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

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



Case Details

This is page 113 out of 172

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VAERS ID: 1297190 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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: Medical History/Concurrent Conditions: Multimorbidity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021496563

Write-up: Decompensation cardiac; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100050714. A 77-year-old patient of an unspecified gender received the second dose of BNT162B2 (COMIRNATY, batch/lot number: unknown, strength: 0.3 mL), via an unspecified route of administration on 13Apr2021 (at 77-year-old) at 0.3 mL, single for COVID-19 immunisation. Medical history included multimorbidity. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, batch/lot number: unknown) via an unspecified route of administration on 22Mar2021 (at 77-year-old) at unspecified dose and frequency for COVID-19 immunisation. The patient experienced decompensation cardiac on 13Apr2021. The outcome of the event was fatal. The patient died on 14Apr2021. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1297191 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Cardiovascular disorder, Circulatory collapse, Depressed level of consciousness, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021496552

Write-up: Consciousness clouding; Dyspnoea; Bradycardia; Circulatory instability; Circulatory failure; This is a spontaneous report downloaded from the Regulatory Authority (RA)-WEB [Regulatory authority number DE-PEI-202100051624]. A non-contactable physician reported an 88-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: ET3045) as 0.3 mL, single for COVID-19 immunization. Medical history and concomitant medications were not reported. In Apr2021, the patient had consciousness clouding, dyspnoea, bradycardia, circulatory instability and circulatory failure with fatal outcomes on 14Apr2021. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events for all events per regulatory authority was unclassifiable No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Consciousness clouding; Dyspnoea; Bradycardia; Circulatory instability; Circulatory failure


VAERS ID: 1297192 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 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: Anemia (Requires a transfusion); Atrioventricular block (NOS); Chronic atrial fibrillation; Chronic renal insufficiency; Decompensation cardiac; Left ventricular failure; Parkinson''s disease; Tachyarrhythmia absoluta
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021496543

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB, DE-PEI-202100051625. An 83-year-old female patient received BNT162B2 (COMIRNATY, 0.3 mL), via an unspecified route of administration on 08Apr2021 (at the age of 83-year-old) (Lot Number: EW8904) as single dose for covid-19 immunisation. Medical history included ongoing left ventricular failure, ongoing Parkinson''s disease, ongoing chronic atrial fibrillation, ongoing chronic renal insufficiency, ongoing anemia (required a transfusion), ongoing tachyarrhythmia absolute, ongoing decompensation cardiac, ongoing atrioventricular block (NOS). The patient''s concomitant medications were not reported. On 10Apr2021, the patient died due to unknown cause of death. The patient died on 10Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1297193 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary artery disease
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary angioplasty
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021496534

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB DE-PEI-202100051716. A 57-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EX3599), via an unspecified route of administration on 28Apr2021 as single dose for covid-19 immunization. Medical history included coronary angioplasty from an unknown date and unknown if ongoing, ongoing coronary artery disease. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 29Apr2021.The patient died on 29Apr2021. It was not reported if an autopsy was performed. This report is serious - death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1297195 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 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: 2021-04-13
   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 artery disease NOS; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021496487

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, company number DE-PEI-202100051722. A 64-year-old male patient received bnt162b2 (COMIRNATY, lot number: EW8904), via an unspecified route of administration on 08Apr2021 (at the age of 64-years-old) as a single dose for covid-19 immunisation. The patient medical history included ongoing coronary artery disease NOS and ongoing dementia. The patient''s concomitant medications were not reported. The patient experienced sudden cardiac death on 13Apr2021. The outcome of the event was fatal. The patient died on 13Apr2021. Cause of death was sudden cardiac death. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1297197 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-07
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: Medical History/Concurrent Conditions: Dementia; Disease Parkinson''s
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021496539

Write-up: Lung embolism/suspected pulmonary embolism; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority- DE-PEI-CADR2021059368. Safety Report Unique Identifier- DE-PEI-202100051095. An 86-year-old male patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) at single dose for covid-19 immunisation. Medical history included Disease Parkinson''s, dementia. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY) at 0.3ml, single for prophylactic vaccination. The patient experienced lung embolism on an unspecified date. About 4 weeks after the second vaccination with Comirnaty, the patient died with a suspected pulmonary embolism. The patient died on an unspecified date. It was not reported if an autopsy was performed. Source of assessment was PEI. Result was Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Lung embolism/suspected pulmonary embolism


VAERS ID: 1297210 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-26
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Arrhythmia
SMQs:, Myocardial infarction (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: LOSARTAN ALMUS; LOSARTAN + HIDROCLOROTIAZIDA; EUTIROX; PRADAXA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Hypothyroidism; Ischaemic stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021498164

Write-up: Acute coronary syndrome; very severe pain between the neck and the heart that worsen at bedtime and get up and stay in a coma; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. Regulatory authority number ES-AEMPS-839779. An 88-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 05Mar2021 (Batch/Lot Number: ET1831) as a single dose for COVID-19 immunization. Medical history included hypothyroidism, ischaemic stroke, and hypertension. Concomitant medications included losartan potassium (LOSARTAN ALMUS) taken for high blood pressure and to lower the risk of stroke from 11Feb2012 and ongoing; hydrochlorothiazide, losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA) taken for hypertension and to lower the risk of stroke from 11Feb2012 and ongoing; levothyroxine sodium (EUTIROX) taken for hypothyroidism from 11Feb2012 and ongoing; and dabigatran etexilate mesilate (PRADAXA) taken to avoid another stroke from 11Feb2012 and ongoing. The patient experienced acute coronary syndrome and a very severe pain between the neck and the heart that worsen at bedtime and get up and stay in a coma (arrythmia) on 26Mar2021. The patient died on 26Mar2021. The death certificate showed cardiac arrhythmia as the immediate cause of death and acute coronary syndrome as the main cause. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute coronary syndrome; very severe pain between the neck and the heart that worsen at bedtime and get up and stay in a coma


VAERS ID: 1297216 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-21
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram abdomen, Mesenteric vein thrombosis, Portal vein thrombosis, Splenic vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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: Medical History/Concurrent Conditions: Down''s syndrome; Neuropsychiatric syndrome; Subluxation hip; Urinary incontinence
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Abdominal CT; Result Unstructured Data: Test Result:Venous ischaemia due to thrombosis of portal vein; Comments: and intrahepatic branches, splenic vein and superior mesenteric vein. Transmural necrosis of practically the entire small intestine.
CDC Split Type: ESPFIZER INC2021501761

Write-up: Splenic vein thrombosis; Mesenteric vein thrombosis; Portal vein thrombosis; This is as spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB ES-AEMPS-844809. A 38-year-old male patient received the second dose of BNT162b2 (COMIRNATY; lot number: EW2239), intramuscularly on 30Mar2021 at 0.3 mL single for COVID-19 immunization. Medical history included Down''s syndrome, urinary incontinence, left hip subluxation and neuropsychiatric disorders (reported as patient''s reasons for vaccination). Unknown if passed COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (lot number: ET1831) on 09Mar2021 at 0.3mL single for COVID-19 immunisation. The patient experienced splenic vein thrombosis, mesenteric vein thrombosis and portal vein thrombosis on 21Apr2021. The patient died on 22Apr2021. Diagnostic impression: massive thrombosis. The clinical course was reported as follows: on 21Apr2021, he came in with vomiting in the morning and in the afternoon he had 2 bowel movements with abundant red blood in the stools, no abdominal pain, afebrile, no other symptoms. The patient underwent lab tests and procedures, which included abdominal CT on 21Apr2021: venous ischaemia due to thrombosis of portal vein and intrahepatic branches, splenic vein and superior mesenteric vein. Transmural necrosis of practically the entire small intestine. The outcome of the events was fatal. It was unknown if an autopsy was performed. Reporter causality assessment: the chronology was compatible. The adverse event was not described in the vaccine data sheet. The outcome after withdrawal and re-exposure could not be assessed. There was insufficient information to rule out alternative causes. Reporter Comment: Additional ADR information: Thrombosis of portal vein as well as its intrahepatic branches, splenic vein and superior mesenteric vein leading to ischaemia of practically the entire small intestine with mural thickening and congestion of the mesentery. The patient''s evolution was one of progressive deterioration until final exitus. As there were no other risk factors except Down''s syndrome, we referred this event for evaluation. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Additional ADR information: Thrombosis of portal vein as well as its intrahepatic branches, splenic vein and superior mesenteric vein leading to ischaemia of practically the entire small intestine with mural thickening and congestion of the mesentery. The patient''s evolution was one of progressive deterioration until final exitus. As there were no other risk factors except Down''s syndrome, we referred this event for evaluation.; Reported Cause(s) of Death: Splenic vein thrombosis; Mesenteric vein thrombosis; Portal vein thrombosis


VAERS ID: 1297219 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biliary colic, Haematemesis, Ultrasound abdomen
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gallbladder related disorders (narrow), Biliary tract disorders (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder disorder (under study by urology.); Breast cancer; Cholelithiasis; Colon cancer; COPD; Cyst of kidney; Hepatic cyst NOS; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:Liver of normal size; Comments: with preserved structure and echogenicity. 17 mm cyst in LHD. No other focal space-occupying lesions or dilatation of the intra- or extrahepatic bile duct are demonstrated. Gallbladder with lithiasis in its lumen, without inflammatory signs. Pancreas not visualized by interposition of intestinal gas. Spleen without significant findings. Kidneys of normal size and morphology, with adequate parenchymal thickness without dilatation of the excretory system. Bilateral kidney cysts. No significant alterations in the retroperitoneum visible. Bladder sparsely replenished, showing two 8 and 19 mm lesions on its right margin that seem to depend on the bladder wall. Cystoscopy evaluation is recommended
CDC Split Type: ESPFIZER INC2021496690

Write-up: Biliary colic; hematic vomit; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is ES-AEMPS-847614. A 79-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Apr2021 at single dose for COVID-19 immunisation. Medical history included hypertension (hypertension arterial), chronic obstructive pulmonary disease (COPD), breast cancer and colon cancer that were surgically intervened, cholelithiasis, liver cyst (hepatic cyst NOS), kidney cysts, bladder wall lesions under study by urology. Patient presented abdominal pain of at least 4 months of evolution in probable relation to cholelithiasis, although she was still under study and pending to be evaluated by surgery. For 4 days the pain in the right upper quadrant worsened, which subsided with the taking of buscapine and paracetamol. Abdominal ultrasound (Mar2021): Liver of normal size, with preserved structure and echogenicity. 17 mm cyst in LHD (left hepatic duct). No other focal space-occupying lesions or dilatation of the intra- or extrahepatic bile duct are demonstrated. Gallbladder with lithiasis in its lumen, without inflammatory signs. Pancreas not visualized by interposition of intestinal gas. Spleen without significant findings. Kidneys of normal size and morphology, with adequate parenchymal thickness without dilatation of the excretory system. Bilateral kidney cysts. No significant alterations in the retroperitoneum visible. Bladder sparsely replenished, showing two 8 and 19 mm lesions on its right margin that seem to depend on the bladder wall. Cystoscopy evaluation is recommended. On 18Apr2021, she went to the hospital due to continuous pain in the right upper quadrant, which limited her activity and was not resolved despite medication. She reported having a semi-liquid black stool for 48 hours before. No fever. No other associated symptoms. Concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (COMIRNATY) on 05Apr2021 for COVID-19 immunisation. On 26Apr2021, she reported not feeling well, but despite this she wanted to get the second dose of Pfizer vaccine. That same day in the afternoon her daughter called her by phone to check how she was and when she did not answer, she went to her home and found her dead sitting on the sofa with traces of hematic vomit, she warned 061. It was decided jointly with the family, after assessing personal history and medical history of recent months, and in the face of evidence of natural death, not activating judicial protocol. Patient was dead due to biliary colic on 26Apr2021. Autopsy was not done. Outcome of event haematemesis was unknown. No follow-up attempts are possible. No further information required. Information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Biliary colic


VAERS ID: 1297229 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-07
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Candida albicans infection; Cardiac insufficiency; Cognitive disorder (due to hemorrhagic stroke in 2001); COPD; Endocarditis infective (due to Candida albicans); Haemochromatosis; Hemorrhagic stroke; Hypertension; Mitral valve replacement; Oxygen saturation decreased (requiring hospitalization on 30Sep2020); Oxygen supplementation; Peripheral arterial occlusive disease (requiring stent placement); Sleep apnoea syndromes (requiring oxygen supplementation); Stent placement; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 PCR; Test Result: Negative
CDC Split Type: FRPFIZER INC2021497841

Write-up: Vaccination failure; COVID-19 pneumonitis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20213844. A 77-year-old male patient who lived in nursery home received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), intramuscular on 21Jan2021 (Batch/Lot number was not reported) as single dose, the second dose intramuscular on 11Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Batch/Lot numbers and sites of vaccination were not available. Medical history included sleep apnoea syndrome from an unknown date and unknown if ongoing requiring oxygen supplementation, cognitive disorder due to hemorrhagic stroke in 2001, hypertension from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing, peripheral arterial occlusive disease from an unknown date and unknown if ongoing requiring stent placement, cardiac failure from an unknown date and unknown if ongoing, mitral valve replacement in 2011, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, haemochromatosis from an unknown date and unknown if ongoing, endocarditis in 2019 due to Candida albicans and Type 2 diabetes mellitus from an unknown date and unknown if ongoing. The patient was previously hospitalized on 30Sep2020 for desaturation. Concomitant medications were not reported. COVID-19 PCR test was negative. A cluster in the nursery home was noted with 12 COVID-19 cases since 07Apr2021, including variant. On 07Apr2021 the patient experienced vaccination failure and COVID-19 pneumonitis, both requiring the patient''s hospitalization and finally leading to his death. The patient was hospitalized for vaccination failure (vaccination failure) from Apr2021 to an unknown date. The patient died on 16Apr2021 at 03:15 am. No autopsy was performed. Death cause was reported as COVID-19 severe hypoxemic pneumonitis. In total, vaccination failure medically confirmed requiring hospitalization in Apr2021 due to COVID-19 severe hypoxemic pneumonitis leading to the patient''s death in a background of several comorbidities. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of vaccination failure and COVID-19 pneumonitis. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including viral genetic studies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: COVID-19 severe hypoxemic pneumonitis; COVID-19 severe hypoxemic pneumonitis


VAERS ID: 1297230 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-04-11
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: O2 saturation; Test Result: 89 %; Comments: under 3L of O2; Test Date: 20210411; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: variant not specified
CDC Split Type: FRPFIZER INC2021496601

Write-up: Vaccination failure; cardiorespiratory decompensation; oxygen desaturation; Covid-19 virus test positive; This is a spontaneous report from a contactable other healthcare professional (HCP) downloaded from the regulatory authority FR-AFSSAPS-LL20212270, Safety Report Unique Identifier FR-AFSSAPS-2021043050. A 96-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular, first dose on 18Feb2021 and second dose on 12Mar2021, at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient experienced vaccination failure on an unspecified date, Covid-19 virus test positive on 11Apr2021, cardiorespiratory decompensation on an unspecified date, oxygen desaturation on an unspecified date. The patient presented with cardiorespiratory decompensation with 89% desaturation under 3L of O2, PCR test carried out on 11Apr2021 Sending of the test positive on 11Apr, variant not specified. The patient died on 11Apr2021. It was unknown if autopsy was performed. The patient underwent lab test included O2 saturation showed 89% (under 3L of O2) on an unspecified date; Covid-19 PCR test showed positive (variant not specified) on 11Apr2021. The outcome of the events was fatal. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Vaccination failure; Covid-19 virus test positive; oxygen desaturation; cardiorespiratory decompensation


VAERS ID: 1297240 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / OT

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: 2021-04-24
   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: XATRAL
Current Illness: Enlarged prostate (benign prostatic hyperplasia treated with Xatral and calcium supplementation)
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate adenoma (treated with Xatral and calcium supplementation)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021496560

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) Database-WEB FR-AFSSAPS-TS20211486, Safety Report Unique Identifier FR-AFSSAPS-2021045307. A 73-year-old male patient received bnt162b2 (vaccine ), dose 1 intramuscular on 21Apr2021 (Batch/Lot Number: EX0893) as single dose at the age of 73-year-old for COVID-19 immunisation. Medical history included only a history of prostate adenoma and benign prostatic hyperplasia ongoing. No cardiovascular risk factor. No history of COVID. No chronic treatment other than for prostate adenoma (Xatral) and calcium supplementation. He was an active retiree who continues his activities in his garden. Concomitant medication(s) included Xatral taken for prostate adenoma, start and stop date were not reported. The patient experienced sudden death on 24Apr2021. The course of events was as follows: He did not complain of any symptoms after vaccination. On Day2 of the vaccine: on the night of 23 to 24Apr2021 sudden death occurred while sleeping. Call for SOS doctor by the family. The doctor who noted the death did not notice any particular anomaly. No autopsy required and not performed. In total, sudden unexplained death on Day2 of the 1st dose of vaccine in a patient with no history, including cardiovascular. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1297380 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-03
Onset:2021-01-16
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Pneumonia, Respiratory disorder
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; CALCIUM CARBONATE; DUTASTERIDE; FOLIC ACID; FLUOXETINE; FUROSEMIDE; PRAVASTATIN; RIVASTIGMINE; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atrial fibrillation; Blood pressure high; Dementia; Enlarged prostate; Pseudoaneurysm; Squamous cell carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021453403

Write-up: Person died; pneumonia; Sudden respiratory symptoms; Abdominal pain; This is a spontaneous from a contactable consumer downloaded from the regulatory authority-WEB. This is a report received [RA} Regulatory authority report number [GB-MHRA-WEBCOVID-202104161642285520] with Safety Report Unique Identifier [GB-MHRA-ADR 25160155]. An 89-year-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1688), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunisation. Medical history included dementia, aortic stenosis, Enlarged prostate, atrial fibrillation, hypertension (HTN), squamous cell carcinoma (SCC), pseudoaneurysm. Patient had not symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included apixaban taken from 25Mar2017 to an unspecified stop date; calcium carbonate (CALCIUM CARBONATE) taken from 26Feb2015 to an unspecified stop date; dutasteride taken from 10Jul2018 to an unspecified stop date; folic acid taken from 24Apr2015 to an unspecified stop date; fluoxetine taken from 26Feb2015 to an unspecified stop date; furosemide taken from 03Sep2016 to an unspecified stop date; pravastatin taken from 26Feb2015 to an unspecified stop date; rivastigmine taken from 26Apr2017 to an unspecified stop date; tamsulosin taken for prostatomegaly from 07Oct2018 to an unspecified stop date. On 16Jan2021, the patient experienced abdominal pain. On 29Jan2021, the patient experienced Sudden respiratory symptoms. On 31Jan2021, the patient experienced pneumonia. The patient''s hospitalization was prolonged as a result of abdominal pain. The events Abdominal pain, pneumonia, Sudden respiratory symptoms were assessed as serious (medically significant). The clinical course was reported as follows: Severe abdominal pain, hospitalised, no cause identified. Sudden respiratory symptoms 29Jan2021, antibiotics for LRTI. Diagnosed with EoL Pnemonia 31Jan2021. Palliative pathway started. Medications withdrawn. 02Feb2021, antibiotics and steroids prescribed. Assessed, no evidence of pneumonia. Recovering until 05Feb2021. Syringe driver inserted by DN. Person died on 18Feb2021. Patient has not tested positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of pneumonia, and sudden respiratory symptoms (respiratory disorder). The patient died on 18Feb2021. It was not reported if an autopsy was performed. The outcome of the event abdominal pain was recovered on 18Jan2021, while unknown for the other events. On 18Feb2021, the person died. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Person died


VAERS ID: 1298063 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (High blood pressure)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021485456

Write-up: feeling ill; Myocardial infarction; This is a spontaneous report from a contactable consumer received from a regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104281921527340-RS9ZJ. Safety Report Unique Identifier GB-MHRA-ADR 25214787. A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on 15Apr2021 at a single dose for covid-19 immunisation. Medical history included hypertension (high blood pressure). Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient started feeling ill on the 16Apr2021 at 3AM. He passed away with cause listed as myocardial Infarction later that day on 16Apr2021. Patient has not tested positive for COVID-19 since having the vaccine. Outcome of the event feeling ill was unknown. The patient died on 16Apr2021 due to myocardial infarction. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1298076 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-30
Submitted: 0000-00-00
Entered: 2021-05-08
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: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021492615

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-202105010808155160-UJQCN. Safety Report Unique Identifier GB-MHRA-ADR 25227069. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. It was reported that the patient died (death) on 30Apr2021. However patient also reported, "I am dead from your so called vaccine". The patient underwent lab tests and procedures which included COVID-19 virus test: negative (no - negative covid-19 test) on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 30Apr2021. 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: death


VAERS ID: 1298121 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-29
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Encephalitis, Listeriosis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow), 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: MEDROL [METHYLPREDNISOLONE]; METHOTREXATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021491344

Write-up: Listeria infection; Meningoencephalitis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB. This report is from the Health Authority . Regulatory authority number is-EOF-20212344. An 82-year-old female patient received bnt162b2 (Pfizer vaccine), intramuscular on an unspecified date at a single dose for covid-19 immunisation. The medical history was not reported. Concomitant medications included methylprednisolone (MEDROL [METHYLPREDNISOLONE]) taken orally from an unspecified start date to an unknown date at 8mg (1x2 tablets) for rheumatoid arthritis; methotrexate (MANUFACTURER UNKNOWN), taken for rheumatoid arthritis from an unspecified start date to Dec2020. On 29Mar2021, the patient experienced listeria infection and meningoencephalitis, which were serious for death. The clinical outcome of the events was fatal. The patient died on an unspecified date due to meningoencephalitis and listeria infection. An autopsy was not performed. SENDER COMMENT: initial report with follow-up info No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Meningoencephalitis; Listeria infection


VAERS ID: 1298122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-09
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood pressure diastolic, Blood pressure systolic, Cerebral haemorrhage, Cerebrovascular accident, Coma, Computerised tomogram, Confusional state, Electrocardiogram, Headache, Oxygen saturation, Pupillary reflex impaired, Pupils unequal, Tachyarrhythmia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZESTRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidemia; Hypertension; Surgery (Surgery for ileum)
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:60 mmHg; Test Date: 20210409; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:80 mmHg; Test Date: 20210409; Test Name: CT scan; Result Unstructured Data: Test Result:Abnormal. Severe stroke episode; Test Date: 20210409; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Abnormal; Comments: atrial fibrillation with ventricular response, ventricular contractions as bigeminy; Test Date: 20210409; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Abnormal; Comments: tachyarrhythmia; Test Date: 20210409; Test Name: Oxygen saturation; Test Result: 77 %
CDC Split Type: GRPFIZER INC2021483963

