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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine is COVID19 and Patient Died

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Case Details

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VAERS ID: 1573486 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Hip fracture, Muscular weakness, Thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 91
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 INC202101010571

Write-up: Thrombosis; Hip fracture; Falling; Weakness in extremity; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority WEB DE-PEI-202100156067. An 82-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Apr2021 as 0.3mL single for covid-19 immunisation. The patient''s medical history was not provided. Concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on unspecified date as 0.3 mL single for covid-19 immunisation. On May2021 the patient experienced weakness in extremity, falling. On 25Jul2021 the patient experienced hip fracture. On 28Jul2021 the patient experienced thrombosis. Outcome of the event thrombosis was fatal, other events was unknown. The patient died on 31Jul2021. It was not reported if an autopsy was performed. The seriousness of the events hip fracture was resulted in hospitalization and was medically significant, thrombosis resulted in hospitalization and death, events falling and weakness in extremity assessed as medically significant. The casual relationship of Comirnaty and all events assessed as Unclassifiable by the PEI. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: thrombosis


VAERS ID: 1573516 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (Hay fever on hazelnut, birch and anaphylactic shock followed 5 years ago. Consumption of almonds); Anaphylactic reaction (Hay fever on hazelnut, birch and anaphylactic shock followed 5 years ago. Consumption of almonds); Asthma (Slightly allergic asthma during pollen count, otherwise no previous illnesses known); Food allergy; Hay fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987565

Write-up: Ventricular fibrillation, death; On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority number DE-PEI-CADR2021124883. Sender (Case) Safety Report Unique Identifier DE-PEI-202100121137, received from Regulatory Authority. A 55-year-old male patient received BNT162B2 (COMIRNATY- mRNA TOZINAMERAN, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on 09Jun2021, DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient had no relevant medical history and concurrent conditions. The patient had allergy of hay fever on hazelnut, birch and anaphylactic shock followed 5 years ago to consumption of almonds. The patient risk factors, or previous illnesses included slightly allergic asthma during pollen count, otherwise no previous illnesses known. Concomitant medications were not reported. On 12Jun2021, on the third day after vaccination, the patient experienced sudden malaise, unconsciousness, rattle, cardiac arrest and ventricular fibrillation. It was reported that rescue team tried to reanimate over 60 minutes, 7 times defibrillator. The patient died on 12Jun2021. The death was due to sudden malaise, unconsciousness, rattle, cardiac arrest and ventricular fibrillation. It was unknown if an autopsy was performed. The outcome of the events was fatal. Comirnaty: Relatedness of drug to reaction(s)/event(s): Source of assessment: PEI/Result of Assessment: C, Inconsistent causal association to immunization. Health Authority comments: Are you or the person concerned known of any allergies, if yes, which: Hay fever on hazelnut, birch and anaphylactic shock followed 5 years ago on consumption of almonds. Information on risk factors or previous illnesses: Slightly allergic asthma during pollen count, otherwise no previous illnesses known / On the third day after vaccination, sudden malaise, unconsciousness, rattle, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death. No follow-up attempts are possible. Information on batch number cannot be obtained.; Reported Cause(s) of Death: On the third day after vaccination, sudden malaise, unconsciousness, wheeze, Cardiac arrest. Rescue team tried to reanimate over 60 minutes, 7 times Defibrillator, ventricular fibrillation, death.; On the third day after vaccination, sudden malaise,


VAERS ID: 1573657 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-05-06
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Test Result: Positive ; Comments: variant PCR based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016245

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority. The Regulatory Authority report number is AT-BASGAGES-2021-39247. An 83 Years old Male patient received BNT162B2 (COMIRNATY) 1st dose on 04Mar2021 (batch/lot number: EJ6790), 2nd dose on 25Mar2021 (batch/lot number ET3620) for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 06May2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. Lab data was variant PCR based B.1.1.7; N501Y positive. The patient''s outcome was fatal. It was unknown whether autopsy has been done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1573767 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-05-10
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Arterial hypertension; Arthrosis; Atrial fibrillation; Breast cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT in an 84-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunisation. The patient''s past medical history included Atrial fibrillation, Arterial hypertension, Arthrosis and Breast cancer. On 10-Apr-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (seriousness criteria death and medically significant). The reported cause of death was Middle cerebral artery stroke. It is unknown if an autopsy was performed. The treatment history was not reported. The concomitant history was not reported. Company comment: Very limited information regarding this event has been provided at this time. Further information will not be received as it a Regulatory Authority report. Translation of Source Document is pending.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be received as it a Regulatory Authority report. Translation of Source Document is pending.; Reported Cause(s) of Death: Middle cerebral artery stroke


VAERS ID: 1573791 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-23
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Bacterial test, Band neutrophil count, Basophil count, Bilirubin conjugated, Blood alcohol increased, Blood alkaline phosphatase increased, Blood bilirubin, Blood urine, Brain natriuretic peptide, C-reactive protein increased, Death, Eosinophil count, Gamma-glutamyltransferase, Glomerular filtration rate, Glucose urine absent, Haemoglobin, International normalised ratio, Mean platelet volume, Monocyte count normal, Neutrophil count, Platelet count decreased, Procalcitonin normal, Protein urine, Prothrombin time, Prothrombin time ratio, Pulmonary embolism, Red blood cell count decreased, Tracheal aspirate culture, Troponin I, Urine ketone body absent, White blood cell count increased, White blood cells urine
SMQs:, Liver related investigations, signs and symptoms (broad), Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Biliary system related investigations, signs and symptoms (broad), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 3
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MILGAMMA N [BENFOTIAMINE;CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE]; ESCITALOPRAM; HELICID [OMEPRAZOLE]
Current Illness: Monoparesis (Lower left limb); Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Central European encephalitis; Concussion; COVID-19; Ilium fracture; Limb contusion (Shoulder)
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 4,67; 1,47; 2,31; 3,69; 3,03; Comments: Ratio; Test Date: 20210624; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 3,96; 2,49; 2,36; 2,85; Comments: Ratio; Test Date: 20210625; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 105,1 s; 66,1 s; 62,6 s; 75,5 s; Test Date: 20210625; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 3,82; Comments: Ratio; Test Date: 20210626; Test Name: Activated partial thromboplastin time; Result Unstructured Data: 101.3 seconds; Test Date: 20210623; Test Name: Glutamic-pyruvate transaminase; Result Unstructured Data: 1.74 ukat/l; Test Date: 20210626; Test Name: Glutamic-pyruvate transaminase; Result Unstructured Data: 11,14 ukat/; Test Date: 20210623; Test Name: Blood alpha amylase; Result Unstructured Data: 4,2 ukat/l; Test Date: 20210623; Test Name: ASAT; Result Unstructured Data: 3,88 ukat/l; Test Date: 20210626; Test Name: ASAT; Result Unstructured Data: 3,88 ukat/l, 30,63 ukat/l; Test Date: 20210624; Test Name: Bacterial culture test; Test Result: Negative ; Result Unstructured Data: endotracheal cannula - klebsiella pneumoniae subspecies pneumoniae, uricult negative for bacteria, Tracheal aspirate: c.albicans 10^7 CFU/ml, Kl. pneumoniae 10^5 CFU/ml; Test Date: 20210623; Test Name: Bacterial urine; Result Unstructured Data: 159; Test Date: 20210623; Test Name: Band neutrophil count; Result Unstructured Data: 7.8 billion per liter; Test Date: 20210624; Test Name: Band neutrophil count; Result Unstructured Data: 3.1billion per liter; Test Date: 20210624; Test Name: Basophil count; Result Unstructured Data: 1.4 billion per litrer; Test Date: 20210623; Test Name: Blood basophils; Result Unstructured Data: 1.4 billion per liter.; Test Date: 20210623; Test Name: Bilirubin conjugated; Result Unstructured Data: 3.6 micromole per liter; Test Date: 20210626; Test Name: Bilirubin conjugated; Result Unstructured Data: 10.4 micromole per liter; Test Date: 20210623; Test Name: Blood alcohol; Result Unstructured Data: 2 ?; Test Date: 20210623; Test Name: Alk phos; Result Unstructured Data: 1,44 ukat/l; Test Date: 20210623; Test Name: Bilirubin; Result Unstructured Data: 7.1 micromole per liter; Test Date: 20210626; Test Name: Bilirubin; Result Unstructured Data: 22.5 micromole per liter; Test Date: 20210623; Test Name: Blood urine; Result Unstructured Data: 0; Test Date: 2021; Test Name: Body mass index; Result Unstructured Data: 25.25 kilogram per square meter.; Test Date: 20210623; Test Name: Brain natriuretic peptide; Result Unstructured Data: 499.2 nanogram per liter; Test Date: 20210624; Test Name: C-reactive protein; Result Unstructured Data: 14 milligram per liter; Test Date: 20210626; Test Name: C-reactive protein; Result Unstructured Data: 282.5 milligram per liter; Test Date: 20210623; Test Name: Eosinophil count; Result Unstructured Data: 1.4 billion per litre; Test Date: 20210624; Test Name: Eosinophil count; Result Unstructured Data: 0.1; Test Date: 20210623; Test Name: GGT; Result Unstructured Data: 3,05 ukat/l; Test Date: 20210623; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,92 ml/s per 1,73 m2; Test Date: 20210623; Test Name: Glomerular filtration rate; Result Unstructured Data: 1,06 ml/s per 1,73 m2; Test Date: 20210624; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,79 ml/s per 1,73 m2; Comments: corrected; Test Date: 20210624; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,91 ml/s per 1,73 m2; Test Date: 20210625; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,27 ml/s per 1,73 m2; Comments: corrected; Test Date: 20210625; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,31 ml/s per 1,73 m2; Test Date: 20210626; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,5 ml/s per 1,73 m2; Comments: corrected; Test Date: 20210626; Test Name: Glomerular filtration rate; Result Unstructured Data: 0,58 ml/s per 1,73 m2; Test Date: 20210623; Test Name: Glucose urine; Result Unstructured Data: 0 millimole per liter; Test Date: 20210623; Test Name: Hemoglobin; Result Unstructured Data: 0; Test Date: 20210623; Test Name: INR; Result Unstructured Data: 2,15; Test Date: 20210625; Test Name: International normalised ratio; Result Unstructured Data: 2.18; Test Date: 20210626; Test Name: International normalised ratio; Result Unstructured Data: 2,59; Test Date: 20210623; Test Name: Mean platelet volume; Result Unstructured Data: 10.5; Test Date: 20210624; Test Name: Mean platelet volume; Result Unstructured Data: 10.3; Test Date: 20210625; Test Name: Mean platelet volume; Result Unstructured Data: 11.8; Test Date: 20210626; Test Name: Mean platelet volume; Result Unstructured Data: 12.4; Test Date: 20210623; Test Name: Monocyte count; Result Unstructured Data: 3.2 billion per liter; Test Date: 20210624; Test Name: Monocyte count; Result Unstructured Data: 3.2 billion per liter; Test Date: 20210623; Test Name: Neutrophils; Result Unstructured Data: 47.8 billion per liter; Test Date: 20210624; Test Name: Neutrophils; Result Unstructured Data: 88.3 billion per liter; Test Date: 20210623; Test Name: Urine pH; Result Unstructured Data: 6; Test Date: 20210623; Test Name: Platelet count; Result Unstructured Data: 89 billion per liter; Test Date: 20210624; Test Name: Platelet count; Result Unstructured Data: 160 billion per liter; Test Date: 20210626; Test Name: Platelet count; Result Unstructured Data: 47 billion per liter; Test Date: 20210625; Test Name: Thrombocyte count; Result Unstructured Data: 74 billion per liter; Test Date: 20210623; Test Name: Procalcitonin; Result Unstructured Data: 0.1 nanogram per millliiter; Test Date: 20210626; Test Name: Procalcitonin; Result Unstructured Data: $g100; Test Date: 20210623; Test Name: Protein urine; Result Unstructured Data: 0; Test Date: 20210623; Test Name: Quick''s test; Result Unstructured Data: 23.9; Test Date: 20210625; Test Name: Quick''s test; Result Unstructured Data: 24.2; Test Date: 20210626; Test Name: Quick''s test; Result Unstructured Data: 28.2; Test Date: 20210623; Test Name: Prothrombin ratio; Result Unstructured Data: 2,17; Test Date: 20210625; Test Name: Prothrombin ratio; Result Unstructured Data: 2,2; Test Date: 20210626; Test Name: Prothrombin ratio; Result Unstructured Data: 2,61; Test Date: 20210623; Test Name: Red blood cell count; Result Unstructured Data: 4.39; Test Date: 20210624; Test Name: Red blood cell count; Result Unstructured Data: 4.84; Test Date: 20210625; Test Name: Red blood cell count; Result Unstructured Data: 3.7; Test Date: 20210626; Test Name: Red blood cell count; Result Unstructured Data: 3.43; Test Date: 20210623; Test Name: Troponin I; Result Unstructured Data: 180.2; Test Date: 20210623; Test Name: Acetone urine; Result Unstructured Data: 0; Test Date: 20210623; Test Name: WBC count; Result Unstructured Data: 13.9; Test Date: 20210624; Test Name: WBC count; Result Unstructured Data: 13.9; Test Date: 20210625; Test Name: WBC count; Result Unstructured Data: 11.9; Test Date: 20210626; Test Name: WBC count; Result Unstructured Data: 9.5; Test Date: 20210623; Test Name: White blood cells urine; Result Unstructured Data: 0
CDC Split Type: CZMODERNATX, INC.MOD20212

Write-up: Massive pulmonary embolism; This case was received via Regulatory Authority (Reference number: 21008615) 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 PULMONARY EMBOLISM (Massive pulmonary embolism) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002339) for COVID-19 immunization. The patient''s past medical history included Limb contusion (Shoulder) in 2004, Concussion in 2014, COVID-19 from February 2021 to March 2021, Central European encephalitis and Ilium fracture in 2018. Concurrent medical conditions included Monoparesis (Lower left limb) and Smoker. Concomitant products included BENFOTIAMINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE (MILGAMMA N [BENFOTIAMINE;CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE]), ESCITALOPRAM and OMEPRAZOLE (HELICID [OMEPRAZOLE]) for an unknown indication. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced PULMONARY EMBOLISM (Massive pulmonary embolism) (seriousness criteria death, hospitalization, disability, medically significant and life threatening). The patient died on 26-Jun-2021. The reported cause of death was Embolism lung. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body mass index: 25.25 (abnormal) 25.25 kilogram per square meter.. On 23-Jun-2021, Alanine aminotransferase: 1.74 (abnormal) 1.74 ukat/l. On 23-Jun-2021, Amylase: 4,2 (normal) 4,2 ukat/l. On 23-Jun-2021, Aspartate aminotransferase: 3,88 (Low) 3,88 ukat/l. On 23-Jun-2021, Bacterial test: 159 (abnormal) 159. On 23-Jun-2021, Band neutrophil count: 7.8 (High) 7.8 billion per liter. On 23-Jun-2021, Basophil count: 1.4 (abnormal) 1.4 billion per liter.. On 23-Jun-2021, Bilirubin conjugated: 3.6 (Low) 3.6 micromole per liter. On 23-Jun-2021, Blood alcohol: 2 (abnormal) 2 ?. On 23-Jun-2021, Blood alkaline phosphatase: 1,44 (High) 1,44 ukat/l. On 23-Jun-2021, Blood bilirubin: 7.1 (abnormal) 7.1 micromole per liter. On 23-Jun-2021, Blood urine: 0 (abnormal) 0. On 23-Jun-2021, Brain natriuretic peptide: 499.2 (High) 499.2 nanogram per liter. On 23-Jun-2021, Eosinophil count: 1.4 (abnormal) 1.4 billion per litre. On 23-Jun-2021, Gamma-glutamyltransferase: 3,05 (abnormal) 3,05 ukat/l. On 23-Jun-2021, Glomerular filtration rate: 0,92 (abnormal) 0,92 ml/s per 1,73 m2 and 1,06 ml/s per 1,73 m2 (normal) 1,06 ml/s per 1,73 m2. On 23-Jun-2021, Glucose urine: 0 (abnormal) 0 millimole per liter. On 23-Jun-2021, Haemoglobin: 0 (abnormal) 0. On 23-Jun-2021, International normalised ratio: 2,15 (abnormal) 2,15. On 23-Jun-2021, Mean platelet volume: 10.5 (normal) 10.5. On 23-Jun-2021, Monocyte count: 3.2 (normal) 3.2 billion per liter. On 23-Jun-2021, Neutrophil count: 47.8 (abnormal) 47.8 billion per liter. On 23-Jun-2021, Platelet count: 89 (Low) 89 billion per liter. On 23-Jun-2021, Procalcitonin: 0.1 (normal) 0.1 nanogram per millliiter. On 23-Jun-2021, Protein urine: 0 (abnormal) 0. On 23-Jun-2021, Prothrombin time: 23.9 (abnormal) 23.9. On 23-Jun-2021, Prothrombin time ratio: 2,17 (normal) 2,17. On 23-Jun-2021, Red blood cell count: 4.39 (Low) 4.39. On 23-Jun-2021, Troponin I: 180.2 (abnormal) 180.2. On 23-Jun-2021, Urine ketone body: 0 (abnormal) 0. On 23-Jun-2021, White blood cell count: 13.9 (High) 13.9. On 23-Jun-2021, White blood cells urine: 0 (abnormal) 0. On 23-Jun-2021, pH urine: 6 (normal) 6. On 24-Jun-2021, Activated partial thromboplastin time: 4,67; 1,47; 2,31; 3,69; 3,03 (High) 4,67; 1,47; 2,31; 3,69; 3,03 and 3,96; 2,49; 2,36; 2,85 (High) 3,96; 2,49; 2,36; 2,85. On 24-Jun-2021, Bacterial test: negative (Negative) endotracheal cannula - klebsiella pneumoniae subspecies pneumoniae, uricult negative for bacteria, Tracheal aspirate: c.albicans 10^7 CFU/ml, Kl. pneumoniae 10^5 CFU/ml. On 24-Jun-2021, Band neutrophil count: 3.1 (abnormal) 3.1billion per liter. On 24-Jun-2021, Basophil count: 1.4 (abnormal) 1.4 billion per litrer. On 24-Jun-2021, C-reactive protein: 14 (abnormal) 14 milligram per liter. On 24-Jun-2021, Eosinophil count: 0.1 (Low) 0.1. On 24-Jun-2021, Glomerular filtration rate: 0,79 ml/s per 1,73 m2 (abnormal) 0,79 ml/s per 1,73 m2 and 0,91 ml/s per 1,73 m2 (abnormal) 0,91 ml/s per 1,73 m2. On 24-Jun-2021, Mean platelet volume: 10.3 (normal) 10.3. On 24-Jun-2021, Monocyte count: 3.2 (normal) 3.2 billion per liter. On 24-Jun-2021, Neutrophil count: 88.3 (abnormal) 88.3 billion per liter. On 24-Jun-2021, Platelet count: 160 (normal) 160 billion per liter. On 24-Jun-2021, Red blood cell count: 4.84 (normal) 4.84. On 24-Jun-2021, White blood cell count: 13.9 (High) 13.9. On 25-Jun-2021, Activated partial thromboplastin time: 105,1 ; 66,1 ; 62,6 ; 75,5 (High) 105,1 s; 66,1 s; 62,6 s; 75,5 s and 3,82 (High) 3,82. On 25-Jun-2021, Glomerular filtration rate: 0,27 ml/s per 1,73 m2 (abnormal) 0,27 ml/s per 1,73 m2 and 0,31 ml/s per 1,73 m2 (abnormal) 0,31 ml/s per 1,73 m2. On 25-Jun-2021, International normalised ratio: 2.18 (abnormal) 2.18. On 25-Jun-2021, Mean platelet volume: 11.8 (normal) 11.8. On 25-Jun-2021, Platelet count: 74 (Low) 74 billion per liter. On 25-Jun-2021, Prothrombin time: 24.2 (abnormal) 24.2. On 25-Jun-2021, Prothrombin time ratio: 2,2 (normal) 2,2. On 25-Jun-2021, Red blood cell count: 3.7 (Low) 3.7. On 25-Jun-2021, White blood cell count: 11.9 (normal) 11.9. On 26-Jun-2021, Activated partial thromboplastin time: 101.3 (High) 101.3 seconds. On 26-Jun-2021, Alanine aminotransferase: 11,14 (abnormal) 11,14 ukat/. On 26-Jun-2021, Aspartate aminotransferase: 3,88, 30,63 (abnormal) 3,88 ukat/l, 30,63 ukat/l. On 26-Jun-2021, Bilirubin conjugated: 10.4 (abnormal) 10.4 micromole per liter. On 26-Jun-2021, Blood bilirubin: 22.5 (abnormal) 22.5 micromole per liter. On 26-Jun-2021, C-reactive protein: 282.5 (abnormal) 282.5 milligram per liter. On 26-Jun-2021, Glomerular filtration rate: 0,5 ml/s per 1,73 m2 (abnormal) 0,5 ml/s per 1,73 m2 and 0,58 ml/s per 1,73 m2 (abnormal) 0,58 ml/s per 1,73 m2. On 26-Jun-2021, International normalised ratio: 2,59 (abnormal) 2,59. On 26-Jun-2021, Mean platelet volume: 12.4 (abnormal) 12.4. On 26-Jun-2021, Platelet count: 47 (Low) 47 billion per liter. On 26-Jun-2021, Procalcitonin: $g100 (abnormal) $g100. On 26-Jun-2021, Prothrombin time: 28.2 28.2. On 26-Jun-2021, Prothrombin time ratio: 2,61 (normal) 2,61. On 26-Jun-2021, Red blood cell count: 3.43 (Low) 3.43. On 26-Jun-2021, White blood cell count: 9.5 (normal) 9.5. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Patient lab test includes activated partial thromboplastin time is not coagulated on 23-Jun-2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Embolism lung


