid therapy 1g / d in the event of an ADEM. 19Jul2021: patient glasgow E2M1V4 at best with eye wandering, reactive intermediate pupils. EEG appears to be reactive with absence of epileptogenic activity. Decrease in corticosteroid therapy to 2 mg/kg/day. 21Jul2021: Neurological opinion: extremely unfavorable neurological and functional prognosis without the prospect of recovery despite treatment, extensive necrosis lesions formed on MRI. In agreement with a discontinuation of active therapies. 23Jul2021: death of the patient. In total, a necrotico-hemorrhagic ADEM table whose etiology may be post-infectious or post-vaccination on D18 of D1 of the BNT162B2 vaccine. The patient died on 23Jul2021. It was not reported if an autopsy was performed. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained. No further information expected. ; Reported Cause(s) of Death: necrotico-hemorrhagic acute disseminated encephalomyelitis


VAERS ID: 1589015 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-11
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiovascular evaluation, Death, Electrocardiogram, Headache, Hypoaesthesia, Neurological examination, Ultrasound Doppler
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DARATUMUMAB; IBRUTINIB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphoid leukaemia; Hypertension arterial (in partial remission)
Allergies:
Diagnostic Lab Data: Test Date: 20210504; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/95 mmHg; Comments: HTA 160/95 which justifies the initiation of treatment with BI TILDIEM LP 120, given a rather high heart rate and control of blood pressure are prescribed; Test Date: 20210505; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/90 mmHg; Test Date: 20210507; Test Name: hypertension; Result Unstructured Data: Test Result:hypertension was moderate at 16/9; Test Date: 20210504; Test Name: The cardiovascular assessment; Result Unstructured Data: Test Result:normal; Test Date: 20210504; Test Name: ECG; Result Unstructured Data: Test Result:returns to a sinus rhythm of 95 / min; Comments: the transthoracic cardiac ultrasound is normal.; Test Date: 20210504; Test Name: Neurological exam; Result Unstructured Data: Test Result:normal; Test Date: 20210507; Test Name: Neurological exam; Result Unstructured Data: Test Result:had normalized after the onset of sensory disorder; Comments: had normalized after the onset of sensory disorders of the lower left hemiface, which resolved spontaneously.Bi Tildiem prescribed for hypertension protects rather than induces arrhythmias, making ventricular heart rhythm disturbances with ibrutinib very unlikely. there was no heart rhythm disturbances for that elsewhere.; Test Date: 20210505; Test Name: doppler ultrasound Doppler ultrasound of the supraortic trunks; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202101038923

Write-up: a feeling of hypoesthesia of the lower half of the left hemiface; Unknown cause of death/death of the patient, recorded on 22May2021 at his home; headaches; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MA20213053. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Apr2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included Hypertension arterial (hypertension) and Chronic lymphoid leukaemia (in partial remission). Concomitant medications included daratumumab and ibrutinib, both for Chronic lymphoid leukaemia as part of a clinical trial. The patient previously took first dose of Comirnaty (lot number unknown) on 23Mar2021 for covid-19 immunisation. Patient experienced Unknown cause of death on 22May2021. Reported as history: death of the patient, recorded on 22May2021 at his home. Mentioned headaches during the last telephone contact with the patient around 11May2021. Consultation on 04May2021: The patient reports "a feeling of left "PFP", with a feeling of hypoesthesia of the lower half of the left hemiface. Neurological exam on 04May2021 is normal. The cardiovascular assessment too. The ECG returns to a sinus rhythm of 95/min, the transthoracic cardiac ultrasound is normal. blood pressure measurement is 160/95 mmHg. HTA 160/95 which justifies the initiation of treatment with BI TILDIEM LP 120, given a rather high heart rate and control of blood pressure are prescribed. On 05May2021, he saw his cardiologist, who performed a Doppler ultrasound of the supraortic trunks which was found to be normal. blood pressure measurement is 160/90 mmHg. The cardiologist confirmed on 07May2021 that the neurological examination had normalized after the onset of sensory disorders of the lower left hemiface, which resolved spontaneously. Bi Tildiem prescribed for hypertension protects rather than induces arrhythmias, making ventricular heart rhythm disturbances with ibrutinib very unlikely. there was no heart rhythm disturbances for that elsewhere. hypertension was moderate at 16/9. Patient also treated for chronic lymphoid leukemia in partial remission with ibrutinib and daratumumab in a therapeutic trial. The death was reported as part of the study as unrelated to the study drugs. The patient died on 22May2021. An autopsy was not performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death/death of the patient, recorded on 22May2021 at his home


VAERS ID: 1589021 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Asthenia, Coordination abnormal, Fatigue
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENOLOL; FLECAINE; DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Balance disorder; Cardiac arrhythmia (treated with medication); Osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101045378

Write-up: acute lung oedema; Great fatigue; could not stand on his legs; intense asthenia; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20213389. A 90-year-old male patient received first dose of BNT162B2 (COMIRNATY), intramuscularly on 24May2021 (lot number FC3558) in the left arm as single dose for COVID-19 immunization. Medical history included Cardiac arrhythmia treated with medication, Balance disorders, Osteoarthritis. Concomitant medications included atenolol, flecainide acetate (FLECAINE), paracetamol (DOLIPRANE). The patient experienced great fatigue in the following week on 31May2021, could not stand on his legs...until death a week later. Pulmonary oedema leading to death at home. The patient''s daughter reported that the patient had presented with an altered general condition in the week following the vaccination with intense asthenia on 31May2021. The patient was found deceased by the housekeeper on 31May2021 with a messy home. The doctor who pronounced the patient dead on 31May2021 did not make a diagnosis, and the death probably occurred on 30May2021. The patient''s daughter thought that her father died of acute lung oedema because she perceived, thanks to her magnetism, that her father had a lung problem. There was no medical confirmation of this hypothesis. The nursing team visiting the home had not noticed any new symptoms since the vaccination. A slowdown had been observed for a while, probably dating from before the vaccination. Outcome: fatal, death on 31May2021. Conclusion: Unexplained death one week after vaccination of a 90 year old patient. It was unknown if autopsy was done. The outcome of event acute lung oedema was fatal, outcome of other events were unknown.; Reported Cause(s) of Death: acute lung oedema