Write-up: Confusion; Sudden intense headache; Tachyarrhythmia; Pupillary reflex absent; Atrial fibrillation; Extensive cerebral hemorrhage; Anisocoria (mydriasis left); Comatose; severe stroke episode; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. The regulatory authority number is GR-GREOF-20212388. A 56-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: Unknown), dose 2 intramuscular on 31Mar2021 as single dose for covid-19 immunization. Medical history included hyperlipidemia from an unknown date, surgery in 2020 (reported as surgery for ileum), hypertension from an unknown date. Concomitant medications included lisinopril (ZESTRIL) taken for hypertension from 05Apr2012 to an unspecified stop date. Patient received the first dose of BNT162B2 for covid-19 immunization on an unspecified date. On 09Apr2021, the patient experienced the following medically significant, life-threatening and fatal events: confusion, sudden intense headache, tachyarrhythmia, pupillary reflex absent, atrial fibrillation, extensive cerebral hemorrhage, anisocoria (mydriasis left), comatose. The patient also experienced severe stroke episode, with unreported outcome. The patient underwent lab tests and procedures which included diastolic blood pressure: 60 mmhg on 09Apr2021, systolic blood pressure: 80 mmhg on 09Apr2021, computerised tomogram scan: abnormal. severe stroke episode on 09Apr2021, electrocardiogram: abnormal on 09Apr2021 (atrial fibrillation with ventricular response, ventricular contractions as bigeminy ), electrocardiogram: abnormal on 09Apr2021 (tachyarrhythmia), oxygen saturation: 77 % on 09Apr2021. Details were as follows: the reporters brother suffered from a severe stroke episode and he was taken to a hospital. He did a CT scan which showed extensive cerebral hemorrhage. The hospital neurosurgeon didn''t approve a surgery. He was taken after another hospital on 09Apr2021where he remained there, unconscious. For all the days then he felt very intense headaches. The patient passed away on 14Apr2021. He had ileus surgery a year prior. No history of thrombophilia, no pre-existing venous disease, no family history of venous disease, no history of malignant tumor were noted. The patient died on 14Apr2021. An autopsy was performed and results were not provided. Death certificate confirmed that the patient passed away on 14Apr2021, from cerebral hemorrhage. Sender Comment: ''Initial report with follow up information'' No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: cerebral hemorrhage


VAERS ID: 1298123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Death, 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: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: QUEPIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease (STARTED 4 DECADES AGO); Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021491367

Write-up: Death; Vomiting; Cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB (GR-GREOF-20212525). An 81-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly, on 01Apr2021 as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (started 4 decades ago) and dementia from 2019. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included quetiapine fumarate (QUEPIN) from 09Sep2020 to 13Apr2021. The patient previously received the influenza vaccination (MANUFACTURER UNKNOWN) for immunisation in Nov2020. The patient experienced death, vomiting, and cardiac arrest on 14Apr2021, reported as medically significant and fatal. The patient died on 14Apr2021. The cause of death was reported as cardiac arrest. An autopsy was not performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1298136 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-19
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   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: Gastritis; Osteoporosis; Pulmonary fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021506471

Write-up: PNEUMONIA; This is a spontaneous report from a non-contactable health professional via Agency, based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS000961), license party for BNT162B2 (COMIRNATY). A 74-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included pulmonary fibrosis, osteoporosis and gastritis, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced shortness of breath and cough and was admitted to the hospital on 19Apr2021. The patient was diagnosed with pneumonia and passed away on 25Apr2021, 18 days after the vaccination. Pneumonia met the seriousness criteria of death, hospitalization and was considered as important medical event. It was not reported if an autopsy was performed. Causality Assessments: per reporter was possible and per Company (BioNTech) was possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1298144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Confusional state, Drug ineffective, Dyspnoea, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021484805

Write-up: suspected COVID-19; suspected COVID-19; weakness; confusion; dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (HU-OGYI-229421). A 93-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly, on 17Mar2021 (Lot number: EP2166) as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced weakness, confusion, and dyspnoea on 19Mar2021, which were reported as fatal. The patient also experienced suspected COVID-19 on 19Mar2021. Therapeutic measures were taken as a result of the events, which included favipiravir (MANUFACTURER UNKNOWN) from 03Apr2021. The patient died at home on 10Apr2021. The cause of death was assessed as suspected COVID-19 (reported as: unknown cause of death). It was not reported if an autopsy was performed. Sender''s Comment: Weakness is expected adverse event of COMIRNATY. Confusion and dyspnoea are not expected adverse events. The symptoms started two days after vaccination. They might have been already the symptoms of the patient''s suspected COVID-19. Based on the above, and in lack of detailed medical information, relationship between death and COMIRNATY is not assessable. The case is serious because the patient died. No further information is expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: suspected COVID-19; suspected COVID-19


VAERS ID: 1298153 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   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: PANTOPRAZOLE; GALFER; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; SINEMET; MIRTAZAPINE; OLANZAPINE; SINEMET; ZOPICLONE; MADOPAR; ESCITALOPRAM; EXELON [RIVASTIGMINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia (Severe anaemia); Dementia; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade
CDC Split Type: IEPFIZER INC2021151590

Write-up: Unknown cause of death; Low grade pyrexia; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB. Regulatory authority report number [IE-HPRA-2021-064078], Safety Report Unique Identifier [IE-HPRA-2021-064078]. A 86-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: EM0477), via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunization. Medical history included anaemia (severe anaemia), Parkinson''s disease and dementia. Concomitant medications pantoprazole 40 mg once daily, ferrous fumarate (GALFER) 305 mg, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE]) once daily, mirtazapine 15 mg, olanzapine, 2.5 mg once daily, carbidopa, levodopa (SINEMET) once daily (200/50 mg), zopiclone oral 7.5 mg, once daily (At night), benserazide hydrochloride, levodopa (MADOPAR) once daily, escitalopram 10 mg once daily, rivastigmine (EXELON [RIVASTIGMINE]) all for unknown indication, carbidopa, levodopa (SINEMET) (150/37.5) thrice daily taken for Parkinson''s disease. On 24Jan2021, patient experienced low grade pyrexia with a body temperature of 37.8 centigrade. Patient was recovered with low grade pyrexia within 2 hrs on 24Jan2021. The patient died on 25Jan2021. Cause of death was unknown (general progressive decline). 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: Unknown cause of death


VAERS ID: 1298229 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-05
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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

Life Threatening? 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: ITPFIZER INC2021491314

Write-up: Stroke 10 days after of receiving the second dose of the pfizer covid-19 vaccine; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-719979. An 81-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 26Mar2021 15:44 (Lot Number: EP2166; Expiration Date: 31May2021) as 30 ug, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 05Mar2021 administered at 16:58 for COVID-19 vaccination. The patient experienced stroke 10 days after of receiving the second dose of the Pfizer covid-19 vaccine on 05Apr2021 15:44. The patient died on an unspecified date due to stroke. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: stroke


VAERS ID: 1298232 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Peripheral ischaemia
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 21
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021491339

Write-up: Right upper limb ischemia, hospitalized in emergency, vascular surgery; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-720509. A 91-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: EX0893), second dose intramuscular, administered in Deltoid Left on 21Apr2021, single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced right upper limb ischemia, hospitalized in emergency, vascular surgery on 22Apr2021. The patient died between the night of 22nd and 23rd April. It was not reported if an autopsy was performed.The outcome of the event was fatal. Sender''s comment: 2nd dose administration of the left deltoid region. Date: 21Apr2021 Actions taken: dispatch to vascular surgery via Emergency medical service. Request date of death. Update 27Apr2021: died between the night of 22nd and 23rd April.; Reported Cause(s) of Death: Right upper limb ischemia, hospitalized in emergency, vascular surgery


VAERS ID: 1298233 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT AVAILABLE / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Enuresis, Haematology test, Intestinal obstruction, Investigation, Oral candidiasis, Platelet count, Pneumonia, Pulmonary embolism, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal obstruction (narrow), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: haematochemical analysis; Result Unstructured Data: Test Result:with particular reference to blood count with plat; Comments: with particular reference to blood count with platelet count and trend of the parameters of the coagulation; Test Name: Impact on quality of life; Result Unstructured Data: Test Result:unknown result; Test Name: platelet count; Result Unstructured Data: Test Result:unknown result; Test Name: SARS-Cov2 swab; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC2021483955

Write-up: Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death; Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death; Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death; Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death; Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death; Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death; Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death; Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-720585. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in deltoid right on 19Mar2021 (Batch/Lot Number: not available) as a single dose for SARS-CoV-2 vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death. The event onset date was reported as 20Mar2021. Additional information: clinical report of the case, with detailed medical history (anamnestic information with particular reference to previous or concomitant pathologies, previous and concomitant therapies) haematochemical analysis with particular reference to blood count with platelet count and trend of the parameters of the coagulation and SARS-Cov2 swab and outcome of any autopsy examination.- Action taken - Medical examination by general practitioner, hospitalization - Impact on quality of life (10/10). The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, death; Fever, asthenia, anorexia, thrush, enuresis, intestinal blockage, bilateral interstitial pneumonia, pulmonary embolism, dea


VAERS ID: 1298234 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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: Medical History/Concurrent Conditions: COPD; Diabetes; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021491296

Write-up: the patient in good health despite the risk factors received vaccination with 1 dose pfizer on 13apr21. after 24 hours he presented high fever and deep astenia. he died on 22apr21; the patient in good health despite the risk factors received vaccination with 1 dose pfizer on 13apr21. after 24 hours he presented high fever and deep astenia. he died on 22apr21; After about 24 hours he developed fever, myalgia and asthenia. He passed away on 22Apr2021; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-720604. A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via intramuscular route in left deltoid on 13Apr2021 11:00 (Batch/Lot Number: EW2246) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, diabetes mellitus from 14Apr2021 to 22Apr2021, hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced pyrexia, asthenia and myalgia on 14Apr2021. The events were fatal and were described as the patient in good health despite the risk factors received vaccination with 1 dose Pfizer on 13Apr21. After 24 hours he presented high fever and deep asthenia. The patient died on 22Apr2021. It was not reported if an autopsy was performed. The outcome of the events was reported as fatal. Reporter''s comment: The 78-year-old patient with diabetes, hypertension and BPCO in good compensation received 1 dose of anti-covid Pfizer vaccine on 13Apr2021. After about 24 hours he developed fever, myalgia and asthenia. He passed away on 22Apr2021.; Reporter''s Comments: The 78-year-old patient with diabetes, hypertension and BPCO in good compensation received 1 dose of anti covid Pfizer vaccine on 13Apr2021. After about 24 hours he developed fever, myalgia and asthenia. He passed away on 22Apr2021.; Reported Cause(s) of Death: the patient in good health despite the risk factors received vaccination with 1 dose pfizer on 13apr21. after 24 hours he presented high fever and deep astenia. he died on 22apr21; the patient in good health despite the risk factors received vaccinat


VAERS ID: 1298235 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19 pneumonia, Computerised tomogram, Computerised tomogram head, Dyspnoea, Fluorescence angiogram, Ischaemia, Lymphadenopathy mediastinal, Pyrexia, Retinal artery embolism, SARS-CoV-2 test, SARS-CoV-2 test negative, Visual impairment
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTORC; MAALOX [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]; RENVELA; LASIX [FUROSEMIDE]; COUMADIN; NORVASC; LOBIVON; CITROSODINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy (arteriopathy in uremic stage IV); Bleeding; Chronic kidney disease stage 5 (chronic kidney disease stage 5 under hemodialysis treatment); Chronic renal failure; Duodenal ulcer (duodenal ulcer with previous bleeding episodes); Gastric ulcer; Heart valvular prosthesis wearer (metal-type aortic valve prosthesis); Hemodialysis; Hepatitis C; Hyperacidity; Hyperphosphataemia; Hypertension arterial; Infection of amputation stump (polymicrobial foot stump infection (acinetobacter)); Nephrectomy (patient with one kidney since 2008); Papillitis optic (papillitis right eye)
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: fever; Result Unstructured Data: Test Result:fever; Test Date: 20210402; Test Name: Computerised tomogram; Result Unstructured Data: Test Result:Multifocal, bilateral parenchymal thickening consi; Comments: Multifocal, bilateral parenchymal thickening consisting of areas of ground-glass in all lung lobes and extensive area of parenchymal consolidation in the right lower lobe are highlighted. Neither pleural nor pericardial effusion. Patency of the main airways. Some mediastinal lymph nodes enlarged. Picture compatible with infectious pulmonary foci of viral etiology attributable to SARS-CoV2; Test Date: 20210403; Test Name: Brain CT; Result Unstructured Data: Test Result:Severe atheroma of the posterior circulation, exte; Comments: Severe atheroma of the posterior circulation, extensive occipital hypo-attenuation area; Test Date: 20210409; Test Name: Fluorescence angiogram; Result Unstructured Data: Test Result:Central retinal artery embolism with nasal ischemi; Comments: Central retinal artery embolism with nasal ischemic areas; Test Date: 20210401; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: ITPFIZER INC2021496775

Write-up: onset of fever, dyspnoea, reduced vision, retinal artery embolism, nasal ischemic areas, bilateral SARS-CoV-2 pneumonia, mediastinal lymphadenopathy, negative SARS-Cov2 swab.; onset of fever, dyspnoea, reduced vision, retinal artery embolism, nasal ischemic areas, bilateral SARS-CoV-2 pneumonia, mediastinal lymphadenopathy, negative SARS-Cov2 swab.; onset of fever, dyspnoea, reduced vision, retinal artery embolism, nasal ischemic areas, bilateral SARS-CoV-2 pneumonia, mediastinal lymphadenopathy, negative SARS-Cov2 swab.; onset of fever, dyspnoea, reduced vision, retinal artery embolism, nasal ischemic areas, bilateral SARS-CoV-2 pneumonia, mediastinal lymphadenopathy, negative SARS-Cov2 swab.; onset of fever, dyspnoea, reduced vision, retinal artery embolism, nasal ischemic areas, bilateral SARS-CoV-2 pneumonia, mediastinal lymphadenopathy, negative SARS-Cov2 swab.; onset of fever, dyspnoea, reduced vision, retinal artery embolism, nasal ischemic areas, bilateral SARS-CoV-2 pneumonia, mediastinal lymphadenopathy, negative SARS-Cov2 swab.; onset of fever, dyspnoea, reduced vision, retinal artery embolism, nasal ischemic areas, bilateral SARS-CoV-2 pneumonia, mediastinal lymphadenopathy, negative SARS-Cov2 swab.; onset of fever, dyspnoea, reduced vision, retinal artery embolism, nasal ischemic areas, bilateral SARS-CoV-2 pneumonia, mediastinal lymphadenopathy, negative SARS-Cov2 swab.; This is as spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-721031. A 76-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular on 31Mar2021 (Lot Number: ET1831) as 0.3 mL, single for COVID-19 immunisation. Medical history included optic neuritis from an unknown date and unknown if ongoing (papillitis right eye), Heart valvular prosthesis wearer from an unknown date and unknown if ongoing (metal-type aortic valve prosthesis), Chronic kidney disease stage 5 from an unknown date and unknown if ongoing (chronic kidney disease stage 5 under hemodialysis treatment), Chronic renal failure from an unknown date and unknown if ongoing , Infection of amputation stump from an unknown date and unknown if ongoing (polymicrobial foot stump infection (acinetobacter) ), nephrectomy from 2008 and unknown if ongoing (patient with one kidney since 2008), duodenal ulcer from an unknown date and unknown if ongoing (duodenal ulcer with previous bleeding episodes), Arteriopathy from an unknown date and unknown if ongoing (arteriopathy in uremic stage IV), Hepatitis C from an unknown date and unknown if ongoing, Gastric ulcer, Hyperacidity, Hyperphosphataemia, Hypertension arterial, hemodialysis and bleeding episodes. Concomitant medications included pantoprazole sodium sesquihydrate (PANTORC) taken for gastric ulcer; aluminium hydroxide, magnesium hydroxide (MAALOX) taken for Hyperacidity; sevelamer carbonate (RENVELA) taken for hyperphosphataemia; furosemide (LASIX) taken for Hypertension arterial; warfarin sodium (COUMADIN) taken for an unspecified indication; amlodipine besilate (NORVASC) taken for Hypertension arterial; nebivolol hydrochloride (LOBIVON) taken for Hypertension arterial; sodium citrate acid (CITROSODINA) taken for an unspecified indication. The patient previously took warfarin sodium (COUMADIN, 5mg tablets 30 divisible tablets (Teofarma S.R.L.) (B01AA03)) for embolism and experienced Gastric bleeding. The patient experienced onset of fever, dyspnoea, reduced vision, retinal artery embolism, nasal ischemic areas, bilateral sars-cov-2 pneumonia, mediastinal lymphadenopathy, negative sars-cov2 swab (death) on 01Apr2021. The patient underwent lab tests and procedures which included computerised tomogram: Multifocal, bilateral parenchymal thickening consisting of areas of ground-glass in all lung lobes and extensive area of parenchymal consolidation in the right lower lobe are highlighted. Neither pleural nor pericardial effusion. Patency of the main airways. Some mediastinal lymph nodes enlarged. Picture compatible with infectious pulmonary foci of viral etiology attributable to SARS-CoV2 on 02Apr2021, computerised tomogram head: Severe atheroma of the posterior circulation, extensive occipital hypo-attenuation area on 03Apr2021, fluorescence angiogram: Central retinal artery embolism with nasal ischemic areas on 09Apr2021, sars-cov-2 test: negative on 01Apr2021, body temperature: fever on 01Apr2021. Therapeutic measures were taken as a result of events. The patient died on 19Apr2021. It was not reported if an autopsy was performed. The outcome of events was fatal. Reporter Comment: After administration of the Comirnaty vaccine onset of fever, dyspnoea, reduced vision, central artery embolism, nasal ischemic areas, death.; Reporter''s Comments: After administration of the Comirnaty vaccine onset of fever, dyspnoea, reduced vision, central artery embolism, nasal ischemic areas, death.; Reported Cause(s) of Death: mediastinal lymphadenopathy; dyspnoea; reduced vision; retinal artery embolism; nasal ischemic areas; bilateral SARS-CoV-2 pneumonia; negative SARS-Cov2 swab; onset of fever


VAERS ID: 1298238 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-09
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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: SINTROM; EUTIROX; SOPAVI; CARDIOASPIRIN; ATENOLOL; GIANT; PANTORC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery bypass (Coronary artery bypass surgery, mitral replacement and tricuspid plastic surgery in September 2020.); Hypertension pulmonary (Pulmonary hypertension caused by mitral stenosis treated surgically in September 2020); Mitral stenosis; Mitral valve replacement; Plastic surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021491300

Write-up: Respiratory crisis appeared about 17 days after administration of 2nd dose; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number IT-MINISAL02-721802. A 82-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET3620), via an unspecified route of administration in left arm on 23Mar2021 at 16:45 as a single dose for Covid-19 immunization. Medical history included pulmonary hypertension (pulmonary hypertension caused by mitral stenosis treated surgically in September 2020), coronary artery bypass in 22Sep2020 (coronary artery bypass surgery, mitral replacement and tricuspid plastic surgery in September 2020). Concomitant medications included atenolol from an unspecified start date to 06Apr2021, acenocoumarol (SINTROM), levothyroxine sodium (EUTIROX) at a dose for 50 microgram (ug), atorvastatin calcium (SOPAVI) at a dose of 20 mg, acetylsalicylic acid (CARDIOASPIRIN) at a dose of 100 mg, amlodipine besilate, olmesartan medoxomil (GIANT) from an unspecified start date to 09Apr2021, pantoprazole sodium sesquihydrate (PANTORC) at a dose of 40 mg on an unspecified date, all for unknown indication. The patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 03Mar2021, as a single dose for Covid-19 immunisation and experienced pneumonitis. On 09Apr2021, the patient experienced cardio-respiratory failure and event was described as respiratory crisis appeared about 17 days after administration of 2nd dose. The patient was hospitalized due to respiratory crisis and died on 14Apr2021. An autopsy was performed and the cause of death from autopsy was cardiogenic shock in a patient suffering from chronic ischemic heart disease with heart failure, acute renal failure on CRI. Reporter comment: Reporter / family member reports not having certainty of correlation to vaccination. No follow up attempt possible. No further information expected.; Reported Cause(s) of Death: cardio-respiratory failure; Autopsy-determined Cause(s) of Death: chronic ischemic heart disease; acute renal failure; cardiogenic shock


VAERS ID: 1298239 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest pain, Myocardial infarction, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   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: Medical History/Concurrent Conditions: Brittle diabetes; Hypertension arterial; IHD; Tabaquism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021491278

Write-up: Vomiting; Asthenia; myocardial infarction; pain in extremity; chest pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER, solution for injection, Lot number EX3599; Expiration Date: 31Aug2021), via intramuscular route of administration in the left arm as 0.3 mL on 24Apr2021 at 16:15 as single dose for COVID-19 immunisation. Medical history included Tabaquism from an unknown date and unknown if ongoing, myocardial ischaemia from 01Jun2017 to an unknown date, Brittle diabetes from 01Jun2017 to an unknown date, hypertension arterial from 01Jun2017 to an unknown date. The patient''s concomitant medications were not reported. On 25Apr2021, the patient experienced vomiting, asthenia, myocardial infarction, pain in extremity and chest pain, all considered as fatal by the reporter who described the events as: ''death from probable heart attack on 26apr2021, preceded on 25apr2021 evening by episode of exertional left hemithorax and arm pain, general asthenia, vomiting. The patient died on 26Apr2021. It was reported as unknown if an autopsy was performed. Clinical course, therapeutic measures, outcome and additional relevant information included as follows: Head of Pharmacovigilance 28Apr2021: Clinical report completed with medical history requested to the reporter for feedback. Reporter reports included as patient was smoker, the day after vaccination, lifted his disabled wife left arm and hemithorax pain, followed by weakness the next day. After lunch, patient went to rest. The emergency department was called but the patient was already deceased. Outcome of the events was fatal. Reporter comment: Death about 48 hours after administration of COVID vaccine. No follow-up attempts possible. No further information expected. Information about lot number already obtained.; Reporter''s Comments: Death about 48 hours after administration of COVID vaccine.; Reported Cause(s) of Death: Infarct myocardial; Asthenia; Pain in arm; Chest aching; Vomiting