VAERS ID: 1573826 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-10
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immune thrombocytopenia, Pulmonary haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 35
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210807044

Write-up: LUNG HEMORRHAGE; SEVERE BLEEDING COMPLICATIONS OF SYMPTOMATIC STEROID-REFRACTORY THROMBOCYTOPENIA (ITP); This spontaneous report received from a health care professional via a Regulatory Authority concerned a 59 year old male. The patient''s weight was 72 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, 1 total, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included amlodipine for drug used for unknown indication. On 10-JUN-2021, the patient experienced severe bleeding complications of symptomatic steroid-refractory thrombocytopenia (itp). On 29-JUN-2021, the patient experienced lung hemorrhage. On an unspecified date, patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. On 15-JUL-2021, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of lung hemorrhage and severe bleeding complications of symptomatic steroid-refractory thrombocytopenia (itp) on 15-JUL-2021. This report was serious (Death, Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage).; Sender''s Comments: V0: 20210807044-Covid-19 vaccine ad26.cov2.s-lung hemorrhage severe bleeding complications of symptomatic steroid-refractory thrombocytopenia (itp). 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: 1573852 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Propranolol 40; novaminsulfon 500; Keppra 250 mg; acetylsalicylic acid 100
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial occlusive disease; Cranioencephalic trauma; Grand mal; Hemiparesis; Korsakoff''s syndrome; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEDCGMA21189997

Write-up: Death; Lung embolism; This case was received via Regulatory Authority (Reference number: 202100064309) 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 DEATH (Death) and PULMONARY EMBOLISM (Lung embolism) in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for Prophylactic vaccination. The patient''s past medical history included Korsakoff''s syndrome, Cranioencephalic trauma in 1989, Arterial occlusive disease, Grand mal, Hemiparesis and Nicotine abuse. Concomitant products included propranolol hydrochloride (propranolol 40), metamizole sodium, levetiracetam and acetylsalicylic acid for an unknown indication. On 26-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and PULMONARY EMBOLISM (Lung embolism) (seriousness criteria death and medically significant). The patient died on 28-Apr-2021. The reported cause of death was Lung embolism. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route), the reporter did not provide any causality assessments. No treatment medication was provided. Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1574671 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-06-09
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Autopsy, Cardiac arrest, Cardiogenic shock, Death, Myocarditis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Myocarditis; Cardiac arrhythmia; Heart arrest; This case was received via Regulatory Authority (Reference number: 202100134159) 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 MYOCARDITIS (Myocarditis), ARRHYTHMIA (Cardiac arrhythmia) and CARDIAC ARREST (Heart arrest) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for an unknown indication. No Medical History information was reported. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death and medically significant), ARRHYTHMIA (Cardiac arrhythmia) (seriousness criteria death and medically significant) and CARDIAC ARREST (Heart arrest) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was Myocarditis. An autopsy was performed. The autopsy-determined cause of death was cardiogenic shock in acute left ventricular myocardial infarction. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up information received on 04-Aug-2021 and contains no new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: cardiogenic shock in acute left ventricular myocardial infarction


VAERS ID: 1574673 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? 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: DEMODERNATX, INC.MOD20212

Write-up: Lung embolism; Thrombosis; This case was received via Regulatory Authority (Reference number: 202100135167) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM (Lung embolism) and THROMBOSIS (Thrombosis) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Lung embolism) (seriousness criteria death, medically significant and life threatening) and THROMBOSIS (Thrombosis) (seriousness criteria death, medically significant and life threatening). 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. No concomitant medications were reported. No treatment information was provided. Company Comment: Very limited information regarding this events has been provided at this time. Further information will not be requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information will not be requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1574709 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-25
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100146583

Write-up: Myocarditis; Sudden cardiac death; This case was received via Regulatory Authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) and SUDDEN CARDIAC DEATH (Sudden cardiac death) in a 56-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002183) for COVID-19 vaccination. No Medical History information was reported. On 20-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria death, hospitalization and medically significant) and SUDDEN CARDIAC DEATH (Sudden cardiac death) (seriousness criteria death, hospitalization and medically significant). The patient died on 25-Jun-2021. An autopsy was performed. The autopsy-determined cause of death was lymphozyt?re myokarditis. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications reported. Autopsy was done on 07-JUL-2021. No treatment medications reported. Company Comment: Very limited information regarding this event has been provided at this time. Further information will not be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be requested.; Autopsy-determined Cause(s) of Death: Lymphozyt?re Myokarditis


VAERS ID: 1574714 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003609 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pulmonary embolism, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Syncope; Groggy; This case was received via Regulatory Authority (Reference number: 202100148174) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM, SYNCOPE and SOMNOLENCE (Groggy) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003609) for an unknown indication. No Medical History information was reported. On 29-Jun-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (seriousness criteria death, hospitalization and medically significant), SYNCOPE (Syncope) (seriousness criterion medically significant) and SOMNOLENCE (Groggy) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was Lung embolism. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (Syncope) and SOMNOLENCE (Groggy) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided. Reporter''s Sender''s Comments: Very limited information has been provided at this time. Translation has been requested.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1574753 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Off label use, Product use issue, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Medication errors (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101010375

Write-up: fulminant pulmonary artery embolism; increasing dyspnea with cardiac arrest; increasing dyspnea with cardiac arrest; Patient received first dose of VAXZEVRIA(non pfizer vaccine) and Eventually received Comirnaty(pfizer vaccine); Patient received first dose of VAXZEVRIA(non pfizer vaccine) and Eventually received Comirnaty(pfizer vaccine); This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority [DE-PEI-202100156003]. A 54-year-old male patient (weight 130 kg, and height 185 cm) received bnt162b2 (COMIRNATY) via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: FF0900) as DOSE 2, SINGLE for covid-19 immunisation; covid-19 vaccine (VAXZEVRIA), via an unspecified route of administration on 18May2021 (Batch/Lot number was not reported) at DOSE 1, SINGLE for covid-19 immunisation. Medical history included obesity and Arterial hypertension. The patient''s concomitant medications were not reported. This report is serious - death, hospitalization, life threatening. On 21Jul2021 the patient experienced Dyspnoea. On 26Jul2021 the patient experienced Lung embolism. The patient''s outcome was: fatal for Dyspnoea and Lung embolism and cardiac arrest. The patient died on 27Jul2021. It was not reported if an autopsy was performed. Senders comment: Pulmonary embolism with cardiac arrest, rescue lysis and Extracorporeal Life Support with Venoarterial Extracorporeal Membrane Oxygenation. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Lung embolism; Dyspnoea; cardiac arrest; cardiac arrest


VAERS ID: 1574754 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-09
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / -

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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   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: Medical History/Concurrent Conditions: Coronary heart disease (stable)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101009957

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the Agency WEB regulatory authority DE-PEI-202100156054. A 63-years-old male patient received second dose of BNT162B2 (COMIRNATY) via unspecified route on 05May2021 (Lot Number: EX8679) 0.3 ml single for COVID-19 immunisation. Medical history included coronary heart disease (stable). The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY) 0.3 ml single for COVID-19 immunisation on 07Apr2021. The patient experienced sudden cardiac death (death, life threatening) on 09Jun2021. The patient died on 09Jun2021. It was unknown if an autopsy was performed. Relatedness of BNT162B2 to event by RA was assessed as unclassifiable. Sender Comment: known CHD, but was stable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1574755 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiocardiogram, Asthenia, Babinski reflex test, Brain herniation, Cerebral venous sinus thrombosis, Coagulation factor, Computerised tomogram head, Confusional state, Dizziness, Generalised tonic-clonic seizure, Glycosylated haemoglobin, Headache, Hemiparesis, Interchange of vaccine products, Muscular weakness, Neck pain, Off label use, Platelet count
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus with ketoacidosis; Erectile dysfunction; Hyperglycaemia
Allergies:
Diagnostic Lab Data: Test Name: partial thromboplastin time; Result Unstructured Data: Test Result:full anticoagulation was carried out; Test Name: coronary computed tomography angiography; Result Unstructured Data: Test Result:increase in congestive bleeding; Comments: with accompanying cerebral edema with persistent extensive sinus thrombosis despite therapeutic anticoagulation.; Test Name: Babinski reflex; Test Result: Positive ; Comments: on the right; Test Name: coagulation; Result Unstructured Data: Test Result:normal; Test Name: cranial computed tomography; Result Unstructured Data: Test Result:increase in congestive bleeding; Comments: with accompanying cerebral edema with persistent extensive sinus thrombosis despite therapeutic anticoagulation.; Test Name: HBA1c; Test Result: 11.4 %; Test Name: Platelets; Result Unstructured Data: Test Result:normal
CDC Split Type: DEPFIZER INC202101009973

Write-up: Hemiparesis; Tonic-clonic convulsion/generalized tonic-clonic seizure; Weakness; slight weakness in his left arm and leg; Neck pain; Light headedness; Thrombosis of venous sinuses; headache; confused; Brain stem herniation; 1st dose VAXZEVRIA/2nd dose COMIRNATY; 1st dose VAXZEVRIA/2nd dose COMIRNATY; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. Report number; DE-PEI-202100156056. A 38-year-old male patient received 1st dose of BNT162B2 (COMIRNATY) at single dose on 19Jul2021 as second vaccination at 38-year-old via an unknown route for COVID-19 immunisation, and 1st dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) at single dose on an unknown date in May2021 as first vaccination via an unknown route for prophylactic vaccination. The patient''s medical history included Erectile dysfunction (ED), diabetes mellitus with ketoacidosis and hyperglycaemia. Concomitant drug was not provided. On 15Jul2021 patient experienced first time neck pain (also reported as patient experienced Cervical pain after Vaxzevria vaccination in May2021). On 22Jul2021 the patient experienced neck pain aggravated, light headedness. On 23Jul2021 the patient experienced weakness. On 26Jul2021 the patient experienced hemiparesis, tonic-clonic convulsion. The patient also experienced thrombosis of venous sinuses on an unknown date in Jul2021. The clinical course was reported as follows: Cranial computed tomography (CCT), Coronary computed tomography angiography (CCT-A) with diagnoses: extensive thrombosis of the superior sagittal sinus, the right transverse and sigmoid sinus, as well as several superficial bridging veins bihemispherically. congestive bleeding right occipital and left frontal cerebral edema, brainstem entrapment. Patient reported since 15Jul2021 about neck pain that was why he had been to the massage. From 22Jul2021 the neck pain increased, there was an unspecific dizziness. Since Friday, 23Jul2021, he also noticed a slight weakness in his left arm and leg, which was why he had problems with walking. He felt increasingly bad over the weekend. Due to persistent neck pain, he presented himself to the emergency room on Sunday. There he received an analgesic for the existing neck pain. On Monday, 26Jul2021 the patient presented himself with persistent weakness, neck pain and hemiparesis and suffered a generalized tonic-clonic seizure which ceased after administration of 10 mg midazolam. This was followed by an interview with the emergency doctor in the PRIVACY Clinic. On arrival the patient was awake, there was a hemiparesis on the left, a neglect to the left and a positive Babinski reflex on the right. When asked, the patient denied headaches. The patient was admitted while still awake and oriented, a Partial Thromboplastin Time-controlled full anticoagulation was carried out, and the already-started antiepileptic therapy was continued. The coagulation was normal on admission, the platelets were normal. On admission there was also diabetic ketoacidosis with Erectile dysfunction (ED) of diabetes mellitus with a HBA 1c of 11.4%, the therapy was carried out with fluids, insulin and close electrolyte controls, as well as electrolyte substitution. In the course of this, the headache continued to increase, and the patient became confused and had to be intubated. Several Cranial computed tomography (CCT) and Coronary computed tomography angiography (CCT-A) controls showed an increase in congestive bleeding with accompanying cerebral edema with persistent extensive sinus thrombosis despite therapeutic anticoagulation. Ultimately, under maximum therapy, there was Brain stem herniation. It remains unclear whether the previous vaccination was related to the sinus thrombosis; the patient certainly had other risk factors. Nevertheless, a notification according to Institute of Side effects has been made about a possible vaccination complication, but the batch number of the vaccination could not be determined. Outcome of thrombosis of venous sinuses was fatal. Patient died on 28Jul2021. Outcome of the other events was unknown. This report was serious with seriousness of death, hospitalization, life threatening. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Thrombosis of venous sinuses


VAERS ID: 1574756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cor pulmonale, Echocardiogram, Fibrin D dimer, Inappropriate schedule of product administration, Interchange of vaccine products, Off label use, Pulmonary embolism
SMQs:, Cardiac failure (narrow), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (narrow), Medication errors (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echocardiography; Result Unstructured Data: Test Result:Pulmonary heart disease; Test Name: D-dimer; Result Unstructured Data: Test Result:increased
CDC Split Type: DEPFIZER INC202101010060

Write-up: Lung embolism; pulmonary heart disease; COMIRNATY as second vaccination / VAXZEVRIA as 1st vaccination; COMIRNATY as second vaccination / VAXZEVRIA as 1st vaccination; second vaccination on 16Jul2021 / 1st vaccination on 04May2021; This is a spontaneous report from a non-contactable other health care professional downloaded from the Regulatory Authority. Report number; E-PEI-202100156059. A female patient of an unknown age received 1st dose of BNT162B2 (COMIRNATY, lot number FF0900) at single dose as second vaccination on 16Jul2021 for COVID-19 immunisation, and 1st dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) at single dose as 1st vaccination on 04May2021 for prophylactic vaccination. Medical history and concomitant drug were not provided. The patient experienced also lung embolism. Lab data included D-Dimer increased and Echocardiography revealed pulmonary heart disease. Outcome of lung embolism was fatal. Patient died on an unknown date (also reported unknown cause of death). It was unknown if autopsy was performed. Outcome of the other events was unknown. This report was serious with seriousness criteria of death, hospitalization, life threatening. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: lung embolism


VAERS ID: 1574757 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Chest X-ray, Dyspnoea, Inflammatory marker test, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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: Test Name: thorax x-ray; Result Unstructured Data: Test Result:infiltrate; Test Name: Infection values; Result Unstructured Data: Test Result:increased; Comments: laboratory
CDC Split Type: DEPFIZER INC202101009926

Write-up: Pneumonia; Dyspnoea; Acute kidney failure; This is a spontaneous report from a non-contactable physician downloaded from the Agency WEB DE-PEI-202100156064. An 87-year-old female patient received BNT162B2 (COMIRNATY, lot number EX8679) at 0.3 ml single dose via an unknown route on 05May2021 at 87-year-old for COVID-19 immunisation. Medical history and concomitant drug were not provided. On 16May2021 the patient experienced dyspnoea, acute kidney failure, and pneumonia. Lab data included infection values increased (laboratory), chest X-ray infiltrate. Patient died on 04Jun2021. The patient''s outcome was fatal (it was also reported that patient died of unknown cause of death). This report was serious with seriousness criteria of death, hospitalization, life threatening. No follow-up attempts are possible; No further information is expected.; Reported Cause(s) of Death: Pneumonia; dyspnoea; acute kidney failure


VAERS ID: 1574958 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 87
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: This case was received via Regulatory Authority (Reference number: 202100134331) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced THROMBOSIS (seriousness criteria death and medically significant). The patient died on 12-Jul-2021. The reported cause of death was Clot blood. An autopsy was not performed. Concomitant medication was not provided. Treatment information was not provided. Company comment: This case concerns a 45 year-old male patient who experienced the fatal unexpected event of thrombosis on the vaccination day. The patient died 2 months and 27 days after receiving the dose of the mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time. Translation has been requested.; Sender''s Comments: This case concerns a 45 year-old male patient who experienced the fatal unexpected event of thrombosis on the vaccination day. The patient died 2 months and 27 days after receiving the dose of the mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time. Translation has been requested.; Reported Cause(s) of Death: Clot blood


VAERS ID: 1574990 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2017-07-01
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Angiogram, Blood fibrinogen, Cardiac arrest, Cerebral artery occlusion, Cerebral thrombosis, Coma scale, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Depressed level of consciousness, Diarrhoea, Echocardiogram, Electroencephalogram, Fibrin D dimer, Loss of consciousness, Malaria antigen test, Neurological examination, Platelet count, Polymerase chain reaction, Respiratory arrest, SARS-CoV-2 test, Smear test, Thrombocytopenia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 1487
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: Cerebral malaria (Returned from traveling 2 weeks ago. Positive for infections with Plasmodium Falciparum and Ovale)
Preexisting Conditions: Medical History/Concurrent Conditions: Plasmodium falciparum infection; Plasmodium ovale infection
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: CT angiography; Result Unstructured Data: Test Result:No signs of Pulmonary embolism; Test Date: 20210727; Test Name: Fibrinogen; Result Unstructured Data: Test Result:01.50 am: 12.1 not specified; Test Date: 20210727; Test Name: Fibrinogen; Result Unstructured Data: Test Result:05.00 am: 11.3 not specified; Test Date: 20210726; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:3 not specified; Test Date: 20210726; Test Name: Computerised tomogram abdomen; Result Unstructured Data: Test Result:Nothing abnormal; Test Date: 20210726; Test Name: CT brain scan; Result Unstructured Data: Test Result:No blood supply to the brain; Test Date: 20210726; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:Bilateral infiltrates of the lungs.; Test Date: 20210726; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Normal EF pump function; Test Date: 20210726; Test Name: Electroencephalogram; Result Unstructured Data: Test Result:No electrical activity in the cerebral cortex; Test Date: 20210726; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:02:39 pm: 2.2 not specified; Test Date: 20210727; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:01.50 am: 4.9 not specified; Test Date: 20210727; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:05.00 am: 4.2 not specified; Test Date: 20210726; Test Name: Malaria antigen test; Result Unstructured Data: Test Result:positive for Plasmodium Falciparum and Oval; Test Date: 20210727; Test Name: Neurological examination; Result Unstructured Data: Test Result:revoked brainstem reflexes - clinical braindead; Test Date: 20210727; Test Name: Neurological examination; Result Unstructured Data: Test Result:Two independent examinations; Test Date: 20210726; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:71 not specified; Test Date: 20210727; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:51 not specified; Test Date: 20210726; Test Name: PCR; Result Unstructured Data: Test Result:PCR positive for Plasmodium Falciparum and Ovale; Test Date: 20210726; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Two times with negative results; Test Date: 20210726; Test Name: Smear; Result Unstructured Data: Test Result:Malaria smear positive for Plasmodium Falciparum; Test Date: 20210726; Test Name: Smear; Result Unstructured Data: Test Result:and Ovale. Parasit infectionsdegree around 1%
CDC Split Type: DKPFIZER INC202101010166

Write-up: Lost blood supply to the brain; OBS Cerebral thrombosis; Respiratory arrest; Not contactable (GCS 3); Vaccine-induced Immune thrombosis and thrombocytopenia (VITT); Unconscious; Cardiac arrest; Abdominal pain; Vomiting for some days; Diarrhea over some days; This is a spontaneous report from a contactable physician and another physician downloaded from the Regulatory Authority, regulatory authority number DK-DKMA-WBS-0081270. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 20Jul2021 (Batch/Lot Number: FD0932) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included cerebral malaria (Returned from traveling 2 weeks ago. Positive for infection with Plasmodium Falciparum and Ovale) from 26Jul2021. The patient''s concomitant medications were not reported. The patient previously took Comirnaty, dose 1 intramuscular on 14Jun2021 (Batch/Lot Number: FC2336) as single dose for COVID-19 immunisation. On 26Jul2021, 6 days after the 2nd vaccination, the patient developed Thrombocytopenia, Cerebral artery occlusion, Cerebral thrombosis, Respiratory arrest, Cardiac arrest, Unconscious and Consciousness decreased. In Jul2021 the patient experienced Diarrhea, Vomiting and Abdominal pain. The ADRs were by the reporter reported resulting in hospitalisation on 26Jul2021, being life threatening and Fatal on 27Jul2021 (as reported). The patient was first treated with empirical antibiotics (not specified) and several antidots (not specified) without any effect. The patient was intubated at connected to a respirator. Later the patient was treated for malaria with Artesunate. The ADR Cardiac arrest was recovered on 26Jul2021. The ADRs Consciousness decreased, Vomiting, Abdominal pain, Unconscious and Diarrhea have an unknown outcome. The outcome of ADRs Cerebral artery occlusion, Cerebral thrombosis, Respiratory arrest and Thrombocytopenia were fatal on 27Jul2021. Reported causes of death: Thrombocytopenia, Cerebral artery occlusion, Cerebral thrombosis, Respiratory arrest and Cerebral malaria. Autopsy has been requested, and results are awaited. Causality: The original reporter stated that the findings from Computerised tomogram thorax can be seen with infection with COVID-19. The original reporter stated that treatment was stopped after two neurologists had identified the patient as braindead and further treatment was stopped. The other reporter stated that they primarily suspect the infection with malaria as being the reason for the patient''s condition, but that they cannot rule out that vaccination may have contributed to the development of VITT and the symptoms of a cerebral thrombosis. The thrombocytopenia can be due to the infection with malaria alone, but she will not rule out COMIRNATY. The physician is uncertain if the vaccine and malaria infection may have enhanced each other and caused stronger symptoms. The patient underwent lab tests and procedures which included CT brain scan, 26Jul2021: No blood supply to the brain; Computerised tomogram thorax, 26Jul2021: Bilateral infiltrates of the lungs; CT angiography, 26Jul2021, No signs of Pulmonary embolism; Computerised tomogram abdomen, 26Jul2021: Nothing abnormal; Echocardiogram, 26Jul2021: Normal EF pump function; Glasgow coma scale, 26Jul2021: 3 unit not specified; Electroencephalogram, 26Jul2021: No electrical activity in the cerebral cortex; COVID-19 PCR test, 26Jul2021: Two times with negative results; Thrombocyte count, 26Jul2021: 71 unit not specified; Thrombocyte count,27Jul2021: 51 unit not specified; Fibrin D dimer, 26Jul2021: 02:39 pm: 2.2 unit not specified; Fibrin D dimer,27Jul2021: 01.50 am: 4.9 unit not specified; Fibrin D dimer, 27Jul2021: 05.00 am: 4.2 unit not specified; Fibrinogen, 27Jul2021: 01.50 am: 12.1 unit not specified; Fibrinogen, 27Jul2021: 05.00 am: 11.3 unit not specified; Malaria antigen test, 26Jul2021: positive for Plasmodium Falciparum and Oval; Smear, 26Jul2021: Malaria smear positive for Plasmodium Falciparum and Ovale. Parasite infections degree around 1%; PCR, 26Jul2021: PCR positive for Plasmodium Falciparum and Ovale; Neurological examination, 27Jul2021, Two independent examinations - revoked brainstem reflexes - clinical braindead; Results for PF-4 awaits. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Cerebral artery occlusion; Cerebral thrombosis; Respiratory arrest; Thrombocytopenia; Cerebral malaria


