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From the 11/26/2021 release of VAERS data:

Found 19,532 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1328766 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; TULOBUTEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021538548

Write-up: Cerebral infarction; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of the two reports. A 95-year-old female patient received BNT162B2 (COMIRNATY; Number: ER9480; Expiration Date: 31Jul2021), via an unspecified route of administration on 20Apr2021 as 1st dose, single for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. No information on family history was provided. Concomitant medications included furosemide (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported; tulobuterol (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebral infarction on 25Apr2021, which is serious as it lead to death. Details were as follows: On 25Apr2021 (5 days after vaccination), the patient died. The cause of death was noted as cerebral infarction. It was not reported if an autopsy was performed. The reporting pharmacist classified the event as serious sue to fatal outcome, and causality assessment between BNT162B2 and the event was reported as uncertain at present. The patient died on 25Apr2021. It was not reported if an autopsy was performed.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : JP-PFIZER INC-2021538915 same drug, reporter and event; different patient; Reported Cause(s) of Death: cerebral infarction


VAERS ID: 1328774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haematemesis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:not provided; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021541943

Write-up: Haematemesis; Vomiting; This is a spontaneous report from a contactable pharmacist and from a contactable physician. This report was received via a Pfizer sales representative. An 87-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date in 2021 at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced haematemesis and vomiting, which were serious for death. The course of the event was as follows: on unknown date in 2021 at (the day of vaccination), the patient received a dose of BNT162b2. On unknown date in 2021 (the day of vaccination), the patient experienced vomiting and haematemesis. On unknown date in 2021 (unknown days after vaccination), the patient died. Body temperature before vaccination was not provided. The clinical outcome of the events was fatal. The patient died on an unspecified date in 2021 due to haematemesis and vomiting. An autopsy was being performed at the other hospital with unknown results. The causality between the event and BNT162b2 was unknown. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: haematemesis; vomiting


VAERS ID: 1328778 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021542418

Write-up: Loss of consciousness; Cardiac arrest; Marked coronary artery stenosis; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is v21106100. A 95-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: ER9480, Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 11May2021, at 13:45 as 1ST DOSE, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced loss of consciousness and cardiac arrest on 11May2021, at 18:40; the patient also experienced marked coronary artery stenosis on 11May2021. The patient underwent lab tests and procedures which included body temperature: 36.2 Centigrade on 11May2021 before vaccination. Details were as follows: On 11May2021 (the day of vaccination), the patient had a light dinner. After the meal, she experienced loss of consciousness while brushing her teeth. Cardiac arrest occurred. Around 19:00, resuscitation was started. The patient underwent tracheal intubation and received drip infusion (LACTEC 500) and BOSMIN 1A intravenously (IV). She was urgently transported to Hospital B and was confirmed dead. On 13May2021 at 09:30, legal autopsy was performed at the hospital. Marked coronary artery stenosis was noted. A diagnosis of death with unknown cause was made. The reporting physician classified the events as serious (per death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases was noted as advanced age. The reporting physician commented as follows: The department of legal medicine would perform further investigation for several months. If no vaccination had been given, heart disorder could be the plausible cause. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 11May2021.; Reported Cause(s) of Death: Loss of consciousness; Cardiac arrest; Marked coronary artery stenosis


VAERS ID: 1328783 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210508; Test Name: SpO2; Test Result: 94 %; Comments: 16:30 room air; Test Date: 20210508; Test Name: SpO2; Result Unstructured Data: Test Result:89- 91 %; Comments: After IV drip decreasing tendency; Test Date: 20210508; Test Name: SpO2; Result Unstructured Data: Test Result:89-92 %; Comments: on admission room air Oxygen 3L/min; Test Date: 20210509; Test Name: SpO2; Result Unstructured Data: Test Result:89-90 %; Comments: 03:30 Oxygen 5L/min; Test Date: 20210509; Test Name: SpO2; Result Unstructured Data: Test Result:89 - 94 %; Comments: 06:52 Oxygen 5L/min; Test Date: 20210509; Test Name: SpO2; Result Unstructured Data: Test Result:88-89 %; Comments: 09:50 Oxygen 10L/min; Test Date: 20210509; Test Name: SpO2; Test Result: 89 %; Comments: 11:20
CDC Split Type: JPPFIZER INC2021549715