VAERS ID: 1298240 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 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: 2021-04-25
   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; ATORVASTATIN; SERTRALINE; TELMISARTAN; CARVEDILOL; CROMATONFERRO; LEVETIRACETAM; LIXIANA; OMEPRAZOLE; ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Chronic obstructive bronchopneumopathy; Coronavirus infection (the patient had been hospitalized for 3 months for COVID-19); Dilated cardiomyopathy; Emphysema pulmonary; Hospitalisation; Hypercholesteremia; Hyperuricaemia; Hyposthenia; Interstitial pneumonia; Mitral insufficiency; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021496772

Write-up: The patient died suddenly collapsing on the sofa after walking around the house with the walker, WITHOUT showing particular symptoms (fever, dyspnoea, cough, malaise); This is a spontaneous report from contactable physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-722172. An 87 years old male patient received 1st dose of BNT162B2 (COMIRNATY, lot#EX0893, Batch expiration: 31Jul2021) on 23Apr2021 16:00 at single dose on left arm for COVID-19 immunisation. Medical history included Previous coronavirus infection (the patient had been hospitalized for 3 months for COVID-19), interstitial pneumonia / cerebral stroke, discharged in January 2021. Hyposthenia, Dilated cardiomyopathy, Emphysema pulmonary, Chronic obstructive bronchopneumopathy, Hyperuricaemia, Mitral insufficiency, AFib, Hypercholesteremia. Concomitant drugs included furosemide, atorvastatin, sertraline, telmisartan, carvedilol, ferrous gluconate (CROMATONFERRO), levetiracetam, edoxaban tosilate (LIXIANA), omeprazole, allopurinol. The patient died suddenly collapsing on the sofa after walking around the house with the walker, WITHOUT showing particular symptoms (fever, dyspnoea, cough, malaise). Family members called the ambulance and the death was confirmed. Death date was 25Apr2021 11:00. It is unknown if autopsy was done. Outcome of the event was fatal. Reporter''s comment: Family members reported that he did not show any particular symptoms on the day of death nor the days before, after vaccination. No follow-up attempts possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: sudden death


VAERS ID: 1298241 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IDROQUARK; METFORAL
Current Illness: Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021501424

Write-up: myocardial infarction; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-722567. A 87-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Apr2021 (Batch/Lot number was not reported) as 0.3 mL, single for SARS-CoV-2 vaccination. Medical history included ongoing Hypertension arterial, ongoing type 2 diabetes mellitus. Concomitant medications included hydrochlorothiazide, ramipril (IDROQUARK) taken for Hypertension arterial, start and stop date were not reported; metformin hydrochloride (METFORAL) taken for type 2 diabetes mellitus, start and stop date were not reported. The patient experienced myocardial infarction on 20Apr2021. The patient died on 20Apr2021 due to myocardial infarction. It was unknown if an autopsy was performed. The outcome of the event myocardial infarction was fatal. No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained. No further information is expected.; Reported Cause(s) of Death: myocardial infarction


VAERS ID: 1298248 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Chromaturia, Computerised tomogram, Dyspnoea, Lung cancer metastatic, Pyrexia, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 53
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:lung cancer and metastasis; Test Name: Urine analisys; Result Unstructured Data: Test Result:normal; Comments: did not show anything abnormal
CDC Split Type: ITPFIZER INC2021493288

Write-up: lung cancer and metastasis; bronchitis; urine have a dark color; fever for three / four days; breathlessness/difficulty breathing; This is a spontaneous report from a contactable consumer (patient''s son). A 79-year-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 22Mar2021 (lot number and expiration date were not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of COMIRNATY vaccine on 22Mar2021, after which he had a fever for three / four days and breathlessness. A few days later they left together for the mountain, but when they returned, their father''s health conditions progressively worsened, as he had bronchitis and had difficulty breathing. He realized that the urine had a dark color, they were analyzed, but the analyzes did not show anything abnormal. He underwent a CT scan and lung cancer and metastases were found. The patient did not have any symptoms and the analyzes carried out recently did not reveal any particular pathology. From 17Apr2021 he begins to receive supportive care, but he was getting worse and died on 24Apr2021. The patient recovered from the fever in Mar2021. The outcome of the remaining events was unknown. The patient died on 24Apr2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: lung cancer and metastases


VAERS ID: 1298551 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hypertension; Wallenberg syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021488214

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number is v21104533. A 55-year-old male patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: ER7449; Expiration Date: 30Jun2021), via an unspecified route of administration on 17Apr2021 at 11:00 at a single dose for covid-19 immunisation. Medical history included hypertension, cerebral infarction, and Wallenberg syndrome. The patient had no family history. The patient had no history of adverse drug reaction. Concomitant medication included acetylsalicylic acid (BAYASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: ER2659, Expiration date 30Jun2021) on 27Mar2021 at 55 years of age for covid-19 immunisation. On 19Apr2021, two days after the vaccination (as reported), the patient experienced acute myocardial infarction, which was serious for death. The clinical course of the event was as follows: on 19Apr2021, the patient was going to work the night shift but he did not come to work. On 20Apr2021, the following day, when a policeman visited his home, the patient was found dead. The patient underwent lab tests and procedures which included body temperature: 36.0 degrees Centigrade on 17Apr2021 before vaccination. The clinical outcome of the event was fatal (on 19Apr2021, two days after the vaccination, as reported). The patient died in Apr2021 due to acute myocardial infarction. An autopsy was performed, and as a result of an autopsy, acute myocardial infarction was diagnosed. The reporting pharmacist classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as unassessable. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction; Autopsy-determined Cause(s) of Death: acute myocardial infarction was diagnosed


VAERS ID: 1298552 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Condition aggravated
SMQs:

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:
Current Illness: Living in residential institution; Schizophrenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021488218

Write-up: suddenly his condition was aggravated; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority number v21104419. A 70-year-old male patient received the first single dose of BNT162B2 (COMIRNATY; lot ER9480, expiry date 31Jul2021) on 22Apr2021 at 11:00, for COVID-19 immunisation. Medical history included ongoing schizophrenia and was in residential care. Concomitant medications were not reported. Body temperature before vaccination was 36.0 ?C. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 28Apr2021 at 07:30 (6 days after the vaccination), suddenly his condition was aggravated. The patient died on 28Apr2021 at 07:30 (6 days after the vaccination). It was not reported whether an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and the vaccine was unassessable. There was no other possible cause of the event such as any other diseases. ; Reported Cause(s) of Death: suddenly his condition was aggravated


VAERS ID: 1298553 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Electrocardiogram, Physical examination, Protein urine, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Proteinuria (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Electrocardiogram ST-T segment abnormal; Hypertension; Left ventricular hypertrophy; Protein urine present
Allergies:
Diagnostic Lab Data: Test Date: 20201201; Test Name: Blood pressure; Result Unstructured Data: Test Result:165/102; Test Date: 20210421; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Celsius; Comments: Before vaccination; Test Date: 20201201; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Left ventricular hypertrophy, ST-T abnormal; Test Date: 20200801; Test Name: medical examination; Result Unstructured Data: Test Result:similar things to 01Dec2020; Test Date: 20201201; Test Name: Protein urine; Result Unstructured Data: Test Result:3+
CDC Split Type: JPPFIZER INC2021488226

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Agency. The regulatory authority report number is v21104678. A 44-year and 5-month-old female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 21Apr2021 at 14:10 (Lot Number: ER7449; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunisation. Medical history included hypertension (165/102), anaemia, left ventricular hypertrophy, ST-T abnormal, and protein urine 3+. The patient''s concomitant medications were not reported. The patient experienced subarachnoid haemorrhage on 25Apr2021 (4 days after vaccination), which required hospitalization from 25Apr2021 to 26Apr2021 (5 days after vaccination) for 1 day and was reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was 36.3 degrees Celsius on 21Apr2021. The patient was single and lived with her mother. The patient had three siblings (elder brother and a younger brother). It was reported that there were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 21Apr2021, the patient received the vaccine. There were no noteworthy episodes such as pre-existing condition or treatment on the vaccine screening questionnaire. The patient did not work on the vaccination day. On 22Apr2021 (the day after the vaccination), the patient went to work late and worked (from 09:30 to 18:30). On 23Apr2021 at 16:01, the patient came to work. On 24Apr2021 at 08:31, the patient left work (night shift). On the same date, the patient visited another hospital for the discharge procedure of the mother. On 25Apr2021, shortly after 07:00, the elder brother called the reporter''s hospital and reported as follows: The patient was found lying in a warehouse of supermarket where she was working on the side by a colleague at the work. The patient was instantly transported to another hospital. However, the patient was in the dangerous condition with tracheal intubation. On 26Apr2021 around 07:40, the younger brother reported to the reporter that the patient died. The reporter asked another hospital where the event was directly understood for other information and suspected side reaction report. However, it was told that the causal relationship with the side reaction to BNT162B2 could not be assessed and rejected. The outline of other symptoms was unknown. The reporting physician commented as follows: The reporter confirmed the medical examination record because of the event. The result of medical examination performed on 01Dec2020 showed required physician visit for hypertension with blood pressure of 165/102 and anaemia and required completed examination for protein urine (3+) on 01Dec2020. The similar things were pointed out even in the result of medical examination performed on 01Aug2020 (as reported). In addition, required complete examination for left ventricular hypertrophy/ ST-T abnormal which was showed as result of electrocardiogram examination was pointed out on 01Dec2020. The notice of the medical examination results was handed out. The results after consultation were not confirmed at reporter''s hospital. Since the patient did provide the above during medical interview at pre-examination, it was judged that patient could be vaccinated with recognition of healthy condition. The patient worked a normal schedule without problem. However, the patient attended on the discharge of the mother after the night shift and took on part-time job on the same evening. Considering the above facts, it was imagined that the patient might have an excessive physical burden. It was unknown whether there was a causal relationship with subarachnoid haemorrhage. In view of cases of cerebral haemorrhage which developed 3 or 4 days after the vaccination, it was considered that a possibility the vaccination itself contributed to the physical burden could not be ruled out. The patient underwent lab tests and procedures which included blood pressure: 165/102 on 01Dec2020, electrocardiogram: left ventricular hypertrophy, ST-T abnormal on 01Dec2020, and protein urine: 3+ on 01Dec2020. The patient died on 26Apr2021. The cause of death was subarachnoid haemorrhage. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the event and BNT162B2 as unassessable. It was reported that other possible cause of the event such as any other diseases was subarachnoid haemorrhage.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1298554 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-30
Submitted: 0000-00-00
Entered: 2021-05-08
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: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021489512

Write-up: Death; This is a spontaneous report from a contactable pharmacist, received via a Pfizer employee. An elderly female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history included underlying chronic diseases (details unknown). The patient''s concomitant medications were not reported. The patient died on 30Apr2021. It was not reported if an autopsy was performed. The detail of the event was as follows: the pharmacist reported that the elderly female patient was vaccinated and passed away. According to the pharmacist, further information about the patient was unknown. The pharmacist also reported that the patient had underlying chronic diseases and the causality was considered to be not related to bnt162b2.; Sender''s Comments: Based on the limited information currently available the death of this elderly female patient in a nursing facility is attributed to patient underlying chronic medical conditions and assessed unrelated to BNT162b2 (COMIRNATY) vaccine. The case will be reevaluated should additional information become available.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1298555 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: Medical History/Concurrent Conditions: Migraine (underlying condition); Sleeplessness
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: Autopsy; Result Unstructured Data: Test Result:the cause of death was unknown; Test Date: 20210503; Test Name: Postmortem CT; Result Unstructured Data: Test Result:the cause of death was unknown
CDC Split Type: JPPFIZER INC2021500067

Write-up: Sudden death; cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21104769. A 26-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Apr2021 (Batch/Lot number was not reported) at 26-years-old as a single dose for COVID-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing (underlying condition), sleeplessness from an unknown date and unknown if ongoing. Concomitant medications included benzodiazepine sleeping pills for sleeplessness from an unknown date to an unknown date. On 03May2021, the patient experienced cardio-respiratory arrest (medically significant), and sudden death (death, medically significant). An emergency room visit was required. The clinical course was reported as follows: The patient was a 26-year and 4-month-old male. Body temperature before vaccination was not reported. Family history was nothing noteworthy. Medical history included migraine (underlying disease) and sleeplessness (start date was unknown). Concomitant medications included benzodiazepine sleeping pills for sleeplessness. On 28Apr2021, at an unknown time (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 03May2021 (5 days after the vaccination), the patient experienced sudden death. An autopsy was performed, and the cause of death was unknown. The outcome of the event was fatal. The course of the event was as follows: On 28Apr2021, the patient received the first vaccination for priority groups (the institution which gave the vaccination was unknown as of this report) (the reason for receiving priority vaccination was unknown). On 03May2021 around 21:30 (5 days after the vaccination), the patient was found in cardio-respiratory arrest at home by his family. At 22:06, the patient was rushed to the reporting hospital. During transportation, rigor mortis was already noted; cardiopulmonary resuscitation was performed, but the patient was confirmed dead at 22:23. Despite performing autopsy and postmortem computerised tomography (CT), the cause of death was unknown. The estimated time of death was around noon on 03May2021 according to the police. Legal autopsy was considered unnecessary because any criminal act was unlikely. No pathological anatomy was performed as it was not requested by the family. The family stated that the patient was on a diet since 02May2021. The patient orally took benzodiazepine sleeping pills for sleeplessness. It was said that migraine was his only underlying disease. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Another hospital gave the vaccination, and our hospital was the destination of the ambulance after cardio-respiratory arrest. There was a certain time gap between the estimated time of death and the arrival, and the information on the examinations was limited. This was a sudden death 5 days after the vaccination, but the causal relationship could not be determined because of lack of information. The patient underwent lab tests and procedures which included autopsy: the cause of death was unknown on 03May2021, Postmortem computerised tomogram (CT): the cause of death was unknown on 03May2021. Therapeutic measures were taken as a result of sudden death and cardio-respiratory arrest. The clinical outcome of the event, cardio-respiratory arrest, was unknown. The clinical outcome of the event, sudden death, was fatal. The patient died on 03May2021, around noon, due to sudden death unexplained. An autopsy was performed, and results were not provided (as reported).; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1298556 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: Test Date: 20210429; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021505137

Write-up: Death; This is a spontaneous report from a contactable physician received from a regulatory authority. The regulatory authority report number is v21104650. A 97-year and 10-month-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration, on 29Apr2021 at 10:00 (at the age of 97-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced death on 01May2021 at 10:30, which was reported as fatal. The clinical course was reported as follows: On 29Apr2021 at 10:00 (the day of vaccination), the patient received the first dose of BNT162B2. On 01May2021 at 10:30 (2 days and 30 minutes after the vaccination), the patient died. The patient underwent lab tests and procedures which included body temperature: 36.9 Centigrade on 29Apr2021 (before vaccination). The patient died on 01May2021 at 10:30. The cause of death was reported as unknown. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the event and BNT162B2 as unassessable. It was not reported whether there was other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1298558 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEBILET; PRESTARIUM [PERINDOPRIL]; FLOSIN [TAMSULOSIN HYDROCHLORIDE]; ATORVASTATIN; THROMBO ASS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC2021483576

Write-up: Death; Cardiac arrest of unknown origin; Feeling unwell; Weakness; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number LT-SMCA-4080. A 55-years-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 10Apr2021 (Batch/Lot Number: EW2243) as SINGLE DOSE for covid-19 immunization. The patient''s medical history was not reported. Concomitant medication(s) included nebivolol hydrochloride (NEBILET) taken for an unspecified indication, start and stop date were not reported; perindopril (PRESTARIUM [PERINDOPRIL]) taken for an unspecified indication, start and stop date were not reported; tamsulosin hydrochloride (FLOSIN [TAMSULOSIN HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (THROMBO ASS) taken for an unspecified indication, start and stop date were not reported. The patient''s death was on on 16Apr2021. Patient was feeling unwell on 12Apr2021, weakness on 10Apr2021 and cardiac arrest of unknown origin on 16Apr2021. It was reported that After vaccination the patient complained weakness. On 12Apr2021 the patient felt unwell. On Thursday (15Apr2021) it was difficult for him to climb the stairs to the third floor. On Friday (16Apr2021) he went to work. About 13:30h he felt unwell and died before arrived the ambulance. The autopsy was performed. The cause of death - cardiac arrest of unknown origin. Seriousness criteria was reported as Fatal for all the events. The patient died on 16Apr2021. An autopsy was performed and results were not provided. No further information was provided.; Reported Cause(s) of Death: Cardiac arrest of unknown origin


VAERS ID: 1298610 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMSULOSINE [TAMSULOSIN HYDROCHLORIDE]; PERINDOPRIL ERBUMINE; AMLODIPINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021491372

Write-up: No complaints in advance other than light dizziness according to daughter; patient died suddenly on 23Apr2021; patient was found dead next to bed; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00521271. A 79-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient has no previous COVID-19 infection. Concomitant medications included tamsulosin hydrochloride (TAMSULOSINE); perindopril erbumine; and amlodipine. No complaints in advance other than light dizziness according to daughter. Forensic physician has examined. The patient died suddenly on 23Apr2021; patient was found dead next to bed. It is unknown if the dizziness occurred after vaccination or was already existing prior to vaccination. Outcome of dizziness was unknown. The patient died on 23Apr2021. It was unknown if an autopsy was performed. Reporter''s Comment: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Patient died suddenly on 23Apr. Additional information adverse drug reaction: no, unknown. BSN available: yes. Previous COVID-19 infection: No. Patient found dead next to bed. No complaints in advance other than light dizziness acc to daughter; Forensic physician has examined. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: patient died suddenly on 23Apr2021; patient was found dead next to bed


VAERS ID: 1298611 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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? 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: DILTIAZEM; CLOPIDOGREL; COZAAR PLUS; PLAQUENIL S; SIMVASTATINE; QUETIAPINE; PANTOPRAZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021491371

Write-up: possible acute cardiac death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00521326. An 80-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included diltiazem; clopidogrel; hydrochlorothiazide, losartan potassium (COZAAR PLUS); hydroxychloroquine sulfate (PLAQUENIL S); simvastatine; quetiapine; pantoprazole, all taken for an unspecified indication, start and stop date were not reported. On 25Apr2021, the patient experienced possible acute cardiac death. The patient died on 25Apr2021. An autopsy was not performed. Reporter''s comments: Previous COVID-19 infection: No. Other diagnostic procedures: no. Past drug therapy : covid-19 vaccin pfizer injvlst with no adverse reaction. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: possible acute cardiac death


VAERS ID: 1298612 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Fatigue, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (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:
CDC Split Type: NLPFIZER INC2021496827

Write-up: Cerebral infarction; Nausea; Not feeling well; Fatigue; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00524611. An 83-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: ER7812) via an unspecified route of administration on 22Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. No past drug therapy. No previous COVID-19 infection. 3 days after start (25Mar2021), the patient experienced not feeling well and fatigue; 4 days after start (26Mar2021), the patient experienced nausea; and 8 days after start (30Mar2021), the patient experienced cerebral infarction. The patient died on an unspecified date due to the events. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: nausea; not feeling well; fatigue; Cerebral infarction


VAERS ID: 1298616 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure fluctuation, Cerebral haemorrhage, Cerebral infarction, Dyspnoea, Malaise, Pneumonia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), 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: 2021-04-26
   Days after onset: 7
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: Blood pressure high; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021502270

Write-up: cerebral infarction; severe cerebral hemorrhage; Cardiac arrhythmia; severe breathing problems because of a lung infection; dyspnea; Trouble with bloodpressure; unwell; collapsed; This is a spontaneous report from a contactable consumer or other non hcp. A 73-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, osteoporosis from an unknown date and unknown if ongoing. Concomitant medications included unspecified drugs taken for osteoporosis and hypertension. The patient experienced unwell (non-serious) and collapsed (medically significant) on 19Apr2021. Later that day, the situation aggravated and the patient was admitted to the hospital. A cerebral infarction was detected, and the patient was hospitalized. Standard of care with blood thinners was given. The following night several complications occurred. The patient experienced severe cerebral hemorrhage (medically significant), cardiac arrhythmia (medically significant) and severe breathing problems because of a lung infection (pneumonia) (medically significant). The patient ended up at the Intensive care unit on life-support. The outcome of all events except cerebral infarction was unknown. After a week the patient got weaker every day and died on 26Apr2021 due to cerebral infarction. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: cerebral infarction


VAERS ID: 1298626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021491348

Write-up: DEATH; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Uyjy34. A 71-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 06Apr2021 13:00 (Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 14Apr2021 patient died, cause of death was unknown. It was not reported if an autopsy was performed. The reactions/case was considered to be Serious due to Death. No more information is available regarding this case. Sender Comment: This report was submitted by the daughter (BLINDED) of patient. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: DEATH


VAERS ID: 1298640 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW 2243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021497078

Write-up: health deteriorated; This is a spontaneous report from a contactable consumer received by email. This consumer reported two different cases for two patients. This is 1st of 2 reports, describing events for male patient. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: EW 2243) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient health deteriorated after vaccination, as a result patient died. Therefore, the reporter wanted to report an adverse reaction of a conditionally approved vaccine. The reporter had already reported the situation to Regulatory Authority and would like to inform company that an e-mail of similar content will be sent to the company''s headquarters. No further information was provided.; Reported Cause(s) of Death: health deteriorated


VAERS ID: 1298642 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-27
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Psychomotor retardation, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   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: Test Date: 20210327; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:Low; Comments: Oxygen saturation low
CDC Split Type: PLPFIZER INC2021484003

Write-up: Respiratory failure; Pneumonia; Oxygen saturation low; Dyspnoea; Psychomotor retardation; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 1 at the age of 86-year-old, intramuscular, administered in left arm on 15Mar2021 12:00 (Lot Number: ET3674; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced respiratory failure, pneumonia, oxygen saturation low, dyspnoea, and psychomotor retardation on 27Mar2021 at 10:00; and SARS-CoV-2 infection on 27Mar2021. The patient died on 04Apr2021. It was unknown if an autopsy was performed. The events were reported as medically significant. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; pneumonia; dyspnoea; psychomotor retardation; respiratory failure; low oxygen saturation