VAERS ID: 1575016 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002339 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrioventricular block complete
SMQs:, Conduction defects (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002339) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (seriousness criteria death and medically significant). The patient died on 30-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was withdrawn on 24-May-2021. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment: This is a case of death in a 54-year-old male subject, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 54-year-old male subject, who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-04-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy bronchus, Chronic obstructive pulmonary disease, Computerised tomogram, Disease recurrence, Haemoglobin, Haemoptysis, International normalised ratio, Organising pneumonia, Platelet count, Pulmonary embolism, Pulmonary haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Embolic and thrombotic events, venous (narrow), Eosinophilic pneumonia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNISOLON [PREDNISOLONE]; GHEMAXAN; ERDOPECT; XARELTO; PANTOPRAZOL [PANTOPRAZOLE]; IPRATROPIUM/SALBUTAMOL CIPLA; TARGINIQ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Atrial fibrillation; COPD; Coronary heart disease; Hemoptysis
Allergies:
Diagnostic Lab Data: Test Name: Bronchoscopy samples; Result Unstructured Data: Test Result:no evidence of tuberculosis; Test Name: CT scan; Result Unstructured Data: Test Result:there was dense shading in the upper right block; Comments: there was dense shading in the upper right block, suitable as a bleeding area, but suspicion of lung cancer or tuberculosis also arose. In addition, a small pulmonary embolism was found.; Test Name: Hemoglobin; Result Unstructured Data: Test Result:87; Comments: The lowest value during the treatment period was 87; Test Date: 20210405; Test Name: Hemoglobin; Result Unstructured Data: Test Result:127; Comments: after acute haemorrhage on the day of admission ranged from 87 to 116.; Test Date: 20210422; Test Name: Hemoglobin; Result Unstructured Data: Test Result:93; Comments: on the morning of the day of death, when the haemorrhage had just started again, 93.; Test Date: 20210404; Test Name: INR; Result Unstructured Data: Test Result:2.2-1.9; Comments: on arrival (Xarelto medication on discontinuation); Test Date: 20210422; Test Name: INR; Result Unstructured Data: Test Result:1.4-1.1; Comments: on the morning of the day of death; Test Name: Thrombocyte; Result Unstructured Data: Test Result:200; Test Date: 20210409; Test Name: Thrombocyte; Result Unstructured Data: Test Result:122; Test Date: 20210422; Test Name: Thrombocyte; Result Unstructured Data: Test Result:475; Comments: on the morning of death
CDC Split Type: FIPFIZER INC202101010279

Write-up: acute severe hemoptysis; acute severe hemoptysis; COPD; Pulmonary embolism; Pulmonary haemorrhage; Organising pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FI-FIMEA-20213734. An 80-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Mar2021 at single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), coronary heart disease, atrial fibrillation, anticoagulant therapy, and haemoptysis from 2018 (then no specific cause was found, it was suspected to be related to COPD). Concomitant medications included prednisolone (PREDNISOLON) for COPD from 16Apr2021, enoxaparin sodium (GHEMAXAN) for pulmonary embolism from 09Apr2021, erdosteine (ERDOPECT), rivaroxaban (XARELTO) from an unspecified start date to 04Apr2021, pantoprazole (PANTOPRAZOL) from 09Apr2021, ipratropium bromide/salbutamol sulfate (IPRATROPIUM/SALBUTAMOL CIPLA), and naloxone hydrochloride/oxycodone hydrochloride (TARGINIQ) from 12Apr2021. The patient experienced pulmonary embolism, pulmonary haemorrhage, and organising pneumonia on 04Apr2021. On 04Apr2021, patient was hospitalized due to acute severe hemoptysis. On CT scan, there was a dense shadowing in the right upper lobe consistent with a bleeding area, but there was also suspicion of lung cancer or tuberculosis. A small pulmonary embolism was also found. On admission with haemorrhage, lifelessness and with resuscitation recovered. The hemoptysis recurred on 22Apr2021 very severe and the patient died at this time. Bronchoscopy samples taken from the bronchial aspiration specimens showed no evidence of tuberculosis. Results from obduction now obtained and surprisingly no suspected cancer was found in the lungs nor any other explanatory cause for the haemorrhage. The patient case was discussed together with the forensic team now that the obductomy result had been received. It was considered that it highly unlikely that there was a link to the coronary vaccine, as the patient had a history of hemoptysis and had both COPD and anticoagulant therapy, but it was decided to report a possible adverse reaction of the vaccine. The death certificate was written with the underlying cause of death being COPD and the immediate cause of death being pulmonary haemorrhage. Pulmonary embolism and secondary organizing pneumonia found on obduction as contributing factors. 28Jul2021 follow-up physician: Hemoglobin on admission 05Apr2021 was 127; after acute haemorrhage on the day of admission ranged from 87 to 116. The lowest value during the treatment period was 87 and on the morning of the day of death, when the haemorrhage had just started again, 93. Thrombocytes 200-122 (= lowest value on 09Apr2021) - 475 on the morning of death. INR 2.2-1.9 upon admission (rivaroxaban (XARELTO) medication stopped on admission) - then 1.4 - 1.1 on the morning of death. The patient died on 22Apr2021. Outcome of event hemoptysis was unknown. Autopsy has been done. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: based on trhe available information the causality between the fatal events Pulmonary embolism ,secondary organizing pneumonia , pulmonary haemorrhage,hemoptysis ,COPD, and the suspect vaccine BNT162B2 cannot be ruled out completely; Reported Cause(s) of Death: Pulmonary embolism; Organising pneumonia; COPD; Pulmonary haemorrhage


VAERS ID: 1575154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Aspartate aminotransferase, Asthenia, Back pain, Bilirubin conjugated, Blood bicarbonate, Blood bilirubin unconjugated, Blood creatinine, Blood fibrinogen, Blood iron, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Cardiovascular examination, Computerised tomogram, Coombs direct test, Death, Diarrhoea, Echocardiogram, HIV test, Haemolytic anaemia, Haptoglobin, Heart rate, Hepatitis B virus test, Hepatitis C virus test, Immunology test, Influenza like illness, Interchange of vaccine products, Legionella test, Lymphocyte count, Malaise, Mean cell volume, Myalgia, Neutrophil count, Off label use, PCO2, PO2, Platelet count, Prothrombin level, Prothrombin time ratio, Pulmonary embolism, Pyrexia, Red blood cell schistocytes, Reticulocyte count, Serum ferritin, Soluble fibrin monomer complex, Total complement activity test, Troponin, Viral test, Vomiting, White blood cell count, Wrong product administered, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Haemolytic disorders (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cutaneous vasculitis; Idiopathic thrombocytopenic purpura (with favorable evolution under corticotherapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: ALT; Result Unstructured Data: Test Result:524 IU/l; Test Date: 20210718; Test Name: anti-polynuclear cytoplasm; Result Unstructured Data: Test Result:negative; Test Date: 20210718; Test Name: antinuclear; Result Unstructured Data: Test Result:negative; Test Date: 20210718; Test Name: AST; Result Unstructured Data: Test Result:753 IU/l; Test Date: 20210718; Test Name: conjugated bilirubin; Result Unstructured Data: Test Result:22 umol/l; Test Date: 20210718; Test Name: bicarbonate; Result Unstructured Data: Test Result:25.3 mmol/L; Test Date: 20210718; Test Name: free bilirubin; Result Unstructured Data: Test Result:16 umol/l; Test Date: 20210718; Test Name: creatinine; Test Result: 52 umol; Test Date: 20210718; Test Name: fibrinogen; Result Unstructured Data: Test Result:less than 0.4 g/l; Test Date: 20210718; Test Name: anemia; Result Unstructured Data: Test Result:2.5 g/dl; Test Date: 20210718; Test Name: kalemia; Result Unstructured Data: Test Result:3.4 mmol/L; Test Date: 20210718; Test Name: blood pressure; Result Unstructured Data: Test Result:140 per 80 mmHg; Test Date: 20210718; Test Name: natraemia; Result Unstructured Data: Test Result:131 mmol/L; Test Date: 20210718; Test Name: uremia; Result Unstructured Data: Test Result:6.1 mmol/L; Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result:apyretic; Test Date: 20210718; Test Name: cardiovascular examination; Result Unstructured Data: Test Result:regular heart sounds; Comments: regular heart sounds without perceived murmur, no chest pain, soft and painless calves, no edema of the lower limbs, no sign of peripheral hypoperfusion, clear and symmetrical pulmonary auscultation, polypnea without sign of struggle, soft abdomen, depressible, painless, mucocutaneous jaundice; Test Date: 20210718; Test Name: tap scan; Result Unstructured Data: Test Result:no pulmonary embolism; Comments: no pulmonary embolism, doubt on portal thrombosis, hepatomegaly, peritoneal effusion; Test Date: 20210718; Test Name: Coombs; Result Unstructured Data: Test Result:intense cold agglutinins; Comments: intense cold agglutinins not allowing typing of hemolytic anemia; Test Date: 20210718; Test Name: CRP; Result Unstructured Data: Test Result:17.8 mg/l; Test Date: 20210718; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:suspicion of pulmonary embolism; Comments: suspicion of pulmonary embolism in front of right heart signs; Test Date: 20210718; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:clear regression of dilatation and right ventricul; Test Date: 20210718; Test Name: haptoglobin; Result Unstructured Data: Test Result:collapsed; Test Date: 20210718; Test Name: heart rate; Result Unstructured Data: Test Result:116; Comments: bpm; Test Date: 20210718; Test Name: HBV serology; Test Result: Negative ; Test Date: 20210718; Test Name: HCV serology; Test Result: Negative ; Test Date: 20210718; Test Name: HIV test; Test Result: Negative ; Test Date: 20210718; Test Name: Immunofixation of serum proteins; Result Unstructured Data: Test Result:no monoclonal immunoglobulin or light chain; Test Date: 20210718; Test Name: legionella; Test Result: Negative ; Test Date: 20210718; Test Name: lymphocytes; Result Unstructured Data: Test Result:7.29; Comments: Giga per liter; Test Date: 20210718; Test Name: mean corpuscular volume; Result Unstructured Data: Test Result:78; Comments: fl; Test Date: 20210718; Test Name: polynuclear neutrophil; Result Unstructured Data: Test Result:7.4 x10 9/l; Comments: Giga per liter; Test Date: 20210718; Test Name: pco2; Result Unstructured Data: Test Result:27 mmHg; Test Date: 20210718; Test Name: ph; Result Unstructured Data: Test Result:7.58 pH units; Comments: respiratory alkalosis; Test Date: 20210718; Test Name: platelets; Result Unstructured Data: Test Result:138 x10 9/l; Comments: Giga per liter; Test Date: 20210718; Test Name: po2; Result Unstructured Data: Test Result:54 mmHg; Test Date: 20210718; Test Name: FII; Test Result: 26 %; Test Date: 20210718; Test Name: PT/APTT; Result Unstructured Data: Test Result:uninterpretable; Test Date: 20210718; Test Name: schizocyte count; Result Unstructured Data: Test Result:Two times negative; Test Date: 20210718; Test Name: reticulocytes; Result Unstructured Data: Test Result:122 x10 9/l; Comments: Giga per liter; Test Date: 20210718; Test Name: ferritin; Result Unstructured Data: Test Result:10000 ng/ml; Test Date: 20210718; Test Name: fibrin monomers; Result Unstructured Data: Test Result:105.24 ug/L; Test Date: 20210718; Test Name: CH50; Result Unstructured Data: Test Result:less than 15 IU/ml; Test Date: 20210718; Test Name: troponin; Result Unstructured Data: Test Result:593 ug/L; Test Date: 20210718; Test Name: lung swab; Result Unstructured Data: Test Result:PCR adenovirus, bocavirus; Comments: PCR adenovirus, bocavirus, bordetella pertussis, coronavirus, influenza, legionella, metapneumovirus, mycoplasma, parainfluenza virus, rhinovirus, enterovirus, RSV negative; Test Date: 20210718; Test Name: leukocytes; Result Unstructured Data: Test Result:18.5 x10 9/l; Comments: Giga per liter
CDC Split Type: FRPFIZER INC202101010659

Write-up: Feeling sick; Diarrhea; Emesis; Influenza like illness; fever; bilateral back pain; myalgias; asthenia; Death; Embolism pulmonary; Anaemia haemolytic; Interchange of vaccine products; Interchange of vaccine products; Wrong product administered; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority, regulatory authority number FR-AFSSAPS-PO20213976. A 65-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Jul2021 (Lot Number: FE2296) as 0.3 ML SINGLE for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date, at DOSE 2, SINGLE for covid-19 immunisation (not administered). Medical history included Idiopathic thrombocytopenic purpura from 2011 with favorable evolution under corticotherapy, cutaneous vasculitis from 2015 to an unknown date. The patient''s concomitant medications were not reported. Patient previous received 1st IM injection of MODERNA vaccine (lot 3002543) on 27May2021 via Intramuscular for covid-19 immunisation. The patient experienced death on 18Jul2021, embolism pulmonary on 18Jul2021, anaemia haemolytic on 17Jul2021, all with fatal outcome. Influenza like illness on 16Jul2021 with outcome of recovered on 16Jul2021, fever on 16Jul2021 with outcome of unknown, bilateral back pain on 16Jul2021 with outcome of unknown , myalgias on 16Jul2021 with outcome of unknown , asthenia on 16Jul2021 with outcome of unknown , feeling sick on 17Jul2021 with outcome of recovered on 17Jul2021, diarrhea on 17Jul2021 with outcome of recovered on 17Jul2021, emesis on 17Jul2021 with outcome of recovered on 17Jul2021, interchange of vaccine products on 12Jul2021 with outcome of unknown. The patient died on 18Jul2021. Clinical course as follows: On 16Jul2021, influenza-like illness with fever, bilateral back pain, asthenia and myalgias. On 17Jul2021, persistent asthenia, recurrent malaise without loss of consciousness with prodromes, vomiting and diarrhea. Hospitalization on 18Jul2021 around 00:00. On admission, patient conscious and oriented, apyretic, BP 140/80mmHg, HR 116bpm, regular heart sounds without perceived murmur, no chest pain, soft and painless calves, no edema of the lower limbs, no sign of peripheral hypoperfusion, clear and symmetrical pulmonary auscultation, polypnea without sign of struggle, soft abdomen, depressible, painless, mucocutaneous jaundice. Biological workup on entry: anemia at 2.5g/dL, microcytic (MCV at 78fl), reticulocytes at 122G/L, platelets at 138G/L, CRP at 17.8mg/L, leukocytes at 18.5G/L with PNN at 7.4G/L and lymphocytes at 7.29G/L, natraemia at 131mmol/L, kalemia at 3.4mmol/L, creatinine 52uM, uremia 6.1mmol/L, AST 753IU/L, ALT 524IU/L, conjugated bilirubin 22umol/L, free bilirubin 16?mol/L, haploglobin collapsed, schizocyte count 2 times negative, ferritin 10000ng/mL. Blood gas on admission: respiratory alkalosis (pH 7.58) (pO2 54mmHg, pCO2 27mmHg, bicarbonates 25.3mmol/L) not compensated with moderate hypoxemia. Direct Coombs of 18Jul/2021: intense cold agglutinins not allowing typing of hemolytic anemia. Differential diagnoses: infectious hypothesis. HIV, HCV, HBV serology negative. Negative legionella/pneumococcal antigenuria. Protected distal lung specimen from 18Jul2021 : PCR adenovirus, bocavirus, bordetella pertussis, coronavirus, influenza, legionella, metapneumovirus, mycoplasma, parainfluenza virus, rhinovirus, enterovirus, RSV negative. Tumor hypothesis. Immunofixation of serum proteins on 18Jul2021: no monoclonal immunoglobulin or light chain. Autoimmune hypothesis. Autoimmune workup 18Jul2021: antinuclear negative, anti-native DNA negative, anti-polynuclear cytoplasm negative, CH50 <15IU/mL (N $g32). Evolution Initiation of oxygen therapy. On 18Jul2021 at 3:50 am, unconscious, bradycardic and hypotensive then cardiorespiratory arrest (ACR). cardiorespiratory arrest (ACR) recovered after a 10min low flow and 3mg of adrenaline. Thereafter, at least 5 episodes of cardiorespiratory arrest (ACR) rapidly recovered after administration of adrenaline and external cardiac massage. Relay with IV epinephrine electric syringe pump (PSE) at 3mg/h, administration of bicarbonates. trans-thoracic echocardiography (TTE) of 18Jul2021: suspicion of pulmonary embolism in front of right heart signs. Rescue thrombolysis by alteplase 10mg bolus then 90mg. Disappearance of bradycardia episodes, improvement of hemodynamics allowing a decrease of adrenalin to 2mg/h. Broad-spectrum antibiotic therapy with clarithromycin and cefotaxime. TAP scan of 18Jul2021: no pulmonary embolism, doubt on portal thrombosis, hepatomegaly, peritoneal effusion. Transfusion of reheated blood cells, initiation of hydrocortisone therapy 1mg/kg/d. Follow-up (Trans thoracic echocardiography) TTE: clear regression of dilatation and right ventricular dysfunction. Iterative cardiorespiratory arrest (ACR) with initial echocardiography with predominant right heart failure, regressed after salvage thrombolysis in favor of a pulmonary embolism despite normal angiogram. Biological workup on 18Jul2021 9:05 a.m.: TP/TCA uninterpretable, fibrinogen <0.4g/L, FII at 26%, VF at 2%, fibrin monomers at 105.24ug/L, troponin I at 593?g/L. TAP scan of 18Jul2021: no pulmonary embolism, doubt on portal thrombosis. Unfavorable evolution with hemodynamic instability of septic origin and multivisceral failure refractory to volemic resuscitation, transfusion and ino-vasopressor support related to probable mesenteric ischemia linked to the initial low flow. Death on 18Jul2021 at 18:20. Conclusion: Death at Day 6 (D6_ of the 2nd injection of the anti-COVID vaccine in a context of pulmonary embolism not objectified on imaging and hemolytic anemia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1575155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Multiple organ dysfunction syndrome
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), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   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: Congestive (dilated) cardiomyopathy; Hypertension arterial; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Skull trauma
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210823446

Write-up: ARREST CARDIAC; MULTIORGAN FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-PP20211035] concerned a 62 year old male of unknown race and ethnicity. The patient''s weight was 75 kilograms, and height was 175 centimeters. The patient''s past medical history included skull trauma, and concurrent conditions included hypothyroidism, congestive (dilated) cardiomyopathy, and hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-04, expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 29-JUN-2021 for covid-19 vaccination. Drug start period 2 days. No concomitant medications were reported. On 30-JUN-2021, the patient had arrest cardiac and multiorgan failure which led to death on 04-JUL-2021. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of arrest cardiac and multiorgan failure on 04-JUL-2021. This report was serious (Death).; Sender''s Comments: V0- 20210823446- Covid-19 vaccine ad26.cov2.S ? Arrest cardiac, Multiorgan failure. 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).


VAERS ID: 1575164 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Cardiac arrest, Cardiomegaly, Inappropriate schedule of product administration, Interchange of vaccine products
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (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), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101010345

Write-up: cardiac arrest; Interchange of vaccine products; Inappropriate schedule of vaccine administered; atheroma; cardiomegaly; This is a spontaneous report from a contactable other-HCP downloaded from the Regulatory Authority. The regulatory authority report number FR-AFSSAPS-RS20212536. A 48-year-old male patient received bnt162b2 (COMIRNATY) intramuscular on 05Jun2021 (Batch/Lot Number: FC1526) as DOSE 2, single for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), intramuscular from Mar2021 (Batch/Lot Number: Unknown) to Mar2021, at DOSE 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have history of covid. The patient had received a first dose of VAXZEVRIA in Mar2021. Case reported by the vaccination center manager, who had very little information in his possession: He reports the patient''s sudden death on 08Jun2021 a few days after receiving the 2nd dose of vaccine (COMIRNATY), administered on 05Jun2021, without further details. The patient became unwell while driving 3 days after receiving the 2nd dose. He died of a sudden cardiac arrest. An autopsy was performed. According to the family, the patient had no particular history or usual treatment. Additional information obtained by the CRPV from the forensic medicine department that performed the autopsy: At autopsy, the presence of atheroma was observed, as well as cardiomegaly (heart weight: 500 g). In total, sudden death of a 48-year-old man 3 days after Dose 2 (D2) Comirnaty; no known cardiac history or usual treatment but evidence of atheroma and cardiomegaly at autopsy. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiac arrest; Autopsy-determined Cause(s) of Death: cardiomegaly (heart weight: 500 g); atheroma


VAERS ID: 1575179 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death, Pulseless electrical activity, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Cardio-respiratory arrest; Electromechanical dissociation; Fibrillation ventricular; This case was received via Regulatory Authority (Reference number: TS20213218) 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 CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), PULSELESS ELECTRICAL ACTIVITY (Electromechanical dissociation) and VENTRICULAR FIBRILLATION (Fibrillation ventricular) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria death and medically significant), PULSELESS ELECTRICAL ACTIVITY (Electromechanical dissociation) (seriousness criteria death and medically significant) and VENTRICULAR FIBRILLATION (Fibrillation ventricular) (seriousness criteria medically significant and life threatening). On 01-Jul-2021, VENTRICULAR FIBRILLATION (Fibrillation ventricular) had not resolved. The patient died on 01-Jul-2021. The reported cause of death was dissociation electromechanical. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was reported by reporter. France Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-TS20213218. This case concerns a 58-year old female who experienced Cardio-respiratory arrest, Electromechanical dissociation and Fibrillation ventricular. The patient died 16 days after receiving the first dose of the vaccine. The reported cause of death was dissociation. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time.; Sender''s Comments: This case concerns a 58-year old female who experienced Cardio-respiratory arrest, Electromechanical dissociation and Fibrillation ventricular. The patient died 16 days after receiving the first dose of the vaccine. The reported cause of death was Electromechanical dissociation. It is unknown if an autopsy was performed. Very limited information regarding this event/s has been provided at this time.; Reported Cause(s) of Death: Dissociation Electromechanical.