Write-up: Acute pneumonia; bronchial asthma; breathing difficulty/inspiratory dyspnoea; wheezing; SpO2 Oxygen saturation 89- 91, SpO2 Oxygen saturation 88-89; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21106433. A 81-years-old male ( also reported as 81-year and 10-month-old) patient received the first dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 08May2021 13:30 (also reported as ''from 13:30 to 14:30 (the day of vaccination),'' at the age of 81 years old (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) 0.3 ml, single for covid-19 immunization. The patient medical history was not reported. Body temperature before vaccination was 36.3 degrees Centigrade. The patient was receiving blood-thinner medicine and medicines for blood pressure. No information on family history was provided. On 08May2021 16:30, The patient experienced acute pneumonia (death, hospitalization) on 08May2021 16:30 , bronchial asthma (death, hospitalization), breathing difficulty/inspiratory, wheezing and spo2 oxygen saturation 89- 91, spo2 oxygen saturation 88-89. The adverse event involved emergency room visit and hospitalization. The patient was hospitalized from 08May2021 to 09May2021. The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade on 08May2021 Before vaccination , oxygen saturation: 94 % on 08May2021 16:30 room air , oxygen saturation: 89- 91 % on 08May2021 After IV drip decreasing tendency , oxygen saturation: 89-92 % on 08May2021 on admission room air Oxygen 3L/min , oxygen saturation: 89-90 % on 09May2021 03:30 Oxygen 5L/min , oxygen saturation: 89 - 94 % on 09May2021 06:52 Oxygen 5L/min , oxygen saturation: 88-89 % on 09May2021 09:50 Oxygen 10L/min , oxygen saturation: 89 % on 09May2021 11:20. Treatment was given for the events. The clinical outcome of the events pneumonia and bronchial asthma was fatal while the remaining events was unknown. The patient died on 09May2021. It was not reported if an autopsy was performed. The course of the event was as follows: On 08May2021 from around 16:30, the symptoms (such as breathing difficulty, wheezing, and inspiratory dyspnoea) started to appear. SpO2 (oxygen saturation percutaneous) was 94% (room air). On 08May2021 at 19:49, the patient visited the emergency department of the reporter''s hospital as an outpatient where IV drip (SOLDEM 1 200 mL, 1 bottle and SOLU-CORTEF 250 mg, 1 bottle), and inhalation (inhalator, VENETLIN 0.3 mL and normal saline solution 2.0 mL) were administered. After IV drip was completed, SpO2 of 89% - 91% (decreasing tendency) and worsening of wheezing were noted. As the possibility of adverse reactions was suspected, the patient was hospitalized for the purpose of observation of his progress (at 22:00 on 08May2021). At the time of admission (from 22:00), oxygen administration (3L/min, SpO2 of 89% - 92%, room air) was started. Wheezing on exertion was worsened. On 09May2021 at 03:30, oxygen flow rate was changed to 5L/min (SpO2 of 89% - 90%) because of worsening of wheezing and decreased SpO2. On 09May2021 at 06:52, oxygen flow rate was set at 5L/min (SpO2 of 89% - 94%). On 09May2021 at 08:31, DECADRON injection, 3.3 mg, 1 ampule was intravenously administered. On 09May2021 at 09:50, as SpO2 was decreased, oxygen flow rate was changed to 10L/min (SpO2 of 88% - 89%), PCR test was performed (the result was negative), consciousness disturbed (JCS [coma scale]-2) was noted. On 09May2021 at 11:00, indwelling bladder catheter was inserted. On 09May2021 at 11:20, TAZOPIPE for combination injection, 4.5 mg was administered (2 kits in total) (SpO2 89%). On 09May2021 at 14:40, disimpaction was performed (glycerin enema 50%, 60 mL). On 09May2021 at 14:50, furosemide injection 20 mg, 1 ampule was administered. On 09May2021 at 16:00, his breathing was stopped (JCS-300), cardiac massage was started. Adrenaline injection 0.1% syringe was administered. Prevaccination Screening Questionnaire for COVID-19 vaccine as follow: Have you read the Instructions for the COVID-19 vaccine and do you understand the effects and adverse side effects?:Yes Are you currently suffering from any kind of illness and receiving treatment or medication? ?:Yes Name of disease:(Blank), Nature of treatment: blood-thinning medicine and medicine for blood pressure Has a doctor who is treating you for the disease told you that you can have the vaccine today?:No Have you had a fever or gotten sick in the last month?:No Are there any parts of your body that are not feeling well today?:No Have you ever had a convulsion (seizure)?:No Have you ever experienced severe allergic symptoms (such as anaphylaxis) from medications or foods?:No Have you had any vaccines within the last two weeks?:No In light of the results of the questions above and examination, today''s vaccine is :possible ''(by doctor) The reporting physician classified the event as serious (death and hospitalization). There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: acute pneumonia; bronchial asthma