VAERS ID: 1298643 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Electrocardiogram, Haemoptysis, Heart rate, Loss of consciousness, Tachycardia, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   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: Atrial fibrillation (Anticoagulant treatment for atrial fibrillation); Multimorbidity
Allergies:
Diagnostic Lab Data: Test Date: 20210214; Test Name: EKG; Result Unstructured Data: Test Result:Ventricular tachycardia; Test Date: 20210211; Test Name: Heart rate; Result Unstructured Data: Test Result:up to 130; Test Date: 20210211; Test Name: Heart rate; Result Unstructured Data: Test Result:110
CDC Split Type: PLPFIZER INC2021484001

Write-up: Loss of consciousness; spitting out bloody content/coughing up blood; Cardiac arrest; Ventricular tachycardia; Tachycardia; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority number: PL-URPL-3-586-2021. An 88-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 05Feb2021 09:55 (Batch/Lot Number: EK9788; Expiration Date: 13May2021) as 0.3 mL, SINGLE DOSE for Covid-19 immunization. Medical history included multimorbidity, and atrial fibrillation wherein patient had anticoagulant treatment (not specified). The patient''s concomitant medications were not reported. On 11Feb2021, patient experienced tachycardia up to 130, an ambulance was called, HR (heart rhythm) 110 was obtained, it was decided not to hospitalize. On 14Feb2021 at 1:10 pm, patient experienced loss of consciousness preceded by spitting out bloody content/coughing up blood. Emergency ECG: ventricular tachycardia, unsuccessful resuscitation, death. Description of complications: death. Loss of consciousness, sudden cardiac arrest with ventricular tachycardia (onset date 14Feb2021). coughing up blood in the time before loss of consciousness. The reporting person classified them as severe. The URPL also classified the report as severe (death). The data contained in the electronic report is all that is currently at the disposal of URPL - in the case of obtaining additional information, updated version will be sent. The patient died on 14Feb2021 due to the events. It was unknown if an autopsy was performed. Senders comment: tachycardia, loss of consciousness, sudden cardiac arrest, Ventricular tachycardia, spitting blood are not present in SMPC of Comirnaty, they are unexpected adverse reactions. It seems more probable that the mentioned symptoms were related with co-existing diseases, patient age and anticoagulant treatment used. There is time relation between vaccine administration and occurrence of symptoms. The reporter assessed the case as serious. URPL also classified the case as serious. Relatedness of drug to reaction(s)/event(s) Result of Assessment : Unlikely No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Loss of consciousness; spitting out bloody content/coughing up blood; Cardiac arrest; Ventricular tachycardia; Tachycardia


VAERS ID: 1298644 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-16
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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: Cardiovascular disease, unspecified (Cardiovascular disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021491356

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number PL-URPL-3-595-2021. The reporter is contactable to health authority only. An 87-year-old male patient received bnt162b2 (COMIRNATY) dose 1 intramuscular, administered in left arm on 31Mar2021 12:31 (Lot Number: ET3674; Expiration Date: 07May2021) (at age 87 year old) as singe dose for covid-19 immunisation. Medical history included ongoing cardiovascular disease. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest on 16Apr2021 21:50. The event was reported as serious (fatal). The patient died on 16Apr2021. The patient was not autopsied. The immediate cause of death was cardiac arrest. The patient was under the care of a cardiologist and he was treated for cardiovascular diseases. The data contained in the electronic report are all the data available to regulatory authority - if additional information is obtained, another version will be sent. Sender''s comments: The report did not mention any adverse reactions after the administration of Comirnaty, only the health result: death. By e-mail, the regulatory authority obtained information from the agency about cardiovascular diseases in the patient''s medical history. Information was also obtained that the autopsy was not performed, and the direct cause of the patient''s death, i.e. cardiac arrest. Cardiac arrest is not an expected or described adverse reaction following the administration of Comirnata. There is a time relationship between the administration of the vaccine and the occurrence of an adverse reaction. As of April 23, 2021, 123 cases of cardiac arrest were recorded in the regulatory authority database. Given the history of cardiovascular disease, the regulatory authority believes that the cardiac arrest was a temporary coincidence and that the vaccine administration was unlikely to be associated with the vaccine. The person reporting post vaccination adverse reaction qualified it as serious. Due to the health result: death, regulatory authority assessed the post vaccination adverse reaction as serious. The assessment for COMIRNATY and Cardiac arrest was unlikely as per regulatory authority. No follow up attempts needed. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1298647 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Malaise, 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: 2021-03-16
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021491361

Write-up: Cardiac arrest; Malaise; Vomiting; This is a report received from the Regulatory Authority, via E2b. Regulatory authority report number PL-URPL-DML-MLP.4401.2.272.2021. The reporter is contactable to HA only. This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number PL-URPL-DML-MLP.4401.2.272.2021. An 81-year-old male patient received second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 11Mar2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced malaise, vomiting and cardiac arrest on 16Mar2021. The patient died on 16Mar2021. It was not reported if an autopsy was performed. It was reported that on March 11, 2021, the patient was given the second dose of Comirnaty. The patient "on the first and the second day was vomiting and feeling unwell" - it was Saturday, the wife called an ambulance (two paramedics and a doctor came) - temperature and pressure were checked - "to check the pressure, one of the rescuers held the husband and the other examined". The physician assessed that the patient "is okay, nothing is in danger" and did not qualify for hospital treatment. The patient was given an injection (the wife does not know what) and the doctor informed the patient that the patient would be asleep. The family doctor, who came on Tuesday, "called the ambulance too late, my husband ended his life." The death occurred on 16March2021. Direct cause of death: Sudden cardiac arrest - I46. According to the wife''s assessment, the vaccine contributed to the patient''s death. The reporting person did not assess the severity of the adverse reaction. Regulatory Authority classified the application as serious. The data contained in the electronic report are all at the disposal of the regulatory authority in the event of obtaining additional information, the next version will be sent. Sender''s comments: Vomiting and malaise are expected adverse reactions, included in the Summary of Product Characteristics of Comirnata. However, there is no information as to whether the symptoms have subsided or there were other accompanying symptoms. A link to vaccination was assessed as possible. Sudden cardiac arrest is not an expected adverse reaction. Due to insufficient information, a cause and effect relationship has not been established. There is a temporal relationship between the administration of the vaccine and the onset of symptoms. The reporting person did not assess the severity of the adverse reaction, regulatory authority and classified the report as serious. No follow up attempts needed. No further information expected.; Reported Cause(s) of Death: ICD-10 I46 - Cardiac arrest


VAERS ID: 1298696 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cerebral haemorrhage, Fatigue
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: LACROFARM; LIVOSTIN; VOLTAREN [DICLOFENAC]; ATENOLOL ORIFARM; FINASTERID SANDOZ; OMEPRAZOL SANDOZ [OMEPRAZOLE]; KETOCONAZOL ACTAVIS; PARACETAMOL ORIFARM; ACETYLSALICYLSYRA TEVA; DERMOVAT [CLOBETASOL PROPIONATE]; SIMVASTATIN SANDOZ; FELODIPI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021491360

Write-up: Tired; Consciousness disturbed; intracerebral hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-009202. A 74-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Feb2021 (Batch/Lot Number: EJ6797) as single dose for COVID-19 immunisation. Medical history included Alzheimer''s disease Vascular dementia, both unknown if ongoing. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LACROFARM); levocabastine hydrochloride (LIVOSTIN); diclofenac (VOLTAREN [DICLOFENAC]); atenolol (ATENOLOL ORIFARM); finasteride (FINASTERID SANDOZ); omeprazole (OMEPRAZOL SANDOZ [OMEPRAZOLE]); ketoconazole (KETOCONAZOL ACTAVIS); paracetamol (PARACETAMOL ORIFARM); acetylsalicylic acid (ACETYLSALICYLSYRA TEVA); clobetasol propionate (DERMOVAT [CLOBETASOL PROPIONATE]); simvastatin (SIMVASTATIN SANDOZ); felodipin (FELODIPIN TEVA); mirabegron (BETMIGA); and oxycodone hydrochloride (OXYCODONE DEPOT ACTAVIS); ramipril (RAMIPRIL HEXAL). The patient took the first dose of Comirnaty on 22Jan2021 (Batch/Lot number: EJ6134) for COVID-19 immunisation and experienced myalgia and joint pain during five days after the dose. In Feb2021, the patient experienced being tired and consciousness disturbed. After the second dose, the patient became impaired, tired after two days and uncontactable after another two days. The patient was admitted to hospital, an intracerebral hemorrhage was observed. The outcome of the event intracerebral hemorrhage was unknown. The case was assessed as serious (death) by regulatory authority. The patient died 6 days after second dose. The patient died on unspecified date in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Tired; Consciousness disturbed


VAERS ID: 1298714 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebral infarction, Computerised tomogram, Haemoglobin, Platelet count, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

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: Medical History/Concurrent Conditions: Aortic surgery; Myocardial infarct
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: CT scan; Result Unstructured Data: Test Result:occlusion right M1 and beginning of an infarction; Comments: in Arteri cerebri media; Test Date: 202104; Test Name: CT scan; Result Unstructured Data: Test Result:haemorrhage and blood in the ventricles; Test Date: 202104; Test Name: CT scan; Result Unstructured Data: Test Result:massive intracranial haemorrhage; Test Date: 202104; Test Name: Haemoglobin (Hb); Result Unstructured Data: Test Result:140; Test Date: 202104; Test Name: Total Platelet Count (TPC); Result Unstructured Data: Test Result:128; Test Date: 202104; Test Name: Leucocytes; Result Unstructured Data: Test Result:25
CDC Split Type: SEPFIZER INC2021484441

Write-up: Cerebral infarction; cerebral haemorrhage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-027985. An 88-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included aortic surgery with stent and myocardial infarction. The patient''s concomitant medications were not reported.bThe patient experienced cerebral infarction on Apr2021. Approximately two weeks after the vaccination (Apr2021) the patient was brought to hospital after being found at home with weakness in the left body half due to a suspected stroke. CT scan revealed an occlusion right M1 and beginning of an infarction in Arteri cerebri media. Result of blood status: Total Platelet Count (TPC) 128, Haemoglobin (Hb) 140 and Leucocytes 25. A thrombectomy was performed. A subsequent CT unfortunately revealed a cerebral haemorrhage and blood in the ventricles, a possible complication due to the thrombectomy. The following day a new CT scan was performed showing a massive intracranial haemorrhage. Due to the bad prognose, palliative care was initiated, and three days later he passed away. Report assessed as serious; Life threatening. The outcome of event cerebral infarction was not recovered. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1298716 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Death, Paranoia
SMQs:, Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (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: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021491364

Write-up: very paranoid against the personnel; aggression toward personnel/ Got worse after the second dose; death came earlier; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. The Regulatory Authority report number is SE-MPA-2021-028458. An 83-year-old male patient received the second dose of BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot Number: EL1484) as single dose for COVID-19 immunisation. Medical history included stroke. Concomitant medication included unspecified blood-thinning medication due to stroke. The patient previously took the first dose of BNT162B2 (COMIRNATY) on Jan2021 for COVID-19 immunisation and became violent towards staff and very paranoid towards staff. The reporter described that the patient became violent towards staff after he took the first dose of Comirnaty. The man was described as having become both violent and very paranoid towards staff after he took the vaccine doses. Got worse after the second dose, even more violent (Feb2021). According to the reporter, the patient had to get sedation every day and supervision all the time when he was awake. The man died a week after the second dose on an unspecified date in 2021. The reporter stated that the man was taking a blood-thinning medication due to his stroke, therefore believes that the covid vaccine affected the man''s death. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The report was assessed as serious (death). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021512789 Same reporter, patient and product, different event.; Reported Cause(s) of Death: death came earlier; very paranoid against the personnel; aggression toward personnel/ Got worse after the second dose


VAERS ID: 1298719 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001177 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aortic aneurysm rupture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: Abdominal aortic aneurysm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20211

Write-up: Aortic aneurysm rupture; This regulatory authority case was reported by a physician and describes the occurrence of AORTIC ANEURYSM RUPTURE (Aortic aneurysm rupture) in a 95-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001177) for COVID-19 vaccination. Concurrent medical conditions included Abdominal aortic aneurysm. In March 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In March 2021, the patient experienced AORTIC ANEURYSM RUPTURE (Aortic aneurysm rupture) (seriousness criterion death). The patient died in March 2021. The reported cause of death was Aortic aneurysm rupture. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication reported. No treatment information was provided. Company Comment: This is a case of death in a 95-year-old female subject with a medical history of Abdominal aortic aneurysm, who died in the same month after receiving the first dose of vaccine. Based on information received, death was due to Aortic aneurysm rupture, the event is assessed as unlikely related to mRNA-1273.; Sender''s Comments: This is a case of death in a 95-year-old female subject with a medical history of Abdominal aortic aneurysm, who died in the same month after receiving the first dose of vaccine. Based on information received, death was due to Aortic aneurysm rupture, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Aortic aneurysm rupture


VAERS ID: 1298722 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Electrocardiogram ST segment, Electrocardiogram ST segment elevation, Fatigue, Gaze palsy, Ischaemic stroke, Loss of consciousness, Myocardial infarction, Oxygen saturation decreased, Platelet count, Thrombocytopenia, Troponin I, Troponin I increased, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Osteoporosis
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Femur fracture (summer 2020); Hematoma; Platelet count decreased
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: CT brain; Result Unstructured Data: Test Result:Stroke; Test Date: 202104; Test Name: ST; Result Unstructured Data: Test Result:Elevations above the anterior wall; Test Date: 202007; Test Name: platelet count; Result Unstructured Data: Test Result:81-121; Comments: Reduced; Test Date: 202103; Test Name: platelet count; Result Unstructured Data: Test Result:92; Comments: Reduced; Test Date: 202104; Test Name: Thrombocytes; Result Unstructured Data: Test Result:22; Comments: Thrombocytopenia; Test Date: 202104; Test Name: Troponin I; Result Unstructured Data: Test Result:Above 5000
CDC Split Type: SEPFIZER INC2021484492

Write-up: Thrombocytopenia; Myocardial infarct; Ischaemic stroke; troponin I$g 5000; unconscious; wheezing; desaturation; gaze deviation upwards left; ST elevations; fatigue; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number SE-MPA-2021-031915. A 95-year-old male patient received bnt162b2 (COMIRNATY), first dose via an unspecified route of administration on Apr2021, single dose for covid-19 immunisation. Medical history included suspected osteoporosis (ongoing), a previous aortic valve replacement operation (not ongoing) and a femur fracture summer 2020 (not ongoing). The patient has had a tendency to hematoma and reduced platelet count in 23March 2021 (TPC 92) and in July 2020 (TPC 81-121). The patient''s concomitant medications were not reported. On Apr2021,patient experienced adverse events were myocardial infarct, ischaemic stroke and thrombocytopenia. Still in Apr2021, the man has had increasing fatigue past month / months, but was perceived to be as usual when relatives visited him eleven days after the vaccination. Found later that evening unconscious with wheezing and desaturation. Clinically suspected stroke (Ischaemic stroke/Myocardial infarct) with unconsciousness and gaze deviation upwards left which is confirmed by CT brain. ST elevations above the anterior wall and troponin I$g 5000 with concomitant thrombocytopenia 22. The patient has received cortisone but otherwise conservative treatment and died during the night (Apr2021). It was unknown if an autopsy was done. The outcome of the events myocardial infarct, ischaemic stroke and thrombocytopenia were fatal, other events were unknown. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Reported Cause(s) of Death: Thrombocytopenia; Myocardial infarct; Cerebral infarction


VAERS ID: 1301855 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-04-05
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   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: Chronic bronchitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20210

Write-up: Cardiac arrest; This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in an 84-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Chronic bronchitis. On 16-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient died on 06-Apr-2021. The reported cause of death was myocardial infarction of the inferior wall. An autopsy was not performed. No concomitant medication information was provided. No treatment medication information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.; Sender''s Comments: An autopsy report was not provided but a diagnosis of cardiac arrest was provided. Llimited information regarding the death has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Myocardial infarction of the inferior wall


VAERS ID: 1301862 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Hypertension; Hypothyroidism; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Unknown cause of death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Unknown cause of death) and DEPRESSED LEVEL OF CONSCIOUSNESS in a 92-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism, Heart failure, Hypertension and Type II diabetes mellitus. On 13-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DEATH (Unknown cause of death) (seriousness criterion death) and DEPRESSED LEVEL OF CONSCIOUSNESS (seriousness criterion death). The patient died on 14-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021039777 Company comment: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required.; Sender''s Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities. Further information required.; Reported Cause(s) of Death


VAERS ID: 1301881 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-02-18
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: Angiopathy; Diabetes mellitus insulin-dependent; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: Lung embolism; This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM (Lung embolism) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Hypertension, Diabetes mellitus insulin-dependent and Angiopathy. On 16-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 13-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 ml. On 18-Feb-2021, the patient experienced PULMONARY EMBOLISM (Lung embolism) (seriousness criterion death). The patient died on 18-Feb-2021. The reported cause of death was Lung embolism. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided Treatment for the events were not provided Company comment: This is a case of death in a 85-year-old female subject with a medical history of HTN, DM, and angiopathy, who died 5 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 85-year-old female subject with a medical history of HTN, DM, and angiopathy, who died 5 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1303978 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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 INC2021495979

Write-up: Haemorrhage; This is a spontaneous report from a contactable other healthcare professional via the regulatory authority. Regulatory authority report number is 543506. A 71-year-old female patient received bnt162b2 (COMIRNATY, lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced haemorrhage on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. Cause of death was haemorrhage. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Haemorrhage


VAERS ID: 1304002 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-11
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood creatinine, Condition aggravated, Confusional state, Death, Diarrhoea, Dyspnoea, Fall, Neck pain, Pain, Paresis, Peripheral venous disease, Pyrexia, Spinal disorder, Urinary retention
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; EPRIL; PANTOPRAZOL ACTAVIS; ZOLDORM; MST CONTINUS; MIRTAZAPIN MEPHA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Renal impairment; Spinal disorder
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: Blood creatinine; Result Unstructured Data: Test Result:118
CDC Split Type: CHPFIZER INC2021497168

Write-up: Exitus letalis; paresis hand and arm right side; chronic venous insufficiency; Urinary retention; confusional state; diarrhoea; very severe neck pain; nocturnal fall; pain exacerbation of his panvertebral syndrome/pain; pain exacerbation of his panvertebral syndrome; pain exacerbation of his panvertebral syndrome; fever; weakness; dyspnoea; This is a spontaneous report received from a contactable physician via a regulatory authority. Regulatory authority report number CH-SM-2021-14555. A 94-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 28Jan2021 (Lot Number: EM0477) as single dose for covid-19 immunisation. Medical history included renal impairment function, vertebral syndrome. Concomitant medication included acetylsalicylic acid (ASPIRIN CARDIO); enalapril maleate (EPRIL); pantoprazole sodium sesquihydrate (PANTOPRAZOL ACTAVIS); zolpidem tartrate (ZOLDORM), morphine sulfate (MST CONTINUS) taken for vertebral syndrome; mirtazapine (MIRTAZAPIN MEPHA). On 28Jan2021, the patient was vaccinated with Comirnaty. 14 days later, on 11Feb2021, patient develops fever, weakness and dyspnea. On 12Feb2021, Nocturnal fall: pain exacerbation of his panvertebral syndrome. On 16Feb2021, very severe neck pain, more than normal, probably as a result of the fall. On 17Feb2021, renewed fall, found by neighbor next to the bed, had knocked with his stick for help. Decision to enter care home, since the pain can only be treated inadequately in the home environment. On 18Feb2021, MST 10 2x/day, care home admission, in the evening confusional state, diarrhoea On 23Feb2021, further pain exacerbation, increase of MST 2 x 20mg Mirtazapine 15mg at night. On 25Feb2021, Urinary retention, urinary catheter. On 03Mar2021, especially chronic venous insufficiency; paresis hand and arm right side. On 12Mar2021, Exitus letalis. The patient underwent lab tests and procedures which included blood creatinine: 118 on Mar2021. The outcome of the event unknown cause of death was fatal, pain was not recovered, other events was unknown. The patient died on 12Mar2021. It was not reported if an autopsy was performed. A causal relationship between Comirnaty and death was assessed as being unlikely. Sender''s comment (a regulatory authority): Death occurred 43 days after administration of the Comirnaty vaccine in a 94-year-old, polymorbid man. To date, no deaths of elderly people in causal correlation with Covid-19 mRNA-based vaccines are known in the literature. In the immediate aftermath of vaccination, no ADEs of any kind were reported. Only 14 days after vaccination did fever, weakness, and dyspnea occur, which likely promoted the fall. Fever and weakness, although related to the vaccine as described in the monograph and in the international literature, since they occurred 2 weeks after the administration, speak little for a causal correlation. Moreover, it is not possible to exclude other possible causes, such as the infectious one, in this very elderly patient who, however, took care of his wife and therefore it is likely to assume that he went out of the house and carried out minimal activities that could expose him to the risk of infections. In view of the absence of data from the literature for death related to Covid-19 vaccines, given that we cannot exclude other possible causes for the decline in general conditions (first of all the fall), in view of the weak temporal correlation, we judge the causal link between the Comirnaty vaccine and the death of this elderly gentleman unlikely. Reporter comment: Death occurred 43 days after administration of the Comirnaty vaccine. The patient expressed several times that he was ready to die. He was exhausted from caring for his sick, visually impaired wife.; Reporter''s Comments: Death occurred 43 days after administration of the Comirnaty vaccine. The patient expressed several times that he was ready to die. He was exhausted from caring for his sick, visually impaired wife.; Sender''s Comments: Based on Pfizer policy, all death cause unknown events are assessed to be related to the subject drugs. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate ?data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death.