VAERS ID: 1575183 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Dyspnoea, Fatigue, Inappropriate schedule of product administration, Pulmonary embolism, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOSTAIR; CALCIUM AND COLECALCIFEROL; ASPIRIN [ACETYLSALICYLIC ACID]; ESOMEPRAZOLE; TAMSULOSIN; PREDNISOLONE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (often breathless); Bronchiectasis (often breathless); Giant cell arteritis (Treated to good effect with high dose steroids, tapering dose by March 2021); Oesophageal stricture; Vasculitis
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:No evidence of PE
CDC Split Type: GBPFIZER INC202101014369

Write-up: Pulmonary embolism; Syncope; Fatigue; Dyspnoea; First dose on 15Jan2021, second dose on 31Mar2021; This is a spontaneous report from a contactable other healthcare professional and two physicians received from the Regulatory Authority report number is GB-MHRA-ADR 25758376. Safety Report Unique Identifier GB-MHRA-ADR 25758376. A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on 31Mar2021 (at the age of 75-year-old) as single dose for covid-19 immunisation; zoledronic acid monohydrate (ACIDO ZOLEDRONICO TILLOMED), intravenous from 07Apr2021 to an unspecified date, at unknown dose for an unspecified indication. Medical history included giant cell arteritis (treated to good effect with high dose steroids, tapering dose by March 2021) from Dec2020, asthma (often breathless) from an unknown date, bronchiectasis (often breathless) from an unknown date, oesophageal stenosis from an unknown date, and vasculitis from an unknown date, all unknown if ongoing. Concomitant medications included beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for an unspecified indication from 11Feb2021 to an unspecified stop date; calcium carbonate, colecalciferol (CALCIUM AND COLECALCIFEROL) taken for an unspecified indication from Dec2020 to an unspecified stop date; aspirin (acetylsalicylic acid) taken for an unspecified indication from Dec2020 to an unspecified stop date; esomeprazole taken for an unspecified indication from 2008 to an unspecified stop date; tamsulosin taken for an unspecified indication from 2017 to an unspecified stop date; prednisolone taken for asthma, start and stop date were not reported; salbutamol taken for an unspecified indication from 2008 to an unspecified stop date. The patient previously received first dose of BNT162B2 on 15Jan2021 for COVID-19 Immunisation. The patient experienced pulmonary embolism and syncope on an unspecified date, fatigue and dyspnoea on 08Apr2021. Clinical course: 75 yr old male sudden death 17Apr2021 due to pulmonary embolus (PE). No previous history of venous thromboembolism (VTE). Previous Oesophageal stricture so oral bisphosphonate avoided -intravenous. 07Apr2021 at Hospital - planned zoledronic acid intravenous infusion (Tillomed) 5mg followed by severe fatigue/breathlessness the next day (could only walk a few steps) which persisted for about 6 days. He improved for 2 days then suddenly collapsed. Resuscitation unsuccessful. The reporters hypothesised that the combination of vasculitis (pre-coagulant state) + age + unusually severe fatigue from the Zoledronic acid infusion + perhaps the Pfizer vaccine all contributed to the PE. The patient underwent lab tests and procedures which included CT pulmonary angiogram: no evidence of PE on 04Mar2021. This case was reported as serious, serious criteria included death and hospitalization. The outcome of event pulmonary embolism was fatal, the rest of events outcome was unknown. The patient died on 17Apr2021. 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: Pulmonary embolus


VAERS ID: 1575273 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-27
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 20210427; Test Name: Covid-19 test; Test Result: Positive; Comments: Variant sequenced B.1.1.7; N501Y positive.
CDC Split Type: ATPFIZER INC202101016169

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB: AT-BASGAGES-2021-39222. An 82-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, strength: 2 ml), dose 2 via an unspecified route of administration on 10Feb2021 (lot Number: EJ6134; Expiration Date: 30Apr2021) as single dose; and dose 1 via an unspecified route of administration on 20Jan2021 (lot Number: EL1491; Expiration Date: 30Apr2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. As reported, on 27Apr2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. The patient underwent lab tests and procedures which included COVID-19 test: positive on 27Apr2021 with Variant sequenced B.1.1.7; N501Y positive. The patient died on an unspecified date. It was not reported if an autopsy was performed. On 10Aug2021, Investigation results was provided as conclusion: 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 EL1491. 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. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The 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: 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 EJ6134. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The 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; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1575281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIGARD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101022711

Write-up: Cardiac failure congestive; Dyspnoea; This is a Non-Interventional Study report from a contactable Consumer. This is a report received from the Regulatory Authority via an on-line database search. Regulatory authority report No 000940311. This information was initially reported to Regulatory Authority between 24Feb2021 and 06Apr2021 from an unknown Authorization Holder AER# unspecified A 95-year-old male subject received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; leuprorelin acetate (ELIGARD), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 22.5 mg, every 3 months; subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 22.5 mg, every 3 months for prostate cancer. Medical history included prostate cancer from an unknown date. The subject''s concomitant medications were not reported. The subject experienced cardiac failure congestive, dyspnoea on an unspecified date. The action taken in response to the event(s) for leuprorelin acetate was unknown. The outcome of the event was fatal. The subject died on an unspecified date. It was not reported if an autopsy was performed The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment Pfizer is the Marketing authorization holder of COVID-19 VACCINE in the country of incidence. This may be a duplicate report if another marketing authorization holder of COVID-19 VACCINE has submitted the same report to regulatory authorities. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Cardiac failure congestive and Dyspnoea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure congestive; Dyspnoea


VAERS ID: 1575289 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Carcinoma lung
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: Test Result:increased
CDC Split Type: CZPFIZER INC202101016235

Write-up: Cardiac arrest; Fever; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority number CZ-CZSUKL-21009017. A 67-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 25Mar2021 (Batch/Lot Number: Unknown) at the age of 67-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Carcinoma lung. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest (death, hospitalization, medically significant, life threatening) on 30Apr2021, fever (medically significant) on 25Mar2021. The clinical course as following: patient experienced the following adverse reactions after the administration of the first dose of the COMIRNATY vaccine (25Mar2021): Fever every day after vaccination. On 30Apr2021 patient died of cardiac arrest. An autopsy was not done. The patient underwent lab tests and procedures which included body temperature: increased on an unknown date in Mar2021. The outcome of the event fever was unknown, and the outcome of the event cardiac arrest was fatal. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1575290 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: Amyotrophic lateral sclerosis; Arterial hypertension; Hypercholesteraemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987802

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21189374. A 66-year-old female patient received BNT162B2 (COMIRNATY; lot number: ER9480) via an unspecified route of administration on 08Apr2021 as dose number unknown, single for COVID-19 immunisation. Medical history included arterial hypertension, amyotrophic lateral sclerosis and hypercholesteraemia. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 10Apr2021. The patient died on 10Apr2021. It was not reported if an autopsy was performed. Follow-up attempt are not possible. No expected further information.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575307 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987667

Write-up: Pulmonary embolus; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number is DE-PEI-202100144680. A 91-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: Unknown) (at the age of 91-years-old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (COMIRNATY) on 10Mar2021 (at the age of 91-years-old) as 0.3 mL, single for COVID-19 immunisation. On 03Apr2021, the patient experienced pulmonary embolus. Outcome of event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. The casual relationship of Comirnaty and event was assessed as Unclassifiable by the Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolus


VAERS ID: 1575313 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987761

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100145102. A 53-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot number was not reported) as dose number unknown, 0.3 ml, single for covid-19 immunisation. Medical history included coronary disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced acute myocardial on 03Jul2021. The patient died on 03Jul2021 due to acute myocardial infarction. An autopsy was not performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1575314 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-06-03
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Systemic inflammatory response syndrome
SMQs:, Tumour lysis syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987556

Write-up: Systemic inflammatory response syndrome; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100146515. An 86-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: EP9598) (at age 85-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 05Feb2021. The patient''s medical history and concomitant medications were not reported. The patient experienced systemic inflammatory response syndrome on 03Jun2021. The patient died on 03Jun2021. 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: Systemic inflammatory response syndrome


VAERS ID: 1575321 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E028A / UNK - / -

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 INC202100987550

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-PEI-202100150586. A 44-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: 1E028A) as UNKNOWN DOSE NUMBER, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had his first dose of Comirnaty 0.3mL for COVID-19 immunisation on 06Jun2021. The patient experienced also Infarct myocardial. The outcome of the events was fatal. This report is serious - death, life threatening. No autopsy done. No post mortem examination. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1575323 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016103

Write-up: Suspected thrombosis; Suspected embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100157111. A 54-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: FF0900, strength: 0.3 ml) (mRNA tozinameran), at the age of 54 years old, on 02Aug2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown, strength: 0.3 ml), at the age of 54 years old, on 21Jun2021 at single dose for COVID-19 immunisation. On 03Aug2021 (1 day after vaccination), the patient experienced suspected thrombosis / embolism and died unexpectedly. Sudden death without further explanation in the night after the second vaccination. This report was serious - death. The patient died on 03Aug2021. It was not reported if an autopsy was performed. Relatedness of drug to events was assessed as D. Unclassifiable. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Suspected thrombosis; Suspected embolism


VAERS ID: 1575357 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, General physical health deterioration, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 48
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 INC202100987751

Write-up: extreme weakness; Renal failure; General physical condition decreased; Belly ache; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021132091. An 87-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16May2021 (Batch/Lot Number: Unknown) as 0.3 ML SINGLE for prophylactic vaccination. The patient''s medical history and concomitant medications were not reported. On 20May2021, the patient experienced renal failure, general physical condition decreased, belly ache, and extreme weakness. The event renal failure was reported as serious (death). The patient died on 07Jul2021. An autopsy was not performed. The patient has not recovered from belly ache, general physical condition decreased; unknown for extreme weakness; while outcome of renal failure was fatal. Sender comment: Do you or the person concerned have any allergies? If so, which ones? No, cause not found, kidney failure only after tilting and extreme weakness in hospital. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1575358 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-18
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dyspnoea, Malaise, Myocardial infarction, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 28
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 INC202100987990

Write-up: infarct myocardial; diarrhea; dyspnoea; malaise; tachycardia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021145461. An 85-year-old female patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 06Apr2021 (batch/lot number and expiry date unknown) as dose 2, 0.3 ml single for covid-19 immunization. The patient''s medical history was not reported. There were no concomitant medications. On 18Apr2021, the patient experienced infarct myocardial, diarrhea, dyspnoea, malaise, tachycardia. The outcome of the events diarrhea, dyspnoea, malaise, tachycardia was not recovered. The patient died on 16May2021 due to infarct myocardial. It was unknown if an autopsy was performed. Sender''s comment: do you or the person concerned have any allergies? if so, which ones? no information on risk factors or previous diseases none/increasing signs of deterioration since the second vaccination over 4 weeks. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1575359 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nickel sensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100996135

Write-up: Death from pulmonary embolism; Thrombosis; dose 1 : 01-MAY-2021, dose 2: 12-JUN-2021; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021150740. Safety report unique identifier DE-PEI-202100151083. A 51-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12Jun2021 (Lot Number: FA5833; at the age of 51-years) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included nickel allergy. The patient''s concomitant medications were not reported. Historical vaccine included Comirnaty (1st dose, batch unknown) on 01May2021 for COVID-19 immunisation. On 23Jun2021, the patient experienced pulmonary embolism and thrombosis. The patient died on 23Jun2021 and autopsy in forensic medicine showed death from pulmonary embolism. The outcome of thrombosis (medically significant) was not recovered. Drug-reaction/ Event Matrix: Relatedness of drug to reaction /event for all events: Source of assessment PEI. Result of Assessment: D. Unclassifiable Sender''s comment: Are you or the person concerned known of any allergies: Nickel allergy. Information on risk factors or previous illnesses: none / death found. Cause unclear at first. After autopsy in forensic medicine: death from pulmonary embolism. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death from pulmonary embolism


VAERS ID: 1575360 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100996119

Write-up: Vomiting; Nausea; Cardiac arrest 7 days after Comirnaty vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number is DE-PEI-CADR2021151214, Safety Report Unique Identifier is DE-PEI-202100150983. A 30-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 19Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Jun2021, the patient experienced cardiac arrest 7 days after Comirnaty vaccination. On unspecified date, patient experienced vomiting and nausea. Patient initially had nausea and vomiting, a little later cardiac arrest. Outcome of cardiac arrest was fatal, vomiting was not recovered while nausea was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) Cardiac arrest: Source of assessment: Regulatory Authority; Result of Assessment: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest 7 days after Comirnaty vaccination


VAERS ID: 1575361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-07-08
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Dizziness, Dyspnoea, Fatigue, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016098

Write-up: suspected pulmonary embolism; feeling of weakness; Unknown cause of death; Dyspnoea/shortness of breath; Dizziness; Fatigue; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, Safety Report Unique Identifier DE-PEI-202100152003. An 80-year-old female patient received second dose of BNT162B2 (COMIRNATY, Lot Number: EY2172), via an unspecified route of administration on 06May2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2(COMIRNATY) on 15Apr2021 for COVID-19 immunisation. On 08Jul2021 the patient experienced dyspnoea, fatigue and dizziness. On 27Jul2021 the patient experienced unknown cause of death. First severe fatigue with a feeling of weakness, later shortness of breath, circulatory problems and then death with suspected pulmonary embolism. The outcome of event dyspnoea/shortness of breath, dizziness and fatigue was not recovered and of event suspected pulmonary embolism, feeling of weakness was unknown. The patient died on 27Jul2021. It was not reported if an autopsy was performed. This report is serious as death. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. / First severe fatigue with a feeling of weakness, later shortness of breath, circulatory problems & then death with suspected pulmonary embolism. Assessment: Comirnaty/ Death/ PEI: D. Unclassifiable Comirnaty/ Dyspnoea/ PEI: D. Unclassifiable Comirnaty/ Dizziness/ PEI: D. Unclassifiable Comirnaty/ Fatigue/ PEI: D. Unclassifiable No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-04-15
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016076

Write-up: Renal failure; Shingles; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021153365, Safety Report Unique Identifier DE-PEI-202100154859. A 98-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 21Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced renal failure on 21May2021, shingles on 15Apr2021. The outcome of event renal failure was fatal and shingles was not recovered. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender Comment: Information on risk factors or previous illnesses. Patient was physically and mentally fit before the vaccination. Event assessment: renal failure, shingles as Unclassifiable. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1575364 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Malaise, Pain, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016093

Write-up: back pain; Renal failure; severe malaise with increasing pain after vaccination; severe malaise with increasing pain after vaccination; This is a spontaneous report downloaded from the Regulatory Authority. Report number DE-PEI-CADR2021155427, Safety Report Unique Identifier DE-PEI-202100156816, from a non-contactable consumer. A 74-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ml), dose 2 via an unspecified route of administration on 07Jun2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced renal failure on 13Jun2021 (Seriousness Criteria: death, hospitalization). It was also reported as severe malaise with increasing pain after vaccination. After about 4 weeks (Jul2021) hospital admission because of massive back pain. Screams in pain. 14 days hospital stay then died of kidney failure. The patient died on 20Jul2021 because of Renal failure. Outcome of other events was unknown. An autopsy was not performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No / Severe malaise with increasing pain after vaccination. After about 4 weeks hospital admission because of massive back pain. Screams in pain. 14 days hospital stay then died of kidney failure. Event assessment: Comirnaty/ event/PEI /Result of Assessment: D. Unclassifiable No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected. ; Reported Cause(s) of Death: Renal failure


VAERS ID: 1575379 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood sodium, Brain natriuretic peptide increased, C-reactive protein, Death, Electrocardiogram, Glomerular filtration rate, Inflammation, Lung disorder, Multiple organ dysfunction syndrome, Prohormone brain natriuretic peptide, Troponin, Troponin increased
SMQs:, Cardiac failure (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), Pulmonary hypertension (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 4
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: Bedridden (for 3 months); Dementia; Glaucoma; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: hypernatremia; Result Unstructured Data: Test Result:167; Test Date: 20210724; Test Name: CRP; Result Unstructured Data: Test Result:548; Test Date: 20210724; Test Name: ecg; Result Unstructured Data: Test Result:notion of q wave negative; Comments: in d2/d3/avf/V2/V3; Test Date: 20210724; Test Name: GFR; Result Unstructured Data: Test Result:23; Test Date: 20210724; Test Name: proBNP; Result Unstructured Data: Test Result:8242; Test Date: 20210724; Test Name: troponin ic; Result Unstructured Data: Test Result:22
CDC Split Type: FRPFIZER INC202101010497

Write-up: multivisceral failure; proBNP 8242; troponin IC 22; pneumopathy; biological inflammatory syndrome; Death NOS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority report number FR-AFSSAPS-LY20218521. A 91-years-old male patient received bnt162b2 (COMIRNATY), dose 2 on 20Jul2021 as single dose for covid-19 immunisation. Medical history included hypertension arterial, glaucoma, dementia, bedridden for 3 months. No history of COVID19. The patient''s concomitant medications were not reported. On 21Jul2021, patient experienced fever. On 23Jul2021: beginning of treatment by Augmentin for probable inhalation pneumopathy by the Treating doctor (no X-ray made). On 24Jul2021: in front of a persistent dyspnea, the patient was sent to the emergency room. He presented a biological inflammatory syndrome with a CRP 548, a renal insufficiency: GFR 23, hypernatremia 167, troponin IC 22, proBNP 8242. Modified ECG with notion of q wave neg in d2/d3/avf/V2/V3. Dyspnea in a context of multivisceral failure probably related to a pneumopathy. Given the age and the precariousness of the patient''s general condition, the collegial decision was made: no further cardiac exploration but exclusive palliative management, hospitalization in the palliative care unit. Death of the patient on 25Jul2021. In total, death occurred at Day 5 of Dose 2 of Comirnaty. Outcome for the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1575382 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: Diabetes; Ischaemic heart disease; Kidney failure chronic; Obesity.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101016186

Write-up: therapeutic inefficiency; Covid-19 infection, English variant; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-RN20212351. A 60-year-old male patient received BNT162B2 (COMIRNATY), first dose via intramuscular on 05Mar2021 as single dose, second dose via an unspecified route of administration on 01Apr2021 as single dose, for covid-19 immunisation. Medical history included ischaemic heart disease, obesity, kidney failure chronic and diabetes. The patient had no history of Covid-19. The patient''s concomitant medications were not reported. On 26Apr2021, patient presented with a Covid-19 infection, English variant, and therapeutic inefficiency. Non-resuscitative patient and died on 28Apr2021. The outcome of the events was fatal. The patient died on 28Apr2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Covid-19 infection, English variant; therapeutic inefficiency


VAERS ID: 1575395 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-10
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101016174

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from two contactable consumers. This is a report received from the Regulatory Authority. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202107050949162380-DNLOP) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25594557). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) as Dose 2, Single, on an unknown date as dose 1, single for COVID-19 immunization. It was unsure if patient has had symptoms associated with COVID-19 and if patient is enrolled in clinical trial. The patient medical history & concomitant medications were not reported. The patient experienced sars-cov-2 infection on 01Jul2021 (as reported). The patient underwent lab tests and procedures which included COVID-19 virus test with Positive result on 10Jun2021. The patient died on 01Jul2021. 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: SARS-CoV-2 infection; SARS-CoV-2 infection


VAERS ID: 1575490 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Disorder circulatory system; Dyspnoea on effort (recurrent breathing/circulatory problems on exertion).
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary disease (Possible pre-existing coronary heart disease); Diaphragmatic hernia (Examined by GP primarily unremarkable-referral to specialist suspicion of diaphragmatic hernia); Fainting (sometimes passed out).
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100987845