VAERS ID: 1589039 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest pain, Pain in extremity, Pulmonary embolism, Ultrasound Doppler
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 11
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: Abstains from alcohol; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: echodoppler; Result Unstructured Data: Test Result:without abnormalities
CDC Split Type: FRPFIZER INC202101045346

Write-up: Embolism pulmonary; Cardio-respiratory arrest; sudden chest pain; Pain of lower extremities; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PB20215300. This is a 44-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FF0688) at single dose intramuscular on 19Jul2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. No pathological history mentioned (no cardiovascular or other history). Patient was not an alcohol or tobacco user. Patient presented on 25Jul2021 with pain in the left lower limb, an echodoppler done without abnormalities. 05Aug2021 at 10pm, patient experienced onset of sudden chest pain followed by unrecovered cardiopulmonary arrest after cardiopulmonary resuscitation complicated by death. According to emergency doctor, suspected death from pulmonary embolism (not confirmed by biology or imaging). Outcome of Embolism pulmonary and Cardio-respiratory arrest was fatal. Outcome of pain in the left lower limb was not resolved. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Embolism pulmonary; sudden chest pain


VAERS ID: 1589040 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Heart rate, Pyrexia, Respiratory rate
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   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: DOLIPRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; End stage COPD (after smoking); Exeresis; Fibrosis lung; Hypertension pulmonary; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: pulse; Result Unstructured Data: Test Result:quick, fast, regular; Test Date: 20210804; Test Name: fever; Result Unstructured Data: Test Result:37; Test Date: 20210804; Test Name: fever; Result Unstructured Data: Test Result:37.8; Test Date: 20210804; Test Name: respiratory rate; Result Unstructured Data: Test Result:20; Test Date: 20210804; Test Name: respiratory rate; Result Unstructured Data: Test Result:32
CDC Split Type: FRPFIZER INC202101045341

Write-up: Aggravation of existing disorder; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PB20215307. An 81-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot number unknown) Intramuscular at single dose for COVID-19 immunisation on 04Aug2021. Relevant history included end stage COPD after smoking, ischemic heart disease, Multifactorial terminal respiratory failure (under O2 at home between 4 and 6l minutes), hypertension pulmonary, and fibrosis lung since May 2021, and post-lobectomy restriction. Relevant concomitant drug included paracetamol (DOLIPRANE) for pain. On 04Aug2021, in the morning, the patient was less well, more asthenic, more sleepy, but conscious, communicating, no sign of distress respiratory, respiratory rate 20. No sign of concern. The 2nd dose of Pfizer vaccine done at 11:45 am on 04Aug2021. Patient already on doliprane systematically for pain. No effect immediately after the vaccine. At 4.30 p.m, the patient had deterioration of his general condition. Afebrile 37. Cyanotic, gray complexion. Cool hands, no sweat, no marbling. Conscious and communicating patient. No signs of respiratory distress. Reassessed at 7 p.m. Patient always conscious. T = 37.8. Signs of shock. Pulse quick, fast, regular. Mottling+++. respiratory rate 32 without sign of distress, without indrawing. A few moans and sweats at the start of the night. Lightweight. Quiet night afterwards, patient not conscious. Death noted at 8:15 am on 05Aug2021. It is unknown if autopsy was done. No follow-up attempts are possible; no further information expected, information about lot/batch number cannot be obtained ; Reported Cause(s) of Death: Aggravation of existing disorder


VAERS ID: 1589101 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-07-26
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardiac failure, Respiratory distress, SARS-CoV-2 test, Vaccination failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Dilated cardiomyopathy (Rhythmic valvular cardiomyopathy); Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101038919

Write-up: COVID-19; cardiac decompensation; respiratory distress; vaccination failure; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RS20212588. An 81-year-old male patient received bnt162b2 (COMIRNATY), first single dose intramuscularly, administered in Arm Left on 23Mar2021 (Batch/Lot Number: ET3620) and second single dose intramuscularly, administered in Arm Left on 15Apr2021 (Batch/Lot Number: EW2246) for covid-19 immunisation. Medical history included Parkinson''s disease, dilated cardiomyopathy (Rhythmic valvular cardiomyopathy), and chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. About 3 months later, PCR positive on 26Jul2021. The next day 27Jul2021: the patient presented with cardiac decompensation as well as respiratory distress leading to death on 31Jul2021. Search for the variant: L452R mutation. Vaccine failure confirmed around 3 months after the D2 of the Comirnaty vaccine in an 81-year-old patient which led to his death. It was not reported if an autopsy was performed. Additional, investigational results reported from Product Complaint Team included: Conclusion: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5882945 (see File attachment in this investigation record). The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EW2246. 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. Company 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. Conclusion: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5824348 (see File attachment in this investigation record). The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET3620. 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. Company 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: Vaccination failure; covid-19; respiratory distress; cardiac decompensation


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