VAERS ID: 1304016 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Blood creatine, Blood urea, Body temperature, C-reactive protein, COVID-19, Cardiac failure, Chest X-ray, Cough, Drug ineffective, Pneumonia, Pyrexia, SARS-CoV-2 test, Urosepsis
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (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), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: Diabetes; Hypertension arterial; Nonsmoker
Preexisting Conditions: Medical History/Concurrent Conditions: Decubitus (heel); Hip surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: Blood creatine; Result Unstructured Data: Test Result:166 umol/l; Test Date: 20210406; Test Name: Blood urea; Result Unstructured Data: Test Result:16 mmol/L; Test Date: 20210404; Test Name: Body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Test Date: 20210407; Test Name: Chest X-ray; Result Unstructured Data: Test Result:bilateral infiltrates; Comments: chest imaging shown bilateral infiltrates on his lung; bilateral pneumonia; Test Date: 20210330; Test Name: C-reactive protein; Result Unstructured Data: Test Result:120 mg/l; Test Date: 20210407; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: CZPFIZER INC2021492377

Write-up: cough; fevers of 39.5; apathy; heart failure; urosepsis; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; bilateral pneumonia; This is a spontaneous report from a contactable consumer and a physician downloaded from the Regulatory Authority-WEB, regulatory authority number CZ-CZSUKL-21004736. A 73-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 31Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for Covid-19 immunization. Medical history included hip surgery from 14Mar2021 to an unknown date, decubitus ulcer (heel) from Mar2021 to an unknown date, ongoing non-smoker, ongoing hypertension arterial, and ongoing diabetes. Concomitant medication included anti-diabetic (not specified). The patient was recovering in a private medical center after hip surgery (14Mar2021), where he was vaccinated on 31Mar2021. One day before the vaccination, the patient already had elevated levels of CRP-120mg/l. It was reported that the patient died 8 days after the first dose of Comirnaty vaccine, which was administrated on 31Mar2021. On 02Apr2021, the patient was apathetic, he was thirsty, felt cold, was moaning while urinating, and had decubitus on his heel. Since 04Apr2021, the patient had fevers. On 06Apr2021, he had a cough. At night on 06Apr2021, the patient was transported to another hospital. In the hospital, he was diagnosed with severe urosepsis and on 07Apr2021 he had a positive PCR test for Covid-19, chest imaging shown bilateral infiltrates on his lungs also reported as bilateral pneumonia; his condition was getting worse then. The patient died on 08Apr2021 because of heart failure due to severe urosepsis. On 28Apr2021, his physician was contacted and reported that the patient already had elevated levels of CRP-120mg/l one day before the vaccination, since 04Apr2021, the patient had fevers of 39.5, on the day of his admission to the hospital (06Apr2021) urea 16mmol/l, creatinine 166umol/l, the patient died because of heart failure due to severe urosepsis. The patient died on 08Apr2021. It was not reported if an autopsy was performed. The outcome of other events was unknown. Bilateral pneumonia assessed by Healthcare professional: Result of Assessment: not related; Fever assessed by Healthcare professional: Result of Assessment: not related; Urosepsis assessed by Healthcare professional: Result of Assessment: not related; Apathy assessed by Healthcare professional: Result of Assessment: not related; Cough assessed by Healthcare professional: Result of Assessment: not related. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: The patient died on 08Apr2021 because of heart failure due to severe urosepsis.


VAERS ID: 1304017 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: ANOPYRIN; TAMSULOSIN; JANUVIA [SITAGLIPTIN]; SIOFOR; LESCOL XL; TRITACE COMBI; KALIUM CHLORATUM; GLIMEPIRIDE; INDAPAMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atherosclerosis (central grade III, lower cerebral arteries grade III); Chronic bronchitis (atrofic); Coronary artery atherosclerosis (Grade III); Emphysema pulmonary (chronic vesicular emphysema pulmonary); Hyperlipidaemia; Ischaemic heart disease; Thrombocytopenia (without progresion); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: CZPFIZER INC2021492392

Write-up: Acute exacerbation of chronic heart failure; fever; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority, regulatory authority report number CZ-CZSUKL-21004753. A 76-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 08Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for Covid-19 immunization. Medical history included ischaemic heart disease, emphysema pulmonary (chronic vesicular emphysema pulmonary), coronary artery atherosclerosis (Grade III), chronic bronchitis (atrophic), hyperlipidaemia, arterial hypertension, atherosclerosis (central grade III, lower cerebral arteries grade III), Type II diabetes mellitus, and progression-free thrombocytopenia (without progression); all from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ANOPYRIN), tamsulosin (TAMSULOSIN), sitagliptin (JANUVIA), metformin hydrochloride (SIOFOR), fluvastatin sodium (LESCOL XL), amlodipine besilate, ramipril (TRITACE COMBI), potassium chloride (KALIUM CHLORATUM), glimepiride (GLIMEPIRIDE), and indapamide (INDAPAMIDE); all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient received the first dose of vaccine Comirnaty on the 08Mar2021. The next day (09Mar2021), a fever and an exacerbation of chronic heart failure occurred, which progressed to cardiac arrest and the patient died. The outcome of event fever was unknown. He did not suffer from COVID-19. The patient underwent lab tests and procedures which included Sars-cov-2 test: negative on 09Mar2021. The presence of SARS-CoV-2 RNA was not detected in the nasopharyngeal swab before autopsy. The patient died on 09Mar2021. An autopsy was performed on 10Mar2021 that revealed diabetes mellitus type II, central atherosclerosis grade III, atherosclerosis of the coronary arteries grade III, atherosclerosis of the cerebral arteries grade III, chronic athropic bronchitis, chronic vesicular lung emphysema, arterial hypertension, recent myocardial myomalacia of the left ventricular papillary muscles and the posterior wall of the left ventricle of the heart (microscopically verified), post-infarction scar of the posterior wall of the left ventricle, florid dispersive myocardial myofibrosis (diagnosed microscopically), lipomatous myocardial infiltration, aortomitral defect, eccentric cardiac hypertrophy (490 g) - cor bilateral, chronic venostasis in organs, swelling of the brain, swelling of the lungs, angiosclerotic encephalopathy, lipomatous atrophy of the pancreas, diffuse hyperplasia of the adrenal cortex, vascular nephrosclerosis, cortical and medullary cysts of the kidneys, osteophytes of the vertebrae of the thoracic and lumbar spine, adenomyomatous hyperplasia of the prostate, prostatolithiasis, haemorrhagic urocystitis. Cause of death: chronic heart failure, exacerbated. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Acute on chronic heart failure; Autopsy-determined Cause(s) of Death: eccentric cardiac hypertrophy; swelling of the brain; central atherosclerosis grade III, atherosclerosis of the coronary arteries grade III, atherosclerosis of the cerebral arteries grade III; chronic vesicular pulmonary emphysema; chronic atrophic b


VAERS ID: 1304020 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Mesenteric vascular occlusion, Mesenteric vein thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (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: Test Name: CT abdomen; Result Unstructured Data: Test Result:ntraoperative findings
CDC Split Type: DEPFIZER INC2021491368

Write-up: Mesenteric vascular occlusion; Mesenteric vein thrombosis; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, company number DE-PEI-202100049001. A 78-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EW8904) as 0.3 mL, single for covid-19 immunization. The patient''s medical history was not reported. The patient has no concomitant medications. On 11Apr2021, the patient experienced mesenteric vascular occlusion and mesenteric vein thrombosis on 11Apr2021. It was reported that the patient had CT abdomen on an unknown date with intraoperative findings. The outcome of the events was fatal as the patient died due the events on an unspecified date. It was not reported if an autopsy was performed Reporter''s comments: "CT abdomen, intraoperative findings." Causal relationship between the adverse event(s) and the administration of Comirnaty was assessed as unclassifiable by the regulatory authority. No follow-up attempts needed/possible, follow-up automatically provided by regulatory authority; Reporter''s Comments: CT-Abdomen; Reported Cause(s) of Death: Mesenteric vascular occlusion; Mesenteric vein thrombosis


VAERS ID: 1304021 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 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: 2021-04-16
   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: RAMIPRIL
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021491315

Write-up: Acute myocardial infarction; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100050361. A 65-year-old male patient received BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EW8904), via an unspecified route of administration on 15Apr2021 at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history included ongoing hypertension. Concomitant medication included ramipril taken for an unspecified indication, start and stop date were not reported. The patient experienced acute myocardial infarction on 16Apr2021 with fatal outcome. The patient died on 16Apr2021. It was not reported if an autopsy was performed. This report is serious - death (as reported). Causal relationship between the adverse event(s) and the administration of Comirnaty was assessed as "inconsistent causal association to immunization" by the Regulatory Authority. No follow-up attempts are needed/possible, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1304022 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Atrial fibrillation, Cardiogenic shock, Haematochezia, Hyponatraemia, Hypotension, Myocarditis, Normocytic anaemia, Pericardial effusion, Septic shock, Transaminases increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), 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), Gastrointestinal haemorrhage (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 45
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 INC2021496575

Write-up: Tachyarrhythmia absoluta; Acute hypotension; Anaemia normocytic; Bloody stool; Acute renal failure; Hyponatraemia; Septic shock; Cardiogenic shock; Perimyocarditis; Transaminases increased; Effusion pericardial; This is a spontaneous report from a physician downloaded from the regulatory authority. Regulatory Authority Number is DE-PEI-202100050709. This report was serious due to death. An 83-year-old female patient received BNT162B2 (COMIRNATY, lot number EP9598) at 03.3 ml single dose on 08Mar2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. On 12Mar2021 the patient experienced bloody stool, tachyarrhythmia absoluta, acute hypotension, transaminases increased, anaemia normocytic, hyponatraemia, perimyocarditis, effusion pericardial, septic shock, cardiogenic shock, acute renal failure. Patient dies on 27Apr2021. Outcome of the events was fatal. Autopsy was performed, no results available. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Tachyarrhythmia absoluta; bloody stool; acute hypotension; transaminases increased; anaemia normocytic; hyponatraemia; perimyocarditis; effusion pericardial; acute renal failure; Septic shock; Cardiogenic shock


VAERS ID: 1304026 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021501420

Write-up: breast pain; Chest pain; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is [DE-PEI-CADR2021059564] and Safety Report Unique Identifier [DE-PEI-202100051076]. A 101-year-old male patient received BNT162B2 (COMIRNATY) via unspecified route unknown single for COVID-19 immunization on 27Mar2021. The patient''s medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced breast pain and chest pain, 2 days hospital stay, then discharge on 06Apr2021. On 07Apr2021 the patient experienced unknown cause of death, suddenly deceased on 07Apr2021. Cause of death and other details was unknown, it is unknown if an autopsy was done. The patient''s outcome of the events breast pain and chest pain was not resolved, for unknown cause of death was fatal. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses: No previous illnesses, no medication / chest pain, 2 days hospital stay, then discharge, discharge on 06Apr2021, suddenly deceased on 07Apr2021. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1304028 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker wearer (Pacemaker); Dialysis; Vascular shunt (Shunt in hydrocephalus)
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (4 months ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021467505

Write-up: Pneumonia; This is a spontaneous report from a non-contactable consumer. This is the second of two reports. The first report is a report downloaded from the Agency Regulatory Authority-WEB DE-PEI-CADR2021051718. This consumer reported events for two separate vaccine doses. This is the report reporting events related to the first dose of the vaccine. A 70-years-old male patient received bnt162b2 (COMIRNATY, Strength: 0.3mL), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing dialysis, ongoing Shunt in hydrocephalus, ongoing Pacemaker, Stroke 4 months before. The patient''s concomitant medications were not reported. The patient was landed in hospital with pneumonia in 2 days on 19Mar2021 with no fever, then discharged. The outcome of the event pneumonia was recovered on an unknown date. Sender comments: The person did not concern any allergies. Information on risk factors or previous illnesses: dialysis, Pacemaker. Shunt in hydrocephalus. Stroke 4 months ago / My father, care level 5, dialysis patient, received the first vaccination on March 17th. Landed in hospital with pneumonia in 2 days with no fever, then discharged. And on April 14th. he got the second vaccination, no fever, no complaints, died after 4 days. The emergency doctor could not determine the cause of death. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1304040 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-08
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 28
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary heart disease; Skin cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021507619

Write-up: stroke; This is a spontaneous report from a contactable consumer. A 89-years-old patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Feb2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included coronary artery disease, skin cancer. The patient''s concomitant medications were not reported. The patient experienced stroke on 08Mar2021. Event reported as serious with death, hospitalization, disability, life threatening. The patient died on 06Apr2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Lot/batch number has been requested.; Reported Cause(s) of Death: stroke


VAERS ID: 1304048 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, C-reactive protein, Death, Electrocardiogram, Haemoglobin, Heart rate, Neutrophil count
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: SIMVASTATIN "KRKA"; ALLOPURINOL; TOSTRAN; ANCOZAN
Current Illness: Atrial fibrillation; Dyspnoea; Shooting pain
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (No alcohol in a year.); COVID-19; Comments: The dyspnoea was recovering around christmas, but then worsening.
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Blood test; Result Unstructured Data: normal; Test Date: 20210409; Test Name: C-reactive protein; Result Unstructured Data: 18; Test Date: 20210409; Test Name: Electrocardiogram; Test Result: Inconclusive ; Result Unstructured Data: Sinus tachycardia. Incomplete left sided bundle branch block. Suspected left sided ventricular hypertrophy with repolarising changes in all leads.; Test Date: 20210409; Test Name: Hemoglobin; Result Unstructured Data: 7.9 (slight hypohaemoglobinaemia and units not specified); Test Date: 20210409; Test Name: Pulse rate; Test Result: Inconclusive ; Result Unstructured Data: 117 heart beats per minute; Test Date: 20210409; Test Name: Blood neutrophils; Result Unstructured Data: 7.5 (slightly increased) Units not specified
CDC Split Type: DKMODERNATX, INC.MOD20210

Write-up: death 1.5 days after vaccination.; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death 1.5 days after vaccination.) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. The dyspnoea was recovering around christmas, but then worsening. The patient''s past medical history included COVID-19 in November 2020 and Alcohol abuse (No alcohol in a year.) in 2020. Concurrent medical conditions included Dyspnoea since November 2020, Shooting pain since December 2020 and Atrial fibrillation. Concomitant products included Simvastatin from 17-Dec-2019 to an unknown date for Blood cholesterol increased, LOSARTAN POTASSIUM from 07-Jan-2015 to an unknown date for Blood pressure high, ALLOPURINOL from 01-Feb-2013 to an unknown date for Gout, TESTOSTERONE (TOSTRAN) from 06-Mar-2019 to an unknown date for Testosterone low. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 10-Apr-2021 The patient died on 10-Apr-2021. The cause of death was not reported. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood test: normal (normal) normal. On 09-Apr-2021, C-reactive protein: 18 (High) 18. On 09-Apr-2021, Electrocardiogram: sinus tachycardia. incomplete left sided bundle br (Inconclusive) Sinus tachycardia. Incomplete left sided bundle branch block. Suspected left sided ventricular hypertrophy with repolarising changes in all leads.. On 09-Apr-2021, Haemoglobin: 7.9 (abnormal) 7.9 (slight hypohaemoglobinaemia and units not specified). On 09-Apr-2021, Heart rate: 117 (Inconclusive) 117 heart beats per minute. On 09-Apr-2021, Neutrophil count: 7.5 (High) 7.5 (slightly increased) Units not specified. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Senders comments confirmed date of death confirmed and lab data updated.; Sender''s Comments: Limited information regarding the death has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1304049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Encephalitis, Epilepsy, Meningitis, Seizure
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 65
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: CLOPIDOGREL; CITALOPRAM; XARELTO
Current Illness: Chronic obstructive airways disease; Overweight; Smoker; Wheelchair user
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021496680

Write-up: meningitis; encephalitis; seizures; epileptic seizures; cerebral hemorrhage with consequences that resulted in death; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority. A 73-years-old female patient received BNT162B2 (COMIRNATY), dose 1, via an unspecified route of administration on 26Jan2021 (Batch/Lot Number: EJ6134; Expiration Date: 30Apr2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing wheelchair user, ongoing Smoker, cerebral thrombosis from 2006 to an unknown date, ongoing Chronic obstructive airways disease, ongoing overweight. Concomitant medication(s) included clopidogrel taken for thrombosis prophylaxis from 13Oct2015; citalopram taken for depression from 01Jan2008; rivaroxaban (XARELTO) taken for thrombosis prophylaxis from 17Sep2015. The patient experienced cerebral hemorrhage with consequences that resulted in death (death, hospitalization) on 04Feb2021. As a consequence of Cerebral hemorrhage the patient experienced meningitis, encephalitis and after 2 months of treatment increasing seizures and epileptic seizures. The patient is operated and gets a bleeding again the next day with and is operated a second time. Treatment was discontinued and the patient dies on 11Apr2021. An autopsy was not performed. There is no information regarding test results. The outcome of the events was Fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: meningitis; encephalitis; seizures; epileptic seizures; Cerebral hemorrhage


VAERS ID: 1304077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-01-21
Onset:2021-04-22
   Days after vaccination:457
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatinine, Blood glucose, Blood glucose increased, Blood lactic acid, Blood potassium, Blood pressure increased, Blood pressure measurement, Blood sodium, Body temperature, Cerebral haemorrhage, Chest X-ray, Coma scale, Coma scale abnormal, Computerised tomogram, Eosinophil count, Haematocrit, Haemoglobin, Heart rate, International normalised ratio, International normalised ratio increased, Loss of consciousness, Lymphocyte count, Mean cell volume, Monocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Platelet count decreased, Pneumonia aspiration, Prothrombin level, Prothrombin level increased, Red blood cell analysis, SARS-CoV-2 test, Scan brain, Vomiting, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified (Hypertension excluded); Iron deficiency; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: HCO3; Result Unstructured Data: Test Result:26.9; Test Name: Creatinine; Test Result: 0.7 mg/dl; Test Name: Glucose; Test Result: 260 mg/dl; Test Date: 20210422; Test Name: Glucose; Test Result: 240 mg/dl; Test Name: Lactate ion; Result Unstructured Data: Test Result:2.4; Test Name: K; Result Unstructured Data: Test Result:4.0 mEq/l; Test Name: Blood pressure; Result Unstructured Data: Test Result:187/97 mmHg; Test Name: Sodium; Result Unstructured Data: Test Result:139 mEq/l; Test Name: temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Name: Chest Rx; Result Unstructured Data: Test Result:possible bronchoaspiration; Test Date: 20210422; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:No signs of acute cardiopulmonary decompensation.; Comments: In both lung bases, some ill-defined millimeter nodular images are identified that in the context could be secondary to occupation of a small airway by bronchoaspiration. No signs of acute cardiopulmonary decompensation.; Test Date: 20210422; Test Name: glasgow; Result Unstructured Data: Test Result:4; Test Name: CT; Result Unstructured Data: Test Result:massive intraventricular hemorrhage; Test Name: Eosinophils; Test Result: 0.1 %; Test Name: Hematocrit; Test Result: 41.6 %; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.1 g/dl; Test Name: Heart rate; Result Unstructured Data: Test Result:79; Comments: bpm; Test Date: 20210422; Test Name: INR; Result Unstructured Data: Test Result:3.8; Test Date: 20210422; Test Name: Lymphocytes; Test Result: 8.2 %; Test Name: MCV; Result Unstructured Data: Test Result:94.5; Comments: fL; Test Name: Monocytes; Test Result: 3.0 %; Test Name: Neutrophils; Test Result: 88.5 %; Test Name: Sat O2; Test Result: 95 %; Test Name: SatO2; Result Unstructured Data: Test Result:41.6; Test Name: pCO2; Result Unstructured Data: Test Result:51.0; Test Name: pH; Result Unstructured Data: Test Result:7.345; Test Name: Platelets; Result Unstructured Data: Test Result:133.0; Comments: 10e3 / uL; Test Date: 2018; Test Name: Platelets; Result Unstructured Data: Test Result:133.0; Comments: 10e3 / uL; Test Date: 2020; Test Name: Platelets; Result Unstructured Data: Test Result:150.0; Comments: 10e3 / uL; Test Date: 20210422; Test Name: Low platelets; Result Unstructured Data: Test Result:133000; Comments: Units:/uL; Test Name: PO2; Result Unstructured Data: Test Result:26.0; Test Name: Prothrombin Activity; Result Unstructured Data: Test Result:18.0; Test Name: Red blood cells; Result Unstructured Data: Test Result:4.4; Comments: 10e3 / uL; Test Date: 20210422; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210422; Test Name: Scan brain; Result Unstructured Data: Test Result:Extensive hemoventricle with hydrocephalus; Comments: Extensive hem ventricle with hydrocephalus and transependymal transudation; Test Name: Leukocytes; Result Unstructured Data: Test Result:9.4; Comments: 9.4 10e3 / uL
CDC Split Type: ESPFIZER INC2021491305

Write-up: Haemorrhage intracerebral; Unconscious; vomiting; possible broncho aspiration; Blood pressure was 187/97 mmHg; Glasgow 4.; Glucose: 260 mg / dL; INR(international normalized ratio): 3.8; Prothrombin Activity: 18.0; Low platelets: 133000/uL; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-842453. A 83-years-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: EW4815) as single dose for COVID-19 immunisation; acenocoumarol (SINTROM), oral from 21Jan2020 (Batch/Lot number was not reported) to an unspecified date, at 4 mg for atrial fibrillation. Medical history included PD of iron deficiency and type II diabetes mellitus September 2020. Reasons for the patient''s vaccination was Over 65 years of age, Cardiovascular disease (excluding HT(Hypertension)). Concomitant medication(s) included bisoprolol (BISOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient has Chronic treatment with Bisoprolol 2.5 1/2-0-0, Sintrom 4mg according to calendar. The patient previously received first dose of COMIRNATY (Lot number: ET7205) on 29Mar2021 for COVID-19 immunisation. On 22Apr2021, Patient who lived alone and had been found by a relative on the floor of her home with traces of vomiting around. BP(Blood pressure): 187/97 mmHg; Temperature 36.3 C; HR 79 bpm; Sat. O2 (%) 95; Unconscious. Glasgow 4. Summary of additional tests: Biochemistry Emergencies: Glucose: 260 mg / dL, Creatinine: 0.7 mg / dL, Sodium: 139 mEq / L, K+(Potassium): 4.0 mEq / L. Emergency blood count: Hemoglobin: 14.1 g / dL, Hematocrit: 41.6%, MCV(Mean corpuscular volume): 94.5 fL, Red blood cells: 4.4 10e3 / uL, Platelets: 133.0 10e3 / uL, Leukocytes: 9.4 10e3 / uL, Neutrophils: 88.5%, Lymphocytes: 8.2% , Monocytes: 3.0%, Eosinophils: 0.1%. Coagulation Emergencies: INR(international normalized ratio): 3.8, Prothrombin Activity: 18.0. Venous blood gases: pH: 7.345, pCO2(partial pressure of carbon dioxide): 51.0, PO2(partial pressure of oxygen): 26.0, HCO3(Bicarbonate): 26.9, SatO2(Oxygen saturation): 41.6, Lactate ion: 2.4, Image: CT(computed tomography) scan: massive intraventricular hemorrhage. Chest Rx(X/Ray): possible bronchoaspiration. Applied treatment: vitamin K. In analysis of 2018 platelets of 133.0 10e3 / uL and in 2020 150.010e3 / uL. In analysis of 2018, platelets of 133.0 10e3 / uL and in 2020, 150.010e3 / uL. On 22Apr2021, the patient had Glucose 240mg/dl, Thorax X-ray: In both lung bases, some ill-defined millimeter nodular images are identified that in the context could be secondary to occupation of a small airway by bronchoaspiration. No signs of acute cardiopulmonary decompensation, INR:3.8, lymphocytes: 8.2%, Low platelets: 133000/uL, COVID-19 PCR test was negative, Scan brain: Extensive hemoventricle with hydrocephalus and transependymal transudation. On an unknown date in 2021, the patient died. It is unknown if autopsy was done. No follow-up attempts are possible. No further information expected. Information about batch number already obtained.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: Blood pressure was 187/97 mmHg; vomiting; Unconscious; Haemorrhage intracerebral; possible broncho aspiration; Glucose: 260 mg / dL; Glucose: 260 mg / dL; INR(international normalized ratio): 3.8; Prothrombin Activity: 18.0; Low platelets: 133000/uL