Write-up: Circulatory failure; Myocardial infarction / STEMI; initial unconsciousness; This is a spontaneous report from a contactable consumer (patient''s chilld) downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-38503. A 51-year-old male patient received the second dose of bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 25Jul2021 14:00 (at the age of 51 years old) (Lot Number: FD0168) as dose 2, single for COVID-19 immunization. Medical history included coronary artery disease (possible pre-existing coronary heart disease), diaphragmatic hernia (examination by the general practitioner primarily unremarkable - referral to specialist, suspicion of possible diaphragmatic hernia), ongoing Dyspnoea on effort (recurrent breathing/circulatory problems on exertion), fainting (sometimes passed out), ongoing disorder circulatory system. The patient had no concomitant medications. The patient took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. He was vaccinated at 14:00 on 25Jul2021 and in the evening the incident happened. Patient experienced initial unconsciousness and Myocardial infarction / STEMI (ST-segment elevation myocardial infarction). The next day on 26Jul2021, patient had circulatory failure and at 05:50, he died in the intensive care unit. Therapeutic measures were taken as a result of the events. Rescue transport to hospital, initial outpatient treatment in the emergency department until the onset of circulatory arrest - followed by ECMO (extracorporeal membrane oxygenation), PCI (percutaneous coronary intervention), treatment in the cardiac intensive care unit. Death the following morning. Patient had a history of recurrent respiratory and circulatory problems. Examination by the general practitioner was unremarkable - referral to a specialist, suspicion of a possible diaphragmatic hernia. Appointment could not be kept due to emergency / death. Possible pre-existing coronary heart disease - diagnosis not made by doctor. Suspicion that vaccination may have aggravated this possible CHD or led to the final infarction. The events ''initial unconsciousness'' and ''Myocardial infarction / STEMI'' resulted in an emergency room visit. The patient was hospitalized due to ''Myocardial infarction / STEMI'' and ''Circulatory failure''. The patient''s outcome was not recovered/not resolved for Unconsciousness, for the rest of the events was fatal. The patient died on 26Jul2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Circulatory failure; Myocardial infarction / STEMI


VAERS ID: 1575492 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-04-13
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: ATPFIZER INC202101016132

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is AT-BASGAGES-2021-39201. A 65 years old female patient received the first dose of Comirnaty at single dose on 07Jan2021, the second dose of Comirnaty at single dose on 29Jan2021, both for COVID-19 immunisation. Relevant history and concomitant dugs were not reported. On 13Apr2021 the patient experienced Vaccination failure / SARS-CoV-2 infection. The outcome of event was unknown. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1575493 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-04
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: N501Y-positive; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016136

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39207. A 78-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EJ6797; Expiration Date: 30Apr2021) as single dose, dose 1 via an unspecified route of administration on 12Jan2021 (Batch/Lot Number: EJ6796; Expiration Date: 30Apr2021) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on 04Mar2021. The patient underwent lab test and which N501Y-positive on 04Mar2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of sars-cov-2 infection was fatal. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EJ6796 and EJ6797. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2 infection


VAERS ID: 1575494 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-22
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Variant Sequenced; Result Unstructured Data: Test Result:Variant Sequenced B.1.1.7 N501Y positive
CDC Split Type: ATPFIZER INC202101016177

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number AT-BASGAGES-2021-39223. A 92-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: Unknown) as SINGLE DOSE, dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: EL1491; Expiration Date: 30Apr2021) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 22Mar2021 the patient experienced Vaccination failure and SARS-CoV-2 infection. The case was reported as serious due to death, medically significant. The patient underwent lab tests and procedures which included Variant Sequenced B.1.1.7 N501Y positive on an unknown date. The outcome of the events was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. Investigation results received on 10Aug2021: Product-Description: Compound bnt 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1. Lot number: EL1491 and expiration date: 30Apr2021. Conclusion: 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 EL1491. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No Lot-Specific Trend Identified. Site Sample Status: Not Received. No follow-up attempts possible. Information about lot/batch number of 2nd dose cannot be obtained. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1575495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-30
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Test Result: Positive ; Comments: Variant PCR based B.1.1.7; N501Y positive.
CDC Split Type: ATPFIZER INC202101016183

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician and concerns downloaded from the WEB AT-BASGAGES-2021-39224. A 93-year-old female patient received the second and first dose of BNT162B2 (COMIRNATY), second dose on 11Feb2021 (Lot Number: EJ6134; Expiration Date: 30Apr2021), first dose on 21Jan2021 (Lot Number: EL1491; Expiration Date: 30Apr2021), both via an unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 30Mar2021, the patient experienced SARS-CoV-2 infection death. The patient performed PCR, Variant PCR based B.1.1.7; N501Y positive. The cause of death was unknown. Autopsy was not reported. The outcome of events was fatal. 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 5616433 (see File attachment in this investigation record) The complaint for 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 EL1491. 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. It concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. It 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. 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 5686343 (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 EJ6134. 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. It concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. It 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 possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575496 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-24
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Test Name: SARS-cov-2 test; Test Result: Positive ; Comments: Variant: B.1.1.7 ; N501Y positive
CDC Split Type: ATPFIZER INC202101016111

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 93-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on an 05Mar2021 (Batch/Lot number EP2163, Batch expiry date: 31May2021) as single dose, dose 2 via an unspecified route of administration on an 26Mar2021 (Batch/Lot number ET7205, Batch expiry date: 31Jul2021) as single dose, for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 24Apr2021 the patient experienced Vaccination failure, SARS-CoV-2 infection. Variant Sequenced B.1.1.7; N501Y positive. The patient''s outcome was fatal for SARS-CoV-2 infection. Product complaint investigation conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET7205. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. 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 EP2163. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1575497 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-07-18
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Variant PCR based B.1.617.2; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016119

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39259. A 52-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EW2239; Expiration Date: 31Jul2021) at single dose, and the first dose via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: ET1831; Expiration Date: 30Jun2021) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure, and sars-cov-2 infection on 18Jul2021. The patient underwent lab tests and procedures which included variant PCR based B.1.617.2: Positive (N501Y) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. 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 lots EW2239 and ET1831. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1575498 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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 Name: SARS-COV-2; Result Unstructured Data: Test Result: Variant PCR based: B.1.1.7; N501Y positive.
CDC Split Type: ATPFIZER INC202101016125

Write-up: SARS-CoV-2 infection; Vaccination failure; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39260. A 62-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on an 17Mar2021 (Batch/Lot number ET1831, Batch expiry date: 30Jun2021) as single dose, dose 2 via an unspecified route of administration on an 03Apr2021 at patient age of 62-year-old (Batch/Lot number EW2239, Batch expiry date: 31Jul2021) as single dose, for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 24Apr2021 the patient experienced Vaccination failure, SARS-CoV-2 infection. Variant PCR based: B.1.1.7; N501Y positive. The patient''s outcome was fatal for SARS-CoV-2 infection. Product complaint investigation conclusion: 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 of the reported lot EW2239. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot ET1831. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The 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 possible. No further information expected. ; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1575499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Headache, Malaise, Pneumonia, Unresponsive to stimuli, Vascular dementia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100999557

Write-up: Pneumonia; Unresponsive to stimuli; Vascular dementia; Contusion; Headache; Malaise; This is a spontaneous report from a contactable other health professional received from the Regulatory Authority; the Regulatory Authority report number is 595495. An 83-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced pneumonia, unresponsive to stimuli, vascular dementia, contusion, headache, and malaise, all with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Contusion; Headache; Malaise; Pneumonia; Unresponsive to stimuli; Vascular dementia


VAERS ID: 1575536 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute psychosis, Completed suicide, Euphoric mood
SMQs:, Suicide/self-injury (narrow), Systemic lupus erythematosus (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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: MADOPAR
Current Illness: Disease Parkinson''s
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202100997423

Write-up: He wrote a farewell note, probably installed the rope in the garage, then swallowed about 2 packages of sleeping pills and hanged himself; With the first vaccination we already noticed mood swings, after the second vaccination he had a brief, extremely euphoric phase and then shortly afterwards a psychic breakdown; With the first vaccination we already noticed mood swings, after the second vaccination he had a brief, extremely euphoric phase and then shortly afterwards a psychic breakdown; This is a spontaneous report received from a contactable consumer via Regulatory Authority. Regulatory authority report number CH-SM-2021-18663. A 76-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 29May2021 at 76-years-old (Batch/Lot Number: EW6126) as dose 2, single for covid-19 immunisation. Medical history included Parkinson''s disease (Disease Parkinson''s) diagnosed 5 years ago (2016 and ongoing) and being treated with Madopar. Following the diagnosis he initially experienced a depressive phase, but then resolved (not known if treated pharmacologically). The disease is stable with ongoing therapy. Not known if there are other co-morbidities or allergies / intolerances. Concomitant medication included benserazide hydrochloride, levodopa (MADOPAR) taken for Disease Parkinson''s. The patient received both doses of Comirnaty: first dose on 08May2021 (at 76-years-old, single, intramuscular, Lot number EX2405) and second dose on 29May2021. Already after the first dose (latency unknown) family members noticed mood swings. After the second dose, on 29May2021, after about 2 hours, the patient shows a brief euphoric phase followed immediately after by a psychic breakdown. The same symptomatology is reported at the same time on Sunday 30May2021 and also on the afternoon of Monday 31May2021. On Tuesday 01Jun2021 his wife contacted him by phone at 12:00 pm where he did not have any signs of depression and was carrying out his usual activities ("I phoned him at 12:00pm, no signs of depression, he was happy that I wanted to go home earlier. He ate breakfast at 09:00am and the prepared lunch at 01:30pm as always"). At about 03:15pm his son contacted him by telephone and reports that he found him a little down but without worrying signals ("When he phoned with his son at 03:15pm, he was a bit down, but made no hints, on the contrary, he said that he was happy to see him soon). He took his own life (Accomplished suicide) when he was home alone at 04:00pm. He wrote a farewell note, probably installed a rope in the garage and then swallowed about 2 packages of sleeping pills (drug name unknown) and hanged himself. Autopsy pending, probably not ready for inspection until October. It is not known where the event happened. The patient outcome of the event after the second vaccination he had a brief, extremely euphoric phase and then shortly afterwards a psychic breakdown was not recovered. The patient died on 01Jun2021. It was not reported if an autopsy was performed. Event occurred in a country different from that of the reporter. A causal relationship between Comirnaty and events was assessed as unlikely. Regulatory Authority assessed this case as serious with fatal outcome. Sender''s comment: Suicide occurred 3 days after the second dose of Comirnaty in an elderly patient known for Parkinson''s disease and with a history of depression. Psychiatric symptoms manifested with mood swings after the first dose (latency unknown) and then with alternating phases of euphoria and collapse 2h after the second dose. Vaccination and likely death occurred. From the information sent by the reporter, an autopsy is planned, but it is not known when the report will be available. Psychiatric symptom and suicide are not known adverse events for Comirnaty in both the Regulatory Authority monograph and FDA data sheets. In Reports they report no psychiatric symptoms and suicide deaths in adverse events to covid-19mRNA vaccines. Cases of onset of psychotic symptoms in COVID-19 positive patients without prior psychiatric pathology, with resolution of symptoms after recovery from COVID-19, are described in the literature [1]. However, to date, there are no data in the literature on possible psychiatric exacerbations and deaths by suicide following COVID-19 vaccinations. In the database [2], out of a total of 529,095 reports on Comirnaty, 11 cases of completed suicide (PT) are counted. In light of the data at our disposal, given the absence of data in the literature, in a patient known for a previous depressive episode, despite the restricted timing, the causal link between psychiatric symptom and accomplished suicide is judged unlikely. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Summary of Reporter Comment: Suicide occurred 3 days after the second dose of Comirnaty in an elderly patient known for Parkinson''s disease and with a history of depression. Psychiatric symptoms manifested with mood swings after the first dose (latency unknown) and then with alternating phases of euphoria and collapse 2h after the second dose. Vaccination and likely death occurred. From the information sent by the reporter, an autopsy is planned, not known when report is available.; Sender''s Comments: Based on the reported information and possible contributory effects from patient''s medical history of Parkinson''s disease and depression, a causal association between the reported events of complete suicide, acute psychosis and suspect drug bnt162b2 was assessed as unrelated.; Reported Cause(s) of Death: He wrote a farewell note, probably installed the rope in the garage, then swallowed about 2 packages of sleeping pills and hanged himself


VAERS ID: 1575582 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   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 UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   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; Cardiac discomfort; Stomach discomfort
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987771

Write-up: Sudden cardiac death; This is a spontaneous report from a physician downloaded from the WEB, company number DE-PEI-202100133877. A 74-year-old female patient received bnt162b2 (COMIRNATY) at the age of 74-years-old, via an unspecified route of administration on 23Jun2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. Medical history included stomach discomfort, cardiac discomfort and arterial hypertension from unknown dates. The patient''s concomitant medications were not reported. The patient experienced sudden cardiac death on 24Jun2021. The patient died on 24Jun2021. An autopsy was performed and results were not provided. Pathological-anatomical not unequivocally ascertainable, most likely sudden cardiac death in cardiac hypertrophy, 2-vessel CHD; no meaningful connection between vaccination and onset of death. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1575588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-08
   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 UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic stenosis, Aortic valve incompetence, Cardiogenic shock, Dyspnoea, International normalised ratio, International normalised ratio increased, Platelet count, Platelet count decreased, Thrombosis
SMQs:, Cardiac failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (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), 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: 2021-04-12
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement (mechanical)
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: INR; Result Unstructured Data: Test Result:over 7; Test Date: 20210408; Test Name: platelets; Result Unstructured Data: Test Result:low
CDC Split Type: DEPFIZER INC202100987709

Write-up: INR over 7; Aortic stenosis; Aortic insufficiency; Shock/cardiogenic shock; Dyspnoea; Low platelets; Thrombosis; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number is DE-PEI-202100145039. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Apr2021 (lot number and expiry date: unknown) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history mechanical aortic valve replacement. Concomitant medications were not reported. On 08Apr2021, the patient experienced aortic stenosis, aortic insufficiency shock (cardiogenic shock), dyspnoea, low platelets, and thrombosis. On 11Apr2021, the patient showed International normalised ratio (INR) over 7. The patient underwent lab tests and procedures which included platelets: low on 08Apr2021; and international normalised ratio (INR): 7 on 11Apr2021. The patient died on an 12Apr2021 due to the events. It was unknown if an autopsy was performed. The health authority (PEI) assessed the event as B. intermediate. Sender''s comment: Hospital referral 5 days after vaccination, chemical laboratory INR over 7, fault with mechanical aortic valve with aortic stenosis and aortic insufficiency, consequently progressing cardiogenic shock and exitus letalis 6 days after the vaccination. Basic illness: mechanical aortic valve replacement, year of birth given only. No follow-up attempts are possible, information on lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: aortic insufficiency; Aortic stenosis; Dyspnoea; Low platelets; Thrombosis; shock/cardiogenic shock; exitus letalis; INR over 7


VAERS ID: 1575589 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D012A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autoimmune haemolytic anaemia, Cardiac arrest, Diastolic dysfunction, Haemolysis, Hyperkalaemia, Hypoxia, Lactic acidosis, Pulmonary embolism, Renal failure, Right ventricular failure, Septic shock
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987590

Write-up: cardiovascular arrest; Pulmonary embolism; Autoimmune haemolytic anaemia; acute right heart failure; other microembolic hypoxaemia; Haemolytic crisis; Severe lactic acidosis; hyperkalaemia; kidney failure; septic shock; Diastolic Dysfunction; This is a spontaneous report from a non-contactable physician downloaded from the WEB, regulatory authority number DE-PEI-202100146481. A 68-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26May2021 at 68-years-old (Batch/Lot Number: 1D012A) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took first dose of bnt162b2 (COMIRNATY, strength 0.3 ml), on 27Apr2021 at 68-years-old for covid-19 immunisation. The patient experienced pulmonary embolism (death) on 15Jun2021, autoimmune haemolytic anaemia (death) on 15Jun2021, cardiovascular arrest in 22Jun2021 with outcome of unknown, acute right heart failure in 2021 with outcome of unknown, other microembolic hypoxaemia in 2021 with outcome of unknown, haemolytic crisis in 2021 with outcome of unknown, severe lactic acidosis in 2021 with outcome of unknown, hyperkalaemia in 2021 with outcome of unknown, kidney failure in 2021 with outcome of unknown, diastolic dysfunction in 2021 with outcome of unknown, septic shock in 2021 with outcome of unknown. The patient died on 23Jun2021. An autopsy was performed and results were not provided. This report is serious due to death. Comirnaty/ all events/ Unclassifiable. Reporter''s comment: Diagnosis/ies: The lethal outcome on 09Apr2021. Sudden intrahospital cardiovascular arrest on 22Jun2021 a. e. as a result of acute right heart failure with microembolic. Pulmonary artery embolism V. a. other microembolic hypoxaemia in severe autoimmune haemolytic anaemia with V. a. Haemolytic crisis. Severe lactic acidosis, hyperkalaemia, kidney failure. Diastolic Dysfunction, septic shock. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Diagnosis/ies: The lethal outcome on 09Apr2021. Sudden intrahospital cardiovascular arrest on 22Jun2021 a. e. as a result of acute right heart failure with microembolic. Pulmonary artery embolism V. a. other microembolic hypoxaemia in severe autoimmune haemolytic anaemia with V. a. Haemolytic crisis. Severe lactic acidosis, hyperkalaemia, kidney failure. Diastolic Dysfunction, septic shock.; Reported Cause(s) of Death: Autoimmune haemolytic anaemia; Pulmonary embolism


VAERS ID: 1575590 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Echocardiogram, Ejection fraction, Epistaxis, Fall, Physical examination, Platelet count, Thrombocytopenia, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 38
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: Adiposis; Angioplasty; Aortic sclerosis; Aortic valve stenosis (High grade; mean graded atrioventricular=34 mmHg); Arterial stenosis; Atrial fibrillation (Persistent atrial fibrillation, CHA2DS2VASc score 5, HAS-BLED score 2); Cardiac catheterization (Non-ST-Elevation Myocardial Infarction: Balloon angioplasty and stenting of the main trunk...); Coronary heart disease (Coronary three-vessel disease); Hyperlipidemia; Hypertensive heart disease; Ischemic cardiomyopathy; Nicotine abuse; Non ST segment elevation myocardial infarction; Obesity; Obstructive sleep apnoea syndrome; Peripheral arterial occlusive disease (Peripheral Arterial Oclusive Disease stage lla of the pelvic/thigh type); Pulmonary hypertension (World Health Organization group II); Renal insufficiency (Chronic renal failure st. 5, current glomerular filtration rate 14.8 ml/min.); Stenosis (High-grade stenosis of the brachiocephalic trunk); Stenosis; Type II diabetes mellitus (newly diagnosed, Hb1AC currently 6.2 %)
Allergies:
Diagnostic Lab Data: Test Name: ejection fraction; Test Result: 30 %; Test Name: Clinical examination; Result Unstructured Data: Test Result:Clinically, laboratory serochemically and radiogra; Comments: ..radiographically, we were able to confirm the picture in the context of decompensated heart failure with known Ischemic Cardiomyopathy and high-grade aortic valve stenosis. We started i.v. diuretic therapy with furesis. Furthermore, the renal retention parameters deteriorated.; Test Date: 20210416; Test Name: Platelets; Result Unstructured Data: Test Result:30,000; Test Name: echocardiographically; Result Unstructured Data: Test Result:detectable cardiac arrest
CDC Split Type: DEPFIZER INC202100987578

Write-up: Thrombocytopenia; Decompensated heart failure; Epistaxis; ventricular fibrillation; Fell in the bathroom adn had to be resuscitated; This is a spontaneous report from a non-contactable physician downloaded from the WEB, regulatory authority number DE-PEI-202100146577. An 84-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ET3674) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. Medical history included arterial stenosis, atrial fibrillation (Persistent atrial fibrillation, CHA2DS2VASc score 5, HAS-BLED score 2), coronary heart disease (Coronary three-vessel disease), aortic sclerosis, type 2 diabetes mellitus (newly diagnosed, Hb1AC currently 6.2 %), renal insufficiency (Chronic renal failure st. 5, current glomerular filtration rate 14.8 ml/min), obesity, pulmonary hypertension (World Health Organization group II), hyperlipidemia, nicotine abuse, cardiac catheterization from 23May2019 (at Non-ST-Elevation Myocardial Infarction: Balloon angioplasty and stenting of the main trunk towards the Ramus Circumflexus and provisional stenting of the Ramus Inter Ventricularis Anterior ostium. Very good long-term result after Root cause analysis intervention 2017. Balloon angioplasty of the right iliac artery for severe stenosis), aortic valve stenosis from 08Jun2020 (High grade aortic valve stenosis in invasive measurement from 08Jun2020 mean graded atrioventricular=34 mmHg), stenosis in the Ramus Inter Ventricularis Anterior from 08Jun2020 (High Care Unit of 08Jun2020: In-stent restenosis of the main stem, significant stenosis in the Ramus Inter Ventricularis Anterior), stenosis of the left subclavian artery with subclavian steal phenomenon from 12Jun2020, Hypertensive heart disease, Peripheral Arterial Oclusive Disease (Peripheral Arterial Oclusive Disease stage lla of the pelvic/thigh type), Adiposis, Obstructive sleep apnoea syndrome, and stenosis of the brachiocephalic trunk. The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY) on 03Mar2021 for covid-19 immunisation. On 30Mar2021, the patient experienced epistaxis. On 05Apr2021, the patient experienced decompensated heart failure. On 16Apr2021, the patient experienced thrombocytopenia. The events caused hospitalization on an unspecified date. It was also reported that the patient had decompensated heart failure with highly reduced Left ventricular ejection fraction (30%). On admission, the patient was in a clearly reduced general condition. Clinically, laboratory serochemically and radiographically, the physicians were able to confirm the picture in the context of decompensated heart failure with known ischemic cardiomyopathy and high-grade aortic valve stenosis. They started intravenous (IV) diuretic therapy with furesis. Furthermore, the renal retention parameters deteriorated. On 07May2021, the patient fell in the bathroom and had to be resuscitated. Resuscitation measures were started immediately. Emergency intubation followed. After a total of 2 mg of adrenaline, they observed ventricular fibrillation. Resuscitation measures were continued including one-time defibrillatiory and further adrenaline administration, but showed no effect. In case of degeneration into persistent asystole and echocardiographically detectable cardiac arrest, resuscitation measures had to be discontinued without success. The patient died on 07May2021 at 21.38 hrs. The patient underwent lab tests and procedures which included clinical examination: clinically, laboratory serochemically and radiographically, we were able to confirm the picture in the context of decompensated heart failure with known Ischemic Cardiomyopathy and high-grade aortic valve stenosis. They started intravenous (IV) diuretic therapy with furesis. Furthermore, the renal retention parameters deteriorated on an unspecified date; and platelet count: 30,000 on 16Apr2021. Therapeutic measures were taken as a result of decompensated heart failure and epistaxis. The events decompensated heart failure and epistaxis resulted to fatal outcome. The outcome of events thrombocytopenia, fall, and ventricular fibrillation were unknown at the time of death. The patient died on 07May2021 at 21:38 hours. It was not reported if an autopsy was performed. Reporter''s Comment: Platelets on 16Apr2021 33,000 No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Platelets on 16Apr2021 33,000; Reported Cause(s) of Death: Decompensated heart failure; Epistaxis