VAERS ID: 1328793 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-03
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Altered state of consciousness, Arrhythmia, Atrial fibrillation, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood pH, Body temperature, C-reactive protein, COVID-19, Cardiac failure congestive, Fibrin D dimer, Glomerular filtration rate, Haemoglobin, Heart rate, Imaging procedure, International normalised ratio, Lethargy, Lymphocyte count, Microscopy, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Procalcitonin, Prothrombin time, Respiratory rate, SARS-CoV-2 test, Sulphur dioxide test, Thrombocytopenia, Vaccination failure, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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: ATENOLOL; BURINEX; AMIROL; OMEPRAZOLE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cataract; Chronic kidney disease; Hypertension; Osteoarthritis spinal
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: Alk phosphatase; Result Unstructured Data: Test Result:143 IU/l; Comments: (40-104 units/L) RAISED; Test Name: HCO3; Result Unstructured Data: Test Result:22; Test Date: 20210407; Test Name: bilirubin; Result Unstructured Data: Test Result:29.6 umol/l; Comments: (0-21micromol/L) RAISED; Test Date: 20210407; Test Name: Creatinine; Result Unstructured Data: Test Result:118 umol/l; Comments: (45-84micromol/L) RAISED; Test Name: blood pH; Result Unstructured Data: Test Result:7.498; Test Date: 20210403; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4; Comments: rectal; Test Date: 20210407; Test Name: C-reactive protein; Result Unstructured Data: Test Result:50.3 mg/l; Comments: RAISED; Test Date: 20210407; Test Name: D dimer; Result Unstructured Data: Test Result:563 ng/ml; Comments: (0-500ng/ml) ABNORMALLY HIGH; Test Name: GRF; Result Unstructured Data: Test Result:about 38; Test Date: 20210407; Test Name: GRF; Result Unstructured Data: Test Result:39; Comments: ml/min/1.73m2; Test Date: 20210404; Test Name: Hb; Result Unstructured Data: Test Result:10.5 g/dl; Comments: LOW; Test Date: 20210403; Test Name: heart rate; Result Unstructured Data: Test Result:54; Comments: slow AF; Test Date: 20210403; Test Name: Pulse rate; Result Unstructured Data: Test Result:54; Test Date: 20210404; Test Name: Imaging for COVID-Pneumonia; Result Unstructured Data: Test Result:No significant abnormality; Test Date: 20210404; Test Name: INR; Result Unstructured Data: Test Result:1.13; Comments: (0.94-1.06 ratio) RAISED; Test Date: 20210404; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.82 g/l; Comments: (1.3-3.6 X 109 g/L) LOW; Test Date: 20210404; Test Name: Urine microscopy; Result Unstructured Data: Test Result:E.coli ESBL positive cultivated; Test Date: 20210404; Test Name: neutrophils; Result Unstructured Data: Test Result:normal; Test Name: SPO2; Test Result: 96 %; Comments: on 15L/min Oxygen. ABGs on 15L/min NMR; Test Date: 20210403; Test Name: SPO2; Test Result: 73 %; Comments: on room air; Test Name: pCO2; Result Unstructured Data: Test Result:28.1; Test Date: 20210404; Test Name: Platelet count; Result Unstructured Data: Test Result:77; Comments: 132-349 X109/L low; Test Name: pO2; Result Unstructured Data: Test Result:79.4; Test Date: 20210407; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.137 ng/ml; Comments: (0.02-0.046 ng/mL) RAISED; Test Date: 20210404; Test Name: PT; Test Result: 11.7 s; Comments: (9.96-11.24s) RAISED; Test Date: 20210403; Test Name: Respiratory Rate; Result Unstructured Data: Test Result:28; Test Date: 20210405; Test Name: Nasal swab (RT-PCR); Test Result: Positive ; Comments: Nasal swab (RT-PCR) Detected: CT=36 Abnormal; Test Name: SO2; Result Unstructured Data: Test Result:97.2; Test Date: 20210404; Test Name: WBC; Result Unstructured Data: Test Result:normal
CDC Split Type: MTPFIZER INC2021541717