VAERS ID: 1304080 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Atrial fibrillation, Body temperature, Cardiac failure congestive, Cholangitis, Complications of transplanted kidney, Confusional state, Dyspnoea, Jaundice, Malaise, Multiple organ dysfunction syndrome, Ocular icterus, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Physical examination, Pulmonary oedema, Pyrexia, Respiratory failure, SARS-CoV-2 test, Sepsis
SMQs:, Cardiac failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (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), Dementia (broad), Acute central respiratory depression (narrow), Infectious biliary disorders (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conjunctival disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis (on treatment with adalimumab); Chronic kidney disease; Cognitive impairment (oriented as dementia); Dementia; Ex-smoker; Hypertension; Hypertensive retinopathy (grade II-III); Hyperuricemia; Kidney failure; Kidney graft dysfunction (requiring hemodialysis); Kidney transplant (Cadaveric donor kidney transplant with suboptimal graft function and kidney failure.); Major depression (with ideas of autolysis); Physical impairment (oriented as dementia)
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: low-grade fever; Test Date: 20210315; Test Name: saturation; Test Result: 86 %; Test Date: 20210315; Test Name: palpation; Result Unstructured Data: Test Result:with crackles at the bases and a distended and tym; Comments: with crackles at the bases and a distended and tympanic abdomen that was not painful; Test Date: 20210209; Test Name: Ag SARS.CoV2 test; Test Result: Negative ; Test Date: 20210324; Test Name: SARS.CoV2 PCR; Test Result: Negative
CDC Split Type: ESPFIZER INC2021491362

Write-up: sepsis due to probable cholangitis; sepsis due to probable cholangitis; decompensated congestive heart failure (CHF); atrial fibrillation with rapid ventricular response; hyperactive confusional syndrome; multiple organ failure; Acute pulmonary oedema/acute lung edema with respiratory failure; Acute pulmonary oedema/acute lung edema with respiratory failure; deterioration in graft function/Cadaveric donor kidney transplant with suboptimal graft function; saturation of 86%; dyspnea; conjunctival jaundice; distended and tympanic abdomen; mild skin jaundice; malaise; edema in both LES (lower extremities); low-grade fever (37.5C); This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-845123. A 67-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), on 20Feb2021 (Lot: EM0477) as 1 st dose, single and on 13Mar2021 (Lot: ER7812) as 2 nd dose, 0.3 mL, single; both intramuscular for covid-19 immunisation. Medical history included hypertension; hypertensive retinopathy (grade II-III); ankylopoietic spondylitis (on treatment with adalimumab); hyperuricemia; major depression (with ideas of autolysis); former smoker; chronic kidney disease in 2004; kidney transplant (Cadaveric donor kidney transplant with suboptimal graft function and kidney failure.) on 27Nov2018; cognitive and functional impairment (oriented as dementia); dementia; kidney failure and suboptimal graft function (requiring hemodialysis). No known allergies. The patient''s concomitant medications were not reported. The patient previously took bleomycin, dacarbazine, doxorubicin hydrochloride, vinblastine sulfate (ABVD) and experienced dependent (institutionalized). Rapid Ag SARS.CoV2 test on 09Feb2021 was negative. On 15Mar2021 (two days after receiving the second dose), she presented conjunctival jaundice and mild skin jaundice, malaise, dyspnea, and edema in both lower extremities (LES). At 24 hours (on 15Mar2021), he presented a low-grade fever (37.5C), increased dyspnea, circulation and saturation of 86%, with crackles at the bases and a distended and tympanic abdomen that was not painful on palpation. He was admitted with sepsis due to probable cholangitis, which triggered decompensated congestive heart failure (CHF) refractory to diuretic treatment and acute lung edema with respiratory failure. He also presented deterioration in graft function, requiring hemodialysis, atrial fibrillation with rapid ventricular response, and hyperactive confusional syndrome. SARS.CoV2 PCR 24Mar2021 was negative. Despite the treatment instituted, no clinical or analytical improvement was observed, triggering multiple organ failure. The outcome of the event dyspnoea was not recovered while for sepsis, cholangitis, cardiac failure congestive, atrial fibrillation, confusional state, ocular icterus, jaundice, malaise, oedema peripheral, pyrexia, oxygen saturation decreased and abdominal distention was unknown. Given the baseline situation of the patient, comfort measures were prioritized, with death on 24Mar2021. The patient died due multiple organ failure and acute pulmonary oedema/acute lung edema with respiratory failure on 24Mar2021. It was unknown if an autopsy was performed. Main Diagnosis was acute respiratory failure due to acute pulmonary edema. Other diagnostics decompensated heart failure refractory to diuretic treatment; Sepsis due to probable acute obstructive cholangitis; deterioration of kidney graft function; atrial fibrillation with rapid ventricular response; Hyperactive confusional syndrome and cognitive impairment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute pulmonary oedema/acute lung edema with respiratory failure; Acute pulmonary oedema/acute lung edema with respiratory failure; Multiple organ failure


VAERS ID: 1304083 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Electroencephalogram, Oxygen saturation, SARS-CoV-2 test, Scan brain, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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: OMEPRAZOL; CALCIUM CARBONATE AND VITAMIN D; ACETYLSALICYLIC ACID; AMLODIPINE; SODIUM VALPROATE; PROLIA; TRAZODONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment (Mild); Disorientation; Dysarthria; Facial droop (Right hemiparesis from childhood due to Infantile Paralysis); Hospitalization (due to dysarthria and disorientation, with a diagnosis of isovolemic hypotonic hyponatremia); Hypertension arterial; Hyponatremia; Inappropriate ADH secretion (uncertain etiology); Pain loin; Paraphasia; UTI (due to multisensitive E. Coli.); Ventricular bigeminy
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: EEG; Result Unstructured Data: Test Result:Focal status epilepticus; Test Date: 20210420; Test Name: SatO2; Test Result: 87 %; Test Date: 20210420; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Date: 20210420; Test Name: Scan brain; Result Unstructured Data: Test Result:Residual areas of left frontoparietal encephalomal; Comments: Residual areas of left frontoparietal encephalomalacia. No signs of acute intracranial pathology
CDC Split Type: ESPFIZER INC2021496694

Write-up: Status epilepticus; SARS-COV2 PCR: Positive; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is ES-AEMPS-846623. A 79-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot: EW2246), intramuscularly on 10Apr2021 at 0.3 mL single for COVID-19 immunisation. Medical history included arterial hypertension, pain loin, ventricular bigeminy, facial droop (right hemiparesis from childhood due to infantile paralysis), and mild cognitive impairment. She was admitted from 01Apr2021 to 09Apr2021 due to dysarthria and disorientation, with a diagnosis of isovolemic hypotonic hyponatremia, SIAD (syndrome of inappropriate antidiuretic hormone secretion) (uncertain etiology), and UTI (urinary tract infection) due to multisensitive E. Coli. Concomitant medications included omeprazole, calcium carbonate/colecalciferol (CALCIUM CARBONATE AND VITAMIN D), acetylsalicylic acid 100 mg, amlodipine, sodium valproate, denosumab (PROLIA), and trazodone. On 16Apr2021 she went to the Emergency Service of a hospital due to paraphasia and disorientation, starting treatment with valproic and was discharged. On 20Apr2021, she was admitted due to a non-convulsive status, with progressive onset in recent weeks despite treatment with valproic acid ((poor compliance). No evidence of epilepsy until Apr2021, but there were episodes of similar characteristics on admission in 2020 Therefore, it does not seem like status epilepticus in the context of any acute trigger, but rather a serious epileptic decompensation within an infectious occurrence such as covid19. Previous etiological study without significant alterations, although the patient suffered from infantile cerebral palsy and had mild-moderate cognitive impairment. Diagnostics: Complex focal epileptic status, in a patient with residual brain injury that might be the etiology of the seizure, the injury was old and had decompensated 10 days after vaccination. Severe bilateral pneumonia from COVID19. Lab data on 20Apr2021 included: CT (computed tomography): No signs of acute intracranial pathology. Residual areas of left frontoparietal encephalomalacia; SARS-COV2 PCR: Positive; EEG (electroencephalogram) on admission: Focal status epilepticus; The main novelty was a respiratory worsening, with work of breathing and SatO2(Oxygen saturation) 87% with GN at 6lp. At the respiratory level: Bilateral pneumonia due to severe covid19, requiring oxygen therapy with GN at 5 bpm. COURSE: No improvement despite pharmacological adjustment after 24h. The patient died on 23Apr2021. No autopsy was done. Assessment of causality (SEFV): The patient had severe bilateral Covid-19 pneumonia. Status epilepsy had been described in positive CoVID-19 patients, so there was an alternative causal explanation to the vaccine that could explain the condition. Outcome of event SARS-COV2 PCR: Positive was unknown. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Status epilepticus


VAERS ID: 1304085 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-10
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal wall haematoma, Cardio-respiratory arrest, Post-traumatic stress disorder, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021496501

Write-up: bilateral PTE (Pulmonar thromboembolism); sudden cardiorespiratory arrest due to PTSD (Post-traumatic stress disorder); PTSD (Post-traumatic stress disorder); serious hemorrhagic complication (hematoma of the abdominal wall); This is a spontaneous report received from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-847195. An 89-year-old female patient received bnt162b2 (COMIRNATY) dose 1 via unknown route of administration on 31Mar2021 (Lot Number: EW2239) as 0.3 mL, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Apr2021, patient without risk factors for thrombophilia was admitted for bilateral PTE (pulmonar thromboembolism) 10 days after Covid19 COMIRNATY vaccine without another trigger. Subsequently. On 14Apr2021, the anticoagulant was discontinued due to a serious hemorrhagic complication (hematoma of the abdominal wall) that required embolization. On 15Apr2021 she experienced sudden cardiorespiratory arrest due to PTSD (Post-traumatic stress disorder), with death on 16Apr2021. Cause of death was reported as pulmonar thromboembolism. The outcome of event Pulmonar thromboembolism was fatal and other events was unknown. It is unknown if autopsy was done. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonar thromboembolism


VAERS ID: 1304250 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic shock, Dyspnoea, Hypoxia, Tryptase
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 1
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: MASDIL; EUCREAS; TORASEMID; SEGURIL; PRAVASTATINA [PRAVASTATIN]; ELIQUIS; DIOVAN
Current Illness: Atrial fibrillation; Chronic kidney disease; Hypertension; Hypertrophic cardiomyopathy; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: Blood tryptase; Result Unstructured Data: 30.8 microgram per litre; Test Date: 20210410; Test Name: Blood tryptase; Result Unstructured Data: 33.5 microgram per litre
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: Anaphylactic shock; Hypoxia; Dyspnea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), HYPOXIA (Hypoxia) and DYSPNOEA (Dyspnea) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. The patient''s past medical history included Cardiovascular disease, unspecified Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Chronic kidney disease , Atrial fibrillation and Hypertrophic cardiomyopathy. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, METFORMIN HYDROCHLORIDE, VILDAGLIPTIN (EUCREAS) for Diabetes mellitus, VALSARTAN (DIOVAN) for Hypertension, DILTIAZEM HYDROCHLORIDE (MASDIL), TORASEMIDE (TORASEMID), FUROSEMIDE (SEGURIL) and PRAVASTATINA [PRAVASTATIN] for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death and hospitalization), HYPOXIA (Hypoxia) (seriousness criteria death and hospitalization) and DYSPNOEA (Dyspnea) (seriousness criteria death and hospitalization). The patient died on 11-Apr-2021. The reported cause of death was Anaphylactic shock, Dyspnea and Hypoxia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Tryptase: 30.8 microgram per litre abnormal. On 10-Apr-2021, Tryptase: 33.5 microgram per litre abnormal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.; Reported Cause(s) of Death: Anaphylactic shock; Dyspnea; Hypoxia


VAERS ID: 1304251 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve calcification; Arterial bypass operation; Bladder cancer; Chronic lymphoid leukaemia; Ischaemic cardiomyopathy; Peripheral arterial occlusive disease; Prostatitis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Sudden death unexplained; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (Sudden death unexplained) in a 72-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001413) for COVID-19 vaccination. The patient''s past medical history included Bladder cancer, Aortic valve calcification, Arterial bypass operation, Prostatitis, Chronic lymphoid leukaemia, Peripheral arterial occlusive disease, Type 2 diabetes mellitus and Ischaemic cardiomyopathy. On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with the mRNA-1273 was not applicable. Company Comment: Very limited information regarding the event has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1304282 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood pressure measurement, Death, Heart rate, Malaise, Oxygen saturation, Oxygen saturation decreased, Pallor, Respiratory distress, Restlessness, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

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: LEVOTHYROX; ABASAGLAR; ESOMEPRAZOLE; BISOCE; KARDEGIC; CORN STARCH; ANHYDROUS CALCIUM SULFATE; MICROCRYSTALLINE CELLULOSE; CROSPOVIDONE; DIMETICONE; TITANIUM DIOXIDE; HYPROMELLOSE; MACROGOL 400; MAGNESIUM STEARATE; ACETYLSALICYLATE LYSINE;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Carotid artery atheroma; COVID-19 (requiring up to 5L of O2, corticosteroids and antibiotics.); Diabetes (on insuline); Mixed dementia; Osteoporosis; Tachyarrhythmia
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: blood pressure; Result Unstructured Data: Test Result:130/60 mmHg; Test Date: 20210410; Test Name: blood pressure; Result Unstructured Data: Test Result:130/80 mmHg; Test Date: 20210409; Test Name: heart rate; Result Unstructured Data: Test Result:60 bpm; Test Date: 20210409; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 20210410; Test Name: oxygen saturation; Test Result: 90 %; Comments: 6 am; Test Date: 20210410; Test Name: oxygen saturation; Test Result: 94 %; Comments: 6.15 am; Test Date: 20210410; Test Name: oxygen saturation; Test Result: 85 %; Comments: 6:30 am
CDC Split Type: FRPFIZER INC2021496576

Write-up: Death unexplained; Extreme pallor; restlessness; respiratory distress; did not feel well; vomit; back pain; SatO2 90%; This is as spontaneous report received from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-ST20211683, Safety report unique identifier FR-AFSSAPS-2021044459. An 87-year-old female patient received bnt162b2 (COMIRNATY) dose 2 intramuscular on 09Apr2021 (Lot Number: ET7205) as 0.3 mL, single for covid-19 vaccination. Medical history included diabetes on insulin, covid-19 from Nov2020 to Dec2020 requiring up to 5L of O2, corticosteroids and antibiotics (Symptoms congestion and fatigue lasting about 1 month), complete tachy-arrhythmia by atrial fibrillation arrhythmia, osteoporosis, carotid artery atheroma without stenosis, severe mixed dementia from 2014 (cognitive disorders ++ with score <10/30), mitral valve heart disease. Patient living in residential care for dependent elderly people. GIR 1. Concomitant medications included levothyroxine sodium (LEVOTHYROX), croscarmellose sodium; gelatin (mammal/beef); insulin glargine (ABASAGLAR, bacteria/escherichia coli); esomeprazole; bisoprolol fumarate (BISOCE); acetylsalicylate lysine (KARDEGIC 75 mg), zea mays seed (CORN STARCH), pregelatinized corn starch; anhydrous calcium (hydrogenphosphate); microcrystalline cellulose; crospovidone; dimeticone 100; titanium dioxide; yellow iron oxide; red iron oxide; hypromellose; macrogol 400; anhydrous colloidal silica; magnesium stearate; talc), powder for oral solution in a sachet-dose (dl-lysine (acetylsalicylate); acetylsalicylic acid; ammonium glycyrrhizinate; aroma/fragrance; glycine), lactose monohydrate. The patient previously received first dose of COMIRNATY without events. On 10Apr2021 06:50 am, the patient experienced unexplained death. Constants before vaccination: blood pressure 130/60 mmHg; 60 bpm; SatO2 98%; afebrile. At 7 pm constants normal; afebrile. The day after the vaccination at 10Apr2021 6 am, the patient did not feel well, described an urge to vomit and back pain, blood pressure 130/80 mmHg; SatO2 90%. She was put under 1 L of O2 and seated in bed. At 6.15 am: SatO2 94% under 1L of O2. At 6:30 am: SatO2 85%. Extreme pallor, restlessness, back pain and respiratory distress. Call for urgent medical aid. Death at 10Apr2021 6:50 am. Possible causes of death mentioned by the geriatrician included acute pulmonary embolism, myocardial infarction, ruptured aneurysm. The outcome of event unexplained death was fatal; other events was unknown. No autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1304539 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-10
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK LA / OT

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: ACETYLSALICYLIC ACID
Current Illness: Myocardial infarction; Stenosis aortic valve
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021480833

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is HU-OGYI-228821. An 86-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EP2166), intramuscular in the left arm on 19Mar2021 as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing myocardial infarction and ongoing aortic valve stenosis from unknown dates. Concomitant medication included acetylsalicylic acid (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient experienced death on 10Apr2021. The patient died on 10Apr2021. An autopsy was performed and results were not provided. An autopsy was performed and results were not provided. In the opinion of the patients physician, the death was not related to the vaccination. Sender Comment: The patient died 22 days after vaccination. Death is not expected adverse event of COMIRNATY. It might be related to the patient''s chronic cardiovascular diseases. Based on the above, and in lack of detailed medical information, relationship between death and COMIRNATY is not assessable. The case is serious because the patient died. No further information is expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1304540 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-11
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chemotherapy; Drug therapy; Hypertension; Lymphoma (in terminal stage; she was under palliative chemotherapy treatment and biological therapy.); Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021480834

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (HU-OGYI-229721). A 67-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly in the left upper arm, on 19Mar2021 at 14:00 as 0.3 mL, single for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing obesity, and ongoing lymphoma (in terminal stage; she was under palliative chemotherapy treatment and biological therapy), ongoing palliative chemotherapy, and ongoing biological therapy. The patient''s concomitant medications were not reported. The patient experienced death on 11Apr2021, which was reported as fatal. The patient died at home on 11Apr2021. The cause of death was reported as unknown. An autopsy was not performed. It was reported that the physician does not suppose relationship of the event with the vaccination. Sender''s Comment: Death is not expected adverse event of COMIRNATY. It might be resulted by the patient''s terminal cancer. Time-to-onset (TTO) was 23 days. Based on the above, relationship between death and COMIRNATY is not related. The case is serious because the patient died. No further information is expected. No further information is expected; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the current available information, the event death is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The event might be resulted by the patient''s terminal cancer.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1304541 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Deep vein thrombosis, Inflammatory marker test, Laboratory test, Pneumonia, Pulmonary embolism, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (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: 2021-02-04
   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: PROSTAMOL UNO; XANAX; SERMION [NICERGOLINE]; GERODORM; NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; RIPEDON; CHINOTAL; ACETYLSALICYLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis; Dementia; Hospitalization; Hypertension; Injury; Malignant melanoma
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: chest X-ray; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: inflammatory parameters; Result Unstructured Data: Test Result:high; Test Date: 2021; Test Name: laboratory tests; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: Covid PCR results; Test Result: Negative ; Test Date: 20210124; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210127; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210202; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210204; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021484803

Write-up: Pneumonia; Fever; deep vein thrombosis leading to lung embolism; deep vein thrombosis leading to lung embolism; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority. An 83-year-old male patient received the first dose of the bnt162b2 (COMIRNATY), intramuscularly on 28Jan2021 at 0.3 ml, single for covid-19 immunisation. Medical history included hypertension, dementia, malignant melanoma, arteriosclerosis, and needed hospitalization multiple times in the past few months due to physical injuries. Concomitant medications included serenoa repens extract (PROSTAMOL UNO); alprazolam (XANAX); nicergoline (SERMION [NICERGOLINE]); cinolazepam (GERODORM); pantoprazole sodium sesquihydrate (NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]); risperidone (RIPEDON); pentoxifylline (CHINOTAL); and acetylsalicylic acid (MANUFACTURER UNKNOWN). On 29Jan2021, the patient experienced fever, which required hospitalization and was serious for death. On 01Feb2021, the patient experienced pneumonia required hospitalization and was serious for death. In Feb2021, the patient experienced deep vein thrombosis leading to lung embolism, which was serious for death. The clinical course was as follows: on 28Jan2021, 83-year-old male patient received the first dose of bnt162b2. On 29Jan2021, fever occurred. On 01Feb2021, the patient was admitted in the hospital with a suspicion of pneumonia. Several examinations were carried out including laboratory tests and chest X-ray with unknown results in 2021. The patient''s inflammatory parameters were high but Covid PCR results were negative in 2021. The patient received antibiotics for the pneumonia, but as his state of health was already deteriorating, he passed away on 04Feb2021. The patient underwent lab tests and procedures which included covid-19 PCR test: negative on 24Jan2021, sars-cov-2 test: negative on 27Jan2021, sars-cov-2 test: negative on 02Feb2021, sars-cov-2 test: negative on 04Feb2021. The clinical outcome of the events was fatal. The patient died on 04Feb2021 due to fever, pneumonia, and deep vein thrombosis leading to lung embolism. An autopsy was performed and results were provided. Based on the autopsy report, the cause of death was deep vein thrombosis leading to lung embolism. SENDER COMMENT: since immunity may have not developed yet as the patient received the first dose of Comirnaty on 28Jan2021 and pneumonia was confirmed on 01Feb2021, the causal relationship is unlikely between the suspected drug and the cause of death. Also considering the fact that due to the patient''s already deteriorating state of health, he could have developed pneumonia anywhere, anytime. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pneumonia; fever; deep vein thrombosis leading to lung embolism; deep vein thrombosis leading to lung embolism; Autopsy-determined Cause(s) of Death: deep vein thrombosis leading to lung embolism; deep vein thrombosis leading to lung embolism