VAERS ID: 1575596 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diagnostic procedure
SMQs:

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: Coronary heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack; Infarct myocardial (10 years ago); Non-smoker; Stent insertion NOS
Allergies:
Diagnostic Lab Data: Test Name: diagnostics; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DEPFIZER INC202100996218

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100152819. A 56-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 22Jul2021 as dose 2, single for covid-19 immunisation. The patient''s medical history included infarct myocardial from 2011 to an unknown date (reported as 10 years ago) which was as a single-vessel disease that has been treated with a stent on an unknown date, heart attack on an unknown date, and ongoing coronary heart disease. The patient has seen her cardiologist regularly. There the diagnostics indicated after infarction has been carried out regularly (dates unspecified; unknown results), the prescribed medication (according to guidelines) has been taken reliably, has been a non-smoker and has not had diabetes mellitus or other risk factors. She has not had uttered anginal complaints recently or after the heart attack. The patient''s concomitant medications were not reported. The patient received dose 1 of Comirnaty (strength: 0.3 ml) on 01Jul2021 for covid-19 immunisation. This report is serious - death. It was reported that 2 days after vaccination, on 24Jul2021, the patient experienced unknown cause of death. It was reported that patient had already entered rigor mortis. The woman had died in a semi-sloping prone position on the sofa, probably during the midday rest and was found by her husband. The husband reported seeing his wife last around 12:00 p.m., at which time she was symptom-free. The inquest did not reveal any evidence of an externally apparent cause of death. It was unknown if an autopsy was performed. In particular, the situation in which it was found (lying flat on the prone position, no leakage of pulmonary edema fluid or vomit) and the anamnestic information make death from the known Coronary heart disease appear relatively unlikely. Relatedness of drug to reaction/event as per source of assessment PEI was unclassifiable. Reporter''s Comments: It was a 56-year-old woman who had already entered rigor mortis. The woman had died in a semi-sloping prone position on the sofa, probably during the midday rest (?) And was found by her husband. The husband reported seeing his wife last around 12:00 p.m., at which time she was symptom-free. In medical history I was told of a stable Coronary heart disease, around 10 years earlier myocardial infarction as a single-vessel disease has been treated with a stent. The patient has seen her cardiologist regularly. There the diagnostics indicated after infarction has been carried out regularly, the prescribed medication (according to guidelines) has been taken reliably, has been a non-smoker and has not had diabetes mellitus or other risk factors. She has not have uttered anginal complaints recently or after the heart attack. The vaccination card presented to me for the deceased showed the entry of a BioNTech initial vaccination with the COMIRNATY vaccine on 01Jul2021, the 2nd vaccination with the same vaccine was carried out on 22Jul2021 approx. 48 hours before death. The inquest did not reveal any evidence of an externally apparent cause of death. In particular, the situation in which it was found (lying flat on the prone position, no leakage of pulmonary edema fluid or vomit) and the anamnestic information make death from the known Coronary heart disease appear relatively unlikely. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Summary of Reporter''s Comments: It was a 56-year-old woman who had already entered rigor mortis. The woman had died in a semi-sloping prone position on the sofa. The situation in which it was found (lying flat on the prone position, no leakage of pulmonary edema fluid or vomit) and the anamnestic information make death from the known Coronary heart disease appear relatively unlikely.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575599 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100996809

Write-up: Unknown cause of death; first dose of COMIRNATY (strength: 0.3 ml) on 07May2021 and the second dose on 16Jul2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100152920. A 74-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Jul2021 (Batch/Lot Number: FF0900) as dose 2, 0.3 mL single (at the age of 74-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of COMIRNATY (strength: 0.3 ml) on 07May2021 and the second dose on 16Jul2021. 12 days after vaccination, on 28Jul2021, the patient experienced unknown cause of death. The event unknown cause of death was considered serious, fatal by the regulatory authority. It was unknown if an autopsy was performed. No follow-up activities possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575600 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-07-29
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Interchange of vaccine products
SMQs:, Medication errors (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: MARCUMAR
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPEI202100155098

Write-up: This case was received via Regulatory Agency (Reference number: 202100155098) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH in a 74-year-old male patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) for Prophylactic vaccination. Concurrent medical conditions included Hypertension. Concomitant products included PHENPROCOUMON (MARCUMAR). On 26-Apr-2021, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (unknown route) 1 dosage form. On 19-Jul-2021, the patient received second dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product). The patient died on 29-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product) outcome was unknown. For mRNA-1273 (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Company comment: This case concerns an 74-year old male with medical history of Hypertension who died after receiving mRNA-1273. The cause of death was not reported. 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 09-Aug-2021: Additional document attached on 9-AUG-2021.contain concomitant drug and medical history were added; Sender''s Comments: This case concerns an 74-year old male with medical history of Hypertension who died after receiving mRNA-1273. The cause of death was not reported. 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: Unknown cause of death.


VAERS ID: 1575603 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Gout; Heartburn
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016086

Write-up: Infarct myocardial; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority report number is DE-PEI-202100157147. A 37 years old male patient received bnt162b2 (COMIRNATY, strength 0.3 ml), via an unspecified route of administration on 22Jun2021 (Batch/Lot number was not reported) (at the age of 36 years old) as single dose for covid-19 immunisation. Medical history included heartburn; gout; asthma and allergy; all from an unknown date and unknown if ongoing. Concomitant medication included omeprazole (OMEPRAZOL) taken for an unspecified indication, start and stop date were not reported. On 26Jun2021, the patient experienced Infarct myocardial, serious resulting in death. Diagnosis was confirmed by autopsy. The patient''s outcome was fatal for Infarct myocardial. The patient died on 26Jun2021. An autopsy was performed that revealed infarct myocardial. Relatedness of drug to reaction/event Infarct myocardial by Regulatory Authority was Unclassifiable. Sender Comment: Result of autopsy: fateful course, no connection to medication or vaccination. - Significant enlargement of the heart (550 g) - Atheroma plaques in all three main branches of the coronary artery - Pale heart muscle with streaky, reddish bleeding in places - Acute congestion of blood in the internal organs - pulmonary edema - Enlargement of the liver and fatty liver. The autopsy findings show a very recent heart attack. Despite only slight narrowing of the coronary arteries, a significant enlargement of the heart evidently led to an oxygen deficiency and thus to a heart attack. The autopsy - - did not reveal any evidence of a competing cause of death. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial; Autopsy-determined Cause(s) of Death: Infarct myocardial


VAERS ID: 1575607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, Fibrin D dimer, Interchange of vaccine products, Off label use, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: echo; Result Unstructured Data: Test Result:right heart strain; Test Name: D-dimer; Result Unstructured Data: Test Result:increased
CDC Split Type: DEPFIZER INC202101016081

Write-up: pulmonary artery embolism suspected; Interchange of vac patient receives one dose of Astra Zeneca and the patient receives the BNT162b2 vaccine as their second dose; Interchange of vac patient receives one dose of Astra Zeneca and the patient receives the BNT162b2 vaccine as their second dose; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100158187. A female patient of an unspecified age received BNT16B2 (COMIRNATY), 2nd dose via an unspecified route of administration on 16Jul2021 (Lot Number: FF0900, expiration date unknown) as a single dose (INITIAL PFIZER DOSE) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received VAXZEVRIA with 1st does (lot number and expiration date were unknown) on 04May2021 for covid-19 immunisation. The patient experienced pulmonary artery embolism suspected (death, hospitalization, life threatening) on an unspecified date. The patient underwent lab tests and procedures which included echocardiogram: right heart strain, D-dimer: increased, both on an unknown date. The patient died due to unknown cause of death and pulmonary artery embolism suspected on an unspecified date. It was not reported if an autopsy was performed. Relatedness of Comirnaty to Lung embolism: Result of Assessment: Unclassifiable from Regulatory Authority. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death; pulmonary artery embolism suspected


VAERS ID: 1575609 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / 1 - / -

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 INC202101026276

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100159350. A 54-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 25Jun2021 (Batch/lot number: FD9234), at age 54 years old, as dose 1, 0.3 ml single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sudden cardiac death. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was done. The health authority assessed the relatedness of drug reaction to event as D: Unclassifiable (Source of assessment: Regulatory Authority). No follow-up attempts possible. No further information is expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1575610 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / -

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: 2021-08-04
   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: COPD; Cor pulmonale; Coronary heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101026671

Write-up: Myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority: DE-PEI-202100159351. A 68-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Aug2021, at the age of 68-years-old, (Lot Number: FE9174) as dose 2, single for covid-19 immunisation. Medical history included ongoing Cor pulmonale, ongoing coronary heart disease, and ongoing chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. On 04Aug2021, 10 hours after vaccination, the patient experienced fatal Myocardial infarction. The patient died on 04Aug2021. It was not reported if an autopsy was performed. ; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1575668 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-26
   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: Death, Labyrinthitis, Tonsillar inflammation, Wrong product administered
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diarrhea
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987599

Write-up: inner ear infection; Shortly after the vaccination, tonsillitis treated with antibiotics / Tonsillar inflammation; first vaccination was with VAXZEVRIA, then vaccinated the patient with COMIRNATY; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number DE-PEI-CADR2021124249. Additional case identifier: DE-PEI-202100120370. A 50-year-old male patient received BNT162B2 (COMIRNATY, solution for injection) dose 2 via an unspecified route of administration on 05Apr2021 (Lot number was not reported) as dose 2 (initial Pfizer dose), single for COVID-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration from an unspecified date (Lot number was not reported) to an unspecified date, at dose 1, single for an COVID-19 immunisation. Medical history included diarrhoea. Patient had no previous illnesses. The patient''s concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. The first vaccination was with VAXZEVRIA on an unspecified date. On 05Apr2021, the vaccination center vaccinated the patient with COMIRNATY according to the vaccination records found, because the deceased was under 60 years of age and the recommendation of the Standing Committee on Vaccination to restrict the AstraZeneca vaccination to the age group more than 60 years old was implemented at short notice by the vaccination center from 01Apr2021. On an unspecified date shortly after the vaccination, the patient had inner ear infection, where he was given antibiotics (it was not known at which doctor''s office). On an unspecified date, patient tonsillitis (tonsillar inflammation) treated with antibiotics. On 26Apr2021 10:40 am, patient died (unknown cause of death). Patient had no risk factor known, pre-existing conditions according to the treating physician on 18Mar2021, lastly at doctor office due to diarrhoea. o signs of illness/bleeding were found (the deceased was found lying in bed, box of paracetamol 500 mg and prednisolon acid 10 mg were found in a drawer at the location. The patient''s outcome was fatal for unknown cause of death, not recovered/not resolved for tonsillar inflammation, unknown for inner ear infection. The patient died on 26Apr2021. An autopsy was performed and results were not provided. The casual relationship of COMIRNATY and events were assessed as Unclassifiable. Reporter''s comment: clarification of vaccine situation, information about medical history Sender''s comment: Do you or the person concerned have any allergies? If so, which ones? Allergy against ibuprofen Information on risk factors or previous diseases no risk factor known, pre-existing conditions According to the treating physician on 18Mar2021, lastly at doctor office due to diarrhoea /. was found dead in his apartment on 26Apr2021 at 10.40 a.m., no autopsy carried out. No follow-up attempts are possible. Information on Batch/Lot numbers cannot be obtained. No further information is expected.; Reporter''s Comments: clarification of vaccine situation, information about medical history; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575670 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alveolitis, Autoimmune disorder, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: 2021-06-17
   Days after onset: 51
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Lung fibrosis (stabilised by medication); Rheumatic disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatological examination
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987700

Write-up: respiratory exhaustion; Alveolitis; Autoimmune disorder; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021134690. A 74-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Apr2021 (Batch/Lot Number: EX3599) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included Rheumatic disorder from 1990 and ongoing, Lung fibrosis from 2017 and ongoing (stabilised by medication), examination from 16Apr2021 11 am to an unknown date (Last examination with pulmonary fibrosis and rheumatism coordinating specialist: no significant change in the situation with rheumatism/pulmonary fibrosis, still stable. C vaccination recommendation maintained). Father was apparently not told anything about the mechanism of action or the associated waste products (peptides) and the resulting body''s own defense reactions. Patient still tried. Fear propaganda was stronger than reason, unfortunately. This is probably what happened to the vast majority of people who indulge in one-sided media insinuations. Just consider the very low percentage (%) of deaths among Covid-19(C)-sufferers. On16Apr2021, Covid-19 (C) vaccination recommendation. The patient''s concomitant medications were not reported. The patient experienced alveolitis (death, hospitalization) on 17Jun2021, autoimmune disorder (hospitalization) on 27Apr2021 with outcome of not recovered, respiratory exhaustion(hospitalization) on an unspecified date with outcome of unknown. The patient''s hospitalized and hospitalization was prolonged as a result of events, also reported as Hospital admission/Intense care unit (ICU), respiratory exhaustion, extracorporeal membrane oxygenation. The patient was hospitalized from 03Jun2021 to an unknown date. On 14Jun2021, treatment with particulate immune system blocker (without success). The patient died on 17Jun2021. An autopsy was not performed. Sender comment: Do you or the person concerned have any allergies? If so, which ones? None. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Alveolitis


VAERS ID: 1575671 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Breathing difficult; Heart attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987783

Write-up: Myocardial infarction old; Tachycardia; shortness of breath; chest pain; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number is DE-PEI-CADR2021134810. A 61-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 14May2021 at 12:50 (Batch/Lot Number: Unknown) (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing GOLD II chronic obstructive pulmonary disease (COPD), myocardial infarction/heart attack from 01Jan2021, severe back pain from 10May2021 to 14May2021 and feeling of not being able to breathe from 10May2021 to 14May2021. The patient''s concomitant medications were not reported. On 14May2021, patient experienced tachycardia, shortness of breath and chest pain. On 17May2021, patient experienced myocardial infarction old. The patient was hospitalized on an unspecified date due to the events. Therapeutic measures were taken as a result of myocardial infarction old. Outcome of myocardial infarction old was fatal, tachycardia was not recovered while rest of events was unknown. The patient died on 17May2021. An autopsy was not performed. Sender''s comment: My father was treated on 14May2021 at 12:50 by his general practitioner with BionTech vaccinated. He was suffering from stage GOLD II CHRONIC OBSTRUCTIVE PULMONARY DISEASE. In the week of 10May2021 to 14May2021 he had severe back pain and always the feeling of not being able to breathe. In retrospect, the doctors believe that he had already been suffering a heart attack. After the vaccination on 14May2021, he got severe shortness of breath again and chest pain. At around 9 p.m. (date unspecified), he was taken to the hospital by ambulance. The patient was taken to the emergency room of the university hospital and underwent emergency surgery. He died on 17May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: In retrospect, the doctors believe that he had already been suffering a heart attack. After the vaccination on 14May2021, he got severe shortness of breath again and chest pain. At around 9 p.m. (date unspecified), he was taken to the hospital by ambulance. The patient was taken to the emergency room of the university hospital and underwent emergency surgery. He died on 17May2021.; Reported Cause(s) of Death: Myocardial infarction old


VAERS ID: 1575672 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-07-16
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   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: DEPFIZER INC202100987988

Write-up: Death sudden; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number DE-PEI-CADR2021145491 with Safety Report Unique Identifier DE-PEI-202100145786. A 65-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Jun2021 (Batch/Lot Number: FC3095) as dose 2, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced ''death sudden'' on 16Jul2021. It was mentioned that patient fell dead off the bike while cycling without outside influence, resuscitation frustrated, patient was very sporty. The patient died on 16Jul2021. An autopsy was not performed. Event assessment : Comirnaty/ event/PEI /Result of Assessment: D. Unclassifiable. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no information on risk factors or previous illnesses none / fell dead off the bike while cycling without outside influence, resuscitation frustrated, patient was very sporty. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1575673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-09
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987987

Write-up: Chronic obstructive pulmonary disease; Lung embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021145517. A 72-years-old male patient received bnt162b2 (COMIRNATY, lot ER7812), via an unspecified route of administration on 27Mar2021 at unknown dose, 0.3ml single for Covid-19 immunisation. The patient medical history was not reported. No concomitant medications reported. On 09Apr2021 the patient experienced Lung embolism; COPD (Chronic obstructive pulmonary disease) on unspecified date, both with fatal outcome. Therapeutic measures were taken as a result of the events. The patient died on 09Apr2021. It was not reported if an autopsy was performed. Sender comment: Information on risk factors or previous diseases not available. The patient tracheostomized in Chronic obstructive pulmonary disease, ventilated, suddenly massively increased ventilation pressure, immediate respiratory and circulatory arrest. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lung embolism; Chronic obstructive pulmonary disease


VAERS ID: 1575674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-03
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D018A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Gait disturbance, Headache, Pain, Pelvic pain, Pulmonary embolism, Renal pain, Venous thrombosis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   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: Deep vein thrombosis leg; Joint surgery (two)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987749

Write-up: Lung embolism/pulmonary embolism; venous thrombosis; Pain NOS; Headache; severe pain occurred in the kidney/pelvic area; severe pain occurred in the kidney/pelvic area; deep seated pain in the hip area; no longer ate much/loss of appetite; felt limp; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021147664. A 79-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 09Jun2021 (Lot Number: 1D018A) as dose number unknown, 0.3 mL single for COVID-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing, and two joint operations. The patient''s concomitant medications were not reported. On 03Jul2021, the patient experienced pain NOS and headache. On 05Jul2021, the patient experienced lung embolism. It was reported that since vaccination, the patient has felt limp and no longer ate much, she had loss of appetite on unspecified date in 2021. In the night of 03Jul2021 to 04Jul2021, severe pain occurred in the kidney/pelvic area and deep seated pain in the hip area and headaches. The intake of painkillers became necessary. In the evening of 05Jul2021, the person concerned passed away. A venous thrombosis was suspected, which was led to pulmonary embolism. The outcome of the event severe pain occurred in the kidney/pelvic area and deep seated pain in the hip area was recovered on 04Jul2021, the outcome of the event was not recovered for pain NOS and headache, the outcome of the event lung embolism/pulmonary embolism and venous thrombosis was fatal, while the outcome of the events was unknown. The patient died on 05Jul2021. It was not reported if an autopsy was performed. Sender comment: Do you or the person concerned have any allergies? If so, which ones? No. Information on risk factors or previous diseases After two joint operations, the Leg thromboses. The one surgery in a The other operation was in both legs / Since the second operation, the leg has been damaged. Vaccination, the person concerned has felt limp and no longer ate much Loss of appetite In the night of 03Jul2021 to 04Jul2021 severe pain occurred in the Kidney/pelvic area and deep seated Pain in the hip area and Headaches. The intake of Painkillers became necessary. In the evening of 05Jul2021, the person concerned passed away. A venous thrombosis is suspected, which is led to pulmonary embolism. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lung embolism/pulmonary embolism; venous thrombosis


VAERS ID: 1575675 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-01
   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 - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100996096

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority. The Regulatory Authority Number is DE-PEI-CADR2021150610, and the Sender''s (Case) Safety Report Unique Identifier is DE-PEI-202100151101. A 47-year-old male patient received the first dose of BNT162B2 (COMIRNATY; strength: 0.3 ml; lot number: unknown), via an unspecified route of administration on 29Jun2021 (at an unspecified age) at dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jul2021, the patient experienced infarct myocardial. The patient died on an unspecified date in 2021. It was unknown if autopsy was done. Outcome of the event was fatal. Relatedness of BNT162B2 (COMIRNATY) to the event was D. unclassifiable (source of assessment: Regulatory Authority). 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: Infarct myocardial.