Write-up: covid-19 infection; covid-19 infection; Congestive Heart Failure; Atrial Fibrillation; Arrhythmia; Acute kidney injury; Altered consciousness; Thrombocytopenia; Increased lethargy; This is a spontaneous report from a contactable physician. A 96-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection), dose 2 intramuscular, administered in Arm Left on 11Feb2021 (Lot Number: EL8723) as 2nd dose, single; dose 1 intramuscular, administered in Arm Left on 21Jan2021 (Lot Number: EM0477) as 1st dose, single for covid-19 immunisation. Medical history included hypertension, atrial fibrillation, chronic kidney disease since 2016, right eye cataract, spinal osteoarthritis. Non-smoker. Concomitant medications included atenolol at 100 mg daily; bumetanide (BURINEX) at 1 mg daily; amitriptyline hydrochloride (AMIROL) at 10 mg nocte; omeprazole at 20 mg twice daily; paracetamol at 1 g, as needed (tds) and Diarolyte sachet as needed (twice daily). The patient experienced covid-19 infection 03Apr2021. The patient was hospitalized for covid-19 infection on 03Apr2021. The patient experienced Dyspnea (Hypoxia), Tachypnea (RR more than 25bpm), Respiratory failure (Type 1 Respiratory Failure), Arrhythmia (atrial fibrillation known case), Hypoxemia (SPO2 73% RA rising to 95% on 15L/min NRM), Acute kidney injury (CKD - GFR about 38), Altered consciousness, Increased lethargy, Thrombocytopenia (Platelets - 77). On 05Apr2021 she was administered treatment with Remdesivir 200mg iv stat, then 100mg iv daily, Dexamethasone 6mg iv daily and Augmentin 1.2g 8hrly IV. The patient underwent lab tests and procedures which included: Nasal swab (RT-PCR) - positive on 05Apr2021 (new infection, Detected: CT=36 Abnormal). On admission (03Apr2021: Rectal Temp 36.4; RR=28; Pulse=54; Heart 54 - Slow AF; SpO2 on room air - 73%. Oxygen saturations rose to 96% on 15L/min Oxygen. ABGs on 15L/min NRM: pH 7.498; pCO2 28.1; pO2 79.4; SO2 97.2; HCO3 22. Imaging for COVID-Pneumonia (04Apr2021) No significant abnormality. On 04Apr2021 WBC, Neutrophils - normal, Lymphocytes 0.82 (1.3-3.6 X 109 g/L) LOW, Hb - 10.5 (12-15.5g/dL) LOW, Platelets - 77 (132-349 X109/L) LOW, PT 11.7 (9.96-11.24s) RAISED, INR 1.13 (0.94-1.06 ratio) RAISED, Imaging for COVID-Pneumonia: No significant abnormality, Urine microscopy E.coli ESBL positive cultivated. On 07Apr2021 D-DIMER 563 (0-500ng/ml) ABNORMALLY HIGH, Creatinine 118 (45-84micromol/L) RAISED, Bilirubin 29.6 (0-21micromol/L) RAISED, Alk phosphatase 143 (40-104 units/L) RAISED, GFR 39 ml/min/1.73m2, CRP 50.3 (0-5mg/L) RAISED, Procalcitonin 0.137 (0.02-0.046 ng/mL) RAISED. The patient died on 09Apr2021. It was unknown if an autopsy was performed. Cause of death: Hypoxia due to COVID-19 infection. Significant contributory causes: Congestive Heart Failure; Atrial Fibrillation. Outcome of the events covid-19 infection, Congestive Heart Failure, Atrial Fibrillation was fatal; of the other events was unknown. Follow-up attempts completed. No more information are expected.; Sender''s Comments: This patient experienced Fatal vaccination failure since a COVID-19 Infection developed 1 month 23 days days after the administration of the 2nd dose. The doses were properly spaced (42 days between the 1st and second dose).The vaccine preventable illness, COVID-19 infection, showed unfavorable course with Respiratory failure, Hypoxemia and Congestive Heart Failure, Atrial Fibrillation as significant contributory factors to the fatal outcome. Other serious events, like Arrhythmia, Acute kidney injury, Altered state of consciousness, Thrombocytopenia further worsened the clinical course of current infection. 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: Hypoxia due to COVID-19 infection; Congestive Heart Failure; Atrial Fibrillation; Hypoxia due to COVID-19 infection