VAERS ID: 1304542 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-04-15
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021464088

Write-up: Drug Ineffective; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is HU-OGYI-243321. A 60-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: ET3620), intramuscular on 21Mar2021 as 0.3 mL, single, first dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced covid-19 on 15Apr2021, at 09:40, which was serious as it lead to death. The patient died on 15Apr2021. It was not reported if an autopsy was performed. Sender Comment: According to the SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient received the first dose of Comirnaty on 21Mar2021 and passed away on 15Apr2021 after getting infected with the virus, therefore immunity may have not developed yet. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1304543 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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: HUPFIZER INC2021506843

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number HU-OGYI-252321. A 69-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Left Arm on 08Apr2021 (Batch/Lot Number: EW2239) as for covid-19 immunisation. On 06Mar2021 the patient received the first dose of BNT162B2 vaccine. The patient medical history and concomitant medications were not reported. The patient died on 16Apr2021. The cause of death was unknown. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1304544 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-04-13
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: COVEREX AS; RIVOTRIL; HALOPERIDOL; NEBIVOLOL; CLEXANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Hypertension; Paranoia
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021484804

Write-up: Cardiopulmonary insufficiency; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number HU-OGYI-253221. An 81-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EP2166), intramuscular into the left arm on 18Mar2021 as 0.3 mL, single for covid-19 immunisation. Medical history included dementia Alzheimer''s type, hypertension and paranoia from an unknown date. Concomitant medications included perindopril arginine (COVEREX AS) taken for hypertension from 07Apr2021 to 13Apr2021; clonazepam (RIVOTRIL) taken for agitation from 07Apr2021 to 13Apr2021; haloperidol (MANUFACTURER UNKNOWN) taken for dementia from 07Apr2021 to 13Apr2021; nebivolol (MANUFACTURER UNKNOWN) taken for hypertension from 07Apr2021 to 13Apr2021; enoxaparin sodium (CLEXANE) taken for thrombosis prophylaxis from 07Apr2021 to 13Apr2021. On 13Apr2021, the patient experienced cardiopulmonary insufficiency, which was serious as it lead to death. The patient was hospitalized from 07Apr2021 till 13Apr2021. It was reported that the patient did not require hospitalization due to sequelae of the vaccination but rather because of his worsening condition due to his severe Alzheimer''s type dementia. On 13Apr2021 at 23:15, the patient passed away. According to the patients death certificate, the cause of death was circulatory and respiratory insufficiency. While hospitalized, the patient received nebivolol, perindopril arginine for hypertension, clonazepam for agitation, haloperidol for dementia and enoxaparin sodim for thrombosis prophylaxis. The patient died on 13Apr2021. An autopsy was performed and results were not provided. Sender Comment: The patient received the first dose of Comirnaty on 18Mar2021 and passed away on 13Apr2021 therefore immunity may have not developed yet. The reporter physician also assessed the fatal outcome as not related to the vaccine. Based on the above, the causal relationship is not related between the suspected drug and the adverse event. The case is considered serious because the patient passed away. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: circulatory and respiratory insufficiency; circulatory and respiratory insufficiency


VAERS ID: 1304621 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Cardio-respiratory arrest, Colonoscopy, Headache, Insomnia, Investigation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Hypertension (narrow), Respiratory failure (broad)

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: HYRIMOZ [ADALIMUMAB]; MESALAZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20210425; Test Name: blood pressure; Result Unstructured Data: Test Result:210 mmHg; Comments: systolic; Test Date: 20210424; Test Name: blood tests; Result Unstructured Data: Test Result:normal; Comments: with indices of inflammation and fecal Calprotectin within the normal limits; Test Date: 202010; Test Name: colonoscopy; Result Unstructured Data: Test Result:extension of the lesions up to the transversus; Comments: extension of the lesions up to the transversus (Mayo score 1-2); Test Date: 20210425; Test Name: impact on quality of life; Result Unstructured Data: Test Result:10/10
CDC Split Type: ITPFIZER INC2021501419

Write-up: Severe headaches and death after 3 days from the administration of the booster of the anti COVID Pfizer vaccine; Insomnia; Blood pressure increased/systolic blood pressure 210 mmHg; Severe headaches and death after 3 days/Cardio-respiratory arrest; This is a spontaneous report received from a contactable consumer and a physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-722091. A 76 years old male patient received the second booster dose BNT162B2 (COVID 19 COMIRNATY VACCINE (PFIZER), lot number EX3599) via intramuscular administration in left shoulder on 22Apr2021 at single dose for COVID-19 immunisation. Medical history included ulcerative colitis since 1990 treated first with mesalazine associated with steroids in the exacerbation phases and with azathioprine in 2008 then suspended: From 2015 to 2020 laboratory clinical remission, in the second half of 2020 disease recurrence; colonoscopy October 2020 showed extension of the lesions up to the transversus (Mayo score 1-2). From November 2020 hospital prescription of Hyrimoz in addition to mesalazine, with subsequent symptomatic remission and normalization of blood tests performed on 24Apr2021 with indices of inflammation and fecal Calprotectin within the normal limits. Concomitant medications included adalimumab (HYRIMOZ) from Nov2020 for ulcerative colitis; mesalazine. The patient received the first dose of comirnaty on 01Apr2021 for covid-19 immunisation with no adverse drug reaction (ADR). Local Center of Pharmacovigilance 28Apr2021: contacted and request sent to the attending physician to prepare clinical report complete with case history; waiting for a reply. Subject not hypertensive, no cardiovascular pathologies, treated with Hyrimoz for ulcerative colitis. At the first dose on 01Apr2021 no ADR; immediately after the second dose initially mild headache then worsened, insomnia. On 25Apr2021 very strong headache all day. In the evening, systolic blood pressure 210 mmHg (blood pressure increased), at 21:30 called emergency, arrived at 21:52. Emergency sheet reports (as far as legible): unconscious patient, cyanotic skin, mydriasis, cardiorespiratory arrest, unblocked airways, manual ventilation and chest compression, administered adrenaline 1 fl intravenous. Declaration of death at 22:30. Severe headaches and death after 3 days from the administration of the booster of the anti COVID Pfizer vaccine. The emergency form and the clinical report of the attending physician will be attached to the National Network of Pharmacovigilance. Relatives are trying to have an autopsy performed. Measures taken (Cardiac massage with telephone assistance from the emergency service of the hospital until their arrival, then resuscitation with defibrillator continued), impact on quality of life (10/10). Local Center of Pharmacovigilance 29Apr2021: attached clinical report received from the general practitioner and intervention of emergency on 25Apr2021. From November 2020 hospital prescription of Hyrimoz in addition to mesalazine, with subsequent symptomatic remission and normalization of blood tests performed on 24Apr2021 with indices of inflammation and fecal Calprotectin within the normal limits. Therefore the patient at the time of vaccination was in good clinical condition in relation to the aforementioned pathology. Local Center of Pharmacovigilance 30Apr2021: Hear from the attending physician, autopsy performed today. The relative autopsy report is awaited. Outcome was fatal. Reporter''s comments: Ulcerative rectal colitis. Azathioprine intolerance.; Reporter''s Comments: Ulcerative rectal colitis. Azathioprine intolerance; Reported Cause(s) of Death: Insomnia; Blood pressure increased/systolic blood pressure 210 mmHg; Severe headaches and death after 3 days/Cardio-respiratory arrest; Severe headaches


VAERS ID: 1304622 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-25
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021501426

Write-up: Administration of the first Pfizer vaccine dose on 10Apr2021. On 25Apr2021 he suddenly fainted and rescuers who intervened within 10 minutes tried to revive him for 30 minutes.; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB [IT-MINISAL02-722534]. A 76-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot#: Ew2246) via intramuscular at 0.3 ml single on 10Apr2021 from 10:00 to 11:00 in right arm for COVID-19 immunisation. Medical history included heart disease. Concomitant medication was not reported. Administration of the first Pfizer vaccine dose on 10Apr2021. On 25Apr2021, Sunday morning, patient suddenly fainted and rescuers who intervened within 10 minutes tried to revive him for 30 minutes. The general practitioner, who had been contacted, excluded that it may have been caused by the vaccine. He hypothesized an ischemia, an embolism or rupture of the aorta. Patient suddenly lost consciousness and rescuers, who intervened within 10 minutes, tried to revive him for 30 Min, even with a defibrillator. Patient died in Apr2021. He took medications regularly and specific tests every 6 months. On 30Apr2021, the emergency report sent by the reporter who contacted communicates: No autopsy was performed because he died at home and the doctor who declared the death did not ask us for anything. The outcome of event was fatal. Reporter comment: heart disease No follow-up attempts possible. No further information expected.; Reporter''s Comments: heart disease; Reported Cause(s) of Death: lost consciousness


VAERS ID: 1304623 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-04-19
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Choledocholithiasis; Decompensation cardiac; Femur fracture; Hypokalaemia; Hypokinesia; IHD; Interstitial lung disease; LBBB; Permanent atrial fibrillation; Pneumonitis
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: SARS-CoV-2 molecular test; Test Result: Negative ; Test Date: 20210412; Test Name: SARS-CoV-2 molecular test; Test Result: Negative ; Test Date: 20210419; Test Name: SARS-CoV-2 molecular test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021501428

Write-up: ischemic and valvular heart disease; ischemic and valvular heart disease; Positive molecular swab in subject vaccinated on 16Jan and 06Feb. Dead.; vaccination failure; This is as spontaneous report received from a contactable Healthcare Professional (HCP) downloaded from the Agency-WEB. The regulatory authority report number is IT-MINISAL02-722826. A 99-year-old female patient received BNT162B2 (COMIRNATY) via intramuscular administered in Arm Left (shoulder) on 06Feb2021 as 2nd dose, 0.3 ml single (Batch/Lot Number: EL0725; Expiration Date: 31Mar2021), via intramuscular administered in Arm Left (shoulder) on 16Jan2021 as 1st dose, 0.3 ml single (Batch/Lot Number: EJ6797; Expiration Date: 30Apr2021) for covid-19 immunisation. Medical history included left bundle branch block (LBBB), femur fracture from 04Nov2020, hypokinesia, ischemic heart disease (IHD), permanent atrial fibrillation, choledocholithiasis from 30Dec2020, hypokalaemia, pneumonitis from 30Dec2020, interstitial lung disease from 01Jan2015, decompensation cardiac. The patient''s concomitant medications were not reported. The patient experienced positive molecular swab on 19Apr2021 in subject vaccinated on 16Jan2021 and 06Feb2021 and died. Reported evident signs of decompensation on the day of death. Most relevant cause of death reported as ischemic and valvular heart disease. The patient underwent SARS-CoV-2 molecular test and revealed negative on 29Mar2021 and on 12Apr2021; revealed positive on 19Apr2021. The patient died on 24Apr2021. It was not reported if an autopsy was performed. The reported cause of death was ischemic and valvular heart disease, positive molecular swab. Outcome of the events was fatal. Reporter comment: Death certificate attached. Most relevant cause of death: ischemic and valvular heart disease.; Reported Cause(s) of Death: Positive molecular swab; Positive molecular swab; ischemic and valvular heart disease; ischemic and valvular heart disease


VAERS ID: 1304624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-03
Submitted: 0000-00-00
Entered: 2021-05-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Anuria, Asthenia, Decreased appetite, Dehydration, Nervous system disorder, Pneumonia aspiration, Pneumonitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (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), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021501425

Write-up: asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; suspected aspiration pneumonia; asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; anuria; dehydration; worsening of neurological conditions; asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is [IT-MINISAL02-723165]. An 81-year-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Alzheimer''s disease from 30Apr2012 to an unknown date, renal failure from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized on 03Apr2021. Patient received treatment included hydration and antibiotics for the events. The patient died on 20Apr2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. Reporter''s Comment: after the second dose of Pfizer vaccine loss of appetite, dehydration and subsequent appearance of suspected aspiration pneumonia and anuria for which hospitalization was required. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: after the second dose of Pfizer vaccine loss of appetite, dehydration and subsequent appearance of suspected aspiration pneumonia and anuria for which hospitalization was required..; Reported Cause(s) of Death: asthenia, loss of appetite, worsening of neurological conditions, appearance of pneumonia (ab ingestis?) and acute renal failure then hospitalized; suspected aspiration pneumonia; asthenia, loss of appetite, worsening of neurological conditions, appe


VAERS ID: 1304784 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, 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), Respiratory failure (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pancreatitis acute
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021506944

Write-up: Respiratory arrest / cardiac arrest; Vomiting; This is a spontaneous report from a contactable physician received via Regulatory Authority. A 90-year-old male patient received BNT162B2 (COMIRNATY; Lot number: unknown), dose 1 intramuscular on 06May2021, at 10:30 as single dose for covid-19 immunization. Medical history included pancreatitis acute from an unknown date. The patient''s concomitant medications were not reported. The patient experienced respiratory arrest / cardiac arrest on 06May2021, at 11:45, and vomiting on 06May2021. The reporting physician classified the events as serious as they resulted in death. It was unknown whether the patient received any vaccination within 4 weeks prior to BNT162B2. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was not unknown whether the patient had any allergies to medications, food, or other products. On 06May2021 at 10:30, the patient received the first dose of BNT162b2. On 06May2021 (about 1 hour after the vaccination), the patient experienced vomiting. On 06May2021 at 11:45 (1 hour and 15 minutes after the vaccination), the patient experienced respiratory arrest / cardiac arrest. Therapeutic measures were taken as a result of respiratory arrest / cardiac arrest; the patient received adrenaline administration and resuscitative measure in response to the event. The course of the event was as follows: About 1 hour after vaccination at the short stay (at the nursing home/senior living facility), the patient was transported by emergency to the reporting hospital due to the respiratory arrest/cardiac arrest after vomiting. The event resulted in emergency transport to the reporting hospital. The outcome of the events was fatal. The patient died on 06May2021. An autopsy was not performed and the exact cause of death was unknown. This case was reported because the causality with the vaccine cannot be ruled out completely. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender''s Comments: Based on the close temporal relationship, the association between the fatal events cardiorespiratory arrest and vomiting with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1304785 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Cardio-respiratory arrest, Dyskinesia, Pyrexia, Sputum increased, White blood cell count
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), Dyskinesia (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: Medical History/Concurrent Conditions: Dyslalia; Dysphagia; Hospitalization; Nasogastric tube insertion; Parkinson''s disease (for more than 5 years); Progressive supranuclear palsy
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210430; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: 2 hours after vaccination; Test Date: 20201112; Test Name: CRP; Result Unstructured Data: Test Result:0.37; Test Date: 20201112; Test Name: white blood cell (W); Result Unstructured Data: Test Result:6400
CDC Split Type: JPPFIZER INC2021509322

Write-up: sputum increased; Cardio-respiratory arrest; Pyrexia of 37.5 degrees centigrade; Neck movement from side to side; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21104881. A 70-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 30Apr2021 at 13:37 (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) at 70-years-old as a single dose for COVID-19 immunization. The patient''s medical history included progressive supranuclear palsy from an unknown date and unknown if ongoing, hospitalization from 22Jul2020 to an unknown date, Parkinson symptoms from an unknown date and unknown if ongoing (for more than 5 years), nasogastric tube insertion from 02Sep2020 to an unknown date, dyslalia from an unknown date and unknown if ongoing, and dysphagia from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took influenza vaccine on 10Nov2020 for immunization (at another hospital). On 30Apr2021 at 13:52, the patient experienced neck movement from side to side (non-serious). On 30Apr2021 at 15:37, the patient experienced pyrexia of 37.5 degrees Centigrade (non-serious). On 01May2021 at 02:30, the patient experienced cardio-respiratory arrest (death, medically significant). The clinical course was reported as follows: The patient was a 70-year-old male. Body temperature before vaccination was 36.4 degrees Centigrade. Historical vaccine included influenza vaccine on 10Nov2020 at another hospital. Medical history included progressive supranuclear palsy. Family history and concomitant medications were not reported. On 30Apr2021 at 13:37 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 30Apr2021 at 13:52 (15 minutes later from the vaccination), the patient was in normal condition except his neck movement from side to side. On 30Apr2021 at around 15:37 (2 hours later form the vaccination), the patient developed pyrexia of 37.5 degrees centigrade. On 01May2021 at 02:30 (1 day after the vaccination), the patient was found in cardio-respiratory arrest. Outcome of the event, cardio-respiratory arrest, was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: The patient had been hospitalized in the reporting hospital (Hospital A) since 22Jul2020. Although the onset time was unclear, the patient had Parkinson symptoms for more than 5 years. The previous physician (Hospital B) diagnosed progressive supranuclear palsy. Around Jun2020, the patient began to gradually have difficulty in oral intake. On 29Jun2020, the patient was admitted to Hospital B for close examination. The patient was confined to bed, needed total assistance, was having swallowing auxiliary food; under this condition, the patient was transferred to the reporting hospital. Pursuit eye movement was possible. The patient had difficulty to move his lips and tongue. The patient had flexion of both elbows and strong muscle tightness and was confined to bed. In the late Aug2020, the patient could not eat anymore. On 02Sep2020, a nasogastric tube was inserted, and tube feeding was started. At another hospital (Hospital C), the patient received an influenza vaccine without experiencing a particular problem on 10Nov2020, and blood test revealed white blood cell (W) 6400 and C-reaction protein (CRP) 0.37 on 12Nov2020. On 30Apr2021 at 13:37, the patient, who was in normal condition, received a coronavirus vaccine (performed by the reporting physician). Thereafter, the patient was observed for 15 minutes and was in normal condition except his neck movement from side to side (on 30Apr2021 at 13:52). However, about 2 hours later, the patient had pyrexia of 37.5 degrees Centigrade without other changes (no change in blood pressure and SO2). On 01May2021, the patient remained unchanged at 01:30, but was found in cardio-respiratory arrest at 02:30. The reporting physician classified the event, cardio-respiratory arrest, as serious (death) and assessed the causality between the event and bnt162b2 as unassessable. As for the events, neck movement from side to side and pyrexia of 37.5 degrees Centigrade, outcome, seriousness classification, and causality assessment were not reported. It was not reported whether there was other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient originally had Parkinson symptoms with dyslalia and dysphagia. The patient did not have cough frequently. He usually had no sputum caught in, but sputum was extracted when suction was performed. This time, the volume of sputum increased due to low-grade fever caused by the vaccine, and the difficulty in sputum discharge might have led to the death. The patient underwent lab tests and procedures which included body temperature: 36.4 Centigrade on 30Apr2021 (before vaccination), body temperature: 37.5 Centigrade on 30Apr2021 (2 hours after vaccination), C-reactive protein (CRP): 0.37 on 12Nov2020, white blood cell (W): 6400 on 12Nov2020. The clinical outcome of the events: dyskinesia and pyrexia, was unknown. The clinical outcome of the event, cardio-respiratory arrest, was fatal. The patient died on 01May2021 due to cardio-respiratory arrest. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1304786 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021509325

Write-up: Cerebral infarction; This is a spontaneous report from a contactable pharmacist. This report was received via a Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cerebral infarction, which was serious for death. The patient died on an unspecified date due to cerebral infarction. It was not reported if an autopsy was performed. Causality assessment for the event were not provided. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: A causal relationship between the event "Cerebral infarction" and suspect product bnt162b2 (COMIRNATY), is possible based on the information provided, safety profile and a temporal association. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1304787 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Cardio-respiratory arrest, Imaging procedure, Ruptured cerebral aneurysm, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: Test Date: 20210430; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Name: autopsy imaging (AI); Result Unstructured Data: Test Result:subarachnoid haemorrhage and basilar artery; Comments: aneurysm rupture
CDC Split Type: JPPFIZER INC2021509396

Write-up: sudden disturbed consciousness; Cardio-respiratory arrest; basilar artery aneurysm rupture; subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21104899. A 63-year and 1-month old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration, on 30Apr2021 at 13:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardio-respiratory arrest on 03May2021 at 10:30 and basilar artery aneurysm rupture and subarachnoid haemorrhage on 03May2021, which were reported as fatal. The patient also experienced sudden disturbed consciousness on 03May2021, which required hospitalization 03May2021. The clinical course was reported as follows: On 30Apr2021 (the day of vaccination), at 13:30, the patient received BNT162B2 vaccination. On 03May2021 (3 days after vaccination), no change was observed in the physical condition, and the patient had no subjective symptoms. The patient was on the night shift on 01May2021, and she was on holiday on 03May2021. On 03May2021, while the patient was doing her shopping in a shopping mall, she experienced sudden disturbed consciousness, and she was emergently transferred to the medical institution which was different from the reporting medical institution. On 03May2021 at around 10:30 (2 days 10 hours 30 minutes after the vaccination), when the patient arrived in the medical institution, she had cardio-respiratory arrest, and cardiopulmonary resuscitation was performed. However, return of spontaneous circulation was not achieved, and the patient was confirmed to be dead. The diagnoses of subarachnoid haemorrhage and basilar artery aneurysm rupture were made with autopsy imaging (AI) on an unspecified date, and these events were considered as the causes of death. No autopsy was performed based on the patient''s family''s wishes. The patient underwent lab tests and procedures which included body temperature: 36.6 centigrade on 30Apr2021 (before vaccination). Therapeutic measures were taken as a result of cardio-respiratory arrest as aforementioned. The clinical outcome of sudden disturbed consciousness was unknown. The patient died on 03May2021. The causes of death were reported as cardio-respiratory arrest, basilar artery aneurysm rupture, and subarachnoid haemorrhage. An autopsy was not performed. The brain surgeon who confirmed death reported that the event was unrelated to BNT162B2 vaccination. The reporting physician assessed the causality between the events and BNT162B2 as unassessable (since the causality between the event and BNT162b2 was unknown).; Reported Cause(s) of Death: basilar artery aneurysm rupture; subarachnoid haemorrhage; Cardio-respiratory arrest


VAERS ID: 1304788 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   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: Angina pectoris; Cardiac failure
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210501; Test Name: Body temperature; Result Unstructured Data: Test Result:37s Centigrade; Comments: continued
CDC Split Type: JPPFIZER INC2021510219