VAERS ID: 1575679 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-22
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 5
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: Ascites; Hepatic cirrhosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016091

Write-up: deceased; thrombus in the abdominal area; This is a spontaneous report received from a non-contactable Consumer downloaded from the Medicines Agency (MA) WEB number DE-PEI-CADR2021151187, Safety Report Unique Identifier DE-PEI-202100151072. An 82-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 31Mar2021 (lot number: unknown) via unknown route of administration at 0.3ml single dose for COVID-19 immunisation. Medical histories included Hepatic cirrhosis from unknown date and ongoing; Ascites from unknown date and ongoing. Concomitant medications were not reported. On 22Apr2021 the patient experienced thrombus in the abdominal area (hospitalization). On 27Apr2021 the patient experienced deceased. The patient''s outcome was not recovered for Thrombosis, fatal for Unknown cause of death. It was not reported if an autopsy was performed. The event assessment for all events to the suspect drug was reported as Unclassifiable. Sender Comment: Information on risk factors or previous illnesses liver cirrhosis, ascites / The patient was in inpatient treatment. Diagnoses: cirrhosis of the liver, ascites. No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Reported Cause(s) of Death: deceased


VAERS ID: 1575681 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-04
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C006A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal gland cancer; Cancer; Nephrectomy (one kidney removed in 1986)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016087

Write-up: Died; Weakness/feeling weak until completely powerless; Cough; Dyspnoea/shortness of breath; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021152779, Safety Report Unique Identifier: DE-PEI-202100153668. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 20May2021 (Lot Number: 1C006A) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included adrenal gland cancer from 1986 to an unknown date, ongoing Chronic renal insufficiency, Information on risk factors or previous illnesses included renal insufficiency; one kidney removed in 1986 due to cancer. The patient''s concomitant medications were not reported. The patient experienced died on 14Jun2021, cough on 05Jun2021, dyspnoea/shortness of breath on 04Jun2021, weakness/feeling weak until completely powerless on 11Jun2021. Two weeks after 2nd vaccination shortness of breath, then cough, then feeling weak until completely powerless; died three and a half weeks after 2nd vaccination. The outcome of the event died was fatal. The patient died on 14Jun2021. An autopsy was not performed. The outcome of the other events was not recovered. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575682 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-24
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematocrit, Haemoglobin, Nausea, Palpitations, Pneumonia viral, Pulmonary embolism, Thrombocytopenia, Thrombophlebitis superficial, Thrombosis, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pleuropneumonia; Polyglobulia
Allergies:
Diagnostic Lab Data: Test Name: Hct; Result Unstructured Data: Test Result:greater than 51 V% %; Test Name: Hct; Result Unstructured Data: Test Result:48 V% %; Test Name: Hb; Result Unstructured Data: Test Result:17.7 g/dl; Test Name: Hb; Result Unstructured Data: Test Result:17.6 g/dl; Test Name: thrombopenia; Result Unstructured Data: Test Result:95/nl
CDC Split Type: DEPFIZER INC202101016089

Write-up: palpitations; thrombosis right/suspected Right thrombosis femoral; nausea; vomiting; viral pneumonia; Thrombophlebitis of superficial arm veins; fulminant pulmonary embolism/ Lung embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority. Report number: DE-PEI-CADR2021154121. Sender''s (Case) Safety Report Unique Identifier: DE-PEI-202100155749. A 16-year-old male patient received second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 01Jul2021 at single dose for covid-19 immunisation. Medical history included polyglobulia, pleuropneumonia from Mar2021 to an unknown date. The patient''s concomitant medications were not reported. On 25Jul2021, the patient experienced fulminant pulmonary embolism/Lung embolism, thrombosis right. The patient recently in hospital stays due to palpitations - dyspnea extr. Performance kink - no cause found. The patient experienced thrombophlebitis of superficial arm veins. Mainly viral pneumonia, the patient was again hospitalization from 11Jul2021 to 14Jul2021 and received antibiotic infusion. Here already polyglobules Hb 17.7 g / dl, Hct greater than 51V%. On 24Jul2021, admission due to collapse nausea, vomiting. On 25Jul2021, resuscitation. The patient experienced LAE (laparoscopic appendectomy)/suspected Right thrombosis femoral. Noticeable volume depletion when admitted with polyglobules Hb 17.6 g / dl, At admission. Hct 48 V%, thrombopenia 95 / nl. Therapeutic measures were taken as a result of fulminant pulmonary embolism/ lung embolism, thrombosis right/suspected right thrombosis femoral, viral pneumonia. The outcome of event fulminant pulmonary embolism/ Lung embolism was fatal and other events was unknown. The patient died on 27Jul2021. It was not reported if an autopsy was performed. This report was reported as serious as death. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? none Relatedness of drug to reaction(s)/event(s) (for every event) Source of assessment: Regulatory Authority Result of Assessment: D. Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: fulminant pulmonary embolism/ Lung embolism


VAERS ID: 1575683 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-06-25
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Meningoencephalitis herpetic
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Adenocarcinoma of prostate
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic regurgitation (grade 2); Arterial hypertension; Cerebral disorder; Cerebrovascular insufficiency; Computerized tomogram head; Epileptic seizure; Herpes simplex type I (in the lumbar puncture); Hyperlipoproteinemia; Prostate cancer (state after Prostate cancer); Pulmonary valve insufficiency (grade 2); Transient ischemic attack; Tricuspid regurgitation (grade 2); Unsteady gait; Vigilance decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016082

Write-up: Epileptic fit; Encephalitis herpes; This is a spontaneous report from a non-contactable consumer downloaded from the WEB DE-PEI-CADR2021154535. Sender''s (Case) Safety Report Unique Identifier: DE-PEI-202100155666. An 87-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 20Mar2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3ML SINGLE for covid-19 immunisation. Medical history included Adenocarcinoma of prostate; Aortic regurgitation grade 2, pulmonary valve insufficiency grade 2, Tricuspid regurgitation grade 2, arterial hypertension, HLP (Hyperlipoproteinemia), TIA(Transient ischemic attack), cerebrovascular insufficiency, Z.n. (State after) Prostate cancer / acute change of character with unsteady gait, strongly fluctuating vigilance, epileptic. Seizures, cerebral opacity, evidence of HSV (Herpes simplex viruses) 1 in the lumbar puncture, cCT (Cranial computed tomography) dtl. No known of any allergies. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) strength 0.3 ml, dose 1 on 27Feb2021 for COVID-19 immunization with no adverse reaction. This report was serious for death. On 25Jun2021 the patient experienced Encephalitis herpes (fatal), Epileptic fit (hospitalized). The patient had Exitus letalis on 03Jul2021, 21st after herpes encephalitis HSV1 with epilept. Seizures, onset acutely; Herpes virus reactivation possible after vaccination (unclear)? Patient Previously completely symptom-free in this regard. The patient''s outcome was fatal for Encephalitis herpes, not recovered/not resolved for Epileptic fit. The patient died on 03Jul2021. It was not reported if an autopsy was performed. Sender Comment: Information on risk factors or previous illnesses: AI II (Aortic regurgitation grade 2), PI II (pulmonary valve insufficiency grade 2), TI I (Tricuspid regurgitation grade 2) (I08.2 + G), arterial hypertension, HLP (Hyperlipoproteinemia), TIA(Transient ischemic attack) 8/08 in (G45.92 + G) CVI [cerebrovascular insufficiency] (I67.88 + G), Z.n. (State after) Prostate cancer / acute change of character with unsteady gait, strongly fluctuating vigilance, epileptic. Seizures, cerebral opacity, evidence of HSV(Herpes simplex viruses) 1 in the lumbar puncture, cCT (Cranial computed tomography) dtl. Medullary edema increasing in the course, exit from lethal. Relatedness of drug to reaction(s)/event(s) (for every event) per PEI 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: Encephalitis herpes


VAERS ID: 1575684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-22
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Coma, Hypertension
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016080

Write-up: stroke/Accident cerebrovascular; High blood pressure after the 3rd day. 3 weeks later stroke, coma, death; High blood pressure after the 3rd day. 3 weeks later stroke, coma, death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority number DE-PEI-CADR2021154709. Sender''s Safety Report Unique Identifier: DE-PEI-202100155598. A 70-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (reported as 18Jul2021, pending clarify) (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. No known of any allergies. Never had anything for 70 years. The patient medical history and concomitant medications were not reported. On 22Jun2021 the patient experienced Hypertension. On 08Jul2021 the patient experienced Accident cerebrovascular. High blood pressure from the 3rd day. 3 weeks later stroke, coma, death. All on the same day. The patient died on 08Jul2021. An autopsy was not performed. The patient''s outcome was not recovered/not resolved for hypertension, fatal for accident cerebrovascular, unknown for other event. Result of assessment (source: PEI) unclassifiable. No follow-up activities possible. No further information expected. Batch/LOT number cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1575685 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-07-17
   Days after vaccination:49
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: Cerebrovascular accident, Fatigue, Headache, Pneumonia, Pyrexia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Disease Parkinson''s
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016100

Write-up: kidney failure; fatigue; Headache; Pyrexia; Pneumonia; Stroke; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021155137], Safety Report Unique Identifier [DE-PEI-202100156608]. A male patient of unknown age received the second dose of bnt162b2 (COMIRNATY) on 29May2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history included Disease Parkinson''s from unknown date and ongoing. Concomitant medications were not reported. On 17Jul2021 the patient experienced Pneumonia, Pyrexia, Headache, stroke. Patient experienced kidney failure, fatigue on unknown date. Therapeutic treatment was received for events Pneumonia; Stroke; Headache; Pyrexia. The patient''s outcome was fatal for Pneumonia, unknown for events kidney failure; fatigue and not recovered for other events. The patient died on 01Aug2021, due to Pneumonia. It was not reported if an autopsy was performed. Event assessment between the events with the suspect drug was reported as Unclassifiable. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? : no. Information about risk factors or previous illnesses: Parkinson''s disease / fatigue, fever, headache, intensive care with pneumonia, stroke, kidney failure. Treatment with various antibiotics, painkillers$g no success. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1575686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   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 FF0900 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Death, Malaise, Nausea, Peripheral vascular disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016062

Write-up: Arrhythmia; Circulatory disorder peripheral; Nausea; Vomiting; Malaise; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021155166, Safety Report Unique Identifier DE-PEI-202100156711. A 67-year-old male patient received bnt162b2 (COMIRNATY, mRNA), via an unspecified route of administration on 29Jul2021 (Lot Number: FF0900) as dose number unknown, single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 30Jul2021 the patient experienced vomiting, nausea, circulatory disorder peripheral. On 31Jul 2021 the patient experienced Unknown cause of death. The patient also experienced arrhythmia, malaise. The seriousness of arrhythmia, vomiting, nausea, circulatory disorder peripheral was hospitalized. The patient died on 31Jul2021. It was unknown if an autopsy was performed. The outcome of unknown cause of death was fatal. The outcome of other events was not recovered. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575687 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dyspnoea (dyspnoea during exercise); Palpitation; Tachycardia
Preexisting Conditions: Medical History/Concurrent Conditions: Pressure chest
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016057

Write-up: Myocarditis determined during the autopsy, which, when viewed together, suggests a causal myocarditis related to the vaccination against SARS-CoV2.; conspicuous cardiac arrhythmia; This is a spontaneous report received from a non-contactable consumer downloaded from the WEB. The regulatory authority report number is DE-PEI-CADR2021155185, Safety report unique identifier DE-PEI-202100156753. A 61-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Apr2021 (at unknown age) as single dose for COVID-19 immunisation. The patient''s medical history included: Tachycardia, Palpitation, Dyspnoea (dyspnoea during exercise), all above ongoing, and feeling of pressure on the heart. The patient''s concomitant medications were not reported. Myocarditis determined during the autopsy, which, when viewed together, suggests a causal myocarditis related to the vaccination against SARS-CoV2. The patient''s outcome was fatal for Myocarditis. This report is serious-death. The patient died on an unspecified date. Relatedness of drug to reactions/events. Source of assessment. Result of Assessment was D. Unclassifiable. Sender Comment: Information on risk factors or previous illnesses: Palpitations, dyspnoea during exercise + feeling of pressure on the heart/no known immediate reaction, during an inpatient stay conspicuous cardiac arrhythmia with subsequent resuscitation and death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocarditis; conspicuous cardiac arrhythmia; Autopsy-determined Cause(s) of Death: Myocarditis


VAERS ID: 1575688 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-20
   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 UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: House dust mite allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101016072

Write-up: Stroke died/accident cerebrovascular; Stroke died; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority, regulatory authority number DE-PEI-CADR2021155544. An 81-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 ml, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on 29Apr2021 as single dose for covid-19 immunisation. Medical history included House dust mite allergy. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for prophylactic vaccination. The patient experienced stroke died on an unspecified date. The patient experienced also accident cerebrovascular on an unspecified date, aneurysm on 20May2021. Time Interval between beginning of drug administration and start of reaction / event was 3 weeks. The outcome of events was fatal. The patient died on 23May2021. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events. Source of assessment: Regulatory Authority. Result of Assessment: D. Unclassifiable Sender Comment: Are you or the person concerned known of any allergies? If yes, which? House dust mite allergy / no serious side effects for the time being. On 20May2021, aneurysm died 3 days later. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular; Aneurysm


VAERS ID: 1575698 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   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 UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Cough, Death, Dyspnoea, Immune system disorder, Influenza like illness, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 123
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 INC202101028277

Write-up: Immune System Breakdown; pneumonia; Influenza like illness; fever; apathy; shortness of breath; cough; Unknown cause of death; This is a spontaneous report from a non-contactable consumer. This is the second of two reports. The first report is a report from the Medicines Agency (MA) WEB [DE-PEI-CADR2021034283]. A 95-year-old male patient received the 2nd dose of BNT162B2 (COMIRNATY) intramuscular on 29Jan2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had no allergies. The patient previously received the 1st dose of BNT162B2 (COMIRNATY) intramuscular on 08Jan2021 for COVID-19 immunisation, experienced throat tightness, immune system disorder (NOS), shingles, pneumonia on 26Jan2021; fever, apathy, struggling in sleep, severely weakened immune system on 27Jan2021 visit to the doctor. On 31Jan2021 the patient experienced immune system breakdown and Influenza like illness. Before: good general condition without serious pre-existing illnesses. On 29Jan2021, the patient had the 2nd corona vaccination (DESPITE CLEAR IMMUNE WEAKNESS). On 31Jan2021, the patient experienced fever, apathy, struggling, shortness of breath, cough, onset of pneumonia. On 02Feb2021, the patient was transferred to hospital, pneumonia, collapse of the immune system, life-threatening condition. On 12Feb2021, the patient was transferred back to the retirement home. Since then, bedridden, care level 5. This report is serious - hospitalization. The patient was died with unknown cause of death on 04Jun2021. No autopsy was performed. Outcome of the events immune system breakdown and Influenza like illness was recovered/resolved with sequelae, of the event Unknown cause of death was fatal, of the other events was unknown. 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-202100996489 same patient, first/second dose; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575708 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-21
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EW4815 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioimmunoblastic T-cell lymphoma recurrent, Condition aggravated, Death, Tubulointerstitial nephritis
SMQs:, Acute renal failure (broad), Chronic kidney disease (broad), Malignant lymphomas (narrow), Tubulointerstitial diseases (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease; Dermatomyositis; Leucocytoclastic vasculitis; Mesangiocapillary glomerulonephritis; Prostate adenoma
Preexisting Conditions: Medical History/Concurrent Conditions: Angioimmunoblastic T-cell lymphoma; Cardiac failure congestive
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Nephritis interstitial acute; Condition aggravated; This case was received via Regulatory Authority (Reference number: ES-AEMPS-961434) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of TUBULOINTERSTITIAL NEPHRITIS, ANGIOIMMUNOBLASTIC T-CELL and CONDITION AGGRAVATED in a 78-year-old male patient who received mRNA-1273 (Spikevax) (batch no. EW4815) for COVID-19 vaccination. The patient''s past medical history included Angioimmunoblastic T-cell lymphoma in September 2020 and Cardiac failure congestive. Concurrent medical conditions included Leukocytoclastic vasculitis, Dermatomyositis, Chronic kidney disease, Mesangiocapillary glomerulonephritis and Prostate adenoma. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced TUBULOINTERSTITIAL (seriousness criteria death, hospitalization and medically significant), ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (seriousness criteria death, hospitalization and medically significant) and CONDITION (seriousness criteria death and hospitalization). The patient died on 14-Jun-2021. The reported cause of death was Nephritis interstitial acute and Condition aggravated. It is unknown if an autopsy was performed. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 15-Apr-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was given. No treatment medication was given Company comment- Very limited information regarding these events has been provided at this time. No further follow up information is expected. Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow up information is expected.


VAERS ID: 1575717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-20
   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 UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Asthenia, Inappropriate schedule of product administration, Pneumonia, Seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINEMET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101016150

Write-up: Inappropriate schedule of vaccine administered; aspirated the vomit; Asthenia; Pneumonia; vomited; SEIZURE; This is a spontaneous report received from a contactable consumer downloaded from the Agency WEB. The regulatory authority report number is FI-FIMEA-20213823. A 61-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 19Jul2021 (Lot Number: unknown) as single dose for COVID-19 immunization. Medical history included parkinson''s disease. Concomitant medication included carbidopa monohydrate, levodopa (SINEMET) taken for parkinson''s disease. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 26Apr2021 as single dose for COVID-19 immunization. On 20Jul2021, the second day really bad and at night, the patient experienced seizure and vomited, asthenia, aspirated the vomit and got pneumonia which led to Death. The cause of death was aspiration pneumonia. Autopsy was unknown. The outcome of Inappropriate schedule of vaccine administered was unknown. The outcome of other 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: Aspiration pneumonia


VAERS ID: 1575739 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Bacterial test, Death, Fatigue, SARS-CoV-2 test, Urine analysis
SMQs:, Hypoglycaemia (broad), COVID-19 (broad)

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: ATENOLOL; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; SERETIDE; MONURIL; SERTRALINE HYDROCHLORIDE; AVODART; DAFALGAN; TAMSULOSINE [TAMSULOSIN HYDROCHLORIDE]; DEPAKOTE; CLOZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic schizophrenia; COPD; COVID-19; Obesity
Allergies:
Diagnostic Lab Data: Test Name: Cytobacterioligical urine exam; Result Unstructured Data: Test Result:leukocytes +++; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: Urine stip test; Result Unstructured Data: Test Result:leukocytes +++
CDC Split Type: FRPFIZER INC202101016142

Write-up: Fatigue; Anxiety; Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-LM20212076. A 74-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 27Jul2021 (Lot Number: FF0680) as Dose 1, single for COVID-19 immunisation. Medical history included COVID-19, Arterial hypertension, Chronic schizophrenia, severe obesity, and chronic obstructive pulmonary disease (COPD). Concomitant medications included atenolol; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); fluticasone propionate, salmeterol xinafoate (SERETIDE); fosfomycin trometamol (MONURIL); sertraline hydrochloride; dutasteride (AVODART); paracetamol (DAFALGAN); tamsulosin hydrochloride (TAMSULOSINE); valproate semisodium (DEPAKOTE); and clozapine. The patient experienced death unexplained on 01Aug2021, fatigue and anxiety on an unspecified date. Information sought by the Regulatory Authority: Urinary gene reported by the patient the day before vaccination with pain when urinating. (Prescription of MONURIL present in the long-term drug history). Hyperthermia in the afternoon of 26Jul2021 (38.1 ? C) treated with paracetamol. Cytobacterioligical urine exam and Urine test strip carried out the next day 27Jul2021: leukocytes +++ Monuril in the morning of 29Jul2021. Vaccination on 27Jul2021 D1. Unusual anxiety and fatigue reported by the patient following vaccination; Found dead in his bed on 01Aug2021 (D + 6). no autopsy. Comments: Approximate period of onset of the adverse reaction: If the side effect is immediate, delay: Hospitalization service: Specify:. The outcome of the events fatigue and anxiety was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1575742 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   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 FA7082 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101016226

Write-up: Sudden death; Fever; This is a spontaneous report received from a contactable Physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MA20212995. A 39-years-old male patient received second dose of bnt162b2 (COMIRNATY), at the age of 39-years-old intramuscular on 01Jul2021 17:00 (Lot Number: FA7082) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previous received first dose of bnt162b2 (COMIRNATY) (lot EX7823) at the age of 39-years-old on 10Jun2021 13:30 as single dose for covid-19 immunisation. The patient experienced fever (medically significant) on 02Jul2021 morning, sudden death on 03Jul2021. Treatment was received for fever including intervention of the urgent medical aid service during the night of 02Jul2021 to 03Jul2021. The outcome of fever was unknown. 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: sudden death


VAERS ID: 1575749 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Headache, Malaise, Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Discomfort; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101016213

Write-up: heart attack; Death NOS/sudden death; Headache; Feeling sick; Discomfort; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-NT20213103. A 70-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 11May2021 (at the age of 70 years old) (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included Smoker and discomfort while walking. The patient''s concomitant medications were not reported. The patient experienced death NOS on 07Jun2021, headache on 11May2021, feeling sick on 11May2021. It was reported that: Malaise and headache on the evening of the injection, then sudden death occurring on the night of 07Jun2021. According to the urgent medical aid service doctor, heart attack. Information obtained after contact with the declarant: the patient was not being followed up and had no attending physician. He smoked a lot. In March, he complained of discomfort while walking without further details. Evolution: Death on 07Jun2021. No autopsy. Discomfort and headache occurred on the evening of the first injection (11May2021). 2nd dose not carried out because initially planned on 19Jun2021. The outcome of Headache and Feeling sick was recovered on an unspecified date, of Death NOS/sudden death was fatal, of the other event was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Death NOS/sudden death