VAERS ID: 1328850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: Dementia (already vulnerable with a declining of his health due to dementia and a possible respiratory infection (COVID-19 negative).); Respiratory infection (Patient was already vulnerable with a declining of his health due to dementia and a possible respiratory infection (COVID-19 negative).)
Allergies:
Diagnostic Lab Data: Test Name: covid negative; Test Result: Negative
CDC Split Type: NLPFIZER INC2021539546

Write-up: Vulnerable patient, deterioration in dementia in DD respiratory infection, covid negative/Cause of death was either acute cardiac death or lung embolism; Vulnerable patient, deterioration in dementia in DD respiratory infection, covid negative/Cause of death was either acute cardiac death or lung embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00533140. A 75-year-old male patient received second dose of bnt162b2 (COMIRNATY), on 06May2021 (Lot Number: ET6956) at 2nd dose , single for covid-19 immunisation. Medical history included the patient was already vulnerable with a declining of his health due to dementia and a possible respiratory infection (COVID-19 negative). The patient previously received first dose of bnt162b2 (COMIRNATY) on 06Apr2021 for covid-19 immunisation. Had no complaints after 1st vaccination. The patient''s concomitant medications were not reported. Vulnerable patient, deterioration in dementia in DD (differential diagnosis) respiratory infection, covid negative. The patient experienced sudden death (death) following administration of covid-19 vaccine pfizer injectable solution for covid 19 immunisation. The outcome of sudden death is fatal. Patient had no complaints or side effects on the day of vaccination: no fever, patient was eating and drinking. Patient died suddenly 7 hours after vaccination. Cause of death was either acute cardiac death or lung embolism. Day of vaccination free of complaints, no temp, just sat up at the table, ate and drank well. No contraindication to vaccination. After representative consultation, vaccinated. Patient was vulnerable, the physician doubt whether vaccination contributed to the worsening condition. No Previous COVID-19 infection. The lab data included covid negative. The patient died on 06May2021. It was not reported if an autopsy was performed. Reporter Comment: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: no Date: 06Apr2021 Vulnerable patient, deterioration in dementia in DD respiratory infection, covid negative. Additional information ADR: Day of vaccination free of complaints, no temp, just sat up at the table, ate and drank well. No contraindication to vaccination. After representative consultation, vaccinated. Had no complaints after 1st vaccination. Patient was vulnerable, I doubt whether vaccination contributed to the worsening condition. Iom family decided to report anyway. COVID-19 Previous COVID-19 infection: No. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Patient was vulnerable, I doubt whether vaccination contributed to the worsening condition. Family decided to report anyway.; Reported Cause(s) of Death: DD (differential diagnosis) acute cardiac death DD pulmonary embolism; DD (differential diagnosis) acute cardiac death DD pulmonary embolism


VAERS ID: 1328852 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-05-03
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: NLPFIZER INC2021539480

Write-up: Cardiac arrest; Myocardial infarction; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00534918, received from Regulatory Authority. A 74-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Apr2021 (Batch/Lot Number: ET9096) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient didn''t have COVID-19 infection previous. The patient experienced cardiac arrest on 03May2021, Myocardial infarction (Heart attack) followed by cardiac arrest. Cardiac ultrasound in emergency room hospital. Both events treated with Reanimatie. The outcome of cardiac arrest and heart attack was fatal. Patient died on 03May2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Myocardial infarction; Cardiac arrest


VAERS ID: 1328853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: 2021-04-28
   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: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac fibrillation; Diabetes mellitus; Heart failure; Obesity (BMI=31)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021539531

Write-up: Died within 4 hours; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority -WEB [NL-LRB-00535361]. A 69-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Apr2021 (Batch/Lot Number: ET6956) as 1st dose, single for covid-19 immunisation; Acenocoumarol via an unspecified route of administration from 2020 to 28Apr2021, according to scheme for an unspecified indication. Medical history included diabetes mellitus, obesity (BMI=31), heart failure, cardiac fibrillation from 2020. No Previous COVID-19 infection. Concomitant medication included Insulin. The patient experienced died within 4 hours (Heart attack) on 28Apr2021. Action taken for Acenocoumarol was unknown. The outcome of heart attack is fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no confounding factors confounding factors: Diabetes and heart failure COVID-19 Previous COVID-19 infection: No.; Reported Cause(s) of Death: Died within 4 hours


VAERS ID: 1328871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-03
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 1 LA / -

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: 2021-05-03
   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: Breast cancer; Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021539287

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uwzpr3. A 71-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot Number: EX2405) via an unspecified route of administration, administered in left arm on 14Apr2021 at 12:00 as single dose for covid-19 immunisation. Medical history included breast cancer from 2019 and lung cancer from 2016, both not ongoing (as reported). The patient did currently not have any active cancerous disease or other known diseases. The patient''s concomitant medications were not reported. The patient experienced sudden death on 03May2021. The patient had not had any symptoms following vaccination. The patient died on 03May2021. An autopsy was not performed. The reporter stressed the uncertainty as to whether or not the death could be associated with vaccination, due to the death occurring more than two weeks after vaccination. Thus, Causality by reporter was also registered and set to Uncertain. The clinical investigation did not establish any clear cause of a sudden death. Due to the vaccine being administered some weeks before the sudden death, death as a possible adverse reaction to vaccination could not be ruled out, although the physician was uncertain whether to report it or not. The Regulatory Authority assessed the causal relationship between BNT162B2 and sudden death as possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SUDDEN DEATH


VAERS ID: 1328884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (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: 2021-05-06
   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: Diabetes; Hypercholesterolemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021534752

Write-up: Hemorrhagic stroke; This is a spontaneous report from a contactable pharmacist. An 83-year-old female patient (not pregnant) received the second dose of BNT162B2 (COMIRNATY), via intramuscular in Apr2021 (at an unknown age) at 0.3 mL, single for COVID-19 immunisation. Medical history included diabetes, hypercholesterolemia, and hypertension arterial. Concomitant medications included unspecified medications for treatment of diabetes, hypercholesterolemia, and hypertension arterial. The patient previously received the first dose of BNT162B2 (COMIRNATY) (lot number: unknown) in Mar2021 at the age of 82-year-old via intramuscular for COVID-19 immunisation. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It is unknown if since the vaccination, the patient was tested for COVID-19. On 30Apr2021 at 06:00, the patient was found lying on the floor. She had experienced hemorrhagic stroke and was taken to the hospital on 30Apr2021 at 06:00. She remained hospitalized and died on 06May2021. Autopsy was performed. The outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available and currently known drug safety profile, it is unlikely that event hemorrhagic stroke was related to BNT162B2. The patient''s underlying risk factors/predisposing conditions diabetes, hypercholesterolemia, and hypertension arterial and the advanced age have been assessed to have played a contributory role toward the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Hemorrhagic stroke


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