Write-up: Angina pectoris; Pyrexia of 37s degrees C; This is a spontaneous report from a contactable physician (internist) received from the regulatory authority. Regulatory authority report number is v21104906 via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A patient of 95-year-old female (non-pregnant) received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021) via intramuscularly on 30Apr2021 at 14:15 (at 95-years-old) in the left arm for COVID-19 immunization. The patient had medical history of cardiac failure and angina pectoris. The patient family history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received antihypertensive (not specified) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01May2021 (1 day after the vaccination), pyrexia of 37s degrees C was continued from the next day of the vaccination. On 05May2021 at 02:50 (5 days after the vaccination), chest pain developed, and the patient experienced suspected angina pectoris. On 05May2021 at 04:50 (5 days after the vaccination), cardiac arrest was confirmed. The event angina pectoris resulted in death. The course of the events was as follows: Although the patient had cardiac failure, the patient was doing well with only oral medication. On 05May2021 at 02:50 (5 days after the vaccination), chest pain developed, for which sublingual nitro was administered. However, the symptom did not improve. An autopsy was not performed. Reported cause of death was angina pectoris. Body temperature before vaccination was 36.7 degrees Centigrade. Outcome of pyrexia of 37s degrees C were not reported. The reporting physician classified the event angina pectoris as serious (caused death) and assessed that the causality between the event and BNT162b2 as unassessable. Seriousness classification and causality assessment for pyrexia of 37s degrees C were not reported. Other possible causes of the event such as any other diseases were myocardial infarction and cardiac failure. Follow-up (07May2021): This is a follow-up spontaneous report from a same contactable physician received from the regulatory authority. Regulatory authority report number is v21104906. New information included reporter assessment, clinical information, lab data. The reporting physician commented as follows: She originally had a heart disease, but since she has been suffering from fever since the vaccination, a causal relationship cannot be denied.; Reported Cause(s) of Death: Angina pectoris


VAERS ID: 1304789 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-02
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac disorder, Electrocardiogram
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cellulitis (dorsum of the right hand, improving); Dementia Alzheimer''s type (Hospitalized on 03Dec2020); Syncopal attack; Ventricular fibrillation; Ventricular tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: Body temperature; Result Unstructured Data: Test Result:35.5 Centigrade; Comments: Before vaccination; Test Date: 20201219; Test Name: electrocardiogram; Result Unstructured Data: Test Result:ventricular tachycardia was suspected
CDC Split Type: JPPFIZER INC2021517181

Write-up: Death due to heart disorder; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21105215. A 75-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: ET9096; Expiration Date: 31Jul2021), via an unspecified route of administration on 20Apr2021 at 10:19 at a single dose for covid-19 immunisation. Medical history included dementia Alzheimer''s type (hospitalized on 03Dec2020), ventricular fibrillation, cellulitis (dorsum of the right hand, improving), syncopal attack in Nov2020, and ventricular tachycardia from 19Dec2020 to an unknown date. The patient had no significant family history. The patient''s concomitant medications were not reported. On 02May2021, the patient died due to heart disorder, which was serious for death. The course of the event was as follows: on 26Jan2018, the patient regularly visited the reporter''s hospital as an outpatient for the treatment of Alzheimer''s type dementia. In Nov2020, syncopal attack repeatedly occurred. On 03Dec2020, the patient was admitted to the department of psychiatry of the reporter''s hospital for symptoms (unspecified) due to dementia. On 18Dec2020 and 19Dec2020, the patient developed syncope. On 19Dec2020, based on the results of an electrocardiogram, as ventricular tachycardia was suspected, the patient visited the emergency department of a different hospital as an outpatient where the treatment with ICD (implantable cardioverter defibrillator) was suggested by the physician, but his family did not want him to do and the patient was transferred back to the reporter''s hospital. On 01Apr2021 and 13Apr2021, the patient developed syncope. On 23Apr2021, he was slow to respond to the treatment and developed symptoms (unspecified) accompanied by disturbed consciousness. On 02May2021, the patient''s death was confirmed by the caretakers. The patient underwent lab tests and procedures which included body temperature: 35.5 degrees Centigrade on 20Apr2021 before vaccination. The clinical outcome of the event, death due to heart disorder, was fatal. The patient died on 02May2021 due to heart disorder. It was not reported if an autopsy was performed. The reporting physician considered that he died because of heart disorder. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: it was considered that he died because of cardiac disorder.; Sender''s Comments: Based on the current available information, the event Heart disorder is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of ventricular fibrillation may provide an explanation for the event.; Reported Cause(s) of Death: Heart disorder


VAERS ID: 1304790 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood pressure measurement, Blood test, Body temperature, Cardiac failure acute, Electrocardiogram, Heart rate, Oxygen saturation, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   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: Deep vein thrombosis (on oral treatment with anticoagulant agents); Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: BP; Result Unstructured Data: Test Result:64/46 mmHg; Test Date: 20210426; Test Name: BP; Result Unstructured Data: Test Result:80-90 mmHg; Test Date: 20210424; Test Name: Blood sample; Result Unstructured Data: Test Result:positive to troponin T and CK-MB; Test Date: 20210422; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210423; Test Name: ECG; Result Unstructured Data: Test Result:revealed ST elevation in II, III, and aVF leads; Comments: and T wave abnormalities in anterior wall leads; Test Date: 20210426; Test Name: HR; Result Unstructured Data: Test Result:fluctuated in 100-110 bpm; Test Date: 20210423; Test Name: SpO2; Test Result: 88 %; Test Date: 20210426; Test Name: SpO2; Result Unstructured Data: Test Result:fluctuated in 80-90 %
CDC Split Type: JPPFIZER INC2021517250

Write-up: Acute myocardial infarction; Cardiac failure acute; respiratory failure; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21105121. A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: ET9096; Expiration Date: 31Jul2021), via an unspecified route of administration, on 22Apr2021 at 10:25 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and deep vein thrombosis (on oral treatment with anticoagulant agents). Concomitant medications included unspecified anticoagulant agents. The patient experienced acute myocardial infarction, cardiac failure acute, and respiratory failure on 23Apr2021 at 14:00, which required hospitalization on 23Apr2021 and were reported as fatal. The clinical course was reported as follows: On 22Apr2021 (the day of vaccination), the patient received the vaccination. On 23Apr2021 around 14:00 (1 day after the vaccination), the patient experienced vomiting and subsequently had blood pressure decreased and poor oxygenation (blood pressure (BP): 64/46 mmHg and oxygen saturation (SpO2): 88%). The patient visited the outpatient department of the reporting hospital and was admitted there for respiratory failure. On 24Apr2021, the patient received furosemide (MANUFACTURER UNKNOWN) 10 mg for low urine output; even after this, she did not pass urine. Electrocardiogram (ECG) recorded on admission revealed ST elevation in II, III, and aVF leads and T wave abnormalities in anterior wall leads on 23Apr2021. Later, the blood sample was positive to troponin T and creatine kinase-myocardial band (CK-MB) on 24Apr2021. The patient would receive inpatient unspecified treatment as much as possible for acute coronary syndrome. Continuous infusion of heparin (MANUFACTURER UNKNOWN) 8000 unit (U) and isosorbide dinitrate (NITOROL) was started. Because of no urination and low blood pressure, carperitide (genetical recombination) human atrial natriuretic peptide (HANP) 0.025 gamma was administered. On 26Apr2021, oxygen 15 liters (via reservoir mask) was administered, after which the SpO2 had fluctuated in 80-90%, and heart rate (HR) in 100-110 beats per minute (bpm). Dopamine (MANUFACTURER UNKNOWN) 3.0 mL/hour was administered, and the blood pressure was in 80-90 mmHg; respiratory distress was noted. On 26Apr2021 at 12:15, the patient was confirmed dead. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 26Apr2021 at 12:15. The causes of death were reported as acute myocardial infarction, cardiac failure acute, and respiratory failure. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the events and BNT162B2 as unassessable. There was no other possible cause of the events such as any other diseases.; Reported Cause(s) of Death: Cardiac failure acute; Acute myocardial infarction; respiratory failure


VAERS ID: 1304884 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021496800

Write-up: Sudden death; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00524561. A 69-year-old male patient received the BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on 26Apr2021, at 0.3 mL single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. No previous COVID-19 infection. The patient experienced sudden death on 29Apr2021, no symptoms prior to death. The outcome of the event was fatal. The cause of death was not reported. Autopsy was performed and no results available. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sudden death


VAERS ID: 1304892 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-03-15
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, COVID-19, Death, Drug ineffective, Exposure to SARS-CoV-2, Nausea, Oxygen saturation, SARS-CoV-2 test, Transient ischaemic attack, Vaccination failure
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   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: SOBRIL; OMNIC; ZANIDIP; SELO-ZOK; EXELON [RIVASTIGMINE]; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic ischemic heart disease, unspecified; Hyperplasia of prostate; Living in nursing home; Uncomplicated hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Body temperature; Result Unstructured Data: Test Result:Normal; Comments: Normal (value not specified) on 11Apr2021 14: 30; Test Date: 20210411; Test Name: C-reactive protein; Result Unstructured Data: Test Result:6 mg/l; Comments: 14: 30; Test Date: 20210411; Test Name: Oxygen saturation; Test Result: 96 %; Comments: 14: 30; Test Date: 20210405; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive ; Comments: Result: Positive. B.1.351 lineage. Low Ct value.
CDC Split Type: NOPFIZER INC2021496824

Write-up: NAUSEA; died/Cause of death was unknown; covid19 detected/vaccination failure; covid19 detected/lack of drug effect; covid19 detected/asymptomatic covid-19; exposure to covid-19/Infection exposed; TIA; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uqwd1x. Safety Report Unique Identifier [NO-NOMAADVRE-E2B_00026428]. An 88-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular on 26Jan2021 14:15 (Lot Number: EJ6134) as single dose, dose 1 intramuscular on 05Jan2021 16:15 (Lot Number: EJ6795) as single dose, for covid-19 immunisation. Medical history included Living in nursing home; Chronic ischemic heart disease, unspecified; Hyperplasia of prostate; Uncomplicated hypertension. Concomitant medications included oxazepam (SOBRIL); tamsulosin hydrochloride (OMNIC); lercanidipine hydrochloride (ZANIDIP); metoprolol succinate (SELO-ZOK); rivastigmine (EXELON [RIVASTIGMINE]); apixaban (ELIQUIS). The patient experienced TIA (Transient ischaemic attack) on 15Mar2021, asymptomatic covid-19 on 05Apr2021; exposure to covid-19 from 27Mar2021 - 28Mar2021) (B.1.351 lineage); Infection exposed 27Mar2021-28Mar2021 - possibly also 01Apr2021-02Apr2021. On 05Apr2021, the patient developed vaccination failure, lack of drug effect, COVID-19. Relevant laboratory findings and investigations included in the report: SARS-COV-2 RT-PCR TEST on 05Apr2021, Result: Positive. B.1.351 lineage. Low Ct value). COVID-19 detected as part of infection tracing 05Apr2021 - asymptomatic at the time. Little affected in subsequent days. On 11Apr2021 at 14: 30, the patient developed a little nausea but otherwise in good shape. Relevant laboratory findings and investigations included in the report: C-reactive protein on 11Apr2021 14: 30: 6 mg/l; oxygen saturation on 11Apr2021 14: 30: 96%; body temperature on 11Apr2021 14: 30: Normal (value not specified). On the basis of findings stated above and after conversation with the hospital, the patient started treatment with prednisolone 40 mg. The patient was found dead in bed on 11Apr2021 just before midnight. An autopsy was not performed. The reporter suspected that the patient died with and not because of COVID-19. Cause of death was unknown to the reporter. The patient''s outcome was fatal. The case was considered to be Serious. The outcome of the event died/Cause of death was unknown was fatal, of exposure to covid-19/Infection exposed was recovered on 02Apr2021, of the other events was unknown. Health Authority Comment: Since the vaccine is new, it will be subject to special monitoring to identify any new safety information as soon as possible. It is especially important that serious and/or unusual side effects be reported. Your message is therefore important to expand knowledge about adverse reactions that were not discovered in the studies, and it is an important contribution to international cooperation to maintain safe vaccination worldwide. Causality assessment (Relatedness of drug to reaction(s)/event(s)): Vaccination failure: Source of assessment: Center. Result of Assessment: Possible; Drug ineffective: Source of assessment: Center. Result of Assessment: Possible; COVID-19: Source of assessment: Center. Result of Assessment: No relationship; Nausea: Source of assessment: Center. Result of Assessment: Possible.; Reported Cause(s) of Death: died/Cause of death was unknown


VAERS ID: 1304902 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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 Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:POSITIVE
CDC Split Type: PLPFIZER INC2021505723

Write-up: COVID-19; Drug ineffective; This is a spontaneous report from a contactable nurse forwarded by company representative. The patient (unknown age and gender) completed two doses of BNT162B2 (COMIRNATY) for COVID-19 immunisation, both unknown lot number at single dose, on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced death from COVID despite previous vaccination with two doses of Comirnaty. It was unknown if autopsy was performed or not. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of fatal Covid19 and Drug ineffectively cannot be assessed. The case will be reassessed if additional information becomes available on patient''s medical history, concomitant medications, risk factors if any. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19; Drug ineffective


VAERS ID: 1304903 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021505757

Write-up: shortness of breath; cardiac arrest; fever; This is a spontaneous report from a contactable consumer received by e-mail. A male patient of an unspecified age received BNT162B2 (COMIRNATY, reported as "Pfizer vaccine") via an unspecified route of administration on 12Mar2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient wanted to report an adverse reaction after Pfizer vaccine. On 12Mar2021, the patient (reporter''s grandfather) received a vaccine from the Pfizer company, after two days (14Mar2021) he got a fever that lasted until 01Apr2021. That day (01Apr2021) he was also taken to hospital by an ambulance due to shortness of breath (onset date unknown). On 03Apr2021, he died as a result of cardiac arrest. It was not reported if an autopsy was performed. The patient had no idea how this would be recognized- whether it would be an adverse reaction or it would be added to the statistics because of the effects, but the reporter convinced that it was the vaccine that contributed to the death. The outcome of event fever was recovered on 01Apr2021, the outcome of event "shortness of breath" was unknown, and the outcome of "cardiac arrest" was fatal.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1304905 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Circulatory failure; Dementia (Dementia syndrome); Depressive disorder; Hypertension (hypertensive disease with heart involvement); Ischemic heart disease; Mitral valve insufficiency (Second / third mitral valve insufficience); Tricuspid regurgitation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021491352

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority, Regulatory authority report number PL-URPL-3-594-2021. The reporter is contactable to Health Authority only. An 86-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EW2243; Expiration Date: 31Jul2021), intramuscular, administered in Arm Left on 14Apr2021 16:17 (at the age of 86years) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included treated chronically for hypertensive disease with heart involvement, permanent atrial fibrillation, chronic circulatory failure, ischemic heart disease, mitral valve insufficiency II degree/III degree and tricuspid valve regurgitation, depressive disorder with dementia syndrome; all ongoing. The patient''s concomitant medications were not reported. It was reported that on April 15, 2021 at 15:35, the patient died of cardiac arrest after the resuscitation action of the Emergency Medical Service. The patient died on 15Apr2021. It was unknown if an autopsy was performed. Causality assessment between the (Product Name) COMIRNATY and Reaction/Event: Cardiac arrest was Unlikely. (Source of assessment Regulatory Authority; Method of assessment WHO-UMC; Result of Assessment Unlikely) Sender''s comment: Cardiac arrest is unexpected symptom after vaccination with Comirnaty. Until April 22, 2021, 119 cases of cardiac arrest were reported in the pharmacovigilance database. There is a time relationship between the administration of the vaccine and the occurrence of the side effect. However, taking into account the patient''s medical history (e.g. ischemic heart disease, circulatory failure, hypertension), the Regulatory Authority believes that the cardiac arrest occurred in a temporary coincidence and that the vaccine administration was unlikely. The person reporting post vaccination adverse reaction qualified it as serious. Due to the health result: death, the Regulatory Authority assessed the post vaccination adverse reaction as serious. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1304913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / OT

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: 2021-04-16
   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: SERENAL [OXAZEPAM]; FLUVOXAMINE; IVABRADINE; LISINOPRIL; MEMANTINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021501427

Write-up: The patient died suddenly the next morning, about 21 hours after the vaccine was administered without immediate complications.; This is a spontaneous report from a contactable Physician downloaded from a regulatory authority-WEB PT-INFARMED-J202104-1799. A 76 years old female patient received 1st dose of BNT162B2 (COMIRNATY, lot EW9127) intramuscular on 15Apr2021 12:15 for COVID-19 immunisation at the patient''s usual home, after obtaining her oral consent. Medical history was not provided. Concomitant drugs included oxazepam (SERENAL), Fluvoxamine, Ivabradine, Memantine, Lisinopril. The patient experienced sudden death associated with the use of BNT162B2 on 16Apr2021. The adverse reaction (ADR) occurred about 21 hours after administration of the suspected vaccine. A history of adverse reaction for any drug was unknown. There was no medication error. The outcome of the event was fatal. Result of Assessment: Possible. No follow-up attempts possible. No information expected. ; Reported Cause(s) of Death: Sudden death


VAERS ID: 1304921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Arthralgia, Blood pressure increased, Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Cerebrovascular accident, Chills, Dehydration, Diarrhoea, Dizziness, Heart rate, Insomnia, Lymphadenopathy, Malaise, Myalgia, Nausea, Pyrexia, Swelling, Swelling face, Thirst, Tremor, Ventricular arrhythmia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), 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), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 7
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; Artificial cardiac pacemaker user; Atrial fibrillation; Atrophy; Hemiparesis; Ischemic stroke (Pacemaker and stroke a year and 2 months ago. Left sequelae ischemic stroke recovered); Lacunar infarction; Type 2 diabetes mellitus (insulin-necesitant); Comments: Pacemaker and stroke a year and 2 months ago.
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:11.5/5.7-14.8/7 mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result:17.8/8 mmHg; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Name: pulse; Result Unstructured Data: Test Result:60-65; Test Name: pulse; Result Unstructured Data: Test Result:98
CDC Split Type: ROPFIZER INC2021479601

Write-up: Muscle pain; Severe nausea; Malaise; Swelling of the face and neck; Swelling of the face and neck; Diarrhea; Fever/38 centigrade; Enlarged lymph nodes at the base of the neck; Vomiting; Strong thirst; Strong chills; dehydration; blood pressure increased; Tremor of the chin; Joint pain; Tremor of the fingers; Dizziness; Insomnia; Irreversible cardio-respiratory arrest; Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia; Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia; Recent recurrent stroke with right hemiparesis and mixed aphasia. Permanent pacemaker; This is a spontaneous report from a contactable consumer (patient''s son) and physician downloaded from the regulatory authority, regulatory authority number RO-NMA-2021-SPCOV7038. An 81-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Mar2021 (Lot Number: ET7205) as single dose for COVID-19 immunisation. Medical history included stroke from 2020 to an unknown date (pacemaker and stroke a year and 2 months ago. Left sequelae ischemic stroke), arterial hypertension, atrial fibrillation, hemiparesis, type 2 diabetes mellitus (insulin-necesitant), lacunarism cerebral and cortical atrophy. The patient''s concomitant medications includes unspecified NOACs and oral antidiabetic drugs. The patient previously received 1st dose of bnt162b2 (COMIRNATY, lot: EP2166) on 06Mar2021 for COVID-19 immunization and experienced dizziness, fatigue, headache, and administration site pain. On 28Mar2021, twenty-four hours after vaccination, there was a slight tremor of the fingers, dizziness, insomnia, joint pain. The tremor of the fingers becomes stronger in the next 2-4 days and fever also appears (38 centigrade), very strong joint pain, muscle pain, enlarged lymph nodes at the base of the neck, malaise, strong chills, swelling of the face and neck, very strong tremor of the chin leading to inability to speak, diarrhea, severe nausea and vomiting. Blood pressure was between 11.5/5.7 mm Hg - 14.8/7 mm Hg and pulse was between 60-65 in the first days after booster and in time blood pressure increased to 17.8/8 mm Hg and pulse to 98. There was a strong thirst, but after hydration vomiting followed leading to a strong dehydration. As a treatment, the rapporteur specified that infusions were made in the hospital, but he does not know details. The rapporteur''s comments: On the night of 01 April 2021 at 11:00 p.m., 5 days after the booster, it was necessary to be hospitalized due to numerous side effects. On 02 April 2021, the doctor spoke with my sister and said she was stable and in good condition. On the evening of 03 April 2021, I spoke to my mother on the phone and she told me that she no longer had a fever, nausea and those severe symptoms, being optimistic, but that she still had trembling hands. Unfortunately, on the morning of 04 April 2021 we were informed that she had died. In the reporter''s opinion the events were related to Comirnaty. On 05 April 2021, the medical certificate confirming the death was completed. Actual causes of death: Irreversible cardio-respiratory arrest, Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia and Recent recurrent stroke with right hemiparesis and mixed aphasia. Permanent pacemaker. Other important morbid condition: Chronic atrial fibrillation in treatment with NOACs, type 2 diabetes mellitus insulin-necesitant + oral antidiabetic drugs, arterial hypertension, left sequelae of ischemic stroke, lacunarism cerebral, cortical atrophy, hemiparesis. Following investigation of the case by the regulatory authority the conclusions were: case infirmed regarding a relationship of death with vaccination. Outcome of dehydration and blood pressure increased was unknown, for tremor of the fingers was not recovered; for other non-fatal events was recovered on 03Apr2021. It was unknown if an autopsy was performed. Sender Comment: We don''t know if an autopsy was done. We have no details which of the adverse reactions would have caused the death. We don''t know the diagnosis. The rapporteur was contacted on the reporting email address, but we did not receive any response. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia; Acute myocardial infarction with possible ventricular malignant cardiac arrhythmia; Recent recurrent stroke with right hemiparesis and mixed aphasia. Permanent pacema


VAERS ID: 1304946 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Death
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021506444

Write-up: Death, spontaneous; Some sensations were in the chest; This is a spontaneous report from a contactable consumer reporting on somebody else. A 68-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 22Apr2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma. Concomitant medications included asthma medication. The patient experienced death, spontaneous on 01May2021 and some sensations were in the chest in Apr2021. The outcome of some sensations were in the chest was recovered. The patient died on 01May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death, spontaneous


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