VAERS ID: 1575758 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-07-19
   Days after vaccination:79
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: Auscultation, Blood bicarbonate, Blood count, Blood pressure measurement, Body temperature, C-reactive protein, COVID-19, Computerised tomogram, Computerised tomogram thorax, Drug ineffective, Fibrin D dimer, Heart rate, Investigation, Lymphocyte count, Oxygen saturation, PCO2, PO2, Platelet count, Respiratory rate, SARS-CoV-2 test, Urine analysis, White blood cell count, pH body fluid
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Anaemia; Arterial hypertension; Beta thalassemia minor (diagnosed in 2018); Cancer of prostate (treated with laser, hormone therapy); Cardiac failure; Cholecystectomy; Chronic renal insufficiency (stage 3); Haemorrhage of digestive tract; Ketosis-prone diabetes mellitus; Lumbar spinal stenosis; Proctitis NOS.
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: pulmonary auscultation; Result Unstructured Data: Test Result: diffuse crackles; Test Date: 20210731; Test Name: bicarbonates; Result Unstructured Data: Test Result:23.4 mmol/L; Test Name: blood count; Result Unstructured Data: Test Result:8.3 g/dl; Comments: microcytic anemia at 8.3 g / dL; Test Name: Blood pressure; Result Unstructured Data: Test Result:135/82 mmHg; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210731; Test Name: CT; Result Unstructured Data: Test Result: CT which does not find pulmonary...; Comments: embolism but an increase in parenchymal attacks of severe pneumopathy type Covid-19. CT pulmonary arterial hypertension. Cardiomegaly.; Test Name: Un-injected pulmonary CT; Result Unstructured Data: Test Result:Covid-19 type pneumonia with severe...; Comments: ...involvement (50-75%) of the abnormalities. High blood pressure CT scans with pulmonary artery trunk measured at 33mm; Test Name: CRP; Result Unstructured Data: Test Result:146 mg/l; Test Name: D-dimer; Result Unstructured Data: Test Result:660 ng/ml; Test Name: Heart rate; Result Unstructured Data: Test Result:86; Comments: /min; Test Name: clinical examination; Result Unstructured Data: Test Result: fatty cough, a bilateral and symmetrical; Comments: vesicular murmur with diffuse, non-spastic crackles. No sign of failure; Test Name: lymphopenia; Result Unstructured Data: Test Result:0.2 x10 9/l; Comments: lymphopenia; Test Name: Saturation; Test Result: 88 %; Test Date: 20210731; Test Name: Saturation; Test Result: 96 %; Test Date: 20210801; Test Name: Saturation; Test Result: 90 %; Test Date: 20210731; Test Name: pCO2; Result Unstructured Data: Test Result:33 mmHg; Test Date: 20210731; Test Name: ph; Result Unstructured Data: Test Result:7.47; Test Name: platelet; Result Unstructured Data: Test Result:193 x10 9/l; Test Date: 20210731; Test Name: pO2; Result Unstructured Data: Test Result:62 mmHg; Test Date: 20210802; Test Name: respiratory rate; Result Unstructured Data: Test Result:22/min; Test Date: 20210719; Test Name: RT-PCR Sars-Cov-2 positive; Test Result: Positive; Comments: nasal aspiration sample; Test Name: Screening RT-PCR; Result Unstructured Data: Test Result: positive for the L452R mutation; Test Name: cytobacterioligical urine exam with leukocyturia; Result Unstructured Data: Test Result: cytobacterioligical urine exam with leukocyturia a; Comments: cytobacterioligical urine exam with leukocyturia at 37 / mm3.; Test Name: leukocytosis; Result Unstructured Data: Test Result:5.8 x10 9/l; Comments: leukocytosis.
CDC Split Type: FRPFIZER INC202101016225

Write-up: Vaccination failure; symptomatic Covid-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PO20214066. A 82-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on May2021 (Batch/Lot Number: Unknown) as 0.3 mL, single dose for covid-19 immunisation. Medical history included lumbar spinal stenosis, cholecystectomy, Beta thalassemia minor diagnosed in 2018, AFib, ketosis-prone diabetes mellitus, Arterial hypertension, Proctitis NOS, Haemorrhage of digestive tract, Cancer of prostate treated with laser, hormone therapy, Chronic renal insufficiency stage 3, Cardiac failure and Anaemia. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and symptomatic covid-19 on 19Jul2021. The clinical course was as follows: 30Jul2021: The male patient is hospitalized for the management of a symptomatic Covid-19 with positive test on 19Jul2021 and asthenia, diarrhea, fluctuating fever and difficult alimentation / hydration since 22Jul2021. Suspected vaccine failure. It is put under 4L of O2 before a desaturation at 88%. Blood pressure 135 / 82mmHg, heart rate 86 / min. Clinical examination found a fatty cough, a bilateral and symmetrical vesicular murmur with diffuse, non-spastic crackles. No sign of failure. Biology: leukocytosis 5.8G / L, microcytic anemia at 8.3 g / dL, platelets at 193 G / L, lymphopenia at 0.2G / L, CRP at 146 mg / L, D-dimer at 660 ng / mL. cytobacterioligical urine exam with leukocyturia at 37 / mm3. RT-PCR Sars-Cov-2 positive (nasal aspiration sample). Screening RT-PCR (mutations of interest) positive for the L452R mutation. Increase in oxygen therapy to 8L / min due to desaturation under 4L. Un-injected pulmonary CT: Covid-19 type pneumonia with severe involvement (50-75%) of the abnormalities. High blood pressure CT scans with pulmonary artery trunk measured at 33mm. Initiation of treatment with amoxicillin / clavulanic acid, dexamethasone and anticoagulation with enoxaparin 4000IU. 31Jul2021: 38.7 C, polypneic 30 / min, SpO2 96% under 8L with a high concentration mask. The patient is asthenic, pulmonary auscultation with diffuse crackles. Blood gas: pH 7.47, pO2 62mmHg, pCO2 33mmHg, bicarbonates 23.4 mmol / L. CT which does not find pulmonary embolism but an increase in parenchymal attacks of severe pneumopathy type Covid-19. CT pulmonary arterial hypertension. Cardiomegaly. The patient went under 12L of o2 due to a new episode of desaturation under 8L. Increase in dexamethasone to 20mg / 24h. 01Aug2021: 90% desaturation under 12L of O2, increase to 14L with the mask. 02Aug2021: Clinical worsening: afebrile, multiple deep desaturations under 14L of O2, dyspneic with respiratory rate at 22 / min. Beginning of treatment with tocilizumab and 15L of O2 mask. 03Aug2021: Death of the patient. An autopsy was not performed. The outcome of the events vaccination failure and symptomatic covid-19 were 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: symptomatic Covid-19; Vaccination failure


VAERS ID: 1575765 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-07-14
   Days after vaccination:159
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: Altered state of consciousness, Blood bicarbonate, Blood creatinine, Blood fibrinogen, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood sodium, Body temperature, C-reactive protein, COVID-19, Coma scale, Fibrin D dimer, Heart rate, Oxygen saturation, PCO2, PO2, Physical examination, Prothrombin level, Respiratory disorder, Respiratory rate, SARS-CoV-2 test, Vaccination failure, White blood cell count, X-ray, pH body fluid
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RAMIPRIL; TAMSULOSIN; HUMALOG; PARACETAMOL; MACROGOL; RIVAROXABAN; ASCORBIC ACID; COLECALCIFEROL; Comirnaty
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon (Adenocarcinoma of the right colon discovered on occlusive syndrome); Atrial fibrillation; Cataract; Diabetes mellitus insulin-dependent (insulin-requiring diabetes with neuropathy); Intellectual disability
Allergies:
Diagnostic Lab Data: Test Name: bicarbonate content; Result Unstructured Data: Test Result:23.3 mmol/L; Test Name: creatinine; Result Unstructured Data: Test Result:326 umol/l; Test Date: 20210721; Test Name: fibrinogen; Result Unstructured Data: Test Result:5.18 g/l; Test Date: 20210721; Test Name: LDH; Result Unstructured Data: Test Result:564 IU/l; Test Name: lactate; Result Unstructured Data: Test Result:2.7 mmol/L; Test Name: K; Result Unstructured Data: Test Result:6 mmol/L; Test Name: Na; Result Unstructured Data: Test Result:158 mmol/L; Test Name: temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:6; Test Date: 20210720; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:7; Test Name: CRP; Result Unstructured Data: Test Result:47.5 mg/l; Test Date: 20210721; Test Name: Dimers; Result Unstructured Data: Test Result:3170 ng/ml; Test Name: Heart rate; Result Unstructured Data: Test Result:109; Comments: bpm; Test Name: SpO2; Test Result: 96 %; Comments: SpO2 96% under 15 L / min; Test Date: 20210720; Test Name: SpO2; Test Result: 97 %; Comments: SpO2 97% under 15 L; Test Name: pCO2; Result Unstructured Data: Test Result:35 mmHg; Test Name: pH; Result Unstructured Data: Test Result:7.4; Test Name: physical examination; Result Unstructured Data: Test Result:Irregular heart sounds, aortic hearth murmur; Comments: MV +/+, diffuse ronchi, thoraco-abdominal rocking, polypnea, painless supple depressible abdomen; Test Name: pO2; Result Unstructured Data: Test Result:110 mmHg; Test Date: 20210721; Test Name: prothrombin level; Test Result: 73 %; Test Name: Respiratory rate; Result Unstructured Data: Test Result:40; Comments: / min; Test Date: 20210714; Test Name: SARS CoV2 PCR; Result Unstructured Data: Test Result:SARS CoV2 delta variant infection; Test Name: polynuclear neutrophil; Result Unstructured Data: Test Result:11.12 g/l; Test Name: WB; Result Unstructured Data: Test Result:12.9 g/l; Test Name: pulmonary radiography; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC202101016234

Write-up: disturbances of consciousness; respiratory deterioration; diagnosis of SARS CoV2 delta variant infection/fever and dyspnea; diagnosis of SARS CoV2 delta variant infection/fever and dyspnea; This is a spontaneous report from a contactable physician downloaded from the Agency regulatory authority number FR-AFSSAPS-TS20213351. An 88-year-old male patient received BNT162B2 (COMIRNATY), second dose via intramuscular on 05Feb2021 as single dose, first dose via intramuscular on 18Jan2021 as single dose for covid-19 immunisation. Medical history included adenocarcinoma of colon from 2012 (Adenocarcinoma of the right colon discovered on occlusive syndrome), Diabetes mellitus insulin-dependent (insulin-requiring diabetes with neuropathy), complete arrhythmia by atrial fibrillation, intellectual disability, cataract. Concomitant medication included ramipril; tamsulosin; insulin lispro (HUMALOG); paracetamol; macrogol; rivaroxaban; ascorbic acid; colecalciferol. On 14Jul2021 (5 months from 2nd dose): fever and dyspnea. Consultation at the emergency reception service on 14Jul2021 with diagnosis of SARS CoV2 delta variant infection [polymerase chain reaction (PCR) of 14Jul2021]. Antibiotic therapy with Augmentin 3g/d for 8 days and Solupred 20 mg for 5 days. On 20Jul2021, readmitted to the emergency reception service via the urgent medical aid service for deterioration of his condition, with disturbances of consciousness and respiratory deterioration. Glasgow coma scale (GCS) 7, SpO2 97% under 15 L. At the emergency reception service: GCS 6, heart rate (HR) 109 bpm, temperature (T) 38.5 ?C, Respiratory rate (RR) 40/min, SpO2 96% under 15 L/min. Physical examination: irregular heart sounds, aortic hearth murmur, MV +/+, diffuse ronchi, thoraco-abdominal rocking, polypnea, painless supple depressible abdomen. Hydration, Augmentin, suspension of its usual treatment. Biology: White blood (WB) 12.9 G/L, including polynuclear neutrophil 11.12 G/L, Na 158 mmol/L, K 6 mmol/L, creatinine 326 umol/L, C-reactive protein (CRP) 47.5 mg/L. Blood gas under 15L: pH 7.40, pCO2 35 mmHg, pO2 110 mmHg, bicarbonate content: 23.3 mmol/L, lactate 2.7 mmol/L.. On 21Jul2021: Dimers 3170 ng/mL, fibrinogen 5.18 g/L, lactate dehydrogenase (LDH) 564 IU/L, prothrombin level 73%. On unspecified date, pulmonary radiography: unknown results. Implementation of oxygen therapy 3 L/min from 07/15. Death of the patient on the morning of 22Jul2021. In total, failure of the vaccination with delta-variant COVID-19 pneumonia, 5 months after the 2nd dose of Comirnaty, in a patient at risk of severe form, of unfavorable evolution. The outcome of the events was fatal. The patient died on 22Jul2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: diagnosis of SARS CoV2 delta variant infection/fever and dyspnea; diagnosis of SARS CoV2 delta variant infection/fever and dyspnea; disturbances of consciousness; respiratory deterioration


VAERS ID: 1575768 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: ultrasound; Result Unstructured Data: Test Result: Nothing to report; Comments: ultrasound in 1st trimester; Test Date: 20210616; Test Name: ultrasound; Result Unstructured Data: Test Result: stop of foetal heart activity Intra uterine death; Comments: new ultrasound at 2.5 months of pregnancy.
CDC Split Type: FRPFIZER INC202101039993

Write-up: stop of foetal heart activity; fetus patient/was exposed to BNT162B2 (COMIRNATY), via transmammary; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BR20212888. A fetus patient of an unspecified gender was exposed to BNT162B2 (COMIRNATY), on 11Jun2021 (Lot Number: FD0168) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced stop of foetal heart activity in Jun2021. The patient underwent lab tests and procedures which included ultrasound scan: nothing to report on 10Jun2021 ultrasound in 1st trimester, ultrasound scan: stop of foetal heart activity intra uterine death on 16Jun2021 new ultrasound at 2.5 months of pregnancy. The outcome of the event stop of foetal heart activity was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100996798 Maternal case; Reported Cause(s) of Death: stop of foetal heart activity


VAERS ID: 1576141 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-20
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Barium meal, Computerised tomogram, Endoscopy, Leukopenia, Magnetic resonance imaging, SARS-CoV-2 test, Thrombosis, Vomiting, White blood cell count, X-ray
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 137
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: Anaemia; Bone cancer; Bone disorder
Allergies:
Diagnostic Lab Data: Test Name: Barium meal; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO; Test Name: CT scan; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO; Test Name: Endoscopy; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO; Test Name: MRI; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: white blood cell count; Result Unstructured Data: Test Result:seriously lowered; Test Name: white blood cell count; Result Unstructured Data: Test Result:never recovered; Test Name: X-ray; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: NO
CDC Split Type: GBPFIZER INC202100998323

Write-up: thrombosis arm; Vomiting; Leukopenia; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021624010440-ZUITU. Safety Report Unique Identifier is GB-MHRA-ADR 25742233. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 as dose 1, single for COVID-19 immunisation. Medical history included anaemia, bone cancer, and bone disorder from an unknown date and unknown if ongoing. Patient is not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. Concomitant medications included statins taken for an unspecified indication, chemotherapy pills for bone cancer, monthly bone strengthening injection to the pelvis for bone disorder, all start and stop dates were not reported. On 20Jan2021, the patient experienced leukopenia and vomiting. On an unspecified date, the patient experienced thrombosis arm. The patient was admitted to a hospital due to the events. The patient underwent lab tests and procedures which included barium meal, computerised tomogram (CT) scan, endoscopy, magnetic resonance imaging (MRI) scan, x-ray all with unknown results and no information available, Covid-19 virus test: No - Negative COVID-19 test, white blood cell count was seriously lowered and never recovered on unspecified dates. Outcome of the events of vomiting and thrombosis arm was not recovered. Leukopenia stop date was reported as 07Jun2021. The patient died on 07Jun2021. The cause of death was reported as leukopenia. It was not reported if an autopsy was performed. The clinical course was reported as follows: My mother was vulnerable because of on set of bone cancer. However a couple of hours after receiving the Pfizer shot she started vomiting. She was admitted to hospital A&E a couple of days later as it didn''t stop and was found to have a seriously lowered white blood cell count. She was told this was normal and it would pass in a week. A neighbour called an ambulance a couple of days later, told her that going into hospital was no a good idea because of the Variant and she should recover in 10 days or so. Her doctor repeated this, and said the shot was ''stirring up her meds''. She was eventually admitted to hospital where she vomited every day till her death. She was also found to have thrombosis in her arm, and her white blood cell count never recovered. Patient has not tested positive for COVID-19 since having the vaccine.Please provide details of any relevant investigations or tests conducted: "new, wider kidney stent. Endoscopy. Barium meal and scan. MRI scan. X ray. CT scan. Stomach stent. Total blood transfusion." I do not know the names of the medication, but my mother was taking statins. She had recently started chemotherapy pills and receiving a monthly bone strengthening injection to the pelvis. These medications were removed from her after a month or so in hospital. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Leukopenia


VAERS ID: 1576146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Not had a COVID-19 test)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992455

Write-up: Heart attack; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108021910375450-WGDFM. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot number and Expiry date was unknown) via an unspecified route of administration on 02Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included symptoms associated with COVID-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. On 06Feb2021, the patient experienced heart attack. The patent died on 06Feb2021. 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: heart attack (death).


VAERS ID: 1576210 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-05-05
   Days after vaccination:62
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: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100998354

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108031729017300-XSRUJ, Safety Report Unique Identifier GB-MHRA-ADR 25748658. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 04Mar2021 (also reported as 04Mar2020), (Lot number was not reported) as second dose, single for COVID-19 immunisation. Medical history included suspected covid-19 (unsure when symptoms started). The patient''s concomitant medications were not reported. The patient experienced death on 05May2021 (also reported as 03Feb2021). The patient underwent lab tests and procedures which included covid-19 virus test: Yes - Positive COVID-19 test on an unspecified date. The patient died on 05May2021. It was not reported whether an autopsy was performed. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1576277 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dehydration, Dermatitis exfoliative generalised, Psoriasis, Respiratory failure, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID; SERTRALINE; THIAMINE
Current Illness: Alcohol abuse; Alcoholism; Depression; Psoriasis (Chronic recurrent flares of psoriasis with hospital admissions).
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response).
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Psoriasis; Respiratory failure; Fluid loss; Erythroderma; This regulatory authority case was reported by a physician and describes the occurrence of DERMATITIS EXFOLIATIVE GENERALISED (Erythroderma), PSORIASIS (Psoriasis), RESPIRATORY FAILURE (Respiratory failure) and DEHYDRATION (Fluid loss) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response). Concurrent medical conditions included Alcoholism, Psoriasis (Chronic recurrent flares of psoriasis with hospital admissions.), Depression and Alcohol abuse. Concomitant products included FOLIC ACID from 20-Jul-2021 to an unknown date and THIAMINE from 20-Jul-2021 to an unknown date for Alcoholism, SERTRALINE from 18-Sep-2020 to an unknown date for Depression. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced DERMATITIS EXFOLIATIVE GENERALISED (Erythroderma) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced PSORIASIS (Psoriasis) (seriousness criteria death and hospitalization), RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria death, hospitalization and medically significant) and DEHYDRATION (Fluid loss) (seriousness criteria death and hospitalization). The patient was treated with BETAMETHASONE VALERATE (BETNOVATE) for Psoriasis, at an unspecified dose and frequency; CICLOSPORIN for Psoriasis, at an unspecified dose and frequency and Physical therapy (Resuscitation) for Respiratory failure. The patient died on 31-Jul-2021. The reported cause of death was Erythroderma. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was given fluids to correct the fluid loss as a treatment. It was reported that COVID vaccine was a potential trigger for the flares of psoriasis. On 31Jul 2021, patient deteriorated suddenly, with type 2 respiratory failure, and despite treatment and attempts at resuscitation, patient died. Reporter states that it was not clear whether patient died of pulmonary oedema/heart failure, pneumonia, PE, or ARDS associated with erythroderma. Patient''s death has been referred to the coroner and the post-mortem examination will be conducted. Patient was not enrolled in clinical trial Company Comment: Very limited information regarding this event/s has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Erythroderma


VAERS ID: 1576309 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200707; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; inappropriate schedule of vaccine administered; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). The patient died on an unknown date. The cause of death was not reported. An autopsy was not performed. At the time of death, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2020, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medications were reported. No treatment information was provided. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. This is a case of sudden death in a 39-year-old male patient with no known past medical history, who died 30 days after receiving a dose of the vaccine. This report also refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown). Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 39-year-old male patient with no known past medical history, who died 30 days after receiving a dose of the vaccine. This report also refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown). Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576331 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Leukaemia
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012819

Write-up: Leukemia; This is a spontaneous report from a contactable consumer received from the Regulatory Authority report number is GB-MHRA-WEBCOVID-202108051321493730-MH2SX, Safety Report Unique Identifier GB-MHRA-ADR 25759327. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced leukemia on Apr2021. The patient died on 02Apr2021 due to Leukemia. It was not reported if an autopsy was performed. The outcome of Leukemia 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: Leukemia


VAERS ID: 1576344 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nipple pain, SARS-CoV-2 test
SMQs:, COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101012808

Write-up: Nipple pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051900058590-06OTW. Safety Report Unique Identifier GB-MHRA-ADR 25761414. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced nipple pain on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient died on 07May2021 due to Nipple pain. It was not reported if an autopsy was performed. The outcome of Nipple pain 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: Nipple pain


VAERS ID: 1576388 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   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: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Death; This case was received via Regeulatory Agency (Reference number: ADR 25765678) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a 79-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 21-Mar-2021 The patient died on 21-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Company Comment :This is a case of sudden death in a 79-year-old male subject with no known medical history, who died 5 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Sender''s Comments: This is a case of sudden death in a 79-year-old male subject with no known medical history, who died 5 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1576472 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014749

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108080734040960-PKCKB, Safety Report Unique Identifier GB-MHRA-ADR 25771141. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient medical history and patient''s concomitant medications were not reported. The patient died on 03Aug2021. It was not reported if an autopsy was performed. Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1576503 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Small for dates baby
SMQs:, Neonatal disorders (narrow), Medication errors (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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101047977

Write-up: 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 Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107301012054630-3YTOV. The reporter (mother) provided information both for herself and her baby. This is the baby report. A fetus patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via transplacental on 03Jul2021 (Lot Number: FA1027) as single dose for COVID-19 immunisation. The 30-year-old mother''s medical history was not reported. The mother''s concomitant medication included folic acid taken for folic acid supplementation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via transplacental on 06Mar2021 (lot number: ET8885) for COVID-19 immunisation. The scan on unspecified date in 2021 found a very small sac in the uterus, but much smaller than it should be for 5 weeks. The mother had another scan in 2 weeks. At this scan, on unspecified date in 2021, the sac had grown, but there was no sign of life inside (no foetal pole or yolk present). The outcome of the event was fatal on unspecified date in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100977268 mother case;GB-MHRA-WEBCOVID-202107301012054630-3YTOV MHRA; Reported Cause(s) of Death: scan found a very small sac in the uterus. But much smaller than it should be for 5 weeks/At this scan, the sac had grown. But there was no sign of life inside/ no foetal pole or yolk